Item 1. Legal Proceedings
Item 1. Legal Proceedings.
On July 24, 2025, a class action complaint alleging violations of the federal securities laws was filed against the Company and its directors and certain officers in the United States District Court for the District of Massachusetts, or the District of Massachusetts. The complaint, captioned Jboor v. Replimune Group, Inc. et al. , Case No. 1:25-cv-12085-JEK, was filed shortly after the Company announced it received a complete response letter, or CRL, from the FDA for its RP1 BLA for the treatment of advanced melanoma on July 22, 2025 and the subsequent decline in the trading price of the Company's common stock. The Court has appointed a lead plaintiff, or the Lead Plaintiff. On January 13, 2026, Lead Plaintiff filed an amended complaint. Following the second CRL issued by the FDA on April 10, 2026 for the Company's RP1 BLA for the treatment of advanced melanoma, the Lead Plaintiff filed a second amended complaint in the class action that addresses the second CRL. The Company’s and the other defendants’ response is now due August 17, 2026. The Company and the other defendants deny any wrongdoing and will vigorously defend this action.
Following the class action complaint, three shareholders filed separate derivative actions on behalf of the Company in the District of Massachusetts captioned 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 plaintiffs allege substantially similar facts as the class action complaint and assert that the Company’s directors and officers breached their fiduciary duties. The parties have consolidated the derivative actions and agreed to a stay pending further developments in the class action.
On September 10, 2025, the Company received a letter from a shareholder demanding that the Company's board of directors take action to address alleged wrongdoing by certain directors and officers. The demand letter alleged substantially similar facts as the class action and derivative action complaints. The board of directors determined to defer action on the demand pending further developments in the class action.
On September 29, 2025, the SEC, informed the Company that it was conducting an investigation and requested that the Company produce certain documents and communications connected with the RP1 BLA. The investigation is reviewing essentially the same subject matter raised in the litigation following the CRL. On June 24, 2026, the SEC informed the Company that it has concluded its investigation of the Company and that it is not recommending an enforcement action be taken against the Company.
On August 6, 2026, a class action complaint alleging violations of the federal securities laws was filed against the Company and its directors and certain officers in the District of Massachusetts. The complaint, captioned Toor v. Replimune Group, Inc. et al., Case No. 1:26-cv-13612, alleges essentially the same facts and circumstances as the Lead Plaintiff's case. The Company and the other defendants deny any wrongdoing and continue to vigorously defend this action.
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