Join the Replimune Group (REPL) Securities Fraud Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Replimune Group, Inc. (REPL).

If you purchased or held Replimune Group securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Replimune Group

Replimune Group is a Delaware-incorporated, clinical-stage biotechnology company headquartered in Woburn, Massachusetts. The company focuses on developing oncolytic immunotherapies, primarily built on a herpes simplex virus (HSV-1) backbone, to treat cancer.

Its lead asset, RP1 (vusolimogene oderparepvec), was developed for use in combination with nivolumab for advanced melanoma and other solid tumors. Replimune’s business model relies heavily on the success of RP1, which represented its sole late-stage asset during the relevant period.

What’s Being Investigated

The investigation centers on allegations that Replimune and certain officers and directors may have made misleading statements or omissions regarding the regulatory status and commercial prospects of RP1.

According to multiple company press releases and filings, Replimune repeatedly assured investors that its Biologics License Application (BLA) for RP1 was “on track,” and that the FDA had “not identified any potential review issues.”

However, on July 22, 2025, Replimune disclosed that the FDA had issued a Complete Response Letter (CRL) rejecting the BLA, stating that the pivotal IGNYTE study was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.”

Later, on September 18, 2025, the company revealed that a follow-up “Type A” meeting with the FDA left resulted in their conclusion that "a path forward under the accelerated approval pathway has not been determined.“

These disclosures reportedly contradicted earlier public statements and resulted in sharp stock price declines.

Investors and analysts allege that these events raise questions about the adequacy of the company’s internal controls, risk oversight, and the accuracy of its public disclosures.

Key Timeline

• September 9, 2024: Company announces “positive pre-BLA meeting” and states accelerated-approval filing is “on track” and “aligned with FDA.” Investors allege this fostered expectations of near-term approval.
• November 21, 2024: Replimune submits BLA and announces FDA Breakthrough Therapy designation for RP1.
• January 21, 2025: Company states BLA accepted with Priority Review, “no advisory committee planned,” and that the FDA has “not identified any potential review issues.”
• May 22, 2025: Replimune touts “full commercial infrastructure” and readiness for launch, suggesting regulatory approval is likely.
• July 22, 2025: FDA issues CRL, stating IGNYTE trial is “not adequate and well-controlled”; stock drops more than 75%. Investors allege this was the first disclosure of major regulatory setbacks.
• September 2, 2025: Company announces Type A meeting with FDA is scheduled.
• September 16, 2025: Type A meeting with FDA is held.
• September 18, 2025: Company discloses “no path forward” for accelerated approval; shares fall roughly 39%. Multiple outlets tie the drop to this disclosure.

Your Rights and Next Steps

This is an ongoing investigation into potential breaches of fiduciary duty and other alleged misconduct at Replimune Group.

Stockholders who held shares during the relevant period; especially if they suffered losses after the July 22 and September 18, 2025 disclosures, may have certain rights.

Potential next steps:

• Request company books and records under Delaware’s Section 220 to investigate possible mismanagement or oversight failures.
• Pursue a derivative action if evidence suggests the board or officers engaged in bad-faith conduct or knowingly made misleading statements.
• Seek remedies that may include monetary recovery for the company, governance reforms, and compensation clawbacks.

To preserve your rights, it is important to act promptly, as legal deadlines and procedural requirements may apply. Participation in a derivative action does not require you to serve as a lead plaintiff; you may join with other stockholders or support ongoing efforts.

You May Be Entitled to Compensation

If you purchased or held Replimune Group securities and experienced losses following the July and September 2025 disclosures, you may be eligible to participate in this securities investigation.

Time is of the essence, investigations and potential derivative lawsuits are subject to strict deadlines.

To learn more or to join the investigation, complete the form below.