NEW YORK, NY / ACCESS Newswire / July 22, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Replimune Group, Inc. ("Replimune Group, Inc.") (NASDAQ:REPL) concerning possible violations of federal securities laws.
Replimune announced on July 22, 2025, that the FDA ". . . issued a Complete Response Letter (CRL) regarding the Biologics License Application . . . for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma."
The FDA’s CRL, according to Replimune, ". . . indicates that the FDA is unable to approve the application in its present form. The 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."
Following this news, shares of Replimune stock fell over 76% pre-market on July 22, 2025. To obtain additional information, go to:
or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212)363-7500.
WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 17th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212)363-7500
Fax: (212)363-7171
https://zlk.com/
SOURCE: Levi & Korsinsky, LLP
View the original press release on ACCESS Newswire
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