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Regulatory review process for the company's lead candidate begins.
Replimune Group, Inc. (REPL) announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its Biologics License Application (BLA) for RP1, its lead oncolytic immunotherapy candidate. The acceptance initiates the FDA's review process for the treatment.
The BLA resubmission follows previous feedback from the FDA and includes additional data and analyses to support the application. Replimune is now awaiting the FDA's decision on the BLA, which is a critical step towards potential approval and commercialization of RP1.
As of the latest available data, Replimune Group has a free float of 52,832,000 shares.
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