Replimune Provides Update Following Type A Meeting with FDA

Rhea-AI Summary

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.

Positive

• None.

Negative

• No clear path forward under accelerated approval pathway determined
• Complete Response Letter (CRL) indicates FDA's initial rejection of the BLA
• Potential delays in RP1 therapy approval process

WOBURN, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16^th to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.

The company is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined.

“The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial,” said Sushil Patel, Ph.D., CEO of Replimune. “We remain committed to working with the FDA to determine an expeditious path forward for RP1.”

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the content of our interactions with the FDA at our Type A Meeting, the outcome and timing of any resolutions following such meeting, the viability of the continuation of our confirmatory trial in advanced melanoma, and other statements identified by words such as “could,” “expects,” “intends,” “hope,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

FAQ

What was the outcome of Replimune's (REPL) Type A meeting with the FDA on September 16, 2025?

Following the meeting, Replimune is evaluating FDA's feedback, but no clear path forward under accelerated approval pathway has been determined for RP1 therapy.

What is Replimune's RP1 therapy being developed for?

RP1, in combination with nivolumab, is being developed for the treatment of advanced melanoma. The therapy showed a compelling risk-benefit profile in the IGNYTE trial.

Why did Replimune (REPL) receive a Complete Response Letter from the FDA?

The specific reasons for the FDA's Complete Response Letter (CRL) regarding RP1's Biologics License Application were not disclosed in the announcement.

What did Replimune's CEO say about the melanoma community's response to RP1?

CEO Sushil Patel stated that feedback from the melanoma community, including patients and physicians, highlights the unmet need in advanced melanoma and RP1's compelling risk-benefit profile from the IGNYTE trial.

What is the current status of Replimune's RP1 approval process?

Replimune is currently evaluating FDA feedback to determine next steps, as a path forward under the accelerated approval pathway has not been determined following the Type A meeting.