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2019-08-07
VRTX
Moderna up 11% after business update, extension of Vertex partnership
Messenger RNA (mRNA) therapeutics developer Moderna (NASDAQ:MRNA +11%) is up on over 40% higher volume following its Q2 report released this morning that included a pipeline update and an announcement that collaboration partner Vertex Pharmaceuticals (NASDAQ:VRTX -1.4%) has extended their exclusive research partnership aimed at developing mRNA therapies for cystic fibrosis through Q1 2020 with options to extend further depending on progress. Moderna will host its annual R&D Day in New York on September 12.
2019-08-08T00:00:00
2019-08-08T00:00:00
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2019-08-20
VRTX
FDA accepts Vertex application for CF triplet therapy
The FDA accepts for review Vertex Pharmaceuticals' (NASDAQ:VRTX) marketing application for the combination of VX-445 (elexacaftor), tezacaftor and ivacaftor for cystic fibrosis patients with one F508del mutation and one minimal function mutation or two F508del mutations. Under Priority Review status, the agency's action date is March 19, 2020.
2019-08-21T00:00:00
2019-08-21T00:00:00
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2019-08-28
VRTX
Vertex slips 1% on negative Symdeko chatter
Vertex Pharmaceuticals (VRTX -1.1%) is under modest pressure on below-average volume in apparent response to unconfirmed chatter that Symdeko (tezacaftor/ivacaftor and ivacaftor) has been linked to multiple deaths. Shares bottomed at $170.54 (-4%) intraday before recovering. FDA FAERS dashboard Update: FAERS states 30 deaths (search by product name).
2019-08-29T00:00:00
2019-08-29T00:00:00
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2019-08-28
VRTX
Vertex says "no evidence" of Symdeko-related deaths
In a statement to STAT, Vertex Pharmaceuticals (VRTX +0.1%) says it has no evidence linking cystic fibrosis med Symdeko to the reported deaths on the FDA's FAERS dashboard and has received no communication from the agency about the drug's safety. Shares initially sold off ~4% on the news, but have recovered.
2019-08-29T00:00:00
2019-08-29T00:00:00
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2019-09-03
VRTX
Sell-siders like InMode in premarket analyst action
Correvio Pharma (NASDAQ:CORV) initiated with Overweight rating and $6 (193% upside) price target at Cantor Fitzgerald. InMode (NASDAQ:INMD) initiated with Buy rating and $30 (51% upside) price target at Canaccord Genuity. Initiated with Buy rating and $28 price target at UBS. Initiated with Outperform rating and $27 price target at Baird. Initiated with Overweight rating and $27 price target at Barclays. Shares up 4% premarket. MeiraGTx Holdings (NASDAQ:MGTX) initiated with Overweight rating and $40 (98% upside) price target at Piper Jaffray. Sabra Health Care REIT (NASDAQ:SBRA) initiated with Overweight rating and $24 (11% upside) price target at Barclays. Medical Properties Trust (NYSE:MPW) initiated with Overweight rating and $20 (8% upside) price target at Barclays. Sanofi (NASDAQ:SNY) initiated with Outperform rating and $52 (21% upside) price target at Bernstein. Shares up 3% premarket. Vertex Pharmaceuticals (NASDAQ:VRTX) added to Conviction Buy List at Goldman Sachs. Marinus Pharmaceuticals (NASDAQ:MRNS) initiated with Buy rating and $5 (335% upside) price target at H.C. Wainwright. Shares up 3% premarket. Geron (NASDAQ:GERN) initiated with Buy rating and $4 (186% upside) price target at H.C. Wainwright. Shares up 4% premarket. Axonics Modulation Technologies (NASDAQ:AXNX) initiated with Buy rating and $43 (29% upside) price target at Needham.
2019-09-04T00:00:00
2019-09-04T00:00:00
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2019-09-03
VRTX
Vertex to acquire Semma Therapeutics for $950M
Vertex Pharmaceuticals (NASDAQ:VRTX) has agreed to acquire privately held Semma Therapeutics, a developer of stem cell-derived human islets for the potential cure of type 1 diabetes, for $950M in cash. The transaction should close next quarter.
2019-09-04T00:00:00
2019-09-04T00:00:00
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2019-10-16
VRTX
Boehringer Ingelheim launches mid-stage study of new CF treatment
Privately held Boehringer Ingelheim announces the start of enrollment in a Phase 2 clinical trial evaluating different doses of BI 1265162, an epithelial sodium channel inhibitor delivered via the Respimat inhaler, in cystic fibrosis (CF) patients regardless of their mutation status. The primary endpoint of the 98-subject study is the change from baseline in forced expiratory volume in one second (FEV1), a measure of lung function, up to four weeks. The estimated completion date is September 2020. BI 12651621 is designed to keep the airways hydrated and less clogged with mucus via blocking the absorption of sodium. The company says the slow-moving mist delivered by Respimat helps patients inhale the medicine. CF-related tickers: Vertex Pharmaceuticals (VRTX -0.8%), AbbVie (ABBV +0.1%), Proteostasis Therapeutics (PTI +1.2%), Arrowhead Pharmaceuticals (ARWR)
2019-10-17T00:00:00
2019-10-17T00:00:00
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2019-10-16
VRTX
BofA Merrill Lynch sees 25% upside in Vertex in after-hours analyst action
Moleculin Biotech (NASDAQ:MBRX) resumed with Outperform rating and $2 (94% upside) price target at Oppenheimer. Shares up 4% after hours. Vertex Pharmaceuticals (NASDAQ:VRTX) resumed with Buy rating and $220 (25% upside) price target at BofA Merrill Lynch. Regeneron Pharmaceuticals (NASDAQ:REGN) resumed with Neutral rating and $325 (9% upside) price target at BofAML. Merck (NYSE:MRK) resumed with Neutral rating and $90 (7% upside) price target at BofAML. Pfizer (NYSE:PFE) resumed with Neutral rating and $37 (2% upside) price target at BofAML. Eli Lilly (NYSE:LLY) resumed with a Buy rating and $133 (23% upside) price target at BofAML. Gilead Sciences (NASDAQ:GILD) resumed with Neutral rating and $70 (7% upside) price target at BofAML. Bristol-Myers Squibb (NYSE:BMY) resumed with Buy rating and $60 (16% upside) price target at BofAML. BioMarin Pharmaceutical (NASDAQ:BMRN) resumed with Buy rating and $90 (32% upside) price target at BofAML. Shares up 1% after hours. Amgen (NASDAQ:AMGN) resumed with Neutral rating and $215 (6% upside) price target at BofAML. Biogen (NASDAQ:BIIB) resumed with Underperform rating and $200 (12% downside risk) price target at BofAML. Shares down a fraction after hours.
2019-10-17T00:00:00
2019-10-17T00:00:00
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2019-10-18
VRTX
European advisory group backs expanded label for Vertex's Kalydeco
The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending revised labeling for Vertex Pharmaceuticals' (NASDAQ:VRTX) cystic fibrosis (CF) med Kalydeco (ivacaftor). The new labeling, if approved by the European Commission (EC), includes the approval a new 25 mg strength and an extension to the existing indication to include infants at least six months old and weighing from 5 kg to less than 25 kg. A final decision from the EC usually takes ~60 days.
2019-10-19T00:00:00
2019-10-21T00:00:00
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2019-10-21
VRTX
Vertex's Symdeko nabs reimbursement in Australia
Vertex Pharmaceuticals (NASDAQ:VRTX) announces that reimbursement has been established in Australia for cystic fibrosis med Symdeko (tezacaftor/ivacaftor and ivacaftor) for patients at least 12 years old who are homozygous for the F508del mutation or who have one copy of the F505del mutation and another responsive residual function mutation in the CFTR gene. The company says its cystic fibrosis medicines are reimbursed in 17 countries around the world.
2019-10-22T00:00:00
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2019-10-21
VRTX
Vertex Pharma's Trikafta to cost $311K per year
Vertex Pharmaceuticals (NASDAQ:VRTX) has established a wholesale price of $23,896 per 28-day pack of just-approved Trikafta (elexacaftor/tezacaftor and ivacaftor). The cystic fibrosis (CF) med will cost ~$311.5K per year. Considering the earlier-than-expected FDA nod, the company has increased its 2019 CF product revenue guidance to $3.70B - 3.75B from $3.60B - 3.70B. Shares will resume trading at 4:20 pm ET. Update: Shares are up 1% on resumption of trade.
2019-10-22T00:00:00
2019-10-22T00:00:00
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2019-10-21
VRTX
Vertex Pharma +4.1% on Trikafta approval
Vertex Pharmaceuticals (NASDAQ:VRTX) has legged up to a session high today, +4.1%, after receiving FDA approval for its Trikafta therapy for patients with the most common cystic fibrosis mutation. Trikafta (elexacaftor/ivacaftor/tezacaftor) is the first triple combination therapy available for that indication. It's approved for patients 12 and up with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene -- estimated to represent 90% of the cystic fibrosis population. Updated 3:01 p.m.: Vertex was halted at 2:59 p.m. for news pending, up 4.4%. Update: Trading will resume at 4:20 pm ET.
2019-10-22T00:00:00
2019-10-22T00:00:00
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2019-10-21
VRTX
Reimbursement set in Spain for Vertex Pharma CF meds
The Spanish government has OK'd the terms for national reimbursement of Vertex Pharmaceuticals' (VRTX +0.2%) Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor), combined with Kalydeco (ivacaftor), for eligible cystic fibrosis patients, believed to be ~600 people nationwide.
2019-10-22T00:00:00
2019-10-22T00:00:00
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2019-10-24
VRTX
NHS England on board with Vertex CF meds
England's National Health Service (NHS) has agreed to add all currently licensed cystic fibrosis (CF) drugs from Vertex Pharmaceuticals (NASDAQ:VRTX), including future indications, to its formulary for routine access. The company has also established reimbursement in Scotland, Australia and Spain.
2019-10-25T00:00:00
2019-10-25T00:00:00
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2019-10-28
VRTX
CRISPR Therapeutics up 5% on advancement of key programs & collaborations
CRISPR Therapeutics (CRSP +4.7%) is up on modestly higher volume this morning on the heels of its Q3 report that featured progress on multiple programs and a big jump in collaboration revenue driven principally by its partnership with Vertex Pharmaceuticals (VRTX -0.7%) in cystic fibrosis (CF). Revenue: $211.9M (+999%); net income: $138.4M (+373%); EPS: $2.40 (+324%). Enrollment is ongoing in a Phase 1/2 study of allogeneic CAR-T candidate CTX001 in patients with transfusion-dependent beta thalassemia and severe sickle cell disease. Preliminary data should be available in December. Dosing is underway in a Phase 1/2 study of allogeneic CAR-T candidate CX110 in patients with CD19+ malignancies. A Phase 1/2 trial assessing CAR-T candidate CTX120 in multiple myeloma patients should launch in H1 2020. Collaboration partner Vertex Pharmaceuticals has exercised its options to exclusively in-license three additional CF targets using CRISPR-based gene editing. The company will receive $30M upfront, up to $410M in milestones and royalties on net sales. It is negotiating definitive agreements with Bayer (OTCPK:BAYRY -0.2%), expected to close this quarter, related to their joint venture, Casebia Therapeutics, aimed at developing therapies in hemophilia, ophthalmology and autoimmune diseases. CRISPR will manage preclinical development while Bayer will have opt-in rights at IND submission. Rival CRISPR/Cas9 gene editors Intellia Therapeutics (NTLA +3.2%) and Editas Medicine (EDIT +1.7%) are up as well.
2019-10-29T00:00:00
2019-10-29T00:00:00
176
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215
2019-10-29
VRTX
Vertex Pharmaceuticals Q3 2019 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q3 earnings results on Wednesday, October 30th, after market close. The consensus EPS Estimate is $1.17 (+7.3% Y/Y) and the consensus Revenue Estimate is $948.37M (+21.1% Y/Y). Over the last 2 years, vrtx has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time. Over the last 3 months, EPS estimates have seen 18 upward revisions and 2 downward. Revenue estimates have seen 14 upward revisions and 0 downward.
2019-10-30T00:00:00
2019-10-30T00:00:00
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215.070007
2019-10-30
VRTX
Vertex Q3 sales up 21%, guidance affirmed
Vertex Pharmaceuticals (NASDAQ:VRTX) Q3 results: Revenues: $949.8M (+21.1%); product sales: $949.8M (+21.4%). Key product sales: Kalydeco: $249M (+0.8%); Orkambi: $297 (+5.3%); Symdeko/Symkevi: $404M (+58.4%). Net income: $57.5M (-55.3%); non-GAAP net income: $321.5M (+14.0%); EPS: $0.22 (-56.9%); non-GAAP EPS: $1.23 (+12.8%). 2019 guidance: Product sales: $3.70B - 3.75B (unch). Shares down 2% after hours. Previously: Vertex Pharmaceuticals EPS beats by $0.07, beats on revenue (Oct. 30)
2019-10-31T00:00:00
2019-10-31T00:00:00
176.139999
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209.800003
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215.5
2019-10-30
VRTX
Vertex Pharmaceuticals EPS beats by $0.07, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q3 Non-GAAP EPS of $1.23 beats by $0.07; GAAP EPS of $0.22 misses by $0.51. Revenue of $949.8M (+21.1% Y/Y) beats by $1.42M. Press Release
2019-10-31T00:00:00
2019-10-31T00:00:00
176.139999
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209.800003
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215.5
2019-11-04
VRTX
Boston nonprofit playing big role in drug pricing
The Institute for Clinical and Economic Review (ICER), a Boston-based nonpartisan nonprofit with no policy-making role, has emerged as a major influencer on pricing by drugmakers. Examples include Sanofi (SNY +0.6%) and Regeneron Pharmaceuticals' (REGN +0.3%) high cholesterol med Praluent initially priced at $14,600/year, now $4,500 after rebates (heavily influenced by Amgen's (AMGN -0.8%) Repatha, though), Amgen's migraine med Aimovig (erenumab-aooe), $6,900 from $10,000 and Novartis' (NVS +0.6%) SMA gene therapy Zolgensma, $2.1M from estimates as high as $5M. The pricing moderator appears to be ICER's economic model aimed at determining the fair price for medical care based on a concept called QALY or quality-adjusted life-year. It puts a dollar figure on a year of healthy life, calculates how much health a drug restores to a sick patient, then determines the fair price for the value delivered up to a maximum of $150K (based on how much Americans are willing to pay for healthcare and how much healthcare expenditure compares to per-capita income around the world). The QALY concept has been used for over 50 years in various countries but, unsurprisingly, not so much in the U.S. since drug firms have long-opposed such models due to the perception that such pricing systems could lead Medicare to refuse payment for pricey meds. Praluent's net price is consistent with ICER's recommended range for high-risk patients ($4,500 - 8,000) as is Aimovig with its recommended price for migraine sufferers. Countries use a wide range of QALY thresholds, however, from Belgium's ~$190K to Thailand's, a small fraction of Belgium's. ICER's initially focused on pricey procedures, like new radiation therapies, but switched to drugs when Gilead Sciences (GILD +0.7%) launched hepatitis C med Sovaldi in 2013 at $1,000 per pill. Selected tickers: BIB, THW, ARKG, IXJ, BIS, XLV, IDNA, JNJ, PFE, MRK, LLY, BIIB, VRTX, OTCQX:RHHBY, ABBV, NVO, TEVA, TAK, BHC, AZN, GSK, BMY, AGN
2019-11-05T00:00:00
2019-11-05T00:00:00
172.520004
171.5
169.550003
166.740005
169.419998
167.580002
166.710007
170.5
172.419998
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168.729996
170.220001
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173.589996
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176.089996
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201.899994
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207.100006
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209.800003
210
215
215.070007
215.5
218
223.270004
219.050003
2019-11-12
VRTX
SunTrust sees 16% upside in Amgen in premarket analyst action
Alexion Pharmaceuticals (NASDAQ:ALXN) initiated with Buy rating and $125 (15% upside) price target at SunTrust. Amgen (NASDAQ:AMGN) initiated with Buy rating and $256 (16% upside) price target at SunTrust. Arcus Biosciences (NYSE:RCUS) initiated with Buy rating and $20 (162% upside) price target at SunTrust. BioMarin Pharmaceutical (NASDAQ:BMRN) initiated with Buy rating and $110 (46% upside) price target at SunTrust. Biogen (NASDAQ:BIIB) initiated with Buy rating and $337 (15% upside) price target at SunTrust. Shares up 1% premarket. BioXcel Therapeutics (NASDAQ:BTAI) initiated with Buy rating and $24 (500% upside) price target at SunTrust. CONMED (NASDAQ:CNMD) initiated with Overweight rating and $136 (24% upside) price target at JPMorgan. Fate Therapeutics (NASDAQ:FATE) initiated with Buy rating and $25 (72% upside) price target at SunTrust. Shares up 1% premarket. Gilead Sciences (NASDAQ:GILD) initiated with Hold rating and $70 (8% upside) price target at SunTrust. PTC Therapeutics (NASDAQ:PTCT) initiated with Buy rating and $78 (89% upside) price target at SunTrust. Regeneron Pharmaceuticals (NASDAQ:REGN) initiated with Hold rating and $360 (5% upside) price target at SunTrust. Stoke Therapeutics (NASDAQ:STOK) initiated with Buy rating and $46 (54% upside) price target at BTIG Research. Vertex Pharmaceuticals (NASDAQ:VRTX) initiated with Buy rating and $235 (16% upside) price target at SunTrust. Teva Pharmaceutical Industries (NYSE:TEVA) upgraded to Neutral with an $8 (14% downside risk) price target at JPMorgan. AcelRx Pharmaceuticals (NASDAQ:ACRX) downgraded to Neutral with a $2 (12% upside) price target at Credit Suisse. Shares up 3% premarket. Amneal Pharmaceuticals (NYSE:AMRX) downgraded to Underweight at JPMorgan. Shares down 3% premarket. Cellular Biomedicine (NASDAQ:CBMG) downgraded to Neutral with a $19 (6% upside) price target at Baird. Shares up 2% premarket. CytomX Therapeutics (NASDAQ:CTMX) downgraded to Neutral with an $8 (33% upside) price target at Wedbush. Shares down 2% premarket. EyePoint Pharmaceuticals (NASDAQ:EYPT) downgraded to Neutral at H.C. Wainwright.
2019-11-13T00:00:00
2019-11-13T00:00:00
166.710007
170.5
172.419998
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2019-11-18
VRTX
Vertex teams up with Molecular Templates in HSCT conditioning regimens
Vertex Pharmaceuticals (NASDAQ:VRTX) will collaborate with Molecular Templates (NASDAQ:MTEM) to discover and develop novel targeted conditioning regimens aimed at enhancing the process of hematopoietic stem cell transplantation (HSCT), including transplants conducted as part of treatment with gene therapy candidate CTX001, in Phase 1/2 development with CRISPR Therapeutics (NASDAQ:CRSP) for transfusion-dependent beta thalassemia and sickle cell disease. The parties will focus their efforts on discovering a new conditioning regimen leveraging MTEM's engineered toxin body platform, designed to boost the successful engraftment of new cells by selectively targeting and removing specific cells that can interfere with the process. Under the terms of the agreement, VRTX will pay MTEM $38M upfront, including an equity investment, up to $522M in milestones and tiered royalties on net sales on up to two targets. VRTX will have the option to exclusively license the molecules against the designated targets for any indication. MTEM is up 13% premarket on light volume.
2019-11-19T00:00:00
2019-11-19T00:00:00
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223.25
219.369995
220.270004
220
2019-11-19
VRTX
CRISPR Therapeutics down 4% premarket on initial CTX001 data
CRISPR Therapeutics (NASDAQ:CRSP) slips 4% premarket on light volume following its announcement of preliminary data on two patients with severe blood disorders treated with gene therapy CTX001 in Phase 1/2 studies. One patient with transfusion-dependent beta thalassemia who required 16.5 transfusions/year received CTX001 in Q1, followed by neutrophil engraftment (33 days after CTX001 infusion) and platelet engraftment (37 days after CTX001 infusion). At month nine, the patient was transfusion independent with total hemoglobin levels of 11.9 g/dL (normal range for women: 12.0 - 15.5 g/dL, men: 13.5 - 17.5 g/dL), 10.1 g/dL fetal hemoglobin, and 99.8% F-cells (erythrocytes expressing fetal hemoglobin). On the safety front, two serious adverse event occurred: pneumonia in the presence of neutropenia and veno-occlusive liver disease, both subsequently resolved and neither considered CTX001-related. One patient with sickle cell disease (SCD) who experienced seven vaso-occlusive crises (VOCs) per year received CTX001 followed by neutrophil and platelet engraftment 30 days later. At month four, the patient was VOC-free with total hemoglobin levels of 11.3 g/dL, 46.6% fetal hemoglobin and 94.7% F-cells. Three serious adverse events occurred: sepsis in the presence of neutropenia, cholelithiasis (formation of gallstones) and abdominal pain, all subsequently resolved and none considered related to CTX001. The company explains that participants in the trials have progenitor cells collected from peripheral blood. They are edited with CRISPR/Cas9, then reinfused back into the patient as part of a stem cell transplant that includes myeloablative busulfan conditioning (bone marrow is destroyed with chemo and radiation), a very intensive process with side effects, some serious. CRSP will host a conference call this morning at 8:00 to discuss the results. Related ticker: Vertex Pharmaceuticals (NASDAQ:VRTX)
2019-11-20T00:00:00
2019-11-20T00:00:00
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219.369995
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220.550003
2019-12-10
VRTX
EC OKs expanded label for Vertex's Kalydeco
The European Commission (EC) approves the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) in infants with cystic fibrosis (CF) ages six months to less than 12 months weighing at least 5 kg who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. Previously, Kalydeco was approved for patients at least one year old with one of the mutations (in addition to CF patients at least 18 years old with the R117H mutation in the CFTR gene and patients at least 12 years old with the F508del mutation in the CFTR gene).
2019-12-11T00:00:00
2019-12-11T00:00:00
197.889999
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195.479996
200.940002
199.419998
197.139999
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2019-12-12
VRTX
House passes drug pricing bill, Senate unlikely to support
By a 230-192 margin, the U.S. House of Representatives has passed legislation, championed by Speaker Nancy Pelosi, aimed at corralling spiralling drug costs. The bill's key provision would allow the feds to negotiate prices for expensive drugs that lack competition. A minimum of 50 medicines each year would be subject to talks. A last-minute addition was a feasibility study to extend rebates for drug prices that increase faster than inflation to employer-sponsored coverage. The bill has almost no chance to pass in the Republican-controlled Senate, however. Selected tickers: BIB, THW, ARKG, IXJ, BIS, JNJ, XLV, XBI, PFE, MRK, PFE, ABBV, LLY, BIIB, VRTX, OTCQX:RHHBY, NVO, TEVA, NVO, TAK, BHC, NVS, AZN, GSK, BMY, AGN, AMGN, GILD
2019-12-13T00:00:00
2019-12-13T00:00:00
195.479996
200.940002
199.419998
197.139999
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195.830002
201.309998
201.899994
203.860001
207.100006
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209.800003
210
215
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218
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221.75
220.789993
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220
220.550003
218.979996
219.5
217.619995
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217.779999
220.690002
219.979996
220.559998
220.25
220.970001
218.970001
218.949997
219.449997
217.979996
224.029999
223.789993
2019-12-31
VRTX
Drugmakers to hike U.S. prices of over 200 meds
Reuters reports that pharmaceutical companies, including Pfizer (NYSE:PFE), GlaxoSmithKline (NYSE:GSK) and Sanofi (NASDAQ:SNY), are planning to raise prices on more than 200 medicines in the U.S. tomorrow. The price hikes are expected to be relatively modest, almost all below 10% and half between 4 - 6%. Pfizer intends to boost prices on more than 50 drugs, including breast cancer med Ibrance (palbociclib) and arthritis/UC med Xeljanz (tofacitinib). A spokesperson stated that the average increase will be 5.6%. GSK plans to raise prices on more than 30 medicines by 1 - 5%. Sanofi will follow suit on ~10 drugs by 1 - 5%. According to healthcare research shop 3 Axis Advisors, Teva Pharmaceutical Industries (NYSE:TEVA) raised prices on more than 15 drugs by more than 6%. Selected tickers: BIB, THW, ARKG, BME, GRX, IXJ, BIS, CHNA, IDNA, GDNA, KMED, XBI, XLV, BMY, AMGN, BIIB, GILD, VRTX, MRK, LLY, AZN, AGN, JNJ, ABBV, TAK, NVS, OTCQX:RHHBY, NVO
2020-01-01T00:00:00
2020-01-02T00:00:00
210
215
215.070007
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218
223.270004
219.050003
220.059998
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223.25
219.369995
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220.550003
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217.619995
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229.75
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234.610001
233.910004
229.059998
2020-01-29
VRTX
Vertex Pharmaceuticals Q4 2019 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q4 earnings results on Thursday, January 30th, after market close. The consensus EPS Estimate is $1.21 (-6.9% Y/Y) and the consensus Revenue Estimate is $1.01B (+16.2% Y/Y). Over the last 2 years, VRTX has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time. Over the last 3 months, EPS estimates have seen 16 upward revisions and 5 downward. Revenue estimates have seen 11 upward revisions and 5 downward.
2020-01-30T00:00:00
2020-01-30T00:00:00
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2020-01-30
VRTX
Vertex up 3% after hours on Q4 beat, strong Trikafta launch
Vertex Pharmaceuticals (NASDAQ:VRTX) Q4 results: Revenues: $1,413.3M (+62.4%); product sales: $1,413.3M (+62.8%). Key product sales: Kalydeco: $236M (-8.9%); Orkambi: $270 (-14.3%); Symdeko/Symkevi: $332M (+12.9%); Trikafta: $420M. Net income: $583.2M (-61.8%); non-GAAP net income: $444.3M (+31.9%); EPS: $2.23 (-62.6%); non-GAAP EPS: $1.70 (+30.8%). 2020 guidance: Product sales: $5.1B - 5.3B from $3.70B - 3.75B. Shares up 3% after hours.  Vertex Pharmaceuticals EPS beats by $0.48, beats on revenueÂ
2020-01-31T00:00:00
2020-01-31T00:00:00
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2020-01-30
VRTX
Vertex Pharmaceuticals EPS beats by $0.48, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q4 Non-GAAP EPS of $1.70 beats by $0.48; GAAP EPS of $2.23 beats by $1.47. Revenue of $1.26B (+44.9% Y/Y) beats by $250M. Shares +4.2%. Press Release
2020-01-31T00:00:00
2020-01-31T00:00:00
217.619995
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2020-03-09
VRTX
Vertex backs 2020 forecast
Vertex Pharmaceuticals (VRTX -4.3%) says the COVID-19 outbreak has not negatively impacted its supply chain or 2020 outlook, adding that has safety stock to account for potential disruptions and has secured second-source suppliers in a range of geographies. 2020 guidance issued on January 30: Product sales: $5.1B - 5.3B.
2020-03-10T00:00:00
2020-03-10T00:00:00
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2020-03-10
VRTX
Jefferies calls out 11 opportunities amid sell-off
Jefferies Research sees some "particularly compelling opportunities" arising from the recent broad sell-off. Its analysts' top ideas call out higher-quality names, that are generally larger cap, have strong balance sheets, produce strong cash flows and offer differentiation vs. their peers. Jefferies current price targets implies average upside potential of 38%. Highlighted stocks are: Amazon (NASDAQ:AMZN), Activision Blizzard (NASDAQ:ATVI), BlackRock (NYSE:BLK), Home Depot (NYSE:HD), Linde (NYSE:LIN), Mondelez (NASDAQ:MDLZ), Microsoft (NASDAQ:MSFT), Truist Financial (NYSE:TFC), Texas Instruments (NASDAQ:TXN), Vulcan Materials (NYSE:VMC), and Vertex Pharmaceuticals (NASDAQ:VRTX). Some comments on the picks: For Linde, "once the market stabilizes, investors will begin to emphasize earnings visibility amid uncertainty, which should support multiple expansion," writes analyst Laurence Alexander. Analyst Rob Dickerson likes Mondelez for "its long-term growth potential, strong balance sheet and its coffee JV interests, which provide MDLZ with strategic optionality, capital-sourcing, and value-creation upside." For BlackRock, "Capital returns should remain strong with at least $1.2B of buybacks in 2020 and current dividend yield of approx. 3.3%," says analyst Dan Fannon. Analyst Alex Giaimo sees two straight years of double-digit EPS growth for Activision and 22% stock upside driven by a combination of numbers moving higher and multiple expansion.
2020-03-11T00:00:00
2020-03-11T00:00:00
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2020-03-13
VRTX
Key events next week - healthcare
Assuming no COVID-19 cancellations, here is a list of noteworthy events during the week of March 15 - 21 for healthcare investors: MONDAY (3/16): IPO lockups expire for Envista Holdings (NYSE:NVST) and IGM Biosciences (NASDAQ:IGMS). TUESDAY (3/17): American Burn Association Annual Meeting, Orlando (4 days). FDA action date for Eton Pharmaceuticals' (NASDAQ:ETON) ET-105 (unlikely to be met due to a request from the agency changes to the Dosage and Administration section of the proposed Prescribing Information and a human factors study with the revised labeling). IPO lockup expires for Exagen (NASDAQ:XGN). THURSDAY (3/19): FDA action date for Vertex Pharmaceuticals' (NASDAQ:VRTX) elexacaftor/tezacaftor/ivacaftor for cystic fibrosis. FRIDAY (3/20): American Academy of Dermatology Annual Meeting, Denver (5 days). Arcutis Biotherapeutics (NASDAQ:ARQT): ARQ-151 in plaque psoriasis. Brickell Biotech (NASDAQ:BBI): Phase 3 data on sofpironium bromide for primary axillary hyperhidrosis present by development partner Kaken Pharmaceutical Co. Muscular Dystrophy Association Clinical & Scientific Conference, Orlando (5 days).
2020-03-14T00:00:00
2020-03-16T00:00:00
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2020-03-13
VRTX
Healthcare stocks set for rally today
A wide range of healthcare stocks are up premarket as the broad market is poised to jump out of the gate this morning after the recent selloff. Selected tickers: AbbVie (NYSE:ABBV) (+5%), Pfizer (NYSE:PFE) (+6%), Merck (NYSE:MRK) (+2%), Bristol-Myers Squibb (NYSE:BMY) (+4%), Eli Lilly (NYSE:LLY) (+4%), Novartis (NYSE:NVS) (+8%), GlaxoSmithKline (NYSE:GSK) (+2%), AstraZeneca (NYSE:AZN) (+4%), Biogen (NASDAQ:BIIB) (+3%), Amgen (NASDAQ:AMGN) (+4%), Vertex Pharmaceuticals (NASDAQ:VRTX) (+4%), SPDR S&P Biotech ETF (NYSEARCA:XBI) (+5%), Healthcare Select Sector SPDR Fund (NYSEARCA:XLV) (+4%)
2020-03-14T00:00:00
2020-03-16T00:00:00
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2020-03-27
VRTX
Vertex Pharma says supply chain OK
Vertex Pharmaceuticals (NASDAQ:VRTX) confirms that its supply chain and product supply have not been interrupted due to the coronavirus pandemic and it is confident in its operations going forward. Reiterating its statement on March 9, its 2020 outlook remains as is. Shares up a fraction premarket.
2020-03-28T00:00:00
2020-03-30T00:00:00
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2020-04-07
VRTX
Bristol-Myers Squibb to provide medicines to the unemployed and uninsured
New COVID-19 initiatives/developments from healthcare companies include Bristol-Myers Squibb's (NYSE:BMY) expansion of its existing patient support program aimed at helping unemployed U.S. patients who have lost their health insurance coverage due to the pandemic. The company is offering its branded medicines at no charge, including those prescribed via telehealth services. Shares up 2% premarket. Karyopharm Therapeutics (NASDAQ:KPTI) plans to launch a global clinical trial evaluating low-dose Xpovio (selinexor) in severely ill hospitalized COVID-19 patients. Teva Pharmaceutical Industries (NYSE:TEVA) Canadian unit and Huddol are offering free virtual personal assistance services to families for 30 days via Huddol.com during the pandemic supported by funding from Teva. Afterward, services will be available at a discount. Shares up 3% premarket. Infinity Pharmaceuticals (NASDAQ:INFI) expects enrollment to be delayed in its clinical trials as well as new site activations. Supply chain unaffected thus far. Walgreens (NASDAQ:WBA) is working to expand drive-through COVID-19 testing to 15 locations in seven states (AZ, FL, IL, KY, LA, TN and TX). The sites will use Abbott's (NYSE:ABT) ID NOW rapid test. WBA and ABT both up 1% premarket. Tauriga Sciences (OTCPK:TAUG) will collaborate with Aegea Biotechnologies to develop a rapid PCR test for SARS-CoV-2. IQVIA (NYSE:IQV) launches a registry, IQVIA CARE Project, aimed at advancing understanding of the disease. Vertex Pharmaceuticals' (NASDAQ:VRTX) non-profit charitable foundation to donate $5M to support global relief efforts.
2020-04-08T00:00:00
2020-04-08T00:00:00
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2020-04-13
VRTX
Barron's doubles down on 12 YTD winners
Barron's is out with a simple stock screen today that is pretty simple, but also fairly intriguing. The publication ran a screen for S&P 500 companies who have outperformed the index by at least 13 percentage points this year (positive return YTD) and that Wall Street analysts expect to continue growing their earnings in 2020 and over the next five years. The dozen that were churned up by the screen are Akamai Technologies (AKAM -2.1%), Arista Networks (ANET -3.8%), Cabot Oil & Gas (COG -0.2%), Citrix Systems (CTXS -0.0%),  Dollar General (DG +0.6%),  Gilead Sciences (GILD +1.4%),  Nasdaq (NDAQ -4.6%),  Newmont (NEM +4.8%), Old Dominion Freight Line (ODFL -3.9%), Steris (STE -3.1%), Vertex Pharmaceuticals (VRTX +0.9%) and Walmart (WMT +1.8%).
2020-04-14T00:00:00
2020-04-14T00:00:00
232.289993
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2020-04-21
VRTX
Reimbursement set in Switzerland for Vertex CF meds
The Swiss Federal Social Insurance Office has agreed to reimburse Vertex Pharmaceuticals' (NASDAQ:VRTX) Orkambi (lumacaftor/ivacaftor) and Symdeko  (tezacaftor/ivacaftor and ivacaftor) for eligible patients in Switzerland living with cystic fibrosis (CF). The agreement with the government payer also provides for possible rapid patient access to a triple combo regimen (elexacaftor/tezacaftor/ivacaftor and ivacaftor) that is currently under regulatory review there (application filed on March 24).
2020-04-22T00:00:00
2020-04-22T00:00:00
230.509995
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2020-04-23
VRTX
BioSig up 10% on encouraging data on COVID-19 antiviral
BioSig Technologies (BSGM +10%) is up out the gate on the heels of results from laboratory studies comparing the antiviral activity of subsidiary ViralClear's merimepodib to Gilead Sciences' (GILD +2.2%) remdesivir. Cell cultures were pretreated with two concentrations of either merimepodib or remdesivir for four hours before SARS-CoV-2 virus was added. At hour 16, both concentrations of the former and the higher concentration of the latter significantly reduced viral production. At hour 24, both concentrations of both drugs significantly reduced viral production. Additional studies are underway. ViralClear intends to launch clinical trials in COVID-19 next quarter (assuming FDA sign-off). Merimepodib is a broad-spectrum antiviral that Vertex Pharmaceuticals (VRTX +1.5%) was originally developing for hepatitis C and psoriasis.
2020-04-24T00:00:00
2020-04-24T00:00:00
204.059998
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2020-04-27
VRTX
Vertex teams up with Affinia in gene therapies
Vertex Pharmaceuticals (NASDAQ:VRTX) will collaborate with Affinia Therapeutics to engineer novel adeno-associated virus capsids to deliver gene therapies (a capsid is the protein shell of a virus that encloses the genetic material). The partnership will leverage Affinia's proprietary AAVSmartLibrary and associated technology with Vertex's scientific, clinical and regulatory know-how to develop gene therapies for Duchenne muscular dystrophy, myotonic dystrophy type 1 and cystic fibrosis. Under the terms of the deal, Affinia will be eligible to receive over $1.6B in payments and milestones, including $80M in upfront and research milestone fees, and tiered royalties on net sales. Affinia will be responsible for capsid discovery while Vertex will be responsible for the design, development, manufacture and commercialization of the gene therapies. Shares up 2% premarket on light volume.
2020-04-28T00:00:00
2020-04-28T00:00:00
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2020-04-28
VRTX
Wells softens view on Edwards Lifesciences in premarket analyst action
Adverum Biotechnologies (NASDAQ:ADVM) initiated with Buy rating and $17 (36% upside) price target at Goldman Sachs. Alector (NASDAQ:ALEC) initiated with Buy rating and $32 (21% upside) price target at Goldman. Alexion Pharmaceuticals (NASDAQ:ALXN) initiated with Neutral rating and $121 (9% upside) price target at Cantor Fitzgerald. Columbia Care (CCHW CN) initiated with Buy rating and C$4 (63% upside) price target at Ladenburg Thalmann. Dare Biosciences (NASDAQ:DARE) initiated with Buy rating and $7.50 (614% upside) price target at Brookline Capital. Shares up 23% premarket. Global Blood Therapeutics (NASDAQ:GBT) initiated with Buy rating and $112 (44% upside) price target at Stifel. Shares up 1% premarket. Karuna Therapeutics (NASDAQ:KRTX) initiated with Outperform rating and $125 (46% upside) price target at Oppenheimer. Zai Lab Limited (NASDAQ:ZLAB) initiated with Buy rating and $77 (19% upside) price target at Goldman. Zentalis Pharmaceuticals (NASDAQ:ZNTL) initiated with Buy rating and $45 (42% upside) price target at Guggenheim. Other initiations: Buy/$41 at Jefferies, Outperform at SVB Leerink and Overweight at Morgan Stanley. Inspire Medical Systems (NYSE:INSP) upgraded to Buy with a $90 (21% upside) price target at Bank of America. Quest Diagnostics (NYSE:DGX) upgraded to Overweight at Morgan Stanley. This morning the company announced that people can order a COVID-19 blood test online without visiting a doctor's office. Apollo Endosurgery (NASDAQ:APEN) downgraded to Neutral with a $2 (5% downside risk) price target at Piper Sandler. BioNTech (NASDAQ:BNTX) downgraded to Neutral with a $51 (3% upside) price target at Bank of America. Shares down 2% premarket. Edwards Lifesciences (NYSE:EW) downgraded to Equal Weight with a $230 (5% upside) price target at Wells Fargo. Shares up 1% premarket. Intuitive Surgical (NASDAQ:ISRG) downgraded to Neutral with a $510 (1% downside risk) price target at Piper Sandler. Johnson & Johnson (NYSE:JNJ) downgraded to Neutral with a $160 (4% upside) price target at UBS. Vertex Pharmaceuticals (NASDAQ:VRTX) downgraded to Sector Perform with a $260 (3% downside risk) price target at RBC. ViewRay (NASDAQ:VRAY) downgraded to Neutral at Guggenheim. Shares up 3% premarket. Zimmer Biomet Holdings (NYSE:ZBH) downgraded to Neutral at Guggenheim.
2020-04-29T00:00:00
2020-04-29T00:00:00
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2020-04-28
VRTX
Vertex Pharmaceuticals Q1 2020 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q1 earnings results on Wednesday, April 29th, after market close. The consensus EPS Estimate is $1.84 (+61.4% Y/Y) and the consensus Revenue Estimate is $1.28B (+49.1% Y/Y). Over the last 2 years, VRTX has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time. Over the last 3 months, EPS estimates have seen 13 upward revisions and 1 downward. Revenue estimates have seen 12 upward revisions and 0 downward.
2020-04-29T00:00:00
2020-04-29T00:00:00
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2020-04-30
VRTX
Sell-siders impressed with Vertex's strong Q1; shares up 4% premarket
Vertex Pharmaceuticals (NASDAQ:VRTX) is up 4% premarket on light volume on the heels of its Q1 report released after the close yesterday. Sales were up a robust 77% led by the continued strong ramp of new drug Trikafta which posted $895M in sales, up 113% from last quarter. Jefferies Michael Yee boosted his fair value target to $295 (from $275) citing the company's "impressive" pace amid the pandemic and its "strong" longer-term EPS upside and key pipeline data in H2 that "could break the stock out to a new level." Baird's Brian Skorney raised his price target to $245 (from $230) citing the strong ramp of Trikafta which management indicated has already penetrated the majority of eligible U.S. patients. He says peak cystic fibrosis sales are "more or less priced in" and looks for pipeline data for further upside. BMO's Do Kim also boosted his price target ($283 from $279) citing the acceleration of ex-U.S. growth.
2020-05-01T00:00:00
2020-05-01T00:00:00
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2020-04-29
VRTX
Vertex Q1 sales up 77% on strong Trikafta ramp; shares up 3% after hours
Vertex Pharmaceuticals (NASDAQ:VRTX) Q1 results: Product sales: $1,515.1M (+76.7%). Top sellers: Trikafta: $895M; Symdeko/Symkevi: $173M (-45.9%); Orkambi: $234M (-20.1%); Kalydeco: $213M (-12.7%). Net income: $602.8M (+124.4%); non-GAAP net income: $674.5M (+128.0%); EPS: $2.29 (+122.3%); non-GAAP EPS: $2.56 (+124.6%). 2020 guidance: Product sales: $5.3B - 5.6B from $5.1B - 5.3B. Shares up 3% after hours. Vertex Pharmaceuticals EPS beats by $0.72, beats on revenue
2020-04-30T00:00:00
2020-04-30T00:00:00
212.979996
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231.919998
237.949997
225.479996
242.160004
238.309998
255.300003
247.669998
249.660004
246.610001
252.279999
262.410004
255.229996
264.76001
270.459991
273.26001
262.799988
269.369995
267.910004
269.859985
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256.959991
251.050003
251.199997
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264.690002
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271.630005
285.279999
276.470001
277.029999
277
288.690002
284.130005
282.279999
284.619995
284.630005
2020-04-29
VRTX
Vertex Pharmaceuticals EPS beats by $0.72, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q1 Non-GAAP EPS of $2.56 beats by $0.72; GAAP EPS of $2.29 beats by $0.69. Revenue of $1.52B (+77.1% Y/Y) beats by $240M. Press Release
2020-04-30T00:00:00
2020-04-30T00:00:00
212.979996
215.690002
206
202.210007
223.130005
210.089996
224.490005
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247.669998
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271.630005
285.279999
276.470001
277.029999
277
288.690002
284.130005
282.279999
284.619995
284.630005
2020-05-01
VRTX
Vertex gets CHMP positive opinion for CF treatment
Vertex Pharmaceuticals (NASDAQ:VRTX) announces that the European Medicines Agency’s [EMA] Committee for Medicinal Products for Human Use [CHMP] adopted a positive opinion for the label extension of KALYDECO® (ivacaftor), to include the treatment of children and adolescents with cystic fibrosis [CF], ages 6 months and older. The European Commission will now review the CHMP’s positive opinion, and should they issue a favorable adoption, KALYDECO® (ivacaftor) will be the first and only approved medicine in Europe to treat the underlying cause of CF in patients ages 6 months and older with the R117H mutation. Source: press release
2020-05-02T00:00:00
2020-05-04T00:00:00
206
202.210007
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210.089996
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255.300003
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251.050003
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254.899994
264.690002
272.329987
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285.279999
276.470001
277.029999
277
288.690002
284.130005
282.279999
284.619995
284.630005
284.959991
266.5
2020-05-08
VRTX
Time to buy these biopharma names is now, BofA says
"Now is the time we'd get more aggressive in biopharma," BofA says in a new note suggesting a stance shift from defensive to offensive. The biopharma space has outperformed the wider market year-to-date, and 100% of big biotechs and major pharmas logged top- and bottom-line beats for Q1. Nonetheless, it's still up from here, the firm says, noting the industry's COVID-19 drug pipeline is bearing fruit (well controlled trials under way in various areas, and remdesivir (NASDAQ:GILD) already addressing severe/critical patients) and quarantines starting a winding down process in areas worldwide. More specifically, BofA points to expectations for robust second-half growth (6%) at reasonable below-market P/Es; a number of value-creating events in the second half that aren't yet the focus; and goodwill for the industry from the pandemic that lowers policy risk and establishes a positive FDA backdrop. While it's staying bullish on Vertex Pharma (NASDAQ:VRTX) and Eli Lilly (NYSE:LLY), their "differentiated growth profile is mostly appreciated," BofA says. "We would look to names that have an emerging product cycle story as a significant upside driver": That includes Bristol-Myers Squibb (NYSE:BMY), which has six launches coming roughly over the next 12 months; BioMarin (NASDAQ:BMRN), with valrox and vosoritide launches ahead; and Amgen (NASDAQ:AMGN), with AMG 510 and tezepelumab set for launch in 2021. It's got Buy ratings for those three, and raised target prices: A target of $80 on BMY implies 31% upside; $120 on BMRN (26% upside); and $275 on AMGN (18% upside). But it's also raising targets on a pair of companies it's Neutral on: Pfizer (NYSE:PFE) to $42 from $40 (13% upside) and Seattle Genetics (NASDAQ:SGEN) to $170 from $145 (7.4% upside). And though it has an Underperform rating on Biogen (NASDAQ:BIIB), it's boosting that target to $255 from $245 (cutting implied downside to 18.5%).
2020-05-09T00:00:00
2020-05-11T00:00:00
217.240005
231.919998
237.949997
225.479996
242.160004
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255.300003
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278.51001
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286.640015
284.269989
2020-06-10
VRTX
Expanded use of Vertex's Kalydeco OK'd in Europe
The European Commission approves the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) in children with cystic fibrosis as young as six months old and weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The product was previously approved for CF sufferers ages 18 and older with the R117H mutation, and in infants ages six months and older weighing at least 5 kg who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
2020-06-11T00:00:00
2020-06-11T00:00:00
251.050003
251.199997
254.899994
264.690002
272.329987
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285.279999
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266.5
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286.140015
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290.309998
286.279999
291.100006
2020-06-12
VRTX
CRISPR/Cas9 candidates show encouraging action in blood disorders
CRISPR Therapeutics (NASDAQ:CRSP) and collaboration partner Vertex Pharmaceuticals (NASDAQ:VRTX) announce new interim data from two clinical trials evaluating CRISPR/Cas9 gene-editing therapy in patients with transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD). The results were virtually presented at the European Hematology Association (EHA) Congress. Phase 1/2 CLIMB-111 study evaluating CTX001 in TDT: Patient #1, with the β0/IVS-I-110 genotype, required 34 units of packed red blood cells each year before enrollment. The patient achieved neutrophil engraftment 33 days after CTX001 infusion and achieved platelet engraftment in 37 days. The patient was transfusion-independent at month 15 post-treatment. Patient #2, with the β0/IVS-II-745 genotype, required 61 units of packed red blood cells each year. After infusion with CTX001, neutrophil and platelet engraftment occurred in 36 days and 34 days, respectively. The patient remained transfusion-independent five months post-treatment. Phase 1/2 CLIMB-121 study evaluating CTX001 in SCD: Patient #1 experienced seven vasco-occlusive crises (VOCs) and five transfusions of packed red blood cells each of the prior two years before enrollment. Full neutrophil and platelet engraftment achieved in 30 days post-infusion. At month 9, the patient was VOC-free and transfusion-independent. Both studies are ongoing. Dosing being re-initiated at certain sites where the studies were temporarily paused due to COVID-19.
2020-06-13T00:00:00
2020-06-15T00:00:00
254.899994
264.690002
272.329987
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288.690002
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290.309998
286.279999
291.100006
291.309998
299.059998
2020-06-26
VRTX
European advisory group backs Vertex's Kaftrio for cystic fibrosis
The European Medicines Agency's advisory group, CHMP, has adopted a positive opinion recommending approval of Vertex Pharmaceuticals' (NASDAQ:VRTX) Kaftrio (elexacaftor/tezacaftor/ivacaftor) for the treatment of cystic fibrosis patients at least 12 years old who are homozygous for the F508del mutation or heterozygous for the F508del in the CFTR gene with a minimal function mutation. A final decision from the European Commission usually takes ~60 days.
2020-06-27T00:00:00
2020-06-29T00:00:00
288.690002
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294.529999
303.100006
291.399994
2020-06-30
VRTX
England's NHS on board with Vertex's Kaftrio
Vertex Pharmaceuticals (NASDAQ:VRTX +0.2%) announces that England's National Health Service (NHS) will reimburse Kaftrio (ivacaftor/tezacaftor/elexacaftor), combined with Kalydeco (ivacaftor), when approved by the European Commission, expected within the next 60 days (the advisory group CHMP issued a positive opinion last week). NHS is currently paying for Kalydeco, Orkambi (lumacaftor/ivacaftor) and SYMKEVI (tezacaftor/ivacaftor).Â
2020-07-01T00:00:00
2020-07-01T00:00:00
282.279999
284.619995
284.630005
284.959991
266.5
278.51001
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287.959991
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272.820007
265.690002
265.01001
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268.559998
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280.089996
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285.179993
290.309998
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293.829987
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290.559998
294.529999
303.100006
291.399994
291.230011
284.459991
2020-07-29
VRTX
Vertex Pharmaceuticals Q2 2020 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q2 earnings results on Thursday, July 30th, after market close. The consensus EPS Estimate is $2.08 (+65.1% Y/Y) and the consensus Revenue Estimate is $1.39B (+47.7% Y/Y). Analyst expects R&D expense of $401.2M vs. $379.1M in 2Q 2019. Over the last 2 years, VRTX has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time. Over the last 3 months, EPS estimates have seen 14 upward revisions and 6 downward. Revenue estimates have seen 15 upward revisions and 4 downward. Recent earnings Analysis from our contributors:Earnings For Vertex Pharmaceuticals Expected To Jump 64%
2020-07-30T00:00:00
2020-07-30T00:00:00
280.089996
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2020-07-30
VRTX
Vertex posts strong Q2 on robust Trikafta sales
Vertex Pharmaceuticals (NASDAQ:VRTX) Q2 results: Total product sales: $1,524M (+62.1%); Trikafta: $918M; Orakambi: $232M (-26.6%); Kalydeco: $203M (-22.5%); Symdeko/Symkevi: $172M (-52.5%). Net income: $837M (+213.5%); non-GAAP net income: $687M (+110.1%); EPS: $3.18 (+208.7%); non-GAAP EPS: $2.61 (+107.1%). 2020 guidance: Product sales: $5.7B - 5.9B from $5.3B - 5.6B. Vertex Pharmaceuticals EPS beats by $0.53, beats on revenue
2020-07-31T00:00:00
2020-07-31T00:00:00
279.190002
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2020-07-30
VRTX
Vertex Pharmaceuticals EPS beats by $0.53, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q2 Non-GAAP EPS of $2.61 beats by $0.53; GAAP EPS of $3.18 beats by $1.52. Revenue of $1.52B (+61.5% Y/Y) beats by $130M. Shares +1.3%. Press Release
2020-07-31T00:00:00
2020-07-31T00:00:00
279.190002
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2020-08-21
VRTX
Vertex Pharma cystic fibrosis med Kaftrio OK'd in Europe
As expected, the European Commission approves Vertex Pharmaceuticals' (NASDAQ:VRTX) Kaftrio (ivacaftor/tezacaftor/elexacaftor), a combination regimen with ivacaftor, for the treatment of cystic fibrosis patients at least 12 years old with one F508del mutation and one minimal function mutation or two F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In late June, the advisory group CHMP adopted a positive opinion backing approval.
2020-08-22T00:00:00
2020-08-24T00:00:00
284.820007
293.829987
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267.420013
266.5
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266.850006
2020-08-26
VRTX
Dyne Therapeutics on deck for IPO
Dyne Therapeutics (DYN) has filed a preliminary prospectus for a $100M IPO. The Waltham, MA-based biotech develops therapies for genetically driven disorders using its FORCE platform to overcome the limitations of muscle tissue delivery and advance oligonucleotide therapeutics for muscle diseases. Top pipeline programs are myotonic dystrophy, Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy. 2020 Financials (6 mo.): Operating Expenses: $16.5M (+251%); Net Loss: ($16.9M) (-369%); Cash Burn: ($14.6M) (-204%). Potential competitors: Sarepta Therapeutics (NASDAQ:SRPT), NS Pharma (OTC:NPNKF), Pfizer (NYSE:PFE), Capricor Therapeutics (NASDAQ:CAPR), Catabasis Pharmaceuticals (NASDAQ:CATB), Solid Biosciences (NASDAQ:SLDB), PTC Therapeutics (NASDAQ:PTCT), Avidity Biosciences (NASDAQ:RNA), Vertex Pharmaceuticals (NASDAQ:VRTX), Fulcrum Therapeutics (NASDAQ:FULC)
2020-08-27T00:00:00
2020-08-27T00:00:00
290.559998
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303.100006
291.399994
291.230011
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272
279.519989
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2020-09-01
VRTX
FDA accepts three supplemental applications from Vertex for expanded use of CF meds
The FDA has accepted for review three supplemental marketing applications from Vertex Pharmaceuticals (NASDAQ:VRTX) seeking expanded labels for cystic fibrosis (CF) meds  TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO (tezacaftor/ivacaftor and ivacaftor) and KALYDECO (ivacaftor) to include additional rare CFTR mutations. The filings may also allow certain CF patients who are currently eligible for KALYDECO to become eligible for SYMDEKO or TRIKAFTA and certain people currently eligible for SYMDEKO may become eligible for TRIKAFTA. The agency's action date is December 30. Shares down 1% premarket on light volume.
2020-09-02T00:00:00
2020-09-02T00:00:00
291.230011
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2020-09-02
VRTX
J&J bails on flu candidate pimodivir
Johnson & Johnson (NYSE:JNJ) unit The Janssen Pharmaceutical Companies announces that it will terminate development of antiviral pimodivir for hospitalized influenza A patients. Its decision was prompted by preliminary data from a Phase 3 clinical trial that showed pimodivir, combined with standard-of-care treatment, was unlikely to show an incremental benefit. The study and a parallel Phase 3 in outpatients with influenza A will be stopped. Janssen in-licensed exclusive rights to the drug for influenza A from Vertex Pharmaceuticals (NASDAQ:VRTX) in 2014.
2020-09-03T00:00:00
2020-09-03T00:00:00
284.459991
278.48999
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267.579987
263.820007
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268.179993
2020-09-03
VRTX
Vertex Pharmaceuticals reports 7.1% stake in Kymera Therapeutics
Vertex Pharmaceuticals (NASDAQ:VRTX) acquires ~3.15M shares of Kymera Therapeutics (NASDAQ:KYMR), representing 7.1% of its total shares outstanding. Shares were acquired pursuant to Vertex’s collaboration with Kymera and in a private placement that was closed concurrently with the closing of Kymera’s IPO on August 25, 2020. Vertex had paid an initial consideration of $70M, including $50M upfront payment and $20M worth equity investment. Press Release Previously: Kymera Therapeutics prices upsized IPO beyond range at $20 (Aug. 21)
2020-09-04T00:00:00
2020-09-04T00:00:00
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2020-09-10
VRTX
Vertex to file U.S. application for expanded use of Trikafta next quarter
Based on positive results from an open-label Phase 3 study, Vertex Pharmaceuticals (NASDAQ:VRTX) expects to file a U.S. supplemental marketing application next quarter seeking approval of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children ages 6 through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation. The FDA approved the triple combo regimen in October 2019 for CF patients at least 12 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Global regulatory filings will follow. Shares down a fraction premarket. SA Authors are Bullish.Â
2020-09-11T00:00:00
2020-09-11T00:00:00
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2020-09-14
VRTX
EC validates Vertex's marketing application for expanded use of Kaftiro + Ivacaftor
The European Medicines Agency (EMA) has validated Vertex Pharmaceuticals' (NASDAQ:VRTX) Type II Variation Marketing Authorization Application for the expanded indication of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat Cystic Fibrosis (CF) in patients ages 12 years and older with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. The application will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission (EC) regarding the potential approval for these patients. Vertex is a compelling investment case for medium-term players to capture fantastic returns over the next multiple periods on a background of strong fundamentals, writes Zach Bristow in his article "Vertex Pharmaceuticals: 67% YoY Returns With 4% Downside Risk - Calling All Medium-Term Players," at Seeking Alpha. Image Source: Seeking Alpha VXRT has grown around 17% over the past six months.
2020-09-15T00:00:00
2020-09-15T00:00:00
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2020-09-16
VRTX
Moderna expands cystic fibrosis partnership with Vertex Pharma
Moderna (NASDAQ:MRNA) inks a research collaboration and licensing agreement with Vertex Pharmaceuticals (NASDAQ:VRTX) aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for cystic fibrosis (CF). The initial focus of the three-year partnership will be on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs where cystic fibrosis transmembrane conductance regulator (CFTR) protein can be produced. Under the terms of the agreement, Moderna will conduct research to discover and optimize novel LNPs for the delivery of gene-editing therapies to lung cells for the treatment of CF. It will also be responsible for the discovery and manufacturing of LNPs and mRNA constructs encoding gene-editing endonucleases. Vertex will be responsible for providing other components of the gene-editing therapies to be formulated into LNPs, as well as subsequent preclinical and clinical development and potential commercialization efforts. Moderna will receive $75M upfront, up to $380M in milestones and tiered royalties on net sales. This agreement builds on the companies' first partnership deal, inked in July 2016, aimed at the discovery and development of mRNAs for CF. MRNA up 3% after-hours.
2020-09-17T00:00:00
2020-09-17T00:00:00
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2020-09-18
VRTX
European advisory group backs expanded use of Vertex's Kalydeco
The European Medicines Agency's advisory group CHMP has adopted a positive opinion backing the use of Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) in children as young as four months old (previously six months old) with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.  It also backs its use in combination with tezacaftor (Symkevi) in children as young as six years old (previously 12 years old) with CF who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T. A final decision from the European Commission usually takes ~60 days.
2020-09-19T00:00:00
2020-09-21T00:00:00
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2020-09-22
VRTX
CRISPR/Vertex gene therapy nabs accelerated review in Europe for sickle cell
The European Medicines Agency has granted Priority Medicines (PRIME) designation to CTX001, an autologous, ex vivo CRISPR/Cas9 gene-edited therapy for the treatment of severe sickle cell disease (SCD). CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics (CRSP -1.2%) and Vertex (VRTX -0.5%). PRIME status provides for enhanced development support and accelerated review of the marketing application from the European Medicines agency. The drug candidate is in two Phase 1/2 trials designed to assess the safety and efficacy of a single dose of CTX001 in patients with transfusion-dependent beta thalassemia and severe sickle cell disease.
2020-09-23T00:00:00
2020-09-23T00:00:00
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2020-09-25
VRTX
Vertex gets FDA nod to Kalydeco for cystic fibrosis in 4 to 6-month infants
The FDA has approved Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) aged four months to less than six months old, with at least one cystic fibrosis transmembrane conductance regulator gene mutation, that is responsive to Kalydeco based on clinical and/or in vitro assay data. Kalydeco is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older Vertex' three supplemental marketing applications were accepted by the FDA. Also Moderna and Vertex collaborated on gene editing therapies for CF.
2020-09-26T00:00:00
2020-09-28T00:00:00
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2020-10-08
VRTX
Oppenheimer sees divided sector in 'critical' months for biotech
Heading into earnings season for biotech stocks, Oppenheimer is expecting two kinds of companies to come out on the other side: growth or growth-potential names continuing to dominate in an ongoing pandemic environment; and deep-value and SMID-caps, "misunderstood but [delivering] superior management execution." There are a number of overhangs weighing on the sector, the firms says, including "drug pricing, healthcare reform, increasing Medicare/Medicaid enrollment in 2021/22 due to COVID-19 related job and healthcare insurance losses, etc." And that's likely to see the companies in the sector bifurcate into a dumbbell shape. Earnings could be "complicated" - not only due to the stop-start recovery during a raging pandemic, but also with some tough 2019 comps, particularly for Regeneron (NASDAQ:REGN), Vertex (NASDAQ:VRTX) and Alexion (NASDAQ:ALXN). And election issues can still create volatility into year-end: The Senate could be key here on several of those factors (drug pricing, reform), and Oppenheimer isn't sure investors completely understand the wide variation between the candidates on healthcare issues. But on the growth side of the dumbbell, it continues to favor Regeneron and Vertex (even with tough comps). "Standout sales/earnings growth" should continue into 2021, and it likes the pipeline approaches (Regeneron's move into oncology could start demonstrating "significant benefits in 2021"). Vertex's early-stage pipeline should also offer meaningful catalysts next year. It also favors Moderna (NASDAQ:MRNA) ahead of a potential Phase 3 readout of its COVID-19 vaccine candidate in Q4. Its earnings call could give color on how it will guide for 2021 (though full-year guidance is likely on the Q4 call). Meanwhile, value-to-growth names like United Therapeutics (NASDAQ:UTHR) and Gilead Sciences (NASDAQ:GILD) could surprise to the upside as soon as this quarter. United Therapeutics is still executing on its commercial business and is "an uber-cheap name about to enter a potentially strong growth phase." Gilead is probably best-positioned to outperform near-term expectations, Oppenheimer says. As for SMID-caps, it likes Catabasis (NASDAQ:CATB) and aTyr Pharma (NASDAQ:LIFE), each with near-term material catalysts, and Cellectis (NASDAQ:CLLS) with potentially strong clinical data late this year on its allogeneic CAR-T programs. NeuBase Therapeutics (NASDAQ:NBSE) continues to execute strongly. And it's staying cautious on Sarepta (SRPT; Oppenheimer's not surprised by regulator pushback on gene therapy manufacturing) and Alexion (ALXN; a quality name transitioning between product growth cycles).
2020-10-09T00:00:00
2020-10-09T00:00:00
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2020-10-14
VRTX
Vertex Pharma -7.9% as it drops VX-814 study, development (updated)
Vertex Pharmaceuticals (NASDAQ:VRTX) has slipped 7.9% after news that it's discontinuing its Phase 2 study of VX-814 and dropping development. That's based on safety and pharmacokinetic data, the company says. The study of about 50 patients was designed to evaluate safety/PK in VX-814 and its ability to increase functional levels of alpha-1 antitrypsin over 28 days of dosing. "Elevated liver enzymes (AST/ALT) were observed in several patients," Vertex says. "In four patients, across different doses studied, elevations greater than 8 times the upper limit of normal were noted; the elevated liver enzymes have either resolved or are resolving." The company concluded that it's not feasible to safely reach targeted exposure levels (and thus, meaningful increases in AAT levels). A Phase 2 trial of VX-864 - structurally distinct from VX-814 - is still ongoing after its July start, the company says. It also continues to advance multiple small molecule correctors in late-stage research with a goal of advancing at least one additional molecule into development in 2021. Updated 4:55 p.m.: Arrowhead Pharmaceuticals (ARWR) - also focused on liver diseases associated with alpha-1 antitrypsin deficiency - is up 14.9% after-hours.
2020-10-15T00:00:00
2020-10-15T00:00:00
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2020-10-28
VRTX
Vertex Pharmaceuticals Q3 2020 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q3 earnings results on Wednesday, October 28th, after market close. The consensus EPS Estimate is $2.33 (+89.4% Y/Y) and the consensus Revenue Estimate is $1.48B (+55.8% Y/Y). Estimated expenses on a non-GAAP basis: R&D $389.8M and SG&A $172.8M. Over the last 2 years, VRTX has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time. Over the last 3 months, EPS estimates have seen 17 upward revisions and 3 downward. Revenue estimates have seen 15 upward revisions and 3 downward.
2020-10-29T00:00:00
2020-10-29T00:00:00
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2020-10-29
VRTX
Vertex product sales up 62% on strong Trikafta/Kaftrio ramp
Vertex Pharmaceuticals (NASDAQ:VRTX) Q3 results: Revenues: $1,538.3M (+62.0%); product sales: $1,536.3 (+61.7%). Key product sales: Trikafta/Kaftrio: $960M; Symdeko/Symkevi: $156M (-61.4%); Orkambi: $226M (-23.9%); Kalydeco: $194M (-22.1%). Net income: $667.4M (+999%); non-GAAP net income: $697.3M (+116.9%); EPS: $2.53 (+999%); non-GAAP EPS: $2.64 (+114.6%). 2020 guidance: Product sales: $6.0B-6.2B from $5.7B-5.9B. Vertex Pharmaceuticals EPS beats by $0.31, beats on revenue
2020-10-30T00:00:00
2020-10-30T00:00:00
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2020-10-29
VRTX
Vertex Pharmaceuticals EPS beats by $0.31, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q3 Non-GAAP EPS of $2.64 beats by $0.31; GAAP EPS of $2.53 beats by $0.55. Revenue of $1.54B (+62.1% Y/Y) beats by $60M. Cash, cash equivalents and marketable securities as of September 30, 2020 were $6.2B. Combined GAAP R&D and SG&A expenses decreased compared to the Q3 2019 due to a decrease in collaboration payments. Press Release
2020-10-30T00:00:00
2020-10-30T00:00:00
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2020-11-05
VRTX
EC OKs expanded use of Vertex Pharma's Kalydeco for infants with cystic fibrosis
The European Commission (EC) has granted approval of the label extension to Vertex Pharmaceuticals' (NASDAQ:VRTX) KALYDECO (ivacaftor) granules to include the treatment of infants with cystic fibrosis (CF) ages 4 months and older and weighing at least 5 kg who have the R117H mutation or one of the following gating (class III) mutations in the CF transmembrane conductance regulator gene. KALYDECO (ivacaftor) will be now available in Germany and other countries that have entered into long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland. In all other countries, Vertex will work closely with relevant authorities in Europe to secure access for eligible patients. KALYDECO (ivacaftor) is already approved in Europe for people with CF ages 6 months and older weighing at least 5 kg.
2020-11-06T00:00:00
2020-11-06T00:00:00
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2020-11-20
VRTX
Vertex Pharmaceuticals Board approves $500M stock buyback program
Vertex Pharmaceuticals (VRTX +1.6%) Board has authorized a program to repurchase up to $500M of the Company’s common stock through December 31, 2022. As of October 19, 2020, the Company had repurchased the entire $500M of common stock that was authorized under the 2019 Repurchase Program.
2020-11-21T00:00:00
2020-11-23T00:00:00
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2020-12-06
VRTX
CRISPR Therapeutics, Vertex CTX001 data show consistent, sustained response
CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals (NASDAQ:VRTX) report that 10 patients treated with investigational CRISPR/Cas9-based gene-editing therapy, CTX001, show a consistent and sustained response to treatment. All seven patients with transfusion-dependent beta thalassemia, including three who have either a severe or b0/b0 genotype, were transfusion independent at last follow-up and all three patients with sickle cell disease were free of vaso-occlusive crises from CTX001 infusion through last follow-up. Nineteen patients have been dosed with CTX001 across both programs. The two companies also announce that The New England Journal of Medicine published an independently peer-reviewed article, "CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β Thalassemia", including detailed information on the first patient with TDT enrolled in CLIMB-111 and the first patient with severe SCD enrolled in CLIMB-121, at 18 and 15 months of follow-up, respectively. CTX001 is being investigated in these two ongoing Phase 1/2 clinical trials as a potential one-time curative therapy for patients suffering from TDT and severe SCD. “We are pleased with the data presented at ASH, which demonstrate potential benefit and durability among a larger population of patients with transfusion-dependent beta thalassemia and sickle cell disease,” said Samarth Kulkarni, CEO of CRISPR Therapeutics. SA authors rate CRSP as Bullish; Vertex also gets average Bullish ranking by SA authors. SA contributor Nelson Alves says CRSP has a solid pipeline in the genome editing space and is still underfollowed.
2020-12-07T00:00:00
2020-12-07T00:00:00
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2020-12-07
VRTX
Editas Medicine surges 13% after unveiling a novel approach to gene editing therapies to treat hemoglobinopathies
Editas Medicine (NASDAQ:EDIT) joins the gene-editing bandwagon as the company showcases promising pre-clinical data and successful development of a large-scale manufacturing process for EDIT-301, the company’s gene-editing treatment for sickle cell disease and beta-thalassemia. The data announced over the weekend at the 62nd Annual Meeting and Exposition of the American Society of Hematology demonstrate high levels of editing in CD34+ cells from normal donors and sickle cell patients, leading to robust fetal hemoglobin induction. The company expects an IND filing for the treatment by the end of 2020, and shares surged +13.2%. Sickle cell disease, an inherited blood disorder impacting an estimated 100,000 people in the United States, leads to polymerization of the sickle hemoglobin protein, which is inhibited by fetal hemoglobin. "These findings are very encouraging and further support our novel approach to developing and manufacturing EDIT-301 as a best-in-class and durable medicine for the potential treatment of sickle cell disease and beta-thalassemia,” said Charles Albright, Ph.D., Executive Vice President, and Chief Scientific Officer, Editas Medicine. Additionally, the company announced that its large-scale manufacturing process for edited CD34+ cells from normal donors was consistent and robust. During the ASH meeting, CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals (NASDAQ:VRTX) also demonstrated promising data from Phase 1/2 clinical studies for CTX001, an investigational therapy for patients suffering from TDT (transfusion-dependent beta-thalassemia) and severe SCD (sickle cell disease)currently undergoing Phase 1/2 clinical trials.
2020-12-08T00:00:00
2020-12-08T00:00:00
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2020-12-22
VRTX
Vertex Pharma, Skyhawk Therapeutic in licensing pact for RNA splicing modulating therapies
Vertex Pharmaceuticals (NASDAQ:VRTX -0.2%) has announced a strategic research collaboration and licensing agreement with Privately-held Skyhawk Therapeutic, aimed at the discovery and development of small molecules that modulate RNA splicing for the treatment of serious diseases. The company will pay Skyhawk $40M upfront. Skyhawk is also eligible to receive as much as $2.2B in potential milestone payments, as well as potential royalties on future sales. Vertex will be using Skyhawk’s SkySTAR platform that corrects the underlying genetics of disease at the mRNA level.
2020-12-23T00:00:00
2020-12-23T00:00:00
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2020-12-21
VRTX
Vertex receives FDA approval for expanded use of cystic fibrosis therapy
Vertex Pharmaceuticals (NASDAQ:VRTX) announced that it received the FDA signoff for the expanded use of three of its cystic fibrosis medications. TRIKAFTA, previously approved for people with at least one F508del mutation is now approved for 177 additional mutations; authorized for 127 additional mutations, SYMDEKO is now approved for a total of 154 SYMDEKO-responsive mutations; KALYDECO is now eligible for use in a total of 97 KALYDECO-responsive mutations after getting approval for an additional 59 mutations. TRIKAFTA is indicated for people with cystic fibrosis aged 12 years and older, while SYMDEKO and KALYDECO are approved for people with CF ages six years and older and age four months and older, respectively. Cystic fibrosis, due to mutations in the cystic fibrosis transmembrane conductance regulator gene, is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. With the vast majority of CF patients having at least one F508del mutation, the approval for expanded use will benefit more than 600 people with CF, additionally.
2020-12-22T00:00:00
2020-12-22T00:00:00
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2020-12-28
VRTX
Health Canada accepts Vertex Pharma's Trikafta application for priority review
Vertex Pharmaceuticals' (NASDAQ:VRTX) New Drug Submission for TRIKAFTA, an investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in people ages 12 years and older. With Priority Review, the conventional review timeline of 300 days is reduced to 180 days. The expected approval target by Health Canada is in H1 2021.
2020-12-29T00:00:00
2020-12-29T00:00:00
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2021-01-07
VRTX
Imara declined yesterday as its sickle cell treatment appears to be not at par with its peers
Imara (NASDAQ:IMRA) closed in red, down 38% yesterday as investors apparently saw the company's sickle cell data lacked benefit when compared to its peers. Data showed that IMR-687 had no meaningful impact on key measures like fetal hemoglobin ((HbF)) or hemoglobin levels when taken by itself. Combination with HU showed slight benefits in F- cells and fetal hemoglobin levels but hemoglobin decreased on average after 24 weeks. Three of eight combination patients had absolute increases in HbF percentage of greater than 1%, with a mean absolute increase in HbF percentage of 4.3% in that subset of patients Global Blood Therapeutics and Novartis already have approved therapies to treat sickle cell patients while one-time treatments from Bluebird bio (NASDAQ:BLUE) and Vertex/Crispr (NASDAQ:VRTX) (NASDAQ:CRSP) have shown promise for potentially curative therapies, raising the bar. SVB Leerink analyst Joe Schwartz defended the company stating that Covid-19 hurt the trial because of missed visits that “potentially undermined the quality of the data”. He also cited that the drug doses examined are much lower than those expected in future trials, and he believes that “longer and higher dosing” could lead to improved efficacy. SVB Leerink said in a note "Imara’s Phase 2a data announced Wednesday represents a “rearward looking view of IMR-687’s development” and isn’t likely a good indicator of what’s to come in future readouts". Sees the stock’s weakness as a potential buying opportunity ahead of IMRA’s multiple data readouts in 2021. Imara shares are up 3% in premarket trading today.
2021-01-08T00:00:00
2021-01-08T00:00:00
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2021-01-11
VRTX
Vertex Pharma projects a larger long-term opportunity in CF
In a presentation prepared for the J.P. Morgan Healthcare Conference, Vertex Pharmaceuticals (NASDAQ:VRTX) projects a market opportunity of 83K patients with Cystic Fibrosis in the U.S., Europe, Australia, and Canada. In the recent earnings call for Q3 2020, CEO Reshma Kewalramani identified 75K patients for the indication. Attributing the increase to ‘availability of transformational medicines’ and improved country-level data collection, the company estimates 50% of patients undergoing therapies developed by the company while 30K patients remain untreated. Increasing its Cystic Fibrosis opportunity by 16K new patients, the company’s triple combination regimen, TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) obtained regulatory signoff in the U.S. and EU, in 2019, and 2020, respectively for the treatment of people with CF 12 years of age and older with specific mutations in their CFTR gene.
2021-01-12T00:00:00
2021-01-12T00:00:00
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2021-01-11
VRTX
Vertex expects over $6B revenue for 2020 at ~47% YoY growth
Speaking at the 39th Annual JPMorgan Healthcare Conference, CEO of Vertex Pharmaceuticals (NASDAQ:VRTX) Reshma Kewalramani said that the company was expecting a $6.0 - $6.1B revenue for 2020, ~46.5% YoY growth at the midpoint based on GAPP revenue posted in the previous year. The company also disclosed that it filed an IND for the cells-only program for type 1 diabetes awaiting regulatory feedback to advance it to the clinical stage. Meanwhile, VX-864 Phase 2 Proof-of-Concept Study is currently in progress, with a key data readout scheduled for 2021. Presenting the data on the CTX001 program as published in the New England Journal of Medicine, the CEO announced that the program has dosed 20 patients, and it is on track to complete the enrollment in 2021. The company upgraded its market opportunity in Cystic Fibrosis with an estimate of 83K patients in the U.S., Europe, Australia, and Canada, up from ~75K in the previous projection.
2021-01-12T00:00:00
2021-01-12T00:00:00
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2021-01-26
VRTX
Vertex sNDA for cystic fibrosis drug Trikafta accepted by FDA
The FDA has accepted an sNDA from Vertex (NASDAQ:VRTX) for Trikafta to treat children 6 to 11 years old that have cystic fibrosis with a certain genetic mutation. The agency has granted Priority Review for the sNDA with a PDUFA date of June 8, 2021. The application was supported by a global Phase 3 study in children ages 6 through 11 years old with cystic fibrosis that have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation. In a presentation prepared for the J.P. Morgan Healthcare Conference earlier this month, Vertex projected a market opportunity of 83K patients with cystic fibrosis in the US, Europe, Australia, and Canada. Shares are down 1.9% at $236.76 in morning trading.
2021-01-27T00:00:00
2021-01-27T00:00:00
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2021-01-28
VRTX
Vertex gets FDA's go ahead for VX-880 Diabetes trial
Vertex Pharma (NASDAQ:VRTX) gets the greenlight from the U.S. FDA to start a clinical trial for VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell therapy to treat Type 1 Diabetes (T1D). The company plans to initiate a Phase 1/2 clinical trial in the first half of 2021 in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. The Phase 1/2, single-arm, open-label study, which will enroll about 17 subjects, will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880.
2021-01-29T00:00:00
2021-01-29T00:00:00
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2021-01-31
VRTX
Vertex Pharmaceuticals Q4 2020 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q4 earnings results on Monday, February 1st, after market close. The consensus EPS Estimate is $2.58 (+51.8% Y/Y) and the consensus Revenue Estimate is $1.59B (+26.2% Y/Y). Over the last 2 years, VRTX has beaten EPS estimates 100% of the time and has beaten revenue estimates 100% of the time. Over the last 3 months, EPS estimates have seen 17 upward revisions and 3 downward. Revenue estimates have seen 15 upward revisions and 2 downward.
2021-02-01T00:00:00
2021-02-01T00:00:00
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2021-02-02
VRTX
Amicus shares rise on acquisition speculation from Vertex
Amicus Therapeutics (NASDAQ:FOLD) shares are up 6.7% in morning trading after a Dealreporter piece speculated it may be a takeout target for Vertex (NASDAQ:VRTX). The article also points out Biomarin (NASDAQ:BMRN) could be a Vertex acquisition target, though shares of that company are down 0.3% right now. The Dealreporter piece notes, "We have previously highlighted Amicus Therapeutics...as a potential name to keep an eye on, given VRTX's previous interest in the gene therapy space. Separately, Amicus filed an automatic shelf registration with the SEC for the resale of up to 2,554,999 underlying warrants to purchase shares. Amicus filed an SEC Form S-3 shelf offering on Jan. 29, but then amended it on Feb. 2 due to a filing error. Maximum aggregate offering price is $48.9M. Amicus shares were up 6.7% to $20.53 in morning trading.
2021-02-03T00:00:00
2021-02-03T00:00:00
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2021-02-01
VRTX
Vertex Pharmaceuticals EPS misses by $0.06, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q4 Non-GAAP EPS of $2.51 misses by $0.06; GAAP EPS of $2.30 beats by $0.14. Revenue of $1.63B (+29.4% Y/Y) beats by $40M. Cash, equivalents and marketable securities as of Dec. 31, 2020 were $6.7B, an increase of ~$2.9B Y/Y, driven by strong revenue and profitability. FY 2021 product revenue guidance of $6.7 to $6.9B. Press Release The company got the green light from the FDA last week for a trial of a Type 1 diabetes treatment.
2021-02-02T00:00:00
2021-02-02T00:00:00
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2021-02-17
VRTX
CRISPR Therapeutics shares fall on fourth-quarter topline miss
CRISPR Therapeutics (NASDAQ:CRSP) shares fall more than 3% during premarket trading after the company posted fourth-quarter revenue that missed Wall Street estimates, as the company dealt with a slump in collaboration revenue primarily due to the sale of certain licenses under the company’s agreement with Vertex Pharmaceuticals (NASDAQ:VRTX). Total collaboration revenue was $0.2M for the fourth quarter ended December 31, 2020, compared to $77M in the prior-year period. The company also said that it recorded a net loss of $107M in the quarter, compared to income of $30.5M last year. R&D expenses during the quarter rose nearly 70% to $82.4M. Separately, CRISPR Therapeutics was granted Orphan drug designation by the FDA for allogeneic CRISPR/Cas9-mediated genetically modified CAR T cells targeting CD19 antigen for the treatment of acute lymphoblastic leukemia. CRISPR also provided business updates and potential milestones: The company is eligible to receive additional milestone payments from Vertex of up to $800M. CRISPR Therapeutics and its partner ViaCyte plan to initiate a Phase 1/2 trial of their allogeneic stem cell-derived therapy for the treatment of Type 1 diabetes in 2021. Expects to report additional data from its Phase 1 CARBON trial assessing the safety and efficacy of several dose levels of CTX110, its wholly-owned allogeneic CAR-T investigational therapy targeting CD19+, for the treatment of relapsed or refractory B-cell malignancies trial in 2021. Expects to report top-line data from two independent Phase 1 clinical trials assessing the safety and efficacy of several dose levels of CTX130 for the treatment of both solid tumors and certain hematologic malignancies in 2021. Previously (Feb. 16): CRISPR Therapeutics EPS misses by $0.23, misses on revenue.
2021-02-18T00:00:00
2021-02-18T00:00:00
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2021-03-10
VRTX
Vertex Pharma launches VX-880 study in diabetes; secures Fast Track tag
The FDA has granted Fast Track Designation for Vertex Pharmaceuticals' (NASDAQ:VRTX) VX-880 and that the company has initiated a Phase 1/2 clinical trial for VX-880 in patients who have type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemic awareness. This will be a sequential, multi-part trial to evaluate the safety and efficacy of different doses of VX-880. Approx. 17 patients will be enrolled. Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application. VX-880, formerly known as STx-02, is an investigational allogeneic human stem cell-derived islet cell therapy. VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production. The VX-880 clinical trial will involve an infusion of fully differentiated, functional islet cells, as well as the chronic administration of concomitant immunosuppressive therapy, to protect the islet cells from immune rejection.
2021-03-11T00:00:00
2021-03-11T00:00:00
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2021-03-12
VRTX
Merck and Pfizer among top picks to lead 2021 biopharma M&A activity: Goldman Sachs
With an estimated ~$530B war chest in total, large biopharma companies will continue to drive M&A activity in 2021, the analysts at Goldman Sachs predicted in a new analysis of the sector. Noting a ~110% YoY rise in deal volumes in February including ~221% YoY growth in U.S. mid-cap deals, the analysts expect that given a favorable environment, the M&A activity could follow the trend set in 2H 2020. Merck (MRK +0.5%), Pfizer (PFE +0.2%), Bristol-Myers Squibb (BMY -0.2%), Sanofi (SNY -0.3%), and GlaxoSmithKline (GSK -0.5%) are likely to be at the forefront of M&A activity, the analysts argue noting the losses of exclusivity hurting the valuations of potential acquirers. Arguing that therapeutic areas remain a priority for many acquirers, the analysts cite oncology and immunology as areas where many companies are exposed to, with a rising interest in neurology and compelling valuation of “late-stage gene therapy” stocks after recent underperformance. Arvinas (ARVN -1.1%), Blueprint Medicines (BPMC -0.3%), Incyte (INCY -1.3%), Seagen (SGEN -2.5%), Mirati Therapeutics (MRTX -1.4%), and Turning Point Therapeutics (TPTX -3.3%) are highlighted as attractive stocks within oncology space. Karuna Therapeutics (KRTX -0.6%) and argenx SE (ARGX -0.2%) are cited as highly compelling candidates in neurology and immunology, respectively. However, the analysts also point out that Regeneron (REGN -0.4%) and Vertex Pharmaceuticals (VRTX -1.0%) have reached the valuations of their core franchise, yet expecting bolt-on acquisitions and partnerships to dominate the large deals. Highlights of 2021 deal activity among potential targets include the tie-up between Resolution Bioscience and Mirati Therapeutics as well as the rejection by Seagen shareholders of an unsolicited "mini-tender" offer made by TRC Capital Investment.
2021-03-13T00:00:00
2021-03-15T00:00:00
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2021-03-25
VRTX
AstraZeneca’s updated data to address integrity issue; Vertex moves to focus list at Citi in today’s analyst action
Updated interim data provided by AstraZeneca (NASDAQ:AZN) yesterday from its late-stage COVID-19 vaccine trial in the U.S., should address the data integrity issue, UBS wrote in a note. AstraZeneca ADRs are trading marginally up in before hours. The Analysts led by Michael Leuchten with a buy rating on the stock say the 3% difference with the preliminary assessment which indicated ~79% efficacy in preventing symptomatic COVID-19 “is really nothing to be concerned about.” Vertex Pharmaceuticals (NASDAQ:VRTX) was added to Focus List at Citi with the price target of $325.00 per share indicating a premium of ~53.6%. With a buy rating, the analyst Mohit Bansal highlights the current valuation and low investor sentiment despite a slew of potential 2021 catalysts which includes the data read from VX-864 Phase 2 proof-of-concept study in Alpha-1 Antitrypsin (“AAT”) deficiency expected in H1 2021. SPDR Biotech ETF (NYSEARCA:XBI) has just recorded two back-to-back one-day declines of more than ~5% for the first time since the pandemic-driven slump in mid-March 2020. Jefferies analyst Michael Yee sees room for another 10% to 15% slump in the sector which remains 15% lower from February highs. “The macro moneyflow rotation is driving elevated risk across growth and high-beta areas including biotech,” notes the analyst. RBC capital markets’ analyst Brian Abrahams also echoed a similar view. Questioning the feasibility of recent legislative moves to curb the high cost of prescription drugs Abrahams thinks the changes could lead to “at worst a modest impact on drugmakers’ long-term revenue stream.” Viracta Therapeutics (NASDAQ:VIRX) has climbed ~8.0% in the pre-market after Evercore ISI initiated coverage on the stock with an outperform rating. Giving a price target of $45.00 per share, the analysts led by Josh Schimmer calls the stock an ‘oncology diamond’ trading far below the closest peers such as Atara Biotherapeutics (NASDAQ:ATRA) and AlloVir (NASDAQ:ALVR). Viracta was formed following a reverse merger agreement with publicly-traded Sunesis Pharmaceuticals. The combined entity was listed on the Nasdaq under the new ticker symbol “VIRX.” Marker Therapeutics (NASDAQ:MRKR) is trading marginally higher in the pre-market after Piper Sandler initiated coverage on the stock with a recommendation of overweight. The price target of $6.00 per share indicates ~157.5% upside to the previous close. The analyst Joseph Catanzaro expects the company shares to rise as its MultiAA platform, which was identified by Catanzaro as a ‘highly-differentiated’ T cell therapy, advances through the clinical trial. In January, Marker announced that the FDA lifted the partial clinical hold of its Phase 2 trial, evaluating MT-401, a MultiTAA-specific T cell product candidate, in the treatment of acute myeloid leukemia.
2021-03-26T00:00:00
2021-03-26T00:00:00
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2021-03-26
VRTX
Vertex's KAFTRIO combo gets EMA positive opinion for label extension
Vertex Pharmaceuticals (NASDAQ:VRTX) has received positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the label extension of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis. The label expansion will allow the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide. The CHMP positive opinion was based on the results from a global Phase 3 study (Study 445-104) evaluating the triple combination therapy in CF patients ages 12 years and older who are heterozygous for the F508del-CFTR mutation and a CFTR gating mutation (F/G) or a residual function mutation (F/RF). If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine. CF is a rare, life-shortening genetic disease affecting more than 80,000 people globally.
2021-03-27T00:00:00
2021-03-29T00:00:00
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2021-04-20
VRTX
Vertex and CRISPR amend CTX001 development agreement
Vertex Pharmaceuticals (NASDAQ:VRTX) gains 60% rights over the development of sickle cell disease (SCD) therapy CTX001 from CRISPR Therapeutics (NASDAQ:CRSP) for an upfront payment of $900M. The companies have amended their collaboration agreement to develop, manufacture and commercialize CTX001, an investigational CRISPR/Cas9-based gene editing therapy that is being developed as a potentially curative therapy for SCD and transfusion-dependent beta-thalassemia (TDT). Under the terms of the amended agreement, Vertex will lead global development, manufacturing and commercialization of CTX001, and will be responsible for 60% of program costs. Vertex company will also receive 60% of profits from future sales of CTX001 worldwide. Additionally, CRISPR will also has the potential for a $200M payment upon the first regulatory approval of CTX001. CRISPR shares were up more than 4% during premarket trading, while Vertex shares were marginally down.
2021-04-21T00:00:00
2021-04-21T00:00:00
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2021-04-20
VRTX
Vertex bets on CRISPR for beta-thalassemia as Bluebird bio stumbles in Europe
CRISPR Therapeutics (CRSP +5.6%) continues the upward trajectory today on the premarket announcement of an agreement with Vertex (VRTX +0.7%) giving the latter 60% of global profits from future sales of CTX001 for a total consideration of up to ~$1.1B. An experimental CRISPR/Cas9 gene-edited therapy CTX001 is undergoing two Phase 1/2 clinical trials for severe sickle cell disease ("SCD") and transfusion-dependent beta-thalassemia (TDT). Among treatments studied for TDT and SCD based on gene editing technology, CTX001 ‘is the furthest advanced in clinical development,’ according to a press release issued by the companies. With an initial focus on cystic fibrosis and sickle cell disease, Vertex and CRISPR first signed a deal in 2015 targeting CRISPR-Cas9 based gene-editing therapies. The new agreement increases Vertex’s share of profits by 10% indicating an estimated ~$11B value for CTX001 based on a back-of-the-envelope calculation. There was no better time for two collaborators to update on the deal as Bluebird bio just revealed its decision to withdraw Zynteglo from the German market citing pricing disagreements with authorities. Zynteglo is a gene therapy approved in Europe for patients aged 12 years and above with TDT. The setback in Europe has already prompted Stifel to slash the price target of Bluebird bio by as much as ~14.7%.
2021-04-21T00:00:00
2021-04-21T00:00:00
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2021-04-22
VRTX
Vertex inks licensing agreement with Obsidian for gene-editing medicines
Vertex Pharmaceuticals (NASDAQ:VRTX -1.2%) and Obsidian Therapeutics have signed a strategic research collaboration and licensing agreement focused on the discovery of gene-editing medicines using Obsidian’s cytoDRiVE platform technology. Per the terms of the agreement, Vertex will have ‘the exclusive option to license worldwide rights to candidates discovered and developed under the collaboration,’ a statement from two companies said. In return, over the research term, Vertex will pay $75M in upfront payments and research milestones to Obsidian which is also entitled to up to $1.3B in potential milestone payments across up to five potential programs. After the exercise of the option, Vertex will be accountable for preclinical and clinical research and commercialization and Obsidian will be eligible for tiered royalties on future net sales from any products that may result from this collaboration. Obsidian based in Cambridge Mass. expects to submit an IND in mid-2022 for its lead cytoTIL™ program. The signs of Vertex’s rising focus on gene editing space come a few days after the company announced a revised deal with CRISPR Therapeutics for the experimental gene-editing therapy CTX001.
2021-04-23T00:00:00
2021-04-23T00:00:00
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2021-04-26
VRTX
Vertex, CRISPR's CTX001 gene-edited therapy gets EMA 'Priority Medicines' status
Vertex Pharmaceuticals (NASDAQ:VRTX) and CRISPR Therapeutics (NASDAQ:CRSP) announces that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an investigational gene-edited therapy for the treatment of transfusion-dependent beta thalassemia (TDT). PRIME is a regulatory mechanism that provides early and proactive support to developers of promising medicines to optimize development plans and speed up evaluations so these medicines can reach patients faster. The designation was granted based on clinical data from CRISPR and Vertex’s ongoing Phase 1/2 trial of CTX001 in patients with TDT. Vertex gained 60% rights over CTX001 from CRISPR for an upfront payment of $900M, last week.
2021-04-27T00:00:00
2021-04-27T00:00:00
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2021-04-26
VRTX
Vertex to advance VX-548 pain medication to mid-stage trials
Vertex Pharmaceuticals (NASDAQ:VRTX) announces that it will advance the selective NaV1.8 inhibitor, VX-548, into Phase 2 clinical development with clinical trials in patients with both visceral and non-visceral types of acute pain. The decision to move to Phase 2 was based on supportive Phase 1 data in healthy volunteers, including safety, tolerability and pharmacokinetics (PK), the company said. In the early-stage studies, the molecule exhibited a favorable profile at doses considerably lower than those required with the company's previous NaV1.8 inhibitors. The planned Phase 2 studies will be randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty. The primary endpoint in both the planned studies is the time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48). Proof-of-concept studies of VX-548 in acute pain to initiate in the second half of the year.
2021-04-27T00:00:00
2021-04-27T00:00:00
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2021-04-28
VRTX
Vertex Pharmaceuticals Q1 2021 Earnings Preview
Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q1 earnings results on Thursday, April 29th, after market close. The consensus EPS Estimate is $2.69 (+5.1% Y/Y) and the consensus Revenue Estimate is $1.66B (+9.2% Y/Y). Over the last 2 years, VRTX has beaten EPS estimates 88% of the time and has beaten revenue estimates 100% of the time. R&D expense estimate of $371.9M. SG&A expense estimate of $167.6M. Over the last 3 months, EPS estimates have seen 5 upward revisions and 5 downward. Revenue estimates have seen 6 upward revisions and 4 downward.
2021-04-29T00:00:00
2021-04-29T00:00:00
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2021-04-29
VRTX
Vertex beats Q1 consensus as cystic fibrosis therapy drives revenue growth
Today, Vertex Pharmaceuticals (NASDAQ:VRTX) reported Q1 2021 financials which came ahead of expectations thanks to continuing momentum in TRIKAFTA/KAFTRIO sales. Backed by a ~33.3% YoY growth in sales from the cystic fibrosis therapy, the net product revenue has reached ~$1.2B with a ~13.7% YoY growth, a slight slowdown from ~15.7% YoY growth in Q4 2020. The uptake of KAFTRIO in Europe and the continued performance of TRIKAFTA have contributed to the quarterly growth as net product revenue outside the U.S. outperformed with a ~43% YoY growth compared to ~6% YoY growth in the U.S. GAAP Operating income has increased ~8.7% YoY to $888.0M and diluted GAAP Net income per share has risen ~8.7% YoY to $2.49. Supported by revenue growth and profitability and partially offset by share buybacks, the cash and equivalents have improved to ~$6.9B indicating ~3.0% growth from 2020 year-end. Vertex keeps the 2021 guidance unchanged except for a raise in the projected GAAP R&D and SG&A expenses to $3.8 – 4.0B from $2.9 – 3.1B to reflect its amended collaboration with CRISPR. "Beyond CF, we have also seen continued significant progress across our broad pipeline” commented Vertex CEO Reshma Kewalramani. Kewalramani pointed to several trials in progress, including VX-548 in Phase 2 in acute pain, initiation of the Phase 1/2 clinical trial with VX-880 in type 1 diabetes, and the completion of enrollment and dosing in Phase 2 proof-of-concept study with the AAT corrector, VX-864. The company has scheduled a conference call to discuss the results today at 5:30 p.m. ET. Per the amended agreement announced last week, Vertex made an upfront payment of $900M to CRISPR for 60% rights of the sickle cell disease therapy CTX001.
2021-04-30T00:00:00
2021-04-30T00:00:00
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2021-04-29
VRTX
Vertex Pharmaceuticals EPS beats by $0.29, beats on revenue
Vertex Pharmaceuticals (NASDAQ:VRTX): Q1 Non-GAAP EPS of $2.98 beats by $0.29; GAAP EPS of $2.49 beats by $0.20. Revenue of $1.72B (+13.2% Y/Y) beats by $60M. Multiple Phase 2 proof-of-concept study results expected in 2021. Cash, cash equivalents and marketable securities as of March 31, 2021 were $6.9 billion. FY 2021 product revenue guidance of $6.7 to $6.9B. Shares -0.41%. Press Release
2021-04-30T00:00:00
2021-04-30T00:00:00
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2021-05-17
VRTX
Vertex pays $32 million for milestones linked to potential cystic fibrosis therapy
Concert Pharmaceuticals (NASDAQ:CNCE) has added ~6.5% in the post-market after announcing that Vertex Pharmaceuticals (NASDAQ:VRTX) has purchased the potential future milestones related to the company’s asset purchase agreement for VX-561 (deutivacaftor) for $32M. In 2017, the two companies signed the agreement for VX-561 (formerly CTP-656) and other assets targeting cystic fibrosis. Concert Pharma received a one-time cash payment of $160M in connection with the deal and was entitled to $60M in future milestones. Upon the receipt of $32M, the company is no longer eligible for any future milestone obligations. Vertex is trading ~1.2% higher in after hours. “This transaction provided an opportunity to secure non-dilutive capital and strengthens our balance sheet as we continue to advance CTP-543, our lead asset for alopecia areata, through its Phase 3 program,” noted Roger Tung, CEO of Concert Pharma. With the cash proceeds from the transaction, the company expects its liquidity will be adequate to fund operations until Q2 2022. Recently, Vertex revised an agreement with CRISPR Therapeutics by paying $900M for 60% rights in the development of sickle cell disease (SCD) therapy CTX001.
2021-05-18T00:00:00
2021-05-18T00:00:00
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2021-06-03
VRTX
Edwards Lifesciences downgraded to hold, Vertex cut to sell, and more in today's analyst action
Edwards cut to hold at CFRA as shares close to price target CFRA has cut its rating on shares of Edward Lifesciences (NYSE:EW) to hold from buy as the firm believes the company is now fairly valued. Although Edwards will continue to have strong future quarters due to a pickup in procedures, this is already reflected in the share price, according to analyst Kevin Huang. Huang also says he doesn't see any major catalysts for transcatheter mitral and tricuspid valve procedures in the near future. Vertex downgraded, price target slashed at Goldman Sachs Goldman Sachs analyst Christopher Merwin has downgraded shares of Vertex (NASDAQ:VRTX) from neutral to sell. He has a price target of $180, which implies downside of ~8.5% from yesterday's close. Merwin sees growing competition in its core segments, which will lead to growth at a slower pace than its peers. Goldman sees bullishness in diagnostic sector The approval and reimbursement of an increasing number of diagnostic tests to support drug treatments has prompted Goldman Sachs to initiate a host of diagnostic companies as buys. They are Exact Sciences (NASDAQ:EXAS), Guardant Health (NASDAQ:GH), CareDx (NASDAQ:CDNA), and NeoGenomics (NASDAQ:NEO). "These companies have built durable platforms upon which they can quickly innovate and diversify their revenue streams across multiple products," writes Matthew Sykes. But Myriad Genetics is an exception However, Sykes views Myriad Genetics (NASDAQ:MYGN) as a sell. The company has partnerships with companies to determine if their treatments will work with patients based on analysis of homologous recombination repair deficiency ("HRD") and the growing clinical use of PARP inhibitor drugs for patients with the HRD phenotype, the analyst says. But he cautions that these partnerships "will have time-limited exclusivity in certain markets."
2021-06-04T00:00:00
2021-06-04T00:00:00
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2021-06-09
VRTX
FDA OKs expanded use of Vertex's Trikafta in children with cystic fibrosis
The FDA has approved expanded use of Vertex Pharmaceuticals' (NASDAQ:VRTX +1.4%) Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years with certain mutations. Trikafta was previously approved in U.S. for use in people with CF 12 years and older with at least one copy of the F508del mutation or one copy of a mutation that is responsive in vitro. An additional dosage strength of Trikafta tablets is now available (elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg and ivacaftor 75 mg) in connection with this approval. The company has submitted applications for use of Trikafta/Kaftrio in children ages 6 through 11 years to the EMA and the Medicines & Healthcare products Regulatory Agency and plans to file for this expanded use in Switzerland, Australia and Israel this year. Previously (Jan. 26): Vertex sNDA for cystic fibrosis drug Trikafta accepted by FDA
2021-06-10T00:00:00
2021-06-10T00:00:00
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2021-06-11
VRTX
Vertex reaches 52-week low after abandoning phase 2 rare disease drug
Shares of Vertex Pharmaceuticals (NASDAQ:VRTX) reached a 52-week low of $193 this morning following yesterday's after-the-bell announcement it was abandoning development of VX-864 for alpha-1 antitrypsin deficiency ("AATD"). However, analysts are Barclays, Citi, and Bernstein are continuing to back Vertex and see the share price pullback as a potential buying opportunity. The company also has a strong pipeline. Vertex shares are down 8.7% to $197.94 in morning.
2021-06-12T00:00:00
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