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Replimune Shares Plunge Nearly 45% After FDA Concerns Over RP1

On September 18, 2025, investors in Replimune Group, Inc. (NASDAQ: REPL) faced a shocking decline in the company's stock price, which fell by approximately 45% during intraday trading. This drastic drop followed revelations from a Type A meeting conducted with the FDA, indicating that there was no clear pathway for the accelerated approval of their lead drug candidate, RP1. The news prompted concerns among investors, who were already reeling from the effects of a securities class action lawsuit filed against the company.

FDA Meeting Outcomes

The Type A meeting, held on September 16, was intended to clarify the situation surrounding Replimune's Biologics License Application (BLA) for RP1. The FDA's lack of a definitive path moved the market significantly, especially coming on the heels of an earlier rejection on July 22, where the FDA issued a Complete Response Letter (CRL) regarding RP1’s anticipated approval for the treatment of advanced melanoma. This rejection triggered a massive sell-off, as shares experienced a staggering 77% decline.

Background of the Lawsuit

The ongoing lawsuit alleges that Replimune misled its investors about the potential success of RP1 by presenting overly optimistic projections. The complaint points to substantial issues raised by the FDA in its CRL, stating that the IGNYTE trial lacked adequate design and control, thereby compromising any significant evidence of RP1’s effectiveness.

The pain experienced by shareholders stems from a complex web of miscommunication and unrealistic expectations fostered by the company's leadership. Investors who suffered losses due to the dramatic fluctuation in stock valuation are being encouraged to come forward before the lead plaintiff deadline of September 22, 2025, as the law firm Hagens Berman leads the investigation.

Allegations Against Replimune

Key accusations in the lawsuit focus on several critical factors that Replimune allegedly failed to disclose:

1. Overstated Trial Success: The company reportedly overstated the likelihood of success for RP1 based on the IGNYTE trial results.
2. Inadequate Trial Design: There were indications that the design of IGNYTE did not meet the FDA's standards for rigorous evaluation, which led to concerns about its conclusions.
3. Unrevealed Regulatory Issues: The assertion that the clinical trial involved a heterogeneous patient population added complexity, making it difficult for the FDA to interpret the data effectively. It further indicated that the FDA had serious concerns about the design of any confirmatory trials proposed by Replimune.

This lack of transparency has been cited as a direct cause of the stock's collapse, with investors feeling blindsided by the severity of the regulatory backlash.

Hagens Berman Investigation

The investigation spearheaded by Hagens Berman is currently focusing on whether Replimune's management was aware of these significant flaws within the trial's design and the subsequent implications but failed to notify their investors. Partner Reed Kathrein, who is directing the inquiry, emphasized the critical nature of these findings, noting that the FDA's rejection centered on fundamental questions regarding the validity of the data presented by Replimune.

“It’s crucial to understand whether current and past management misled investors about the integrity of the data underpinning their application,” Kathrein stated, as the firm encourages anyone who may have pertinent information to step forward.

Whistleblower Program and Call for Action

Individuals with extra information that could aid in the investigation are being urged to consider the SEC Whistleblower Program, which grants rewards up to 30% of successful recoveries made by the SEC. Those who believe they have relevant information can contact Hagens Berman at 844-916-0895 or via email at [email protected]

Conclusion

The case of Replimune serves as a cautionary tale for investors in the biopharmaceutical industry, illustrating the volatility and potential risks associated with drug approvals. The impact of corporate communication on stock performance cannot be understated, and ongoing developments in this case will be closely monitored by investors and industry observers alike.