Replimune Group, Inc. announced on September 2, 2025, that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled. The purpose of this meeting is to discuss the complete response letter (CRL) received for the company’s Biologics License Application (BLA) for RP1.
The BLA for RP1 in combination with nivolumab was submitted for the treatment of advanced melanoma. Replimune has submitted a briefing document to the FDA in preparation for this critical discussion.
A Type A meeting is typically requested by a company to address a significant regulatory setback, such as a CRL, and to determine a clear path forward for product development. This meeting represents a key step for Replimune in seeking to resolve the issues raised by the FDA regarding RP1's approval.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.