On March 16, 2026, Fennec Pharmaceuticals Inc. announced a significant development regarding its PEDMARK® product, a sodium thiosulfate injection used to mitigate the risk of ototoxicity in pediatric patients undergoing cisplatin chemotherapy. The company entered into a License Agreement with Cipla Limited and Cipla USA, Inc. to resolve ongoing litigation concerning Cipla's application to the U.S. Food and Drug Administration (FDA) for a generic version of PEDMARK. This legal dispute was encapsulated in the case Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23-cv-00123-JKS-MAH (D.N.J.). Under the terms of the agreement, the lawsuit will be dismissed, with both parties bearing their own legal costs. Notably, Cipla has committed to refraining from entering the U.S. market with its generic sodium thiosulfate product until September 1, 2033, although earlier entry may be permitted under specific circumstances. This settlement is expected to bolster Fennec's market position and ensure continued revenue from PEDMARK, which is the first FDA-approved therapy for preventing cisplatin-induced hearing loss in children. The agreement not only resolves the litigation but also reinforces Fennec's strategic outlook, allowing the company to focus on its operational execution and market expansion without the immediate threat of generic competition. The company issued a press release detailing the License Agreement and the resolution of the Cipla litigation, which is included as Exhibit 99.1 in the filing. This development is anticipated to have a noticeable positive effect on Fennec's stock price as it secures market exclusivity for its innovative product, which has already shown significant efficacy in clinical trials.

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