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Replimune, Grace among biotechs with April PDUFA dates
After Orca delay, CBER still expected to rule on Replimune oncolytic virus
April 2, 2026 9:07 PM UTC
FDA has at least 8 PDUFA dates remaining on its April calendar, including a decision on an oncolytic virus.
Vusolimogen oderparepvec from Replimune Group Inc. (NASDAQ:REPL) was to be one of two decisions by Center for Biologics Evaluation and Research in April but CBER already delayed its decision on Treg cell therapy Orca-T from Orca Biosystems Inc. to July 6. Orca said it recently updated CMC data in response to an FDA request...