Thu, Nov. 12, 6:03 PM
- The FDA has approved a label expansion for Harvoni, Gilead Sciences' (GILD -2.8%) tablet treatment for chronic hepatitis C.
- The drug got an OK for expanded use in patients with genotypes 4, 5, and 6 chronic HCV infection as well as in patients co-infected with HIV.
- An alternate therapy of Harvoni plus ribavirin for 12 weeks (vs. 24 weeks of Harvoni) was also approved for treatment-experienced genotype 1 patients with cirrhosis.
- The genotypes 4-6 application was supported by data from trials 1119 and ELECTRON-2, while the HIV co-infection application was supported by data from the ION-4 study.
Wed, Oct. 21, 1:22 PM
Mon, Oct. 5, 7:42 AM
- Thinly traded nano cap Contravir Pharmaceuticals (NASDAQ:CTRV) announces preliminary data showing its investigational lipid prodrug of tenofovir, CMX157, is 60 times more active against the hepatitis B virus (HBV) than Gilead Sciences' (NASDAQ:GILD) Viread (tenofovir disoproxil fumarate) in preclinical studies. The company says the profound difference in potency gives CMX157 the potential to offer significant improvements over Viread in safety and side effects. It says CMX157 can potentially reduce off-target toxicity by virtue of its enhanced absorption technology which utilizes the natural lipid uptake pathway to target the liver, which lowers its systemic exposure compared to tenofovir.
- It plans to file an Investigational New Drug (IND) application with the FDA this quarter and initiate a Phase 2 study in HBV in 2016.
- CMX157 is a novel lipid acyclic nucleoside phosphonate (same class as tenofovir) that delivers high intracellular concentrations of tenofovir diphosphate. Contravir says in vitro studies have also demonstrated that CMX157 is more than 200x more active against all major HIV subtypes than Viread.
- Viread generated almost $1.1B in sales for Gilead the past four quarters.
- CTRV is up 81% premarket but only on 1,000 shares.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sun, Sep. 27, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Fri, Sep. 25, 3:07 PM
- A sharply lower healthcare sector (XLV -3%) has dragged the S&P 500 (SPY -0.2%) into the red and the Nasdaq (NASDAQ:QQQ) down a full 1%. The Dow (DIA +0.4%) remains higher, courtesy of a post-earnings 9% moonshot in Nike.
- Biotechs (IBB -5.7%) and Pharmaceuticals (XPH -5.9%) are hardest hit, continuing to feel the pressure from Hillary Clinton's assault on drug-pricing. Gilead (GILD -2.5%), Biogen (BIIB -3.5%), Celgene (CELG -5.4%), Amgen (AMGN -3.6%), Allergan (AGN -4%), Mylan (MYL -5.6%).
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Thu, Sep. 24, 9:05 AM
- Arrowhead Research (NASDAQ:ARWR) is up 35% premarket on robust volume in response to its announcement of positive top-line results in a Phase 2a clinical trial, called Heparc-2001, assessing its RNAi-based therapeutic candidate, ARC-520, for the treatment of chronic hepatitis B infection. The company will present the data this morning at 11:00 am ET at its analyst day in NY.
- HBV patients who were E-antigen positive (HBeAg-positive) who were on entecavir therapy [Bristol-Myers Squibb's (NYSE:BMY) BARACLUDE] who received a single 4 mg/kg dose of ARC-520 showed a mean maximal 92% (1.2 log) reduction in circulating HBeAg and a best reduction of 98% (1.7 log). Similar knockdowns were also observed in HBV core-related antigen (HBcrAg) from both E-antigen-positive and -negative patients.
- In treatment-naive HBeAg-positive patients, the best peak reduction in surface antigen (HBsAg) was 99% (1.9 log). The mean maximum HBsAg knockdown was 1.05 log through 15 days post-ARC-520 treatment. Data collection is ongoing and will be continued through Day 85 post-ARC-520 treatment.
- About 95% of people with chronic HBV infection have not been treated with nucleoside/nucleotide (NUC) analogue therapy. About half of these are believed to be HBeAg-positive. Patients testing positive for HBV antigens have an active infection. About 350M people worldwide are chronically infected with hep B.
- Related ticker: (NASDAQ:GILD)
Thu, Sep. 17, 7:59 AM
- Interim results from a Phase 2 clinical trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor odalasvir (ACH-3102), in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir), without ribavirin, in HCV-1 patients showed a 100% cure rate (SVR12) in HCV-1 patients (n=6/6) after six or eight weeks of treatment.
- The Phase 2 trial was an open-label, randomized, partial-crossover study to assess the safety, tolerability and efficacy of six or eight weeks of odalasvir and sofosbuvir, without ribavirin, in patients with HCV-1 infection. Eighteen patients were initially enrolled, including six as observational (group 1). Twelve patients completed eight weeks of treatment (50 mg odalasvir/400 mg sofosbuvir) while the observational group received nothing. All twelve subjects achieved SVR24. Following this phase, the six observational patients plus six additional patients (group 2) received six weeks of treatment with the same combo regimen. All achieved SVR24. Six additional rollover patients (group 3) were treated for six weeks with the combo regimen and all achieved SVR12.
- In a summary that is a bit confusing, the company states that 18 subjects (groups two and three) achieved SVR12 after six weeks of therapy, although it states that only group 3 (n=6) achieved this. Also, the total number of patients in groups 2 and 3 is 12 (6 + 6). Group 1 (n=6) is apparently included as well?
- In May, the company inked a global license and commercialization deal with Janssen Pharmaceuticals (NYSE:JNJ) for HCV products containing one or more of Achillion's HCV assets, including odalasvir, ACH-3422 and sovaprevir.
- Previously: Achillion inks collaboration deal with J&J's Janssen Pharmaceuticals in hep C (May 19)
- ACHN is up 5% premarket on light volume.
- Related tickers: (NYSE:MRK) (NYSE:BMY) (NYSE:ABBV)
Mon, Aug. 17, 4:33 PM
- Major stock indexes rebounded from opening declines to finish modestly higher, after a solid housing report showed some strength on a lightly traded Monday.
- Homebuilding stocks paced gainers, including Toll Brothers (TOL +2.3%); Ryland (RYL +2.1%); KB Home (KBH +3.1%), Lennar (LEN +2.7%) and Taylor Morrison Home (TMHC +2.9%).
- The S&P 500 gained 0.5% to 2,102.44; for 2015, it's up 2.12%. The move up came despite a grim reading from New York manufacturing that sent bond yields lower. TLT +0.5%; TBT -0.8%.
- Volumes overall were about 20% below recent average.
- Sector gains were broadly distributed, with a flat energy sector as the laggard. Healthcare stocks performed well, paced by dollar volume leaders Gilead Sciences (GILD +0.7%), Johnson & Johnson (JNJ +1.1%) and Biogen (NASDAQ:BIIB) +1.1%.
Tue, Jun. 16, 2:12 PM
- Receptos (NASDAQ:RCPT) has jumped, +4.4%, to $182.35 on chatter that Wedbush has raised its price target on the stock to $348 and says a takeover is coming.
- The company has been subject to takeover speculation, including suitors like AstraZeneca (NYSE:AZN) talking about a $200/share bid, as well as Teva (NYSE:TEVA) and Gilead (NASDAQ:GILD) discussing $280/share bids.
Wed, May 27, 8:30 AM
- A Phase 2 clinical trial evaluating GlobeImmune's (NASDAQ:GBIM) GS-4774, a therapeutic vaccine candidate for hepatitis B infection, failed to achieve its primary efficacy endpoint of demonstrating a reduction in hepatitis B surface antigen (HBsAg) at week 24 in patients treated with the highest dose of GS-4774 plus ongoing antiviral therapy (OAV) compared to OAV alone. There was a slight increase in viral knockdown in the test group at week 48 but the difference was not statistically significant.
- The 178-subject, randomized, open-label study was designed to assess three different doses of GS-4774 in combination with ongoing oral antiviral therapy in patients with chronic HBV infection whose disease was under control with OAV. The analysis of the data and characterization of the T cell response to GS-4774 and its relationship to HbsAg changes are ongoing.
- GS-4774 is exclusively licensed to Gilead Sciences (NASDAQ:GILD).
- The data will be presented at a future medical conference and will be submitted for publication.
- GBIM shares are down 62% premarket on light volume. GILD is up a fraction premarket also on light volume.
Mon, Feb. 9, 7:34 AM
- All of the patients in a 12-subject Phase 2 trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) ACH-3102 (50 mg) plus Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) (400 mg) in treatment-naive HCV-1 patients achieved sustained viral response for 12 weeks (SVR12) after the completion of six weeks of therapy. The results included patients with high baseline viral load.
- Mean baseline viral load was 10M (7 log10) IU/ml, range 2M (6.23 log10) - 97M (7.99 log10) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6M (6.78 log10) IU/ml. Seven patients were genotype 1a and 5 were genotype 1b.
- 100% of patients (12/12) also achieved SVR24.
- Achillion CMO Dr. David Apelian says, "The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports out belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration. We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sofosbuvir, for treatment-naive genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."
- ACHN is up 12% premarket on higher-than-normal volume.
Wed, Feb. 4, 9:13 AM
Tue, Feb. 3, 4:26 PM
- Gilead Sciences (NASDAQ:GILD) Q4 results ($M): Total Revenues: 7,314 (+134.4%); COGS: 1,063 (+24.0%); R&D Expense: 1,045 (+104.3%); SG&A Expense: 876 (+86.0%); Net Income: 3,462 (+337.5%); EPS: 2.18 (+363.8%).
- Gross Profit: 6,251 (+176.3%); COGS: 14.5% (-33.3%); Gross Margin: 85.5% (+17.9%); Operating Earnings: 4,330 (+238.3%); Operating Earnings Yield: 59.2% (+44.3%); Net Earnings Yield: 47.3% (+86.6%).
- Sales by product: Harvoni: 2,107; Sovaldi: 1,732 (+999%); Atripla: 925 (-0.9%); Truvada: 897 (+10.2%); Compera/Eviplera: 348 (+32.9%); Stribild: 385 (+88.9%); Viread: 311 (+16.5%); Letairis: 181 (+30.7%); Ranexa: 144 (+10.9%).
- 2015 Guidance: Net Product Sales: $26B - 27B; Non-GAAP Gross Margin: 87 - 90%; R&D Expense: $3.0B - 3.3B; SG&A Expense: $3.0B - 3.3B; Effective Tax Rate: 18 - 20%; Diluted impact of certain items: $0.82 - 0.87.
Tue, Feb. 3, 4:07 PM
Wed, Jan. 7, 8:50 AM
- Thinly-traded nano cap Galectin Therapeutics (NASDAQ:GALT) is up 49% premarket on robust volume in response to its report of results from a 30-patient Phase 1 study of GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH).
- The principal objective of the trial was to assess the safety, tolerability and pharmacokinetics of GR-MD-02 but investigators also noted a potential therapeutic effect on fibrosis as measured by a serum biomarker (FibroTest) and liver stiffness (FibroScan). Patients in cohort 3 who received 8 mg/kg GR-MD-02 showed a statistically significant reduction in FibroTest score versus placebo in one of the cohorts.
- Fibrotest is a composite score of six blood tests that correlate to the extent of liver fibrosis.
- NASH represents the next big potential payoff for drug firms after HCV.
- Previously: Galectin NASH treatment meets primary endpoint in Phase 1 (Nov. 10, 2014)
- NASH-associated tickers: (NASDAQ:GILD) (NASDAQ:SHPG) (NASDAQ:LJPC) (NASDAQ:CNAT) (NASDAQ:ICPT) (NASDAQ:RPTP)
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