Mon, Sep. 12, 11:00 AM
Mon, Sep. 12, 9:15 AM
Mon, Sep. 12, 7:10 AM
- Amarin (NASDAQ:AMRN) eases 6% premarket on average volume in response to its announcement that its cardiovascular (CV) outcomes study, REDUCE-IT, evaluating whether Vascepa (icosapent ethyl) reduces CV events in patients with elevated triglyceride levels and other CV risk factors despite being on stabilized statin therapy, will continue as planned. The decision was based on the recommendation of the independent Data Monitoring Committee after its review of the first pre-specified interim efficacy analysis.
- Per the study protocol, the first interim analysis was performed after 60% of the target 1,612 aggregate primary CV events occurred in the 8,175-subject study. The second interim analysis will be done when 80% of the target aggregate CV events have occurred, projected to happen in mid-2017. The database will be locked and the study stopped at this point or at the final analysis, projected to be at the end of 2017.
- Vascepa (AMR101) consists of one gram of the omega-3 acid know as EPA in ethyl-ester form. The company says it is not fish oil, but derived from fish. It is currently approved in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with hypertriglyceridemia (>= 500 mb/dL).
- Shares have quadrupled since bottoming at $0.78 on November 11, 2014.
Thu, Aug. 11, 11:00 AM
Thu, Aug. 11, 10:28 AM
Thu, Aug. 11, 9:15 AM
Wed, Aug. 10, 5:35 PM
Wed, Aug. 10, 5:30 PM
- Amarin (NASDAQ:AMRN) is down 10% after hours on robust volume in response to its announcement that it has initiated a public offering of American Depositary Shares pursuant to a shelf registration. Price, volume and terms have yet to be released.
- Update: The company priced its offering of 21M ADSs at $2.85. Closing date is August 16.
Thu, Aug. 4, 10:21 AM
- Amarin (AMRN -7.2%) Q2 results: Revenues: $33.1M (+87.0%); R&D Expense: $12.6M (+5.0%); SG&A: $26.1M; Operating Loss: ($14.4M) (+46.1%); Net Loss: ($13.4M) (+78.7%); Loss Per Share : ($0.07) (+80.0%); Non-GAAP Loss Per Share: ($0.09) (+40.0%); Quick Assets: $72.5M (-32.2%).
- 2016 Guidance: Net Product Revenue: $112M - 125M.
Thu, Aug. 4, 9:16 AM
- Gainers: CBMX +31%. OCUL +27%. ALIM +18%. GV +18%. SQ +17%. DRAM +16%. XPO +14%. PCRX +12%. FHCO +11%. EPE +10%. EXEL +8%. APHB +7%. SSYS +7%. GOGO +6%. EVOK +5%. TSEM +5%.
- Losers: SGMO -25%. TDOC -21%. INOV -17%. KOOL -13%. SEAS -10%. QUIK -9%. IMGN -9%. CF -8%. AMRN -8%. TRIP -8%. CRC -6%. USCR -6%.
Thu, Aug. 4, 7:08 AM
Wed, Aug. 3, 5:30 PM
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Wed, Jun. 8, 7:46 AM
- Watson Laboratories (NYSE:AGN) filed a motion for voluntary dismissal with the U.S. Court of Appeals yesterday requesting the termination of its appeal of a district court ruling favoring Amarin (NASDAQ:AMRN) related to patent infringement of Vascepa (icosapent ethyl). Amarin sued Watson when it filed an abbreviated New Drug Application (ANDA) seeking approval of a generic version of the product.
- Watson filed the motion following the FDA grant of five-year new chemical entity exclusivity for Vascepa on May 31.
Tue, May 31, 1:54 PM
- Micro cap Amarin (AMRN +7%) is up on double normal volume in response to its announcement that the FDA has determined that Vascepa (icosapent ethyl) capsules are eligible for five-year new chemical entity (NCE) marketing exclusivity under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. The NCE exclusivity will be in effect from the date of FDA approval, July 26, 2012 until July 26, 2017.
- In addition, there is a statutory 30-month stay triggered by patent litigation (the company is automatically notified when a would-be generic competitor files its Abbreviated New Drug Application with the FDA which, in turn, automatically results in patent infringement litigation which triggers the automatic 30-month stay while the patent challenge runs its course) that potentially extends Vascepa's marketing exclusivity to January 26, 2020.
- Vascepa accounted for almost all (99%) of the company's Q1 revenue of $25.5M.
Fri, May 13, 11:35 AM
- Prothena (PRTA +7.6%) initiated with Overweight rating and $60 (44% upside) price target by Barclays.
- Pfizer (PFE +0.5%) initiated with Hold rating and $38 (12% upside) price target by Berenberg.
- Amarin (AMRN +1.9%) initiated with Buy rating and $3.50 (111% upside) price target by Jefferies.
- Align Technology (ALGN +0.9%) initiated with Outperform rating and $84 (10% upside) price target by Credit Suisse.
- Presbia (LENS +2.9%) initiated with Buy rating and $14 (254% upside) price target by Rodman & Renshaw.
- LabStyle Innovations (OTCQB:DRIO +5.4%) initiated with Buy rating and $12 (121% upside) price target by Rodman & Renshaw.
- Juno Therapeutics (JUNO +1.5%) initiated with an Outperform rating and $55 (48% upside) price target by Cowen & Co.
- WebMD Health (WBMD +0.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target increased to $75 (18% upside) from $57.
- Sanofi (SNY +0.3%) upgraded to Overweight from Equal Weight by Barclays. Price target maintained at €84 (20% upside).
- Depomed (DEPO +4.1%) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $19 (4% upside) from $18.
Thu, May 5, 10:26 AM
- Amarin (AMRN -7.2%) Q1 results: Revenues: $25.5M (+60.4%); R&D Expense: $13.7M (+8.7%); SG&A: $28M (+13.4%); Operating Loss: ($23.1M) (+14.4%); Net Loss: ($29.8M) (+6.9%); Loss Per Share: ($0.16) (+11.1%); Non-GAAP Loss Per Share: ($0.14) (+12.5%); Quick Assets: $81.4M (-23.9%); CF Ops: ($24.8M) (-96.8%).
- 2016 Guidance: Net Product Revenue: $105M - 120M (unch).