REPL LEGAL UPDATE: Replimune Group, Inc. Sued after FDA Response Letter -- Investors with Losses are Notified to Contact BFA Law before September 22 Class Action Deadline
Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Replimune Group, Inc. (NASDAQ: REPL) and certain of the Company's senior executives for potential violations of the federal securities laws.
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If you invested in Replimune, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/replimune-group-class-action-lawsuit.
Investors have until September 22, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Replimune securities. The case is pending in the U.S. District Court for the District of Massachusetts and is captioned Jboor v. Replimune Group, Inc., et al., No 1:25-cv-12085.
Why Was Replimune Sued for Securities Fraud?
Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies for the treatment of cancer. Replimune's lead product candidate is RP1, a treatment for melanoma. On June 6, 2024, the Company announced positive top line results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with the immunotherapy drug nivolumab. On November 21, 2024, Replimune announced that it had submitted a biologics license application ('BLA') to the FDA for RP1 on the strength of the results of the IGNYTE Phase 1/2 trial.
During the relevant period, the Company repeatedly touted the results of the IGNYTE Phase 1/2 trial. In truth, the IGNYTE Phase 1/2 trial design was not adequate to produce reliable results.
The Stock Declines as the Truth Is Revealed
On July 22, 2025, Replimune announced that it received a Complete Response Letter from the FDA regarding the BLA for RP1. According to the Company, '[t]he FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.' More specifically, 'the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population.' On this news, the price of Replimune stock fell more than 75% on July 22, 2025.
Click here for more information: https://www.bfalaw.com/cases/replimune-group-class-action-lawsuit.
What Can You Do?
If you invested in Replimune you may have legal options and are encouraged to submit your information to the firm.
All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been named 'Elite Trial Lawyers' by the National Law Journal, among the top '500 Leading Plaintiff Financial Lawyers' by Lawdragon, 'Titans of the Plaintiffs' Bar' by Law360 and 'SuperLawyers' by Thomson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.
https://www.bfalaw.com.
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