FDA Panel Backs Replimune's RP1, Shares Double Premarket
REPL has more than doubled off its 52-week low of $1.5 on elevated volume (2.4× avg).
Summary
An FDA advisory committee voted 10-3 in favor of approving Replimune's RP1 for advanced melanoma, a surprising reversal after FDA staff raised efficacy concerns earlier this week. The stock is up ~128% premarket to $12.44, recovering from a 38% drop on Tuesday when briefing documents questioned the drug's effectiveness. This follows the panel vote reported last night, but the premarket surge reflects fresh conviction as traders price in a likely FDA approval by the August 2 target action date. Replimune, which has a going concern warning and cash only into early 2027, desperately needs this approval to unlock revenue and financing options. The FDA usually follows advisory panel recommendations, though it is not bound by them.
At the time of this announcement, REPL was trading at $12.22 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $454.2M. The 52-week trading range was $1.50 to $12.50. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.