“We are reiterating our Buy rating on AMRN shares after the FDA confirmed the Nov. 14th adcom date for Vascepa’s sNDA. Therefore, we’d expect in the near-term, some type of communication from the agency/company about a delay to the upcoming Sept. 28, 2019 PDUFA, which was originally granted for Vascepa’s sNDA. The next regulatory catalyst will likely be the adcom briefing docs, which will be very important in understanding the FDA’s view on the REDUCE-IT data, expected ~48 hours before the adcom. In terms of timing, as we have previously highlighted, we think this cadence likely pushes out a potential Vascepa sNDA approval to late this year or early 2020. Overall, we remain bullish ahead of the adcom based on our previous research & regulatory checks and ultimately believe Vascepa’s sNDA to include CV risk reduction in patients with TG>135mg/dL and other CV risk factors will be approved.”
According to TipRanks.com, Archila is ranked 0 out of 5 stars with an average return of -10.1% and a 29.7% success rate. Archila covers the Healthcare sector, focusing on stocks such as DBV Technologies SA – American, Madrigal Pharmaceuticals Inc, and NGM Biopharmaceuticals Inc.
Amarin has an analyst consensus of Strong Buy, with a price target consensus of $33.17, implying a 107.6% upside from current levels. In a report issued on September 9, Citigroup also maintained a Buy rating on the stock.
Based on Amarin’s latest earnings release for the quarter ending June 30, the company reported a quarterly GAAP net loss of $1.81 million. In comparison, last year the company had a GAAP net loss of $33.79 million.
Based on the recent corporate insider activity of 69 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of AMRN in relation to earlier this year. Last month, John Thero, the President & CEO of AMRN bought 191,997 shares for a total of $300,010.
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Amarin Corp. Plc is a biopharmaceutical company, which focuses on the commercialization and development of therapeutics for cardiovascular health. Its product development program leverages its experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. It has developed and markets Vascepa capsules through wholesale.