Tue, Mar. 24, 4:06 PM
Thu, Mar. 12, 3:49 PM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) resubmitted New Drug Application (NDA) for daclatasvir in combination with Gilead's (GILD +0.8%) sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C (HCV) genotype 3. BMY amended the original NDA to include data from the Phase 3 ALLY-3 study which showed high cure rates for the regimen, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naive and 86% of treatment-experienced HCV-3 patients. The FDA will review the submission within a six-month time frame.
- HCV-3 is the second most common HCV genotype after HCV-1, affecting over 54M people worldwide compared to over 83M for HCV-1. HCV-3 is generally more aggressive and carries a higher risk of hepatocellular carcinoma (liver cancer).
- Daclatasvir is an nonstructural protein 5A (NS5A) replication complex inhibitor. The precise mechanism of action is unknown, but it is suspected that it deregulates the relationship between NS5A and intracellular HCV replication sites.
- Related tickers: (ABBV +2.4%)(MRK +0.1%)(ACHN +0.8%)(RGLS -3%)
Thu, Mar. 5, 9:20 AM
- Achillion Pharmaceuticals (ACHN -4.2%) Q4 results: Revenues: $0; R&D Expense: $16.4M (+62.4%); SG&A: $5.2M (+52.9%); Operating Loss: ($21.7M) (-60.7%); Net Loss: ($21.6M) (-61.2%); Loss Per Share: ($0.21) (-50.0%).
- FY2014 results: Revenues: $0; R&D Expense: $53.5M (+14.6%); SG&A: $15.9M (+25.2%); Operating Loss: ($69.4M) (-16.6%); Net Loss: ($69M) (-17.1%); Loss Per Share: ($0.70) (-11.1%); Quick Assets: $159.2M (+0.1%).
- 2015 Guidance: R&D Expenses: ~ $85M - 95M; Cash burn: ~ $100M - 110M; Net loss: ~ $0.95.
Thu, Mar. 5, 9:15 AM
Thu, Mar. 5, 7:21 AM
Wed, Mar. 4, 9:13 AM
- Gainers: IFON +44%. NVGN +44%. EFUT +36%. CNDO +27%. W +22%. ATOS +16%. PHMD +20%. ATHM +13%. NURO +12%. SWHC +10%. AMRN +9%. AEO +8%. AMBA +8%. CRMD +8%. SOL +7%. OREX +7%. TIVO +6%. EXAS +5%.
- Losers: CYCC -22%. BOBE -19%. TNET -16%. BV -16%. VEEV -15%. CYTX -8%. ANF -8%. ONCY -6%. ACHN -5%. FAST -5%.
Wed, Feb. 18, 4:48 PM
Thu, Feb. 12, 6:54 AM| Comment!
Wed, Feb. 11, 9:13 AM
Tue, Feb. 10, 4:26 PM
Mon, Feb. 9, 9:12 AM
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, 12:44 PM
Wed, Feb. 4, 12:03 PM
- Achillion Pharmaceuticals (ACHN -14.8%) feels Merck's pain from the FDA's decision to rescind BTD status from its HCV product candidate, dimming the prospects of accelerated reviews for Achillion's.
- Previously: Achillion reports positive interim results for HCV candidates (Dec. 22, 2014)
Wed, Feb. 4, 9:13 AM
Dec. 24, 2014, 9:12 AM
ACHN vs. ETF Alternatives
Achillion Pharmaceuticals Inc is a biopharmaceutical company which focuses on the discovery, development and commercialization of treatments for infectious diseases likehepatitis C virus, or HCV, infection that are once-daily and ribavirin-free.
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