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INVESTOR ALERT: Investigation of Replimune Group, Inc. (REPL) Announced by Holzer & Holzer, LLC

1. Replimune received a Complete Response Letter from the FDA. 2. The FDA found the IGNYTE trial inadequate for effectiveness evidence. 3. This news triggered a stock price drop for Replimune. 4. Holzer & Holzer is investigating potential compliance issues. 5. Legal action may follow affecting investor sentiment and stock recovery.

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FAQ

Why Very Bearish?

Receiving a CRL is a negative indicator for biotech stocks. Historical precedents show significant declines in similar cases, like with Biogen in 2019.

How important is it?

The CRL impacts Replimune's future drug approvals and market perception significantly. Investigations into compliance could lead to further legal issues, which heightens risk.

Why Short Term?

Immediate investor reactions after this news will likely lead to a short-term price drop. Recovery may take longer as new data emerges.

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ATLANTA, July 22, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) complied with federal securities laws. On July 22, 2025, Replimune announced it received a Complete Response Letter (“CRL”) from the FDA regarding the Biologics License Application (“BLA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. In the CRL, the FDA 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, the price of the Company’s stock dropped.  If you purchased Replimune stock and suffered a loss on that investment, you are encouraged to contact Corey Holzer, Esq. at cholzer@holzerlaw.com or Joshua Karr, Esq. at jkarr@holzerlaw.com, call our toll-free number at (888) 508-6832, or visit our website at www.holzerlaw.com/case/replimune-group/ to discuss your legal rights.   Holzer & Holzer, LLC, an ISS top rated securities litigation law firm for 2021, 2022, and 2023, dedicates its practice to vigorous representation of shareholders and investors in litigation nationwide, including shareholder class action and derivative litigation. Since its founding in 2000, Holzer & Holzer attorneys have played critical roles in recovering hundreds of millions of dollars for shareholders victimized by fraud and other corporate misconduct. More information about the firm is available through its website, www.holzerlaw.com, and upon request from the firm. Holzer & Holzer, LLC has paid for the dissemination of this promotional communication, and Corey Holzer is the attorney responsible for its content.     CONTACT:  Corey Holzer, Esq.(888) 508-6832 (toll-free) cholzer@holzerlaw.com

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