Replimune Shares Hit All-Time Low After Second FDA Rejection, Analysts Downgrade
REPL sits 20% above its 52-week low of $1.5 on elevated volume (17× avg).
Summary
Replimune Group shares plummeted to an all-time low, trading down 61% to $1.86 and hitting $1.50 earlier, following the second FDA rejection of its lead drug candidate RP1 for advanced melanoma. This severe market reaction confirms the deep negative sentiment stemming from the FDA's Complete Response Letter, which was initially reported on April 10th via an 8-K filing and news. Analysts have since downgraded the stock and significantly cut price targets, citing no clear path forward for RP1's Ignyte study and substantial risk for the ongoing Phase 3 trial. The company had already announced job cuts and manufacturing scale-backs in response to the initial rejection. This development materially impacts Replimune's investment thesis, signaling profound uncertainty about its future drug development and commercialization prospects. Investors will closely watch for any updates on the company's strategy to address FDA concerns for the Phase 3 study and potential restructuring.
At the time of this announcement, REPL was trading at $1.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $393M. The 52-week trading range was $1.50 to $13.24. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: Dow Jones Newswires.