REPL Shareholder Alert: Replimune Group, Inc. Securities Class Action Lawsuit - Investors With Losses May Contact Levi & Korsinsky

A chronology of Replimune's RP1 regulatory disclosures alleges that between October 20, 2025 and April 10, 2026, investors were told the FDA resubmission was on track while previously communicated study-design concerns allegedly remained unresolved.

NEW YORK, Sept. 2, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP reminds purchasers of Replimune Group, Inc. (NASDAQ: REPL) securities of a pending securities class action on behalf of shareholders who purchased between October 20, 2025 and April 10, 2026. See if you could be eligible to recover. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

REPL closed at a Class Period high of $10.73 on December 8, 2025. By April 13, 2026, shares closed at $1.70, a cumulative decline of roughly $9.03 per share, or approximately 84%. Investors have until October 5, 2026 to seek lead plaintiff status.

Chronology of Material Events

The filing states that the sequence of announcements shaped what the market believed about RP1's approval odds:

• October 20, 2025: The Company announced FDA acceptance of the RP1 biologics license resubmission, stating the agency considered it "a complete response" to the July 2025 complete response letter, with a PDUFA target action date of April 10, 2026.
• November 6, 2025: Quarterly results reported that FDA Type A meeting minutes "indicated that the IGNYTE-3 trial could potentially support approval." Net loss for the quarter was $83.1 million.
• December 8, 2025: Shares reached their Class Period peak of $10.73.
• February 3, 2026: Management described commercial readiness activities as "well underway" ahead of a potential launch. Net loss for the quarter was $70.9 million.
• April 10, 2026: The FDA published a complete response letter rejecting the BLA, stating that study design concerns "clearly communicated" in prior interactions "were not addressed" and that resubmission relied on an early unplanned analysis of 40 patients, 10% of planned enrollment. Shares fell $1.15, or 19.46%, to $4.76 before a trading halt.
• April 13, 2026: After an after-hours release conceding the FDA "preferred" a randomized controlled trial, shares fell another $3.06, or 64.29%, to $1.70 on heavy volume.

How the Alleged Gap Widened Over Six Months

As set forth in the complaint, each successive disclosure reinforced an expectation of imminent approval while allegedly omitting that neither the single-arm IGNYTE trial nor the early IGNYTE-3 data addressed the agency's contribution-of-effect and RECIST v1.1 response-criteria concerns. It is alleged that this omission left the stock priced for an outcome that the underlying trial record did not support.

"Timely disclosure of material developments is fundamental to fair and efficient markets. The chronology here raises questions about whether shareholders were given an accurate picture of unresolved regulatory issues as the PDUFA date approached." -- Joseph E. Levi, Esq.

Calculate your potential recovery or call (212) 363-7500.

Levi & Korsinsky, LLP — Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered.

Frequently Asked Questions About the REPL Lawsuit

Q: How much did REPL stock drop? A: Shares fell approximately 84% from the Class Period high, a decline of about $9.03 per share, after the Company disclosed the FDA's complete response letter rejecting the RP1 biologics license application. Investors who purchased shares during the Class Period at artificially inflated prices and suffered losses may be eligible to seek compensation.

Q: What specific misstatements does the REPL lawsuit allege? A: The complaint alleges Replimune Group, Inc. made materially false or misleading statements regarding whether previously communicated FDA study-design concerns had been addressed and the sufficiency of the data supporting its BLA resubmission during the Class Period. When the FDA's complete response letter was disclosed, the stock price declined sharply.

Q: When did Replimune Group, Inc. allegedly mislead investors? A: The Class Period runs from October 20, 2025 to April 10, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.

Q: What court was the REPL class action filed in? A: The case was filed in the United States District Court for the District of Massachusetts, governed by the Private Securities Litigation Reform Act of 1995.

Q: What do REPL investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. No immediate action is required to remain eligible as an absent class member.

Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.

Q: What if I already sold my REPL shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.

Q: Do I need to go to court or give testimony? A: No. The overwhelming majority of class members never appear in court or give depositions. If there is a settlement or recovery, eligible class members generally submit a claim form to seek their portion.

Q: What if Replimune Group, Inc. goes bankrupt before the case resolves? A: Securities class action claims may survive bankruptcy in many circumstances. D&O insurance policies are frequently a potential source of settlement funds.

CONTACT:\
Levi & Korsinsky, LLP\
Joseph E. Levi, Esq.\
Ed Korsinsky, Esq.\
33 Whitehall Street, 27th Floor\
New York, NY 10004\
[email protected]\
Tel: (212) 363-7500\
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP