Disclosure Under Scrutiny: Replimune’s SEC filings warned generally that RP1 might not win approval, yet allegedly omitted that the FDA had already told the Company its study design concerns were unresolved.

NEW YORK, Aug. 19, 2026 /PRNewswire/ — Levi & Korsinsky, LLP alerts investors in Replimune Group, Inc. (NASDAQ: REPL) that a securities class action has been filed on behalf of shareholders who purchased securities 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.

REPL shares fell from a Class Period high of $10.73 on December 8, 2025 to $1.70 on April 13, 2026, a cumulative decline of approximately 84.16%, or roughly $9.03 per share. The April 10, 2026 session alone took shares down $1.15 (19.46%) to $4.76 before a further $3.06 (64.29%) drop on April 13, 2026. LEAD PLAINTIFF DEADLINE: October 5, 2026.

What the Company Disclosed

SEC filings stated the general possibility of failure: “Without an approval of RP1 from this resubmitted BLA we might not be able to continue the development of RP1 for this indication, if at all, and we may be required to implement a restructuring plan and review our priorities across the RPx portfolio.” Disclosure language indicated an ongoing, cooperative review, describing the October 9, 2025 resubmission as one the FDA “indicated” was “a complete response” to the July 2025 complete response letter, and reporting that the agency had signaled IGNYTE-3 “could potentially support approval.”

Disclosure Gaps Alleged

The complaint challenges those filings as omitting specific, then-existing facts, including:

• That study design concerns the FDA had allegedly “clearly communicated” across multiple interactions were not addressed in the resubmission.
• That the resubmission’s objective response rate data came from an early unplanned analysis of only 40 patients, roughly 10% of the planned 400-patient enrollment.
• That the response criteria used in RPL-001-16 were allegedly not consistent with RECIST v1.1 and may not compare to historical literature.
• That RPL-001-16, as a single-arm study, allegedly could not isolate RP1’s contribution from nivolumab’s.
• That the agency had allegedly recommended using data from the ongoing Phase 3 trial instead.

Why Generic Warnings May Not Protect

The complaint asserts that boilerplate approval-risk language addressed a hypothetical outcome while the specific, known deficiencies allegedly driving that outcome went undisclosed. The FDA’s April 10, 2026 letter stated that RPL-001-16 “is not an adequate and well-controlled clinical investigation that demonstrates substantial evidence of effectiveness.” In an after-market release that same day, the Company conceded “a randomized controlled trial was preferred” by the agency.

“Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company’s operations. The complaint alleges that regulators had already flagged study design deficiencies that investors were not told about.” — Joseph E. Levi, Esq.

Learn more about the case 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: What specific misstatements does the REPL lawsuit allege? A: The complaint alleges Replimune Group, Inc. made materially false or misleading statements regarding whether its RP1 biologics license resubmission addressed previously communicated FDA study design concerns, and regarding the sufficiency of data drawn from an early unplanned 40-patient analysis, during the Class Period. When the FDA’s Complete Response Letter rejecting the RP1 BLA was disclosed, the stock price declined sharply.

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: Who are the defendants named in the REPL lawsuit? A: The complaint names Replimune Group, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.

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 documents do I need to to submit my information? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

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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