GILD
Gilead Sciences, Inc.NASDAQ
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  • Today, 9:43 AM
    • Gilead Sciences (GILD -1.2%) files a New Drug Application (NDA) with the FDA seeking approval of its once-daily pan-genotypic single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced patients with chronic hepatitis C virus (HCV) infection.
    • The intended regimen is 12 weeks in DAA-experienced patients with HCV genotypes 1-6 infection without cirrhosis or with compensated cirrhosis. The principal data supporting the submission was generated in two Phase 3s: POLARIS-1 and POLARIS-4. Data from POLARIS-2 and POLARIS-3 also contributed.
    | Today, 9:43 AM | 61 Comments
  • Today, 7:30 AM
    • Philip van Doorn and team at Marketwatch put together a list of 18 S&P 500 names with consensus sell-side price targets at least 30% above the current price.
    • Ten of the 18 stocks are in healthcare, which has been roughed up by a combination of Obamacare, Clinton's talk about drug pricing (back when all thought she would be the next POTUS), and now Trump joining in the bashing.
    • The list (in order of possible upside): Mallinckrodt PLC (NYSE:MNK) - 56% potential upside, Endo International PLC (NASDAQ:ENDP) - 52% upside, Hanesbrands (NYSE:HBI) - 45% upside, Edwards Lifesciences (NYSE:EW) - 44% upside, Mylan (NASDAQ:MYL) - 42% upside, Allergan (NYSE:AGN) - 39% upside, Alexion (NASDAQ:ALXN) - 37% upside, Activision Blizzard (NASDAQ:ATVI) - 35% upside, Salesforce.com (NYSE:CRM) 34% upside, NRG Energy (NYSE:NRG) - 34% upside, Centene (NYSE:CNC) 34% upside, Gilead (NASDAQ:GILD) 33% upside, Facebook (NASDAQ:FB) 32% upside, Boston Scientific (NYSE:BSX) - 32% upside, Pitney owes (NYSE:PBI) - 32% upside, Molson Coors (NYSE:TAP) - 30% upside, Newell Brands (NYSE:NWL) - 30% upside, Zimmer Bioment (NYSE:ZBH) - 30% upside.
    | Today, 7:30 AM | 25 Comments
  • Mon, Nov. 28, 7:11 AM
    • Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC initiates an open-label Phase 2b study assessing the combination of simeprevir, odalasvir and JNJ-4178 (AL-335) in treatment-naive and treatment-experienced patients with chronic hepatitis C virus infection genotypes 1,2,4,5 and 6 without cirrhosis.
    • Subjects will receive the triple combination for either six or eight weeks. The primary endpoint is the percentage of patients who achieve clinical cure (SVR12) at the end of treatment. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is August 2017. The estimated study completion date is October 2017.
    • An ongoing Phase 2b study is evaluating the triple combo regimen in HCV patients with or without compensated cirrhosis.
    • Simeprevir (Olysio) is an NS3/4 protease inhibitor. Odalasvir is an NS5A inhibitor. JNJ-4178 (AL-335) is a novel uridine nucleotide analog polymerase inhibitor.
    • Related tickers: (NASDAQ:GILD)(NYSE:ABBV)
    | Mon, Nov. 28, 7:11 AM | 12 Comments
  • Fri, Nov. 18, 1:17 PM
    • Thinly traded nano cap GlobeImmune (GBIM -32.4%) slumps on increased volume in the news that Gilead Sciences (GILD -1.4%) has returned HBV therapeutic vaccine candidate GS-4774 to the company.
    • It also announced changes in executive management: CEO Timothy Rodell has resigned, but remains a board member; C. Jeffery Dekker has been appointed President, Secretary and Treasurer and has been named to the board and board members J. William Freytag, Augustine Lawlor, Dan Mitchell and S. Edward Torres have resigned.
    • And finally, the company has terminated its lease for the 40K square feet of office space that served as its headquarters, laboratory and manufacturing site.
    • In July, GlobeImmune filed for voluntary delisting from the Nasdaq Capital Market.
    | Fri, Nov. 18, 1:17 PM | 6 Comments
  • Fri, Nov. 18, 11:13 AM
    • Barron's Ben Levisohn reports that Gilead Sciences (GILD -1.3%) has a range of attractive candidates should it decide to spend some its $32B cash hoard on an acquisition, a virtual certainty after the recent momelotinib disappointment.
    • Considering the company's stated interest in oncology, obvious choices are Incyte (INCY -1.1%) and TESARO (TSRO -3%).
    • Venturing out into the rare disease space, Alexion Pharmaceuticals (ALXN -1.6%), Vertex Pharmaceuticals (VRTX -1.6%) and BioMarin Pharmaceutical (BMRN -1.1%) are attractive fare.
    • None of these companies are a surprise to biotech followers. All have been noted as buyout targets for some time now.
    | Fri, Nov. 18, 11:13 AM | 36 Comments
  • Thu, Nov. 17, 3:07 PM
    • Echoing Piper's Josh Schimmer, Leerink's Michael Schmidt also believes Gilead's (GILD -0.8%) stumble with momelotinib makes Incyte (INCY +4.9%) an attractive acquisition target since Gilead's candidate is no longer a potential risk to Jakafi sales, Incyte's top seller. He has an Outperform rating on the stock and has raised the price target to $115 (9% upside) from $101.
    | Thu, Nov. 17, 3:07 PM | 11 Comments
  • Thu, Nov. 17, 11:53 AM
    • Barron's Ben Levisohn reports that Gilead Sciences' (GILD -0.9%) pipeline stumbles are actually bullish for investors, citing Piper Jaffray's view that the company's development setbacks should force it into a "value-creating science overhaul" including a pipeline reset and M&A transactions.
    • Piper's team says Gilead's modest 6x forward P/E undervalues the HIV franchise and implies no new value creation (e.g., M&A). They chide management for being slow to realize the inevitability of acquisitions to build out its pipeline.
    | Thu, Nov. 17, 11:53 AM | 16 Comments
  • Thu, Nov. 17, 8:35 AM
    • Leerink Partners analyst Geoffrey Porges believes Incyte (NASDAQ:INCY) is, again, on Gilead Sciences' (NASDAQ:GILD) short list of acquisition targets after momelotinib failed to beat Jakafi in a late-stage study. Gilead is widely known to be looking for an acquisition to boost growth.
    • Mr. Porges says the combined company would still overlap in filgotinib and baricitinib but Incyte's passive role in the development and commercialization of baricitinib should not affect filgotinib's prospects very much.
    • INCY is up 5% premarket.
    | Thu, Nov. 17, 8:35 AM | 10 Comments
  • Thu, Nov. 17, 8:27 AM
    • Incyte (NASDAQ:INCY) is up 5% premarket on light volume on the heels of yesterday's announcement that Gilead Sciences' (NASDAQ:GILD) momelotinib failed to best Jakafi (ruxolitinib) in a late-stage myelofibrosis study. GILD is off a fraction on light volume as well.
    | Thu, Nov. 17, 8:27 AM | 5 Comments
  • Wed, Nov. 16, 4:48 PM
    • Two Phase 3 clinical trials, SIMPLIFY-1 and SIMPLIFY-2, assessing Gilead Sciences' (NASDAQ:GILD) Janus kinase (JAK) inhibitor momelotinib compared to ruxolitinib [Incyte's (NASDAQ:INCY) Jakafi] or best alternative therapy (BAT) in patients with myelofibrosis produced different outcomes.
    • SIMPLIFY-1 met its primary endpoint of non-inferiority to ruxolitinib for splenic response rate at week 24 (SRR24) defined as the percentage of patients achieving at least a 35% reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; p=0.011).
    • SIMPLIFY-2 failed to meet its primary endpoint of superiority compared to BAT in patients previously treated with ruxolitinib as measured by SRR24 (momelotinib: 6.7%; BAT: 5.8%; p=0.90). 88% of the patients randomized to the BAT arm continued to receive ruxolitinib while the remainder received chemo, interferon, corticosteroids, other therapies or a combination thereof.
    • Detailed results will be presented at a future scientific conference.
    • Shares are down a fraction after hours.
    | Wed, Nov. 16, 4:48 PM | 29 Comments
  • Mon, Nov. 14, 6:41 PM
    • Results from an open-label Phase 2 clinical trial assessing Gilead Sciences' (NASDAQ:GILD) selonsertib (GS-4997) alone or combination with simtuzumab (SIM) in patients with nonalcoholic steatohepatitis (NASH) and moderate-to-severe liver fibrosis (stages F2 or F3) showed a treatment effect favoring the combination. The data were presented at The Liver Meeting 2016 in Boston, MA.
    • Four measures of liver disease were assessed in three groups of patients: those receiving selonsertib 18 mg with/without SIM; selonsertib 6 mg with/without SIM and SIM alone. There were no differences observed between the combination and selonsertib alone.
    • The proportions of subjects experiencing at least one stage improvement in fibrosis in the three groups were 43% (n=13/30), 30% (n=8/27) and 20% (n=2/10), respectively.
    • The proportions that progressed to cirrhosis were 3% (n=1/30), 7% (n=2/27) and 20% (n=2/10), respectively.
    • The proportions that experienced at least a 15% reduction in liver stiffness were 20% (n=5/25), 32% (n=7/22) and 0% (n=0/7), respectively.
    • The proportions that experienced at least a 30% reduction in liver fat were 26% (n=8/31), 13% (n=3/24) and 10% (n=1/10), respectively.
    • Headache, nausea and sinusitis were the most common selonsertib-related adverse events.
    • The treatment effect of SIM was not enough for Gilead. The company recently terminated its development in NASH.
    | Mon, Nov. 14, 6:41 PM | 36 Comments
  • Sun, Nov. 13, 8:33 PM
    • Results from three Phase 2 clinical trials assessing Merck's (NYSE:MRK) MK-3682B (MK-3682/grazoprevir/ruzasvir) for the treatment of chronic hepatitis C virus (HCV) infection showed virologic cure (SVR12) rates as high as 100%. The data were presented at The Liver Meeting 2016 in Boston, MA.
    • In patients with HCV genotypes 1a, 1b, 2 and 3 treated with MK-3682B with and without ribavirin (RBV) for eight weeks, the cure rates were 93% (n=39/42); 98% (n=45/46); 86% (n-54/63) and 95% (n=98/103), respectively.
    • The same categories of patients treated with MK-3682B with/without RBV for 12 weeks showed cure rates of 98% (n=47/48); 100% (n=40/40); 97% (n=60/62) and 97% (n=155/159), respectively.
    • In HCV genotypes 2 and 3 treated with MK-3682B with/without RBV for 16 weeks, the cure rates were 100% (n=26/26) and 96% (n=72/75), respectively.
    • In the HCV-3 cohorts, 28%, 36% and 81% of the 8-week, 12-week and 16-week groups, respectively, were previously treated with peginterferon/RBV.
    • The most common adverse events (AEs) in patients receiving at least one dose of MK-3682B with/without RBV were headache (22%), fatigue (19%) and nausea (13%). There were two serious treatment-related AEs, both attributed to RBV only. There were nine discontinuations due to AEs, four from RBV only. One patient died due to AEs unrelated to the study drug.
    • MK-3682B is a fixed-dose combination of an NS5B polymerase inhibitor (MK-3682), an NS3/4A protease inhibitor (grazoprevir) and an NS5A inhibitor (ruzasvir).
    • Clinical development of MK-3682B is ongoing.
    • Related tickers: (NASDAQ:GILD)(NYSE:ABBV)(NYSE:JNJ)
    | Sun, Nov. 13, 8:33 PM | 50 Comments
  • Fri, Nov. 11, 8:21 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Gilead Sciences' (NASDAQ:GILD) Vemlidy (tenofovir alafenamide, TAF) 25 mg for the treatment of adults and adolescents (at least 12 years old and 35 kg body weight) with chronic hepatitis B virus (HBV) infection. The data in the application supports the use of Vemlidy in treatment-naive and treatment-experienced adults and adolescents who are e antigen (HBeAg)-positive and HBeAg-negative.
    • A final decision from the European Commission usually takes ~60 days.
    • Vemlidy was OK'd in the U.S. yesterday for use in adults.
    | Fri, Nov. 11, 8:21 AM | 16 Comments
  • Thu, Nov. 10, 1:26 PM
    • The FDA approves Gilead Sciences' (GILD -1.2%) Vemlidy (tenofovir alafenamide)(TAF) 25 mg for the treatment of adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. The agency's action date (PDUFA) was November 11.
    • TAF has similar efficacy to TDF [Viread (tenofovir disoproxil fumarate)] but at 1/10 the dose so it is less stressful on the kidneys and bones.
    | Thu, Nov. 10, 1:26 PM | 42 Comments
  • Wed, Nov. 9, 8:08 AM
    • Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
    • Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN+3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
    | Wed, Nov. 9, 8:08 AM | 48 Comments
  • Mon, Nov. 7, 5:18 PM
    • Mizuho initiates Gilead (NASDAQ:GILD) at Buy. PT of $88. Implied upside 19%.
    • "While Gilead is no longer a favorite among biotech investors and has lost much of its fan club, we like the stock on valuation."
    • Not yet a "table-pounding" buy, but believes GILD will execute over long-term to the benefit of its investors.
    | Mon, Nov. 7, 5:18 PM | 26 Comments