FDA Staff Flag Efficacy Concerns on Replimune's Skin Cancer Drug, Shares Plunge 20%
REPL has more than doubled off its 52-week low of $1.5.
Summary
FDA staff reviewers raised efficacy concerns on Replimune's RP1 drug for advanced melanoma ahead of the July 30 advisory committee meeting. Shares fell 19.7% premarket, reflecting serious doubts about approval prospects. This follows the FDA's acceptance of the BLA resubmission in June and comes as the company faces a going concern warning with cash only into Q1 2027. The negative staff briefing documents significantly increase the risk of a complete response letter, which would be devastating for a company with no approved products and a dwindling runway. The advisory committee vote on July 30 will be the next critical catalyst.
At the time of this announcement, REPL was trading at $6.81 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $724.6M. The 52-week trading range was $1.50 to $12.50. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Reuters.