Pomerantz律所发布Replimune(REPL)证券集体诉讼投资者招募广告，涉及4个月前FDA拒绝RP1上市申请事件

NEW YORK, Aug. 27, 2026 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
The class action concerns whether Replimune and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
You have until October 5, 2026, to ask the Court to appoint you as Lead Plaintiff for the class if you purchased or otherwise acquired Replimune securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.
[Click here for information about joining the class action]
On April 10, 2026, the FDA published a Complete Response Letter ("CRL") rejecting Replimune's Biologics License Application ("BLA") for RP1 in combination with nivolumab. 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."
On this news, Replimune's stock price fell $1.15 per share, or 19.46%, to close at $4.76 per share on April 10, 2026.
Then, on April 10, 2026, after the market closed, the Company 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."
On this news, the Company's share price continued to fall $3.06 per share, or 64.29%, to close at $1.70 per share on April 13, 2026.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Danielle Peyton
Pomerantz LLP
[email protected]
646-581-9980 ext. 7980
SOURCE Pomerantz LLP