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Levi & Korsinsky Informs Replimune Shareholders

Levi & Korsinsky, LLP, a law firm known for its investor protection efforts, has issued an important reminder regarding shareholders of Replimune Group, Inc. (NASDAQ: REPL). The firm has announced that there is a pending securities class action lawsuit tied to the company's recent troubles. For shareholders who acquired their shares between October 20, 2025, and April 10, 2026, the lead plaintiff deadline has been set for October 5, 2026.

The crux of the concern stems from Replimune's handling of its RP1 biologics license application, which the FDA recently rejected in a significant Complete Response Letter dated April 10, 2026. The FDA expressed serious concerns regarding the design of the studies that were submitted in support of Replimune’s application, leading to a dramatic drop in the stock price, which fell from a high of $10.73 on December 8, 2025, to just $1.70 by the close of trading on April 13, 2026—a staggering decline of approximately 84% or $9.03 per share.

Background of the Case

The lawsuit alleges that Replimune misled investors by making materially false statements about its study designs and the preparedness of its regulatory submission. Initially, the company had presented their resubmission to the FDA as a complete response to an earlier deficiency notice, claiming that their product was on a clear path to approval. This was further emphasized by assurances that their commercial readiness activities were sufficiently underway, signaling an imminent product launch.

However, in stark contrast, the FDA cited numerous inadequacies in the clinical trials submitted by Replimune. The letter emphasized that the prior concerns regarding study designs had been inadequately addressed. The miscommunication of this critical information left investors in a vulnerable position, purchasing shares at inflated prices based on false assurances from the company.

Delay and Decline

Investors were initially led to believe they had a solid investment underpinned by what appeared to be a favorable regulatory landscape. The broad optimism was shattered with the FDA's rejection. The agency criticized the insufficient statistical evidence presented, which relied on only a fraction of the planned study enrollment and did not adhere to established response criteria. Despite claims of a strong commercial base ready for a product launch, the fundamental evidence did not support such a conclusion.

The decline in share price reflects investor disillusionment; the stock witnessed significant declines shortly after the rejection notice. On April 10, 2026, the stock fell by approximately 19.5% to $4.76 and continued to plummet to $1.70, exacerbating the losses suffered by shareholders.

Importance of the Lead Plaintiff

The upcoming lead plaintiff deadline of October 5, 2026, is crucial for affected investors. Those who believe they have incurred losses and wish to join the class action to recover damages must act swiftly. The law firm encourages anyone who purchased shares during the specified class period to gather relevant purchase records, as this information will be necessary for participation.

As Joseph E. Levi, Esq. emphasized, companies have a duty to provide a transparent account of known risks and uncertainties, of which shareholders should be made aware. Failure to do so can lead to material misrepresentations, fostering an environment where investors make uninformed decisions. Levi & Korsinsky has a reputation built on rigorous legal advocacy for shareholders and consistently recovering significant amounts for those who have experienced losses in similar cases.

FAQs for Replimune Investors

Q: What specific issues does the lawsuit allege?
A: The lawsuit argues that Replimune made misleading statements regarding its FDA interactions and the adequacy of its clinical data.

Q: How drastic was the stock price drop?
A: Investors saw a decline of roughly 84% from the peak price during the class period.

Q: What can I do if I have sold my shares?
A: If your shares were sold at a loss during the purchase period, you may still be eligible to recover losses.

Q: What is the cost to participate in this action?
A: Generally, there is no upfront cost. Most securities class actions operate under a contingency fee structure, meaning fees are contingent upon a successful recovery.

In conclusion, Replimune Group, Inc. has faced serious allegations following its FDA rejection, positioning shareholders at a significant disadvantage. The upcoming legal actions offer a vital opportunity for affected investors to seek restitution, and Levi & Korsinsky remain committed to advocating for fiduciary rights across the board.