Shares of uniQure (NASDAQ:QURE) climbed roughly 20% on Friday after Replimune Group said it had reached agreement with the U.S. Food and Drug Administration on a pathway to resubmit its Biologics License Application for RP1 used with nivolumab to treat advanced melanoma.
Replimune reported a sharp market response as its stock rose about 70% on the news. The company told investors that, following collaborative communications with the FDA, it intends to resubmit the RP1 BLA in the coming days.
RP1, also identified as vusolimogene oderparepvec, is an oncolytic immunotherapy in clinical-stage development by Replimune. The therapy is being evaluated for use in combination with the checkpoint inhibitor nivolumab for patients with advanced melanoma.
The BLA resubmission represents a reversal from the agency’s earlier decision to reject the filing under the leadership of former FDA Commissioner Marty Makary. Replimune said the newly announced alignment with the FDA followed productive discussions between company representatives and the regulatory agency concerning reconsideration of the application.
The FDA’s change in position comes after Commissioner Makary’s departure earlier this month, a transition that the companies involved have linked to shifting priorities at the agency. The earlier rejection of the RP1 application had been highlighted as one of the more contentious regulatory decisions during Makary’s tenure.
This development had an immediate market effect on biotech equities tied to oncolytic therapies and immuno-oncology, with investors repricing the prospects for RP1 and related programs. uniQure, while not the company resubmitting the BLA, saw its shares move significantly in step with the sector reaction.
Companies and market participants emphasized that the resubmission will occur after the companies and the FDA completed discussions; Replimune stated the filing is expected shortly. Beyond the immediate price moves, the announcement illustrates how regulatory dialogue and agency leadership changes can materially affect clinical-stage biotechnology valuations.
Market snapshot: uniQure shares rose about 20% on the Replimune announcement; Replimune shares rose about 70% on plans to resubmit the RP1 BLA.