Replimune (NASDAQ: REPL) has completed a Type A meeting with the FDA on September 16th, 2025, to discuss the Complete Response Letter (CRL) received for their RP1 therapy. The meeting focused on their Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.
The company is currently evaluating the FDA's feedback, noting that a path forward under the accelerated approval pathway remains undetermined. CEO Sushil Patel emphasized strong support from the melanoma community and highlighted the unmet need in advanced melanoma treatment, citing positive risk-benefit profile observed in the IGNYTE trial.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.