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Replimune surges 85.7% following FDA path-forward agreement on melanoma drug RP1
- Replimune shares surged 85.7% to close at $8.69 on Friday following an announcement that the company and FDA have aligned on a path forward for resubmission of its Biologics License Application.
- The agreement allows the company to resubmit its application for RP1 in combination with Nivolumab to treat advanced melanoma in the coming days.
- This follows two prior FDA rejections over study design concerns, with the company now positioned to resubmit after regulatory discussions.
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Conclusion
REPL rose from $4.68 to $8.69 (+85.68%) on 2026-05-29. Today's volume was 50,862,392 vs. a 20-day average of 6,132,565 (8.29x). The surge coincides with Replimune's announcement of an FDA agreement to resubmit its RP1 BLA for advanced melanoma following collaborative discussions with the agency. The application had previously received Complete Response Letters in July 2025 and April 2026, citing concerns about trial design and patient population heterogeneity.