Fennec Pharmaceuticals’ investigator‑initiated Phase 2/3 STS‑J01 trial in Japan demonstrated a dramatic reduction in cisplatin‑induced ototoxicity, with only 24 % of evaluable patients meeting ASHA criteria for hearing loss and 16 % meeting Brock grading, compared with historically reported rates of 56‑63 % in similar pediatric populations.
The low ototoxicity rates confirm PEDMARK’s safety profile and show that the drug does not blunt cisplatin’s antitumor activity, as the overall tumor response rate remained at approximately 95 % and no adverse events were attributed to PEDMARK.
Fennec’s Q3 2025 financial results provide context for the clinical success: revenue rose to $12.46 million, up 78 % from $6.97 million in Q3 2024, driven by increased PEDMARK sales. Net product sales hit a record, and the company’s net loss narrowed, marking the first profitable quarter from operations.
CEO Jeff Hackman described the quarter as an inflection point, noting record net product sales and the first profitable operating period. Chief Medical Officer Pierre Sayad emphasized that the STS‑J01 findings “add compelling support to the global clinical evidence base for PEDMARK®,” reinforcing the drug’s protective effect.
Strategically, Fennec will pursue regulatory registration in Japan and explore partnership or licensing opportunities, positioning PEDMARK for broader international commercialization and strengthening its competitive advantage in the pediatric oncology market.
Market reaction to the announcement was muted; investors are focusing on the long‑term growth potential rather than short‑term price movements.
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