FDA Accepts RP1 Resubmission for Advanced Melanoma, Sets August 2, 2026 Goal Date
REPL has more than doubled off its 52-week low of $1.5 on light trading volume (0.3× avg).
Summary
Replimune Group announced the FDA has accepted for review its Biologics License Application resubmission for RP1 in advanced melanoma, setting a goal date of August 2, 2026.
Key Events · Product Development and Regulatory · REPL
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FDA Accepts BLA Resubmission
The U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma.
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Expedited Review Timeline Set
The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.
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Follows Prior CRL and Resubmission Agreement
This acceptance follows a previous Complete Response Letter from the FDA on April 10, 2026, and an agreement to resubmit the BLA announced on May 29, 2026.
Analysis · REPL · Life Sciences
This 8-K formally discloses a critical regulatory milestone for Replimune's lead candidate, RP1. Following a previous Complete Response Letter and a subsequent agreement to resubmit, the FDA's acceptance of the BLA resubmission with a PDUFA date of August 2, 2026, and an advisory committee meeting in late July, significantly de-risks the path to potential market approval. This is a major positive development for the company's future prospects.
How filings like this one have moved
In the 30 days to Oct 5, 2026, 42.7% of the 288 measured filings Wiseek scored 9 moved their stock by 5% or more by the next session's close. The median move was -0.53%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, REPL was trading at $10.93 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $919M. The 52-week trading range was $1.50 to $13.24. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.