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VRTX

Vertex defended after setback and Biogen adds another bull at Bernstein; in today’s analyst action

goir/iStock via Getty Images Vertex defended across the board despite the setback Vertex Pharmaceuticals (NASDAQ:VRTX) continues to trade lower with a ~14.0% loss in the pre-market on its decision to halt the development of VX-864 for alpha-1 antitrypsin deficiency, as announced by the company yesterday after the close. However, according to Barclays analyst Gena Wang, the expected weakness in shares today “could create a buying opportunity,” as she argues that the current stock price implies “no value for any pipeline assets and some discount” for its cystic fibrosis (CF) franchise. Reiterating the overweight rating, Wang has however lowered the price target to $285.00 from $302.00 per share indicating an upside of ~31.5%. Pointing to the company’s high growth cystic fibrosis business, Citi analyst Mohit Bansal with a buy rating and a similar price target also sees the stock’s valuations as an attractive entry point. Meanwhile, maintaining the buy rating Guggenheim analyst Debjit Chattopadhyay cut the price target to $240.00 from $285.00 per share implying a premium of ~10.7%. Driven by sales of CF drug TRIKAFTA/KAFTRIO, Vertex financials came ahead of expectations for Q1 2021. Biogen given a Street-high price target by Bernstein Biogen (NASDAQ:BIIB) continues to attract bullish calls after the company received the FDA approval for Alzheimer’s medicine Aduhelm Monday. The latest to join the bandwagon is Bernstein analyst Ronny Gal who upgraded the stock to outperform from market perform. Matching the current Wall Street high, the price target of $500.00 per share implies a premium of ~20.6%. Biogen shares on course to witness the best week in two decades have added ~1.6% in the pre-market. Subject to effective execution, the company is on track to reach broader leadership in Alzheimer’s space, the analyst argues. Gal also predicts strong commercial adoption for the therapy and rules out regulatory scrutiny for new Alzheimer’s treatments until budgetary impact is assessed. Meanwhile, the fallout from the controversial approval of Aduhelm continues with the resignations of several board members of that FDA expert panel that voted against its licensure last year. CareCloud initiated overweight at Cantor CareCloud (NASDAQ:MTBC) is trading ~5.0% higher in the pre-market after Cantor Fitzgerald initiated the coverage of the stock with an overweight recommendation. The price target set to $15.00 per share indicates a premium of ~75.6%. The analyst Steven Halper expects the company’s acquisition-led growth trajectory to continue and argues that the company has a competitive advantage in pricing thanks to its large offshore workforce. In January 2020, the healthcare IT firm previously known as MTBC acquired CareCloud in a cash and stock deal. Ocugen price target cut by analysts Ocugen (NASDAQ:OCGN) lost more than a quarter of its value after the company announced it will pursue a regular pathway for the approval of its COVID-19 vaccine in the U.S. In reaction to a potential slowdown in the commercialization of the vaccine, Cantor Fitzgerald with a neutral rating on the stock has lowered the price target of the stock to a Street-low of $4.00 from $11.00 indicating a downside of ~40.2%. Dropping the probability of success to achieve future sales, the analyst Kristen Kluska has excluded the projected sales for Q4 and 2022. Ocugen has risen ~2.2% in the pre-market today. Meanwhile, Roth Capital Partners analyst Zegbeh Jallah has downgraded the stock to neutral from buy with the price target of $6.00 implying a downside of ~10.3%. Previously, Ocugen expected to submit an Emergency Use Authorization (EUA) application for Covaxin by June. Organon ends the slide after a bullish call from Evercore ISI Organon (NYSE:OGN), Merck spinoff focused on women’s health and biosimilars, snapped a four-day long losing streak yesterday after Evercore ISI initiated the coverage with an outperform rating. The analyst Umer Raffat predicts the stock has upside into the mid-to high-$30s and notes that the company’s low- to mid-single-digit growth target is achievable for the next three years. Despite the multi-year growth target, Organon’s Pro-forma revenue is expected to fall this year. All share price moves are calculated based on the market close unless otherwise stated.

VRTX

Vertex, CRISPR Therapeutics present new CTX001 data in beta thalassemia and sickle cell disease

Vertex Pharmaceuticals (NASDAQ:VRTX) and CRISPR Therapeutics (NASDAQ:CRSP) announce new data on 22 patients, with follow-up of at least 3 months, treated with CRISPR/Cas9-based gene-editing therapy, CTX001. Beta thalassemia: All 15 patients were transfusion independent after CTX001 infusion and had clinically meaningful improvements in total hemoglobin from 8.9 to 16.9 g/dL and fetal hemoglobin from 67.3% to 99.6% at last visit. Sickle cell disease: All seven patients were free of vaso-occlusive crises after CTX001 infusion and had meaningful improvements in total hemoglobin from 11 to 15.9 g/dL and fetal hemoglobin levels from 39.6% to 49.6% at last visit. The safety data from all 22 patients were generally consistent with an autologous stem cell transplant and myeloablative conditioning. Bone marrow allelic editing data collected from patients who have at least six months of follow-up, demonstrated a durable effect. These data were presented during the Joint EHA-ASH Symposium on June 10, 2021. The companies initially inked drug development deal in October 2015 focused on a range of inherited disorders, which was further amended in April 2021. VRTX shares continue to slide 11% premarket following yesterday's decline after company abandoned phase 2 drug for rare genetic disorder. #EHA21

VRTX

Arrowhead up 5% after hours after Vertex abandons rare disease drug

Igor Kutyaev/iStock via Getty Images Arrowhead Pharmaceuticals (NASDAQ:ARWR), which is developing a drug for liver disease associated with alpha-1 antitrypsin deficiency ("AATD"), is up 5% after-hours after Vertex (NASDAQ:VRTX) announced it was abandoning its phase 2 AATD candidate. ARO-AAT works by reducing the liver's production of the mutant alpha-1 antitrypsin (Z-AAT) protein, the cause of progressive liver disease in AATD patients. The candidate is in the middle of the phase 2 SEQUOIA trial.

VRTX

Vertex shares drop 13% after abandoning phase 2 drug for rare genetic disorder (updated)

Jason Butcher/Cultura via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) is abandoning further development of VX-864 for alpha-1 antitrypsin deficiency ("AATD") aS the treatment benefit seen in a phase 2 study is "unlikely to translate into substantial clinical benefit." Shares of Vertex are down 13% to $188.50 in after-hours trading. Compared to placebo, patients on VX-864 saw statistically significant increases in mean functional alpha-1 antitrypsin (fAAT) levels of 2.2 to 2.3 micromolar from baseline in AATD with the PiZZ genotype across the three dosage groups tested. AATD refers to a lack of a protein made by the liver that can impact the functioning of the liver or lungs. Vertex said that as a result of the setback, it will focus on other small molecule collectors.

VRTX

Healthcare gainers for the week led by CLOV's meme-stock fever, CureVac falls on delay in regulatory approval for COVID vaccine

Healthcare sector and Healthcare Select Sector SPDR ETF (XLV) gained 1.92% and 1.76% respectively during the week outpacing S&P 500 gain of +0.40%. Looking at larger stocks (over $2B market capitalization), far and away the sector's top gainer was "meme stock" Clover Health (NYSE:CLOV), ended the week 67% higher, bringing it around a $5.85B market cap. Clover Health Investments +67%. BofA downgraded the stock on valuation after the stock gained 145% in the first two trading days of the week. Biogen (BIIB) +38.6%. Stock rallied 38% on Monday following the news of FDA approval for its Alzheimer's disease treatment Aduhelm (aducanumab). Some analysts have contrasting views on the commercial success of the therapy. SA contributor Lane Simonian remarks on how the FDA Got It Wrong In Approving Biogen's Aducanumab For Alzheimer's Disease. Apollo Medical Holdings (AMEH) +30.9%. Shares gained on inclusion into the S&P SmallCap 600 index. IOVA +30.9%. The company announced 33-month follow up data for lifileucel in advanced melanoma at ASCO21. JMP raises Iovance to market outperform on ASCO data. Karuna Therapeutics (KRTX) +23.8%. The week's top five decliners among healthcare stocks ($2B market cap or more): CureVac (NASDAQ:CVAC) fell 15.7% amid reports of a potential delay in Europe in granting regulatory approval for the company’s COVID-19 vaccine candidate. The European Medicines Agency is not expected to make a decision on its approval before August, Reuters reported. IBEX (IBEX) -13.2%. The company announced HIV clinical pipeline during the week. Organon (OGN) -13.1%. Merck spin-off, Organon began regular trading on NYSE on 3rd June. The company snapped a four-day slide on June 10, gaining 6.6%, after a bullish call from Evercore ISI. Morgan Stanley initiated coverage with a recommendation of equal weight and set PT of $33. Vertex Pharmaceuticals (VRTX) -8%. Shares fell to 52-week low of $193 on Friday on news of abandoning development of VX-864 for alpha-1 antitrypsin deficiency ("AATD"), However, analysts at Barclays, Citi, and Bernstein continue to back Vertex and see the share price pullback as a potential buying opportunity. In another development, FDA OKs expanded use of Vertex's Trikafta in children with cystic fibrosis. I-Mab (IMAB) -8%. Cantor raised PT to $90 citing potential of uliledlimab. H.C. Wainwright's Aaron Fein reiterates his buy rating and $75 PT after data from a phase 1 study of uliliedlimab for advanced solid tumors showed signs of efficacy.

VRTX

Vertex's TRIKAFTA gets Health Canada nod to treat certain patients with cystic fibrosis

Vertex Pharmaceuticals (NASDAQ:VRTX) announces that Health Canada has granted Marketing Authorization for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of certain patients with cystic fibrosis (CF). The approval allows for the use of TRIKAFTA in people 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. The health regulator's decision was based on study results from multiple late-stage trials of the drug. Cystic fibrosis is a rare, life-shortening genetic disease affecting more than 80K people globally. The FDA had approved expanded use of Trikafta to include children with CF ages 6 through 11 years with certain mutations, earlier this month.

VRTX

Vertex Pharma authorizes $1.5 billion share back program

Melpomenem/iStock via Getty Images Vertex Pharmaceuticals (VRTX -0.7%) is trading marginally higher today after the company announced that its board of directors authorized the repurchase of $1.5B of common stock in a buyback program running through the end of 2022. Per the terms, Vertex is set to repurchase shares from time to time on the open market or through privately negotiated transactions subject to general business and market conditions, according to the regulatory filing. As indicated in the graph, Vertex shares have lost more than a third over the past year well underperforming the broader market. Early this month, the shares dropped to a 52-week low in reaction to the company’s decision to abandon the development of VX-864 for alpha-1 antitrypsin deficiency ("AATD"). However, several Wall Street analysts including those from Barclays and Citi defended Vertex highlighting its cystic fibrosis (CF) franchise.

VRTX

Vertex initiated at Raymond James, Altimmune price target lowered, and more in analyst action

naphtalina/iStock via Getty Images Vertex initiated as market perform at Raymond James Raymond James has initiated Vertex Pharmaceuticals (VRTX +2.5%) with a market perform rating. The firm says while shares may appear overly discounted, there is little potential for near-term upside. In addition, the company faces headwinds in its cystic fibrosis portfolio from competition from Abbvie (ABBV +0.7%). PT lowered on Altimmune after pulling the plug on COVID candidate JMP Securities is maintaining its market perform rating on shares of Altimmune (ALT +3.2%) despite the company abandoning its COVID-19 vaccine, AdCOVID. However, the firm is lowering its price target to $31 from $53. Analyst Jonathan Wolleben writes that the company can now focus on ALT-801, the company's candidate for nonalcoholic steatohepatitis ("NASH"), which just reported positive results from an interim analysis of a phase 1 trial. Efficacy, safety of Abbvie's Rinvoq in UC positive BofA Securities analyst Geoff Meacham views the recent data from a late-stage study of Abbvie's (ABBV +0.6%) Rinvoq (upadacitinib) as positive and is reiterating his neutral rating and $113 price target. However, he says negative headlines, as well as potential restrictions and expanded warnings for JAK inhibitors could be a headwind for the drug class. Bernstein's Ronny Gal also viewed the data favorably, as adverse events and discontinuation rates were similar across treatment arms and the placebo arm. Beauty Health Co. a buy at Goldman Sachs Goldman Sachs has initiated shares of Beauty Health Co. (SKIN +6.8%) with a buy rating and a $31 price target (85% upside). The firm sees the company's HydraFacial product as "driving a growing moat" for its new skin health category. Seelos Therapeutics initiated with a buy at Guggenheim Guggenheim Securities has initiated shares of Seelos Therapeutics (SEEL +11.7%) with a buy rating and a $8 price target (203% upside). The company is bullish on Seelos' lead candidate, SLS-002 (intranasal racemic ketamine), for acute suicidal ideation and behavior. The company gives the candidate 60% probability of success in its phase 2 trial. Data on that trial, which could be sufficient for an FDA filing, is expected in 1H 2022. If approved, Guggenheim says SLS-002 could achieve $450M in peak sales.

VRTX

Biotech M&A may heat up with potential targets Horizon Therapeutics, Arrowhead Pharma, analyst says

janiecbros/E+ via Getty Images Biotech M&A is poised to heat up again as shares of the SPDR S&P Biotech’s (NYSEARCA:XBI) have fallen about 25% from their February highs, according to Jefferies. Biotech deals may pick up after a 3-6 month of a large "drawdown" and as prices "normalize" for sellers, according to Jefferies analyst Michael Yee. With "big pharma and biotech flush w/ cash may go after targets now that prices appear to have settled (>$500B of cash in the Russell 3000 HC cos now)," Yee wrote in a note on Friday. Typically, after a 3-6 month correction, pharmaceuticals companies begin to return to deal making and it's also possible that this year pharma may look to deals fearing an FTC in a Biden administration that may put more scrutiny on biotech transactions. Yee also highlighted that so far this year that there only have been two deals for more than $3B including Jazz Pharmaceuticals' (NASDAQ:JAZZ) $7.2B acquisition of GW Pharmaceuticals (NASDAQ:GWPH) and Horizon Therapeutics (NASDAQ:HZNP) purchase $3.05B purchase of Viela Bio (VIE). He also points out that there have been four transactions under $2B, including two in cancer and two in autoimmune. The deals include MorphoSys's (NASDAQ:MOR) planned purchase of Constellation Pharmaceuticals (NASDAQ:CNST), which is scheduled to close this week, and Amgen's (NASDAQ:AMGN) $1.9B acquisition of Five Prime Therapeutics (NASDAQ:FPRX). "Our analysis of biotech M&A suggests Big Pharma tends to acquire during upswings, and certainly after significant pullbacks," Yee wrote. Big M&A occurred during the upswings of Jan 2013-July 2015, Feb 2016-Aug 2018, and Dec 2018-Jan 2021, according to Yee, while M&A "virtually dried up" during stretches of correction between July 2015-Jan 2016 and Aug-Dec 2018. Yee sees AbbVie (NYSE:ABBV), Merck (NYSE:MRK) and Vertex (NASDAQ:VRTX) as potential acquirers, while Gilead (NASDAQ:GILD) has said a large deal in the near term is unlikely, though the company still wants to be active in M&A. Yee's list of potential M&A targets for 2021-2022 in order of market cap include: Horizon Therapeutics (HZNP) Intellia Therapeutics (NASDAQ:NTLA) Fate Therapeutics (NASDAQ:FATE) Arrowhead Pharmaceuticals (NASDAQ:ARWR) Ultragenyx Pharmaceutical (NASDAQ:RARE) TG Therapeutics (NASDAQ:TGTX) Allakos (NASDAQ:ALLK) Iovance (NASDAQ:IOVA) Pacira BioSciences (NASDAQ:PCRX) ALX Oncology (NASDAQ:ALXO) Protagonist Therapeutics (NASDAQ:PTGX) Morphic Holding (NASDAQ:MORF) Deciphera Pharmaceuticals (NASDAQ:DCPH) Phathom Pharmaceuticals (NASDAQ:PHAT) Olema Pharmaceuticals (NASDAQ:OLMA) Ocular Therapeutix (NASDAQ:OCUL) Ardelyx (NASDAQ:ARDX) Epizyme (NASDAQ:EPZM) Rigel Pharmaceuticals (NASDAQ:RIGL) Albireo Pharma (NASDAQ:ALBO) Kadmon (NASDAQ:KDMN) Also see, Biotech M&A could soon pick up following slow 2021 start - Jefferies.

VRTX

Vertex initiates mid-stage trial of VX-548 in acute pain following bunionectomy surgery

Vertex Pharmaceuticals (NASDAQ:VRTX) announces that it has begun a Phase 2 proof-of-concept study in acute pain following bunionectomy surgery with the selective NaV1.8 inhibitor VX-548. The company also expects to commence a second mid-stage study in acute pain following abdominoplasty surgery in the coming weeks. The studies are randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty surgery. The primary endpoint in both studies is the time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48). Vertex expects to post results from the bunionectomy study in the first quarter of 2022. Shares down nearly 1% premarket.

VRTX

Vertex to initiate Phase 3 program in H2 for new triple combination regimen in cystic fibrosis

Vertex Pharmaceuticals (NASDAQ:VRTX) plans to initiate a Phase 3 development program for the new once-daily investigational triple combination of VX-121/tezacaftor/VX-561 (deutivacaftor) in H2 2021. The combination of VX-121/tezacaftor/VX-561 was first identified as having potential for increased efficacy based on its ability to drive higher levels of chloride transport compared to TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in human bronchial epithelial cells in vitro. The combination was evaluated in a Phase 2 study in people with cystic fibrosis (CF). The regimen was generally well-tolerated, and the study met the primary efficacy endpoint. These data suggest the triple combination holds the potential to restore CF transmembrane conductance regulator (CFTR) function in people with CF to even higher levels than seen with other Vertex CFTR modulators and thereby provide enhanced clinical benefit.

VRTX

Vertex Pharmaceuticals Q2 2021 Earnings Preview

Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q2 earnings results on Thursday, July 29th, after market close. The consensus EPS Estimate is $2.36 (-9.6% Y/Y) and the consensus Revenue Estimate is $1.73B (+13.8% Y/Y). Analysts estimate Kalydeco revenue of $179.5M. Over the last 2 years, VRTX has beaten EPS estimates 88% of the time and has beaten revenue estimates 100% of the time. Over the last 3 months, EPS estimates have seen 11 upward revisions and 5 downward. Revenue estimates have seen 13 upward revisions and 2 downward. Vertex had reported first-quarter results that beat Wall Street estimates, driven by the performance of its cystic fibrosis therapy TRIKAFTA, on April 29. Seeking Alpha contributor Chetan Woodun, earlier this month, said that the company is underestimated, and argued that Vertex has "a rich pipeline of clinical developments". The company's shares have lost more than 14% in value year to date. Earlier this month, Raymond James initiated coverage on Vertex with a market perform rating and said that "while shares may appear overly discounted, there is little potential for near-term upside".

VRTX

CRISPR anticipates filing of lead candidate CTX001 in 18 to 24 months

Meletios Verras/iStock via Getty Images CRISPR Therapeutics (CRSP +3.2%) anticipates a regulatory filing on CTX001, a gene editing therapy in development for β-thalassemia and sickle cell disease, within the next 18 to 24 months. CRISPR made the announcement in a business update yesterday as part of its quarterly earnings. The company says more than 45 patients have been dosed with CTX001 across two trials and enrollment should be completed by the end of the year. CRISPR is partnered with Vertex Pharmaceuticals (VRTX +0.4%) on CTX001. In addition, the company plans to report additional phase 1 data this year on CTX110, a chimeric antigen receptor T cell ("CAR-T") therapy targeting CD19 for relapsed or refractory B-cell malignancies. CRISPR also expects to release top-line phase 1 data from two trials by the end of the year on CTX130, which is under development for solid tumors and certain hematologic malignancies.

VRTX

CRISPR's Q2 earnings beat thanks to $900M upfront payment from Vertex

Bill Oxford/iStock via Getty Images CRISPR Therapeutics' (CRSP +3.3%) Q2 2021 earnings beat yesterday was due to a $900M upfront payment the company received last month from Vertex Pharmaceuticals (VRTX +0.4%) as part of their collaboration on CTX001. CTX001 is a gene editing therapy in development for β-thalassemia and sickle cell disease. Q2 GAAP EPS of $9.44 beat by $5.59 while revenue of $900M beat by $483.6M. Thanks to the Vertex payment, net income was $759.2M in Q2, compared to a net loss of $79.7M in Q2 2020. A closer look at CRISPR's balance sheet found that total overall operating expenses in Q2 were $138.1M, a 71% YoY increase. R&D expenses surged 82% from Q2 2020 to $108.3M. In June, CRISPR and Vertex presented new data on CTX001 in 22 patients.

VRTX

CRISPR up ~5% after hours after massive Q2 2021 earnings beat

PhonlamaiPhoto/iStock via Getty Images Shares of CRISPR Therapeutics (NASDAQ:CRSP) rose ~5% after-hours after reporting a blowout Q2 2021 that easily beat Street expectations. Q2 GAAP EPS of $9.44 beat by $5.59 while revenue of $900M beat by $483.6M. CRISPR was buoyed in the quarter by a $900M payment from Vertex (NASDAQ:VRTX) as part of their collaboration on CTX001. CRISPR ended the quarter with $2.59B in cash at the end of Q2, compared to to $1.81B at the end of Q1.

VRTX

Vertex posts Q2 earnings beat, raises FY product revenue forecast

naphtalina/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) reported second-quarter results that beat Wall Street estimates and raised its product revenue forecast for the year. The company's quarterly revenue rose nearly 18% to $1.79B, beating analysts' estimate by $60M. Vertex's revenue performance was primarily driven by the uptake of KAFTRIO in Europe and continued strong performance of TRIKAFTA in the U.S. Net product revenues in the second quarter of 2021 increased 4% to $1.26B in the U.S. and increased 71% to $536M outside the U.S., compared to the second quarter of 2020. The company also hiked its FY product revenue forecast to a range of $7.2B to 7.4B from prior range of $6.7B to 6.9B. Cash, cash equivalents and marketable securities were $6.71B compared with $6.66B as of December 31, 2020. The company also reported adjusted quarterly profit of $3.11, beating analysts' estimate by 75 cents. Shares up marginally post market. Previously (July 29): Vertex Pharmaceuticals EPS beats by $0.75, beats on revenue.

VRTX

Vertex Pharmaceuticals EPS beats by $0.75, beats on revenue

Vertex Pharmaceuticals (NASDAQ:VRTX): Q2 Non-GAAP EPS of $3.11 beats by $0.75; GAAP EPS of $0.26 misses by $0.43. Revenue of $1.79B (+17.8% Y/Y) beats by $60M. Phase 3 study of next-in-class triple combination for CF to begin in the second half of 2021; multiple additional clinical milestones across the pipeline expected in the next 6 to 9 months. Raised 2021 Guidance: Product revenues $7.2 to 7.4 billion; Combined GAAP R&D and SG&A expenses $3.8 to 3.95 billion; Combined Non-GAAP R&D and SG&A expenses $2.25 to 2.3 billion; Non-GAAP effective tax rate 21% to 22%. Press Release

VRTX

Vertex names Stuart Arbuckle as chief operating officer

goir/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) announces that Stuart Arbuckle has been appointed as the company’s Executive Vice President, Chief Operating Officer (COO), effective immediately. Arbuckle has served as Vertex’s Executive Vice President and Chief Commercial Officer since 2012 and expanded his role to include oversight of operations earlier this year. He has more than 30 years of experience leading global sales and marketing efforts at biopharmaceutical companies, including at Amgen and GlaxoSmithKline.

VRTX

Vertex insiders spend millions of dollars in purchases as stock underperforms

sihuo0860371/E+ via Getty Images The CEO of Vertex Pharmaceuticals (VRTX +1.6%) Reshma Kewalramani has raised her bet on the company a little further with the purchase of 10,000 shares. On August 19, Kewalramani has made the insider transaction valued at ~$1.9M to increase her stake to ~73.8K shares, according to a regulatory filing submitted by Vertex (NASDAQ:VRTX) on Monday. Kewalramani’s bet on the company trails that of director Bruce Sachs who bought 15,000 company shares on August 02, at a total value of ~$3.0M raising his stake to ~41.2K shares. As indicated in the graph, Vertex (VRTX) has lost more than 17% in the year so far to underperform the boarder market. However, both Wall Street and Seeking Alpha authors agree over the bullish prospects of the company that mainly focuses on therapeutics for cystic fibrosis.

VRTX

Vertex and Arbor Biotechnologies ink potential $1.2B collaboration agreement

4X-image/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) and Arbor Biotechnologies have signed a collaboration to develop ex vivo engineered cell therapies, using Arbor’s proprietary CRISPR gene-editing technology for select diseases. Under the terms of the agreement, Arbor will receive an upfront cash payment and is eligible to receive up to $1.2B in potential milestone payments. The new agreement between Arbor and Vertex builds upon the companies’ first partnership established in 2018. Under the new deal, Vertex will receive rights to use Arbor’s technology to research and develop ex vivo engineered cell therapies. In addition, Vertex will pay tiered royalties on future net sales on any products that may result from this collaboration. Vertex will also make an investment in Arbor in the form of a convertible note.

VRTX

Health Canada approves Vertex's Kalydeco in pediatric cystic fibrosis indication

SDI Productions/E+ via Getty Images Health Canada has granted Marketing Authorization for Vertex Pharmaceuticals' (NASDAQ:VRTX +1.0%) Kalydeco for use in certain children with cystic fibrosis (CF). The approval allows for the use of the drug in children as young as four months of age who have at least one of certain specific mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene. The label update is based on data from a cohort in the 24-week Phase 3 open-label safety study (ARRIVAL) consisting of six children with CF ages four months to less than six months who have eligible gating mutations. The European Commission had granted approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco, to include the treatment of CF in certain patients ages 6 years and older, in November last year.

VRTX

Vertex slides as Morgan Stanley cuts rating on competitive threat from AbbVie

Zerbor/iStock via Getty Images Vertex Pharmaceuticals (VRTX -2.5%) is trading lower in morning hours after the analysts at Morgan Stanley downgraded their recommendations on the stock to underweight from equal-weight. The analyst Matthew Harrison expects that Vertex (NASDAQ:VRTX) to have a limited upside potential given the emergence of the competitive threat from AbbVie (NYSE:ABBV) with its efforts in cystic fibrosis. Citing upcoming data from AbbVie, the firm thinks it is unlikely for Vertex (VRTX) to rerate higher despite its market leadership in the cystic fibrosis space with a high bar for competitive barriers to new entrants. The price target unchanged at $202 per share implies a premium of ~2.0% to the last close. Read: In 2018, AbbVie took over the full development and commercial rights for the cystic fibrosis program from its partner Galapagos.

VRTX

Vertex Pharma extends downtrend as Stifel paints bearish view

naphtalina/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) is set to end lower for the fourth straight session after Stifel downgraded the stock to hold from buy. While backing the bullish case that the company’s cystic fibrosis (CF) franchise supports its current valuation, the analyst takes a deeper dive into a few of its major pipeline assets, namely VX-147 and the clinical program for type 1 diabetes (T1D) led by VX-880. VX-147 is targeted at reducing proteinuria in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS). “We view each as interesting but still very high risk,” the analyst wrote with skepticism about the potential of the drugs to address a market opportunity that is significant enough for the stock as CF grows to ~$9B-10B. The price target at $213 implies a premium of ~11.3% to the last close. In 2020, Vertex (VRTX) generated $6.2B in net product revenue.

VRTX

Vertex ends agreement with Molecular Templates for conditioning regimens

perets/E+ via Getty Images Molecular Templates (NASDAQ:MTEM) disclosed that Vertex Pharmaceuticals (NASDAQ:VRTX) had terminated a Master Collaboration Agreement signed between the two companies to develop conditioning agents that could enhance the hematopoietic stem cell transplant process. The end of the deal will take effect on Oct. 29. As part of the agreement, Vertex (VRTX) paid Molecular Templates (MTEM) $38M as an upfront payment, including the equity investments. Molecular Templates (MTEM) was also eligible to receive ~$23M if Vertex (VRTX) exercised an option to license engineered toxin body products or add an extra target. In addition to tiered mid-single digit royalties based on net sales, the company was also entitled to receive up to $250M payments linked to development, regulatory and sales milestones. The agreement signed in 2019 was targeted at developing new conditioning regimens to replace chemotherapy, required in conditioning regimens for treating hemoglobinopathies such as sickle cell disease and beta-thalassemia.

VRTX

Vertex early phase 1/2 data shows promise for type 1 diabetes stem cell therapy

towfiqu ahamed/iStock via Getty Images Data from the first person dosed with VX-880, Vertex Pharmaceuticals' (NASDAQ:VRTX) pancreatic islet cell replacement therapy for people with type 1 diabetes, showed a 91% decrease in daily insulin requirements. The result was seen after a single infusion and at half of the target dose. The patient was also receiving immunosuppressive therapy. Results also showed that the patient exhibited strong improvement in glucose control. The phase 1/2 study of VX-880, which has Fast Track designation, was launched in March.

VRTX

Vertex-Mammoth team up to develop in vivo gene-editing therapies

Andy/iStock via Getty Images Vertex Pharmaceuticals (VRTX -0.1%) will use Mammoth Biosciences next-generation CRISPR systems to develop in vivo gene-editing therapies for two genetic diseases. Mammoth’s CRISPR platform consists of a proprietary toolbox of novel, ultracompact Cas enzymes, including Cas14 and Casɸ. Under the agreement, Mammoth Biosciences will receive upfront payments of $41M, including an investment in the form of a convertible note, and is eligible to receive up to $650M in potential future milestone payments across two potential programs. Vertex will also pay royalties on future net sales on any products that may result from the collaboration.

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Health Canada accepts Vertex NDA supplement for Trikafta for cystic fibrosis in children

Zerbor/iStock via Getty Images Health Canada has accepted a supplement to an NDA submitted by Vertex (NASDAQ:VRTX -1.3%) for the cystic fibrosis medicine Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for in children ages 6-11 years old. The supplement has also been granted Priority Review. Vertex said it will also submit the indication to the Canadian Agency for Drugs and Technologies in Health and the Institut national d'excellence en santé et en services sociaux in Quebec for health technology assessments. In June, Health Canada granted marketing authorization to Trikafta to patients 12 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.

VRTX

Vertex Pharmaceuticals Q3 2021 Earnings Preview

Vertex Pharmaceuticals (NASDAQ:VRTX) is scheduled to announce Q3 earnings results on Tuesday, November 2nd, after market close. The consensus EPS Estimate is $3.05 (+15.5% Y/Y) and the consensus Revenue Estimate is $1.86B (+20.8% Y/Y). Recently, Health Canada accepted a supplement to an NDA submitted by Vertex for the cystic fibrosis medicine Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for in children ages 6-11 years old. In August, Seeking Alpha contributor Khaveen Investments called Vertex a "cystic fibrosis leader with lean operating model", and said that the company's long-term growth is expected to be driven by diversification to other rare diseases. Vertex reported second-quarter results that beat Wall Street estimates and raised its product revenue forecast for the year, in July. Over the last 2 years, VRTX has beaten EPS estimates 88% of the time and has beaten revenue estimates 100% of the time. Over the last 3 months, EPS estimates have seen 13 upward revisions and 3 downward. Revenue estimates have seen 16 upward revisions and 1 downward. The company's shares have fallen more than 21% year to date.

VRTX

Vertex Pharma sets guidance ahead of consensus as revenue growth picks up

CharlieAJA/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) has added ~2.3% in the post-market after the company reported better than expected financials for Q3 2021 and raised the full year guidance ahead of expectations. Driven by cystic fibrosis therapies, TRIKAFTA/KAFTRIO, total revenue climbed ~29% YoY to reach ~$2.0B, better than the ~18% YoY growth recorded in Q2 2021. The company attributed the outperformance to a successful launch of KAFTRIO in Europe and strong sales of TRIKAFTA in the U.S., including favorable uptake among children aged 6-11 years. Net income rose ~28% YoY to ~$851.9M, while cash, cash equivalents, and marketable securities added ~5% from 2020 year-end to reach $6.9B. On the R&D front, the company expects Phase 2 clinical results for VX-147 before the end of the year. The proof-of-concept study is designed to evaluate VX-147 for the treatment of people with APOL1-mediated focal segmental glomerulosclerosis. Meanwhile, data from the Phase 2 acute pain program for VX-548 is expected in Q1 2022. "Our financial performance in the third quarter was outstanding, marked by the exceptional continued growth of TRIKAFTA/KAFTRIO,” remarked CEO Reshma Kewalramani. “Based on these results, we are again raising our 2021 product revenue guidance, and we see significant additional growth ahead as we continue to deliver this transformational medicine to more people with CF." For 2021, Vertex (VRTX) has raised the revenue guidance to $7.4B – $7.5B from the previous estimate of $7.2 – $7.4B. However, the consensus estimates indicate only ~$7.3B in revenue for the company in 2021.

VRTX

Vertex Pharmaceuticals EPS beats by $0.51, beats on revenue

Vertex Pharmaceuticals (NASDAQ:VRTX): Q3 Non-GAAP EPS of $3.56 beats by $0.51; GAAP EPS of $3.28 beats by $0.77. Revenue of $1.98B (+28.6% Y/Y) beats by $120M. Press Release Broad pipeline advancing with recent progress marked by unprecedented VX-880 clinical results in T1D; Phase 2 clinical results for VX-147 expected this quarter and for VX-548 in Q1 2022. Cash, cash equivalents and marketable securities were $7.0 billion, an increase of $0.3 billion compared to $6.7 billion as of December 31, 2020. Company raises full-year 2021 guidance for product revenues to $7.4 to $7.5 billion.

VRTX

Vertex gets positive EMA opinion for label extension of Kaftrio combo in cystic fibrosis

Zerbor/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) announces that the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the label extension of the combination of Kaftrio and ivacaftor for the treatment of cystic fibrosis (CF). The expanded label is for the use of the combination in CF patients ages 6 through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The combination is already approved in the EU for the treatment of CF in patients ages 12 years and older who have at least one copy of the F508del mutation in the CFTR gene. CF is a rare, life-shortening genetic disease affecting more than 83,000 people globally.

VRTX

Piper Sandler downgrades Vertex to neutral on slowing cystic fibrosis growth

ozgurdonmaz/E+ via Getty Images Piper Sandler has downgraded Vertex (VRTX -1.4%) to neutral on unfavorable risk-reward as AbbVie (ABBV -0.6%) develops a cystic fibrosis candidate currently in phase 2. The firm has also lowered its price target to $218 (~18% upside). Analyst Do Kim says that while his estimates assume that Vertex will dominate cystic fibrosis sales -- reaching $11B in peak sales -- "we expect the competitor overhang and slowing CF growth to limit near-term upside." One of Vertex's top-selling drugs is the cystic fibrosis treatment Trikafta. He adds that "shares reflect a lack of confidence in pipeline assets after disappointing [alpha-1 antitrypsin deficiency] data." Vertex abandoned development of VX-864 in June following disappointing phase 2 results.

VRTX

Vertex gains 5% on positive VX-147 data in mid-stage focal glomerular sclerosis study

Natali_Mis/iStock via Getty Images Vertex Pharmaceuticals (NASDAQ:VRTX) perks up 5.2% premarket after announcing that, in a Phase 2 proof-of-concept study in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), VX-147 on top of standard of care achieved a statistically significant, substantial and clinically meaningful mean reduction of 47.6% in the urine protein to creatinine ratio at Week 13 compared to baseline. VX-147 was well tolerated. A total of 16 patients were enrolled in the study. There were no treatment discontinuations due to adverse events (AEs), and there were no serious AEs considered related to study drug. Based on these results, Vertex plans to advance VX-147 into pivotal development in APOL1-mediated kidney disease, including FSGS, in Q1 2022. Last month, Vertex secured positive EMA opinion for label extension of Kaftrio combo in cystic fibrosis.

VRTX

Cathie Wood sells a large stake of ARK’s holdings to raise cash for annual ETF distributions

Alena Zharava/iStock via Getty Images Cathie Wood, CEO and CIO of ARK Invest, and her team sold a large portion of their holdings across five of their actively managed ETFs according to daily public transaction records on Monday. ARK clarified in their trade notice that was sent out that “All transaction activity today [12/27/2021] was for purposes of raising cash for the 2021 annual ETF distribution. This cash raise activity has been completed.” ARK Innovation ETF (NYSEARCA:ARKK), which is ARK’s flagship fund, liquidated positions in 43 stocks with the most significant selling positions in Palantir Technologies (NYSE:PLTR), UiPath (NYSE:PATH), and Robinhood Markets (NASDAQ:HOOD). ARKK sold 150K shares of PLTR, 90K shares of PATH, and 81K shares of HOOD. See below for a complete breakdown of ARKK's positions that were sold on Monday. ARK Next Generation Internet ETF (NYSEARCA:ARKW) also dumped a sizable amount of shares across 40 stocks, with Nano Dimension (NASDAQ:NNDM) losing the most at 140K shares, Vuzix Corporation (NASDAQ:VUZI) dropping 130K shares, and Twitter (NYSE:TWTR) losing 113K shares. ARK Autonomous Technology & Robotics ETF (BATS:ARKQ), ARK Genomic Revolution Multi-Sector ETF (BATS:ARKG), and ARK Fintech Innovation ETF (NYSEARCA:ARKF) combined to only dispose of five stocks led by Vertex Pharmaceuticals (NASDAQ:VRTX) with 41K shares. Year-to-date price action: ARKK -21.7%, ARKW -14.1%, ARKQ +3.4%, ARKG -33.2%, and ARKF -15.9%. Cathie Wood gets ready for 2022 after a difficult 2021 but lets her investors know that she believes her strategies can deliver a 30-40% compound annual rate of return during the next five years.

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Why did Intellia soar in 2021 while other gene editing stocks faltered? CRISPR in humans

PhonlamaiPhoto/iStock via Getty Images Gene therapy-focused biotechs are engaged in the development of some of the most cutting-edge treatments. Yet only one has had a standout year: Intellia Therapeutics (NTLA +0.7%). While its peers are all in the red for the year, as of yesterday, Intellia shares are up a whopping 120% year to date. What was the secret to Intellia's success? In June, the company demonstrated that its CRISPR candidate was able to genetically edit cells inside the liver. This is considered a major breakthrough and its shares immediately soared. None of Intellia's peers had this kind of development advancement, and as a result, they have languished. Intellia's breakthrough may place it ahead of competitors. In June, Seeking Alpha contributor Dan Schrack, who is very bullish on Intellia, said that "NTLA-2001 has the potential to be considered a medical cure to a previously fatal disease." That disease is transthyretin amyloidosis ("ATTR"). Intellia has both in-vivo and ex-vivo candidates in its pipeline, though there are more in the former. Several of its in-vivo candidates are partnered with Regeneron Pharmaceuticals (REGN +0.5%), an alliance that could help with research -- and funding -- in the future. Topping the list of worst performing gene editing stocks is Editas Medicine (EDIT +0.4%), down ~60% YTD. The company's lead candidate is EDIT-101, in preclinical stage for Leber Congenital Amaurosis 10 (LCA10), a genetic retinal disorder. With a neutral rating, contributor Jacob Braun today says the company "does not have a drug pipeline to warrant its current valuation." He has a neutral rating. The second worst is CRISPR Therapeutics (CRSP -0.0%), down ~50% YTD. The company made news in April with an amended development agreement with Vertex Pharmaceuticals (VRTX +0.3%) for CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia. Edmund Ingham, a contributor, recommended buying a recent dip in CRISPR shares on the promise of the Vertex collaboration. Apelllis Pharmaceuticals (APLS -0.9%) is also down double digits YTD. Beam Therapeutics (BEAM -0.5%) and Caribou Biosciences (CRBU -1.8%) are down single digits, though Caribou had its IPO in July.

VRTX

Cathie Wood’s healthcare picks gain as Ark funds buy the dip

JuSun/iStock via Getty Images A group of beaten-down healthcare stocks that includes Teladoc (TDOC +5.7%) and CRISPR Therapeutics (CRSP +3.9%) has made a comeback as 2021 draws to a close after ETFs run by notable fund manager Cathie Wood added their stocks into portfolios. According to 24/7 Wall St., several ARK funds, including ARK Genomic Revolution ETF (BATS:ARKG), and ARK Innovation ETF (NYSEARCA:ARKK), have added ~146.8K shares of Teladoc (NYSE:TDOC) in total, making it their largest healthcare pick on Wednesday. CRISPR Therapeutics (NASDAQ:CRSP), Signify Health (SGFY +5.6%), Invitae (NVTA +8.4%), and Berkeley Lights (BLI +8.2%) were among some of the other notable purchases of ARK Invest yesterday. All these stocks have dropped in value in the year so far, sharply underperforming the broader market, as shown in this graph. However, Ark funds have trimmed their holdings on Vertex Pharmaceuticals (VRTX +0.1%) and 10x Genomics (TXG +5.5%), both of which have traded relatively flat over the year.