Replimune completes Type A FDA meeting for RP1 BLA in melanoma; path forward uncertain

Replimune Group, Inc.

Completed Type A FDA meeting on Sept 16, 2025 regarding CRL for RP1+nivolumab BLA in advanced melanoma.
Evaluating FDA feedback; accelerated approval path not yet determined.
CEO cites unmet need and compelling IGNYTE trial risk-benefit; committed to working with FDA.
No timeline or resolution provided; stock may remain volatile pending updates.

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