Today, 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
Dec. 24, 2014, 9:01 AM| 3 Comments
Dec. 23, 2014, 12:45 PM
Dec. 23, 2014, 10:49 AM
- Biotech's negative money flow notwithstanding, investors shun Gilead Sciences (GILD -7.3%) and Achillion Pharmaceuticals (ACHN -17.5%) in light of AbbVie's (ABBV -2.5%) exclusive HCV deal with Express Scripts.
- Previously: Express Scripts/AbbVie HCV deal should not be surprising (Dec. 22)
Dec. 22, 2014, 7:24 AM
- In an open label Phase 2 proxy study, Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) achieved 100% SVR4 in 12 patients in six weeks, independent of baseline viral load, gender and IL28B status. SVR12 results will be reported in H1 2015. The combination therapy was well-tolerated with no serious adverse events reported.
- In a Phase 1 proof-of-concept study in treatment-naive HCV-1 patients, the company's nucleotide inhibitor, ACH-3422, demonstrated a mean maximum reduction in HCV viral RNA load of 4.8 log10 IU/mL within 14 days at a dose of 700 mg (once daily for 14 days). Three of six patients achieved undetectable HCV RNA (<10 IU/mL).
- The company will conduct a conference call this morning at 8:30 am ET to discuss the results.
- Shares are up 62% premarket on robust volume.
Nov. 21, 2014, 8:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of AbbVie's (NYSE:ABBV) Viekirax (a combination of ombitasvir, paritaprevir and ritonavir) plus Exviera (dasabuvir), with or without ribavirin, for patients with chronic HCV genotype 1 infection and Viekirax only, with ribavirin, for patients with HCV genotype 4 infection. A final decision by the European Commission usually takes about 60 days.
- The FDA tagged Viekirax a Breakthrough Therapy and granted priority review of AbbVie's NDA in June.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:CNAT) (NASDAQ:ACHN)
- Previously: Enanta declines HCV drug co-development option with AbbVie
- Previously: AbbVie presents HCV/HIV and liver transplant HCV data
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