Investors allege Replimune Group, Inc. supported its RP1 biologics license resubmission with data from an early unplanned analysis covering only 40 patients — roughly 10% of planned enrollment — which the FDA later deemed insufficient to support an efficacy claim.

NEW YORK, Aug. 26, 2026 /PRNewswire/ — Levi & Korsinsky, LLP alerts investors in Replimune Group, Inc. (NASDAQ: REPL) of a pending securities class action on behalf of purchasers between October 20, 2025 and April 10, 2026. Check if you might be eligible to recover your investment losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

Shares closed at a Class Period high of $10.73 on December 8, 2025 and closed at $1.70 on April 13, 2026, an approximate decline of $9.03 per share, or roughly 84%. The Court has set October 5, 2026 as the deadline to apply for lead plaintiff appointment.

“Investors deserve transparency about material risks that could affect their investments. The complaint asserts that shareholders were not told the resubmission efficacy package rested on an early unplanned analysis of only 40 patients.” — Joseph E. Levi, Esq.

The Alleged 40-Patient Resubmission Data Package

Management told the market in October 2025 that the FDA had accepted the RP1 resubmission and considered it a complete response to the July 2025 complete response letter. The lawsuit asserts that what was not shared was the composition of the efficacy evidence: an early unplanned analysis from the RP1-104 (IGNYTE-3) study representing about 10% of the planned 400-patient enrollment. The FDA’s April 10, 2026 letter stated that this data “is insufficient to support an efficacy claim.”

Evidentiary Standards in Accelerated Approval Submissions

• The action claims the agency had recommended use of data from the ongoing Phase 3 trial to potentially support accelerated approval.
• As alleged, an early unplanned interim analysis of 40 patients was submitted instead.
• The FDA also stated response criteria used in RPL-001-16 were not consistent with RECIST v1.1.
• The agency concluded RPL-001-16 was not an adequate and well-controlled investigation demonstrating substantial evidence of effectiveness.
• The lawsuit asserts these deficiencies made rejection a foreseeable risk not disclosed to shareholders.
• Quarterly net losses of $83.1 million and $70.9 million were reported during Class Period quarters.

Why Data Adequacy Allegedly Matters to Investors

The action claims that positive characterizations of the resubmission’s completeness allegedly inflated REPL’s trading price, and that shares repriced sharply once the agency’s findings became public.

Learn more about the case or call (212) 363-7500.

ABOUT LEVI & KORSINSKY, LLP — Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report. Investors who suffered losses have until October 5, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the REPL Lawsuit

Q: Who is notifying investors about the REPL securities class action? A: Levi & Korsinsky, LLP is notifying investors that a securities class action has been filed on behalf of investors who purchased REPL securities during the class period. The firm is nationally recognized, ranked in the ISS Top 50 for seven consecutive years, and has recovered hundreds of millions of dollars for aggrieved investors.

Q: Who is eligible to join the REPL investor lawsuit? A: Investors who purchased REPL stock or securities between October 20, 2025 and April 10, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses — not on whether you still hold the shares.

Q: What specific misstatements does the REPL lawsuit allege? A: The complaint alleges Replimune Group, Inc. made materially false or misleading statements regarding the adequacy of its RP1 clinical trial designs and the sufficiency of the data supporting its BLA resubmission during the Class Period. When the FDA’s complete response letter rejecting the BLA was disclosed, the stock price declined sharply.

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: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys’ fees and expenses subject to court approval.

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
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP