Fennec Pharmaceuticals Inc. (NASDAQ: FENC) has announced the launch of an investigator‑sponsored study at City of Hope to evaluate its FDA‑approved drug PEDMARK (sodium thiosulfate injection) in adult men with stage II‑III metastatic testicular germ cell tumors. The trial, registered as NCT07218913, will test whether adding PEDMARK to standard cisplatin‑based chemotherapy can reduce cisplatin‑induced ototoxicity in this newly targeted population.
The study represents a strategic expansion of PEDMARK beyond its current pediatric indication. By addressing the unmet need for hearing protection in adult patients receiving cisplatin, the trial could open a substantial new market for Fennec and support future regulatory submissions and reimbursement pathways in adult oncology.
Fennec’s recent financial performance underscores its capacity to fund this initiative. In the third quarter of 2025, the company reported net product sales of $12.5 million, a 79% year‑over‑year increase, and became profitable from operations for the first time. Cash and cash equivalents stood at $21.9 million as of September 30, 2025, providing a solid liquidity base for ongoing clinical development.
CEO Jeff Hackman described the quarter as an inflection point, noting that record sales and profitability confirm the effectiveness of the company’s strategy. Chief Medical Officer Pierre Sayad highlighted the growing clinical interest in mitigating cisplatin‑related hearing loss and emphasized that the trial reflects a broader commitment to improving long‑term quality of life for cancer survivors.
While the announcement does not yet specify enrollment dates or the exact funding arrangement, Fennec is expected to supply the drug and support the study’s operational needs. The trial’s results will be critical in determining whether PEDMARK can be approved for adult use and will inform the company’s future growth trajectory in oncology.
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