NASDAQ: REPL Investor Alert: Lawsuit against Replimune Group, Inc. seeks to recover Investor losses

An investor, who purchased shares of Replimune Group, Inc. (NASDAQ: REPL), filed a lawsuit over alleged violations of Federal Securities Laws by Replimune Group, Inc in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Replimune Group, Inc. (NASDAQ: REPL) have certain options and for certain investors are short and strict deadlines running. Deadline: October 5, 2026. NASDAQ: REPL investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Woburn, MA based Replimune Group, Inc., a clinical-stage biotechnology company, focuses on the development and commercialization of oncolytic immunotherapies to treat cancer in the United States and the United Kingdom.

On October 20, 2025, Replimune Group, Inc. published a press release announcing that the U.S. Food and Drug Administration ("FDA") had accepted the resubmission of the Biologics License Application ("BLA") for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The Company also claimed that "[d]uring the past few months, Replimune has been working to address agency feedback" and that "[a]dditional information, data and analyses were included in the resubmission which will be part of the BLA review." The Company also stated that "[t]he FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025."

However, on April 10, 2026, during market trading, the FDA published a Complete Response Letter ("CRL") rejecting Replimune's BLA. The FDA identified several deficiencies for each of the studies-RPL-001-16 (IGNYTE) and RP1-104 (IGNYTE-3)-submitted by Replimune and found that "the evidence as presented does not meet the evidentiary standards required for regulatory approval, and the results of the additional exploratory analyses of the RPL-001-16 data do not alter our initial conclusion that the RPL-001-16 trial is not an adequate and well-controlled clinical investigation that demonstrates substantial evidence of effectiveness." The FDA further revealed that "[t]o support resubmission of the BLA on October 9, 2025, [Replimune] provided [objective response rate] data from an early unplanned analysis" from RP1-104 which included only 40 patients, 10% of the planned enrollment of 400 patients.

In the CRL the FDA further revealed that it had "clearly communicated" its "concerns with the study design in multiple FDA interactions throughout [Replimune's] development program," but that "the study design concerns previously communicated were not addressed, and the contribution of [RP1] to the observed response rate in RPL-001-16 could not be determined."

Then, on April 10, 2026, after the market closed, Replimune Group, Inc. issued a press release discussing the FDA's response letter for the RP1 BLA. In the press release, Replimune conceded that "a randomized controlled trial was preferred" by the FDA, but also claimed that the FDA communicated that "if the data was sufficiently compelling, a single arm trial could be acceptable for consideration under accelerated approval."

Shares of Replimune Group, Inc. (NASDAQ: REPL) declined from $10.86 per share on June 04, 2026, to as low as $4.76 per share on July 29, 2026.

The plaintiff claims that between October 20, 2025 and April 10, 2026, the defendants made false and/or misleading statements and/or failed to disclose that in connection with the BLA, the study design concerns previously communicated by the FDA were not addressed, that Replimune had submitted data from an early unplanned analysis from RP1-104, which included only 40 patients (10% of the planned enrollment of 400 patients), that as a result, RPL-001-16 and RP1-104 both had deficiencies which were likely to cause the FDA to reject the BLA; and that as a result of the foregoing, defendants' positive statements about Replimune's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Those who purchased shares of Replimune Group, Inc. (NASDAQ: REPL) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.