aibioReplimune 10-Q lists two Massachusetts securities class actions and consolidated derivative suits
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The first class action was filed shortly after the FDA's first RP1 complete response letter. A motion to dismiss it is due to be fully briefed in December; the SEC closed its probe in June without recommending action.
Key facts
- Company
- Replimune Group, Inc. (NASDAQ: REPL)
- News type
- Legal
- Primary source
- Replimune Group 10-Q for the quarter ended September 30, 2026 (SEC EDGAR)
Replimune Group, Inc. (Nasdaq: REPL) disclosed in its quarterly report for the period ended September 30, 2026, filed on October 28, that it faces two putative securities class actions in the United States District Court for the District of Massachusetts, along with consolidated shareholder derivative suits and a shareholder demand. The company and the other defendants deny any wrongdoing and say they will vigorously defend the cases.
The two class actions
The first, Jboor v. Replimune Group, Inc. et al., Case No. 1:25-cv-12085-JEK, was filed on July 24, 2025 against the company and its directors and certain officers. The 10-Q does not name the individual defendants. The complaint was filed shortly after Replimune announced on July 22, 2025 that it had received a complete response letter, or CRL, from the FDA on its RP1 biologics license application for advanced melanoma, and after the subsequent decline in the trading price of its common stock.
The court has appointed a lead plaintiff, who filed an amended complaint on January 13, 2026. After the FDA issued a second CRL on April 10, 2026, the lead plaintiff filed a second amended complaint addressing it. The defendants moved to dismiss that complaint on August 17, 2026, and briefing is scheduled to finish in December 2026. No ruling has been reported.
The second, Toor v. Replimune Group, Inc. et al., Case No. 1:26-cv-13612, was filed on August 6, 2026 against the company and its directors and certain officers. The filing says it alleges essentially the same facts as Jboor. On September 18, 2026 the Jboor lead plaintiff moved to consolidate Toor into Jboor. On October 5, 2026 two plaintiffs in Toor moved to be appointed lead plaintiff, and on October 19, 2026 the company and the other defendants filed a memorandum in opposition.
Derivative suits, a demand and the SEC
Three shareholders filed derivative actions on the company's behalf in the same court: Chea v. Patel et al., Case No. 1:25-cv-12316-JEK, Wright v. Patel et al., Case No. 1:25-cv-12401-WGY, and Vochten v. Patel et al., Case No. 1:25-cv-12484-JEK. The filing does not list the other defendants. The plaintiffs allege substantially similar facts to the class action and assert that directors and officers breached their fiduciary duties. The parties have consolidated the derivative actions and agreed to a stay pending developments in the class action.
On September 10, 2025 the company received a letter from a shareholder demanding that the board act on alleged wrongdoing by certain directors and officers. The board decided to defer action on it.
On September 29, 2025 the SEC told the company it was conducting an investigation and asked for documents and communications connected with the RP1 application. On June 24, 2026 the SEC informed the company that it had concluded the investigation and was not recommending an enforcement action against the company.
The company behind the cases
Replimune describes itself as a clinical-stage biotechnology company working on oncolytic immunotherapy. The FDA granted accelerated approval on August 6, 2026 to its melanoma product, TUDRIQEV, formerly RP1, for use with nivolumab in adults with unresectable advanced cutaneous melanoma whose disease progressed after a PD-1 blocking regimen. The approval rests on objective response rate and duration of response, and continued approval may depend on confirmatory trials. The product became commercially available on October 1, 2026.
The financial position has been strained. The company's annual report for the year ended March 31, 2026 said substantial doubt existed about its ability to continue as a going concern. The 10-Q says that doubt was alleviated after the company raised approximately $141.0 million in net proceeds, after fees and expenses of approximately $9.0 million, from an equity offering completed on August 10, 2026. It also warns that if it cannot raise more capital, substantial doubt could arise again.
For the three months ended September 30, 2026 Replimune reported a net loss of $57,121 thousand, against $83,100 thousand a year earlier,. Cash and cash equivalents were $307.8 million. On September 29, 2026 it agreed a fourth amendment with Hercules Capital, Inc. to draw a term loan advance of not less than $15.0 million, and the loan maturity moved to October 1, 2029 after the approval.