Amarin Corp Plc (AMRN)

[G550driver]

BUY
Price $16.03 (intraday, 9/11/19)
COMPANY UPDATE
Summary
Amarin Corporation PLC
AMRN– NASDAQ
September 11, 2019 Biotechnology Vascepa AdCom Date On The Books; We Remain Bullish Into
The Event
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