Amarin Announces FDA Notification of Advisory Committee Meeting Planned to be Held in November 2019 in Connection With Vascepa® REDUCE-IT™ sNDA
Amarin Corporation plc - American Depositary Shares (AMRN)
Last amarin corporation plc - american depositary shares earnings: 4/30 05:00 am
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Source: GlobeNewswire
PDUFA Date Extension to End of December 2019 Expected Management to Host Conference Call Today at 7:00 p.m. ET BEDMINSTER, N.J. and DUBLIN, Ireland, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced today that it received notice today from the U.S. Food and Drug Administration (FDA) that the FDA plans to hold an advisory committee meeting (AdCom), tentatively scheduled for November 14, 2019, in connection with its review of the pending supplemental new drug application (sNDA) for expansion of Vascepa® (icosapent ethyl) labeling based on the REDUCE-IT™ cardiovascular outcomes study. Before this communication, the FDA had been silent as to whether it would convene an AdCom in connection with its review of the REDUCE-IT sNDA. The FDA expressed, based on the timing of its recent decision to convene an AdCom, that November 14th is the earliest date on which it could hold an AdCom due t
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News
- Amarin to Report First Quarter 2026 Financial Results and Host Conference Call on April 29, 2026GlobeNewswire
- American College of Cardiology (ACC) Scientific Sessions 2026 Underscore the Need for Complementary Therapies Including Icosapent Ethyl (IPE) in Treatment of Elevated Triglycerides and Cardiovascular Risk ReductionGlobeNewswire
- Amarin (AMRN) was upgraded by Zacks Research from "hold" to "strong-buy".MarketBeat
- Amarin Highlights Guideline Recommended Role of Icosapent Ethyl in Managing Cardiovascular Risk Following Release of Updated 2026 ACC/AHA/Multisociety Dyslipidemia GuidelineGlobeNewswire
- New REDUCE-IT Data in Patients at Extreme Cardiovascular Risk and In Vitro Research on the Mechanistic Effects of Eicosapentaenoic Acid (EPA) on Lipoprotein(a) [Lp(a)] Oxidation to be Presented at the American College of Cardiology’s (ACC) Annual ScientifGlobeNewswire
AMRN
Earnings
- 10/29/25 - Beat
AMRN
Sec Filings
- 4/2/26 - Form 4
- 3/2/26 - Form 10-K
- 2/25/26 - Form 8-K
- AMRN's page on the SEC website