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%.
Yesterday, 4:26 PM
- Amarin (NASDAQ:AMRN) Q4 results ($M): Revenues: 16.5 (+63.5%); Operating Expenses: 30.8 (-20.8%); Net Loss: (19.7) (-27.6%); Loss Per Share: (0.11) (+59.3%); Quick Assets: 119.5 (-37.6%).
- Vascepa revenue of $16.5M represented a sequential increase of 17.0% versus Q3. Prescriptions were up 11% sequentially and 55% compared to a year ago.
- Patient enrollment in the REDUCE-IT cardiovascular outcomes trial should be completed this year (8,000 subjects). The study will continue until the attainment of 100% of the 1,612 primary endpoint events which is estimated to happen in 2017 with results ready for publishing in 2018.
- The company does not expect a favorable decision from the FDA regarding its ANCHOR supplemental New Drug Application (sNDA) which had a PDUFA date of December 20, 2013. In September 2014, the agency denied the company's appeal of its decision to rescind the ANCHOR trial Special Protocol Assessment (SPA) and management decided not to appeal further.
- Shares are up 3% after hours on moderate volume.
Yesterday, 4:02 PM
Mon, Mar. 2, 5:35 PM
Thu, Feb. 26, 10:44 AM
- Long-suffering bulls are finally getting some encouraging action from Amarin (AMRN +15.1%). Shares are up 60% in three weeks.
- This morning, the company announced an exclusive agreement with Eddingpharm to commercialize Vascepa (icosapent ethyl) in China, Hong Kong, Macao and Taiwan. Under the terms of the contract, Amarin will receive an upfront cash payment of $15M, up to $154M in development, regulatory and sales-based milestones and tiered double-digit royalties on net sales that could reach the high teens.
Wed, Feb. 18, 10:38 AM
- Long-suffering bulls are finally getting some positive action from Amarin (AMRN +13.6%) after SunTrust Bank upgrades it to Buy from Neutral with a $6 price target.
- The stock sank as low as $0.78 (November 11) which was 96% below its late May 2011 peak of $19.87. Shares cratered in October 2013 after the FDA withdrew its Special Protocol Assessment (SPA) for Vascepa and a negative Ad Comm vote against an expanded label.
- Previously: Panel votes against label expansion for Amarin's Vascepa (Oct. 16, 2013)
- Previously: Amarin tumbles as FDA pulls SPA (Oct. 29, 2013)
Wed, Feb. 18, 9:15 AM
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
- Source: Press Release
Nov. 18, 2014, 12:49 PM
Nov. 18, 2014, 11:41 AM
- Amarin (AMRN +22.4%) is up again today on a 50% increase in volume as money flows into the stock in response to a presentation of new data and analyses from the Marine and Anchor Phase 3 Vascepa (icosapent ethyl) trials. Shares are now up 54% from the low of $0.78 on November 11.
- In a poster session at this week's American Heart Association meeting in Chicago, investigators, Dr. Christie M. Ballantyne presented data that showed the use of Vascepa significantly reduced remnant-like particle cholesterol (RLP-C) levels in patients with triglyceride levels between 200 mg/dL and 500 mg/dL compared to placebo, including patients on statin therapy.
- Vascepa reduced median RLP-C levels 29.8% (p=0.0041) in the Marine study and 25.8% (p=0.0001) in Anchor, both compared to placebo.
- RLP-C is an emerging risk factor for cardiovascular disease. It represents the cholesterol content of a subset of triglyceride-rich lipoproteins called remnants.
- Even with the recent rally, shares are down over 80% from October 2013.
Nov. 6, 2014, 4:03 PM
Nov. 5, 2014, 5:35 PM
- ABCO, ACET, AEL, AGO, AIRM, AL, ALIM, AMRN, ANAC, ANET, APEI, ARC, AUQ, BBRG, BCEI, BEBE, BNFT, BPZ, BRKR, BRS, CFN, CLVS, CPST, CSC, CVT, DAR, DIOD, DIS, DVA, DXCM, EAC, EBS, ECOM, ECPG, ED, EGOV, ELON, ENOC, ENV, EVC, EZPW, FF, FI, FICO, FIVN, FNGN, FSLR, FTEK, FWM, FXCM, GST, GXP, HCI, HGR, HNSN, HPTX, HTGC, IGT, INFI, JJSF, KING, KOG, KTOS, LGF, LNT, LOCO, MATX, MDRX, MDVN, MITK, MM, MNST, MNTX, MRC, MSCC, MTD, NES, NFG, NKTR, NOG, NU, NVDA, NVDQ, OLED, ONTY, PCTY, PFMT, PRO, PSEC, PSIX, QTWO, RBCN, RENT, RIG, ROVI, RPTP, RRMS, RSYS, RXN, SAPE, SF, SFM, SLXP, SPPI, SSTK, SWKS, TCRD, TKMR, TRMR, TRNX, TUMI, UBNT, UEPS, UNXL, VOLC, VRNS, VVC, WAGE, WIFI, XOMA, XOXO, YUME, ZGNX, ZNGA
Nov. 3, 2014, 2:37 PM
Sep. 30, 2014, 7:46 AM
- A 365-patient Phase 2 clinical trial evaluating the safety and efficacy of Acasti Pharmaceuticals' (NASDAQ:ACST) CaPre (highy purified omega-3 concentrate from krill oil) for the treatment of patients with hypertriglyceridemia met all primary and secondary endpoints.
- The trial was a randomized, placebo-controlled, double-blind, dose-ranging study designed to assess CaPre's safety and efficacy in reducing triglyceride levels in patients with mild-to-severe hypertriglyceridemia taking daily doses of 1 gram or 2 grams of CaPre or placebo over a 12-week period. Approximately 90% of the patients had baseline triglycerides between 200 and 499 mg/dL. The remainder had triglycerides between 500 and 877 mg/dL.
- The study met its primary endpoint of a statistically significant mean placebo-adjusted decrease in triglycerides from baseline to week 12. The CaPre 1 gram cohort showed a reduction of 36.4% and the CaPre 2 gram showed a reduction of 38.6%.
- There was a statistically significant decrease of 5.3% from baseline in non-HDL-C compared to placebo. There was a slight increase in HDL-C for both the 1 gram and 2 gram doses.
- Acasti expects complete results from the trial by the end of 2014. It plans to move forward with a Phase 3 trial and a regulatory submission for CaPre as a treatment for severe hypertriglyceridemia.
- Related tickers: (NASDAQ:NEPT) (NASDAQ:AMRN)
Sep. 12, 2014, 12:45 PM
Sep. 12, 2014, 9:21 AM
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