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Kirby McInerney LLP Announces Investigation Against Replimune Group, Inc. (REPL) on Behalf of Investors

1. Replimune faces investigation for potential securities law violations. 2. FDA issued a Complete Response Letter for Replimune's RP1 drug application. 3. The CRL cited inadequate clinical evidence from the IGNYTE trial. 4. Replimune's share price dropped by approximately 77.24% to $2.81. 5. Law firm offers assistance to affected shareholders regarding the investigation.

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FAQ

Why Very Bearish?

The substantial drop in share price reflects significant investor concern post-FDA decision. Historical instances show that regulatory refusals can lead to long-term share price declines, as seen with similar biotech firms.

How important is it?

The article highlights critical legal vulnerabilities and regulatory hurdles that may impact REPL’s future. The drastic price drop signifies heightened sensitivity to news affecting the company's integrity and drug pipeline.

Why Short Term?

The immediate fallout from the FDA's response will likely influence investor sentiment short-term. However, future developments in the investigation or follow-up trials could alter long-term perceptions.

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VRTXKPTIMDCO
NEW YORK, July 23, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ:REPL). The investigation concerns whether Replimune and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices. [LEARN MORE ABOUT THE INVESTIGATION] On July 22, 2025, Replimune disclosed that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for its lead product RP1, in combination with immunotherapy drug nivolumab, for the treatment of advanced melanoma. In the CRL, the FDA indicated Replimune’s IGNYTE trial is “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” On this news, the price of Replimune shares declined by $9.52 per share, or approximately 77.24%, to close at $2.81 per share on July 22, 2025. If you purchased or otherwise acquired Replimune securities, have information, or would like to learn more about this investigation, contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out the form below to discuss your rights or interests with respect to these matters without any cost to you. [CONTACT US] Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. ContactsKirby McInerney LLPThomas W. Elrod, Esq.212-699-1180https://www.kmllp.cominvestigations@kmllp.com

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