Clinical Trials
0
0 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
No trial data available
- A Phase 2/3 clinical trial in Japan demonstrated that PEDMARK significantly reduced cisplatin-induced hearing loss in pediatric cancer patients, with only 16-24% experiencing ototoxicity compared to 56-63% in historical controls. - The study confirmed PEDMARK's safety profile with no interference in cisplatin's antitumor activity, achieving a 95% tumor response rate while protecting hearing function. - These positive results support Fennec Pharmaceuticals' plans to pursue regulatory approval in Japan and explore licensing partnerships for the first FDA-approved ototoxicity prevention therapy.
- Fennec Pharmaceuticals announced an underwritten registered public offering of common shares with Piper Sandler & Co. and Craig-Hallum Capital Group LLC serving as joint book-running managers. - The company plans to use net proceeds primarily to repurchase and redeem certain indebtedness, with remaining funds allocated for working capital and general corporate purposes. - Fennec has granted underwriters a 30-day option to purchase up to an additional 15% of common shares sold in the public offering. - The specialty pharmaceutical company focuses on commercializing PEDMARK® to reduce platinum-induced ototoxicity in cancer patients receiving cisplatin-based chemotherapy.
- The National Institute for Health and Care Excellence (NICE) has recommended Pedmarqsi for preventing cisplatin-induced hearing loss in young patients aged 1 month to 17 years. - Clinical trials demonstrated that Pedmarqsi reduces cisplatin-induced ototoxicity by approximately 50% compared to cisplatin alone, addressing a critical unmet need. - Fennec Pharmaceuticals has an exclusive licensing agreement with Norgine Pharmaceuticals for commercialization in Europe, Australia, and New Zealand. - The licensing agreement includes a $43 million upfront payment and potential additional payments up to $230 million, plus double-digit tiered royalties.
