Fennec Pharmaceuticals Announces Positive Phase 2/3 Data and New Research for PEDMARK at ASCO 2026

2026-05-22SEC Filing 8-K (0001104659-26-065696)

On May 21, 2026, Fennec Pharmaceuticals announced that new research regarding PEDMARK (sodium thiosulfate injection) will be presented at the 2026 ASCO Annual Meeting. Key data includes results from the Japanese Children’s Cancer Group STS-J01 Phase 2/3 trial, which met its primary endpoint. The study showed a significant reduction in cisplatin-induced hearing loss (16-24%) compared to historical controls (56-63%) in pediatric and adolescent patients. Additionally, the company highlighted real-world evidence demonstrating that PEDMARK can be safely integrated into oncology workflows for adults with head and neck cancer and young adults with solid tumors without compromising cisplatin's antitumor activity. A new randomized Phase 1 study for men with metastatic germ cell tumors also opened for accrual in early 2026. While PEDMARK is currently FDA-approved for pediatric patients with localized, non-metastatic solid tumors, these studies aim to expand its clinical utility into adolescent and young adult (AYA) and adult populations.

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