FDA Approves Replimune's Skin Cancer Drug After Two Prior Rejections
REPL has more than doubled off its 52-week low of $1.5.
Summary
Replimune secured FDA accelerated approval for TUDRIQEV (RP1) in advanced melanoma, its first commercial product. The approval follows two prior rejections and a positive 10-3 advisory committee vote on July 30. The IGNYTE trial showed a 24.2% objective response rate and median response duration of 14.1 months. This transforms the company from a pre-revenue biotech with a going concern warning and cash only into Q1 2027 to one with a marketed therapy. The approval is a major derisking event, though confirmatory trials are required. Shares fell 5% premarket, possibly on 'sell the news' or dilution concerns given the recent S-3/A shelf registration for 25.1M shares by Baker Brothers.
At the time of this announcement, REPL was trading at $12.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.1B. The 52-week trading range was $1.50 to $13.90. This news item was assessed with positive market sentiment and an importance score of 10 out of 10. Source: Benzinga.