Replimune announced Friday it plans to resubmit a marketing application for its lead melanoma immunotherapy, RP1, to the U.S. Food and Drug Administration [1].
The move represents a critical attempt to bring vusolimogene oderparepvec to market after the agency twice rejected the treatment. Success would provide a new therapeutic option for melanoma patients, and validate the company's core technology.
This marks the third time [2] the company has sought approval for the drug. The FDA first rejected the application on July 21, 2025 [3]. A second rejection followed in April 2026 [1].
Reports indicate that the decision to pursue another application came after intervention by White House officials [2]. This political involvement coincides with a period of leadership changes within the FDA [4].
Investors reacted positively to the news. Replimune shares saw a pre-market stock surge of more than 60% [1].
The company is now preparing the necessary documentation to address the concerns raised by the FDA during the previous two review cycles. The agency's final decision will determine if RP1 can be commercialized in the U.S. market.
“Replimune shares saw a pre-market stock surge of more than 60%”
The resubmission of RP1 highlights the high-stakes nature of biotechnology approvals and the potential influence of executive branch intervention in regulatory processes. While the stock market responded with optimism, the drug's viability depends on whether Replimune can resolve the specific technical or safety objections that led to the 2025 and 2026 rejections.
