TLDR
- The FDA accepted Replimune Group’s resubmitted Biologics License Application for RP1 combined with nivolumab to treat advanced melanoma patients
- The FDA set a target review date of April 10, 2026, under a Class II resubmission timeline
- Replimune stock jumped 60% in premarket trading following the announcement
- The resubmission addresses feedback from a complete response letter the company received in July 2025
- RP1 is an oncolytic immunotherapy designed to kill tumor cells and activate immune responses against cancer
Replimune Group Inc. saw its stock price surge 60% in premarket trading on October 20, 2025, after announcing FDA acceptance of its resubmitted Biologics License Application. The Woburn, Massachusetts-based biotechnology company received confirmation that the agency will review its application for RP1, a melanoma treatment.
The FDA set April 10, 2026, as the target review date under the Prescription Drug User Fee Act. This timeline follows a Class II resubmission process.
The application seeks approval for RP1 in combination with nivolumab. The treatment targets patients with advanced melanoma who have progressed on anti-PD-1 containing regimens.
This represents a limited patient population with few available treatment options. Current therapies have not worked for these individuals.
Replimune originally submitted its application but received a complete response letter from the FDA in July 2025. A complete response letter means the FDA completed its review but found the application could not be approved in its current form.
Addressing Regulatory Concerns
The company spent several months gathering additional information to address the agency’s concerns. The resubmission includes new data, information, and analyses responding to FDA feedback.
The FDA confirmed the resubmission fully addresses the issues outlined in its July letter. This classification as a complete response allows the review process to move forward.
CEO Sushil Patel stated the company is pleased with the acceptance. He emphasized that RP1 plus nivolumab offers a strong risk benefit profile for patients with limited options.
RP1, also known as vusolimogene oderparepvec, is Replimune’s lead product candidate. The therapy uses a proprietary strain of herpes simplex virus.
Treatment Mechanism and Company Position
The virus has been engineered with a fusogenic protein and GM-CSF. These modifications help the therapy kill tumor cells directly.
The treatment also works to activate the body’s immune response against cancer cells. This dual mechanism represents the oncolytic immunotherapy approach.
Replimune holds a market valuation of $351 million. The company maintains cash reserves that exceed its debt obligations.
Its current ratio stands at 6.94x, indicating strong short-term financial stability. This liquidity position supports ongoing operations and regulatory processes.
The clinical-stage biotechnology company was founded in 2015. It focuses on developing treatments through its proprietary RPx platform.
This platform is based on HSV-1 backbone technology. The company uses this foundation to develop multiple oncolytic immunotherapy candidates.
Previous regulatory interactions included a Type A meeting with the FDA. The agency raised concerns about the IGNYTE trial’s effectiveness and patient population differences.
JPMorgan downgraded the stock from Neutral to Underweight following those concerns. H.C. Wainwright maintained its Neutral rating on the company.
The FDA’s acceptance of the resubmission allows Replimune to continue pursuing approval. The company will work with the agency through the review period leading up to the April 2026 target date.
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