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FENNEC PHARMACEUTICALS (FENC)

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Earnings summaries and quarterly performance for FENNEC PHARMACEUTICALS.

Recent press releases and 8-K filings for FENC.

Fennec Pharmaceuticals Discusses PEDMARK's Market Expansion and Growth
FENC
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • Fennec Pharmaceuticals' PEDMARK, the first and only FDA-approved product to prevent Cisplatin-induced ototoxicity in pediatric patients (ages 1-18), has expanded its market opportunity to adolescent and young adult (AYA) patients (ages 15-39) via NCCN 2A Guidelines.
  • The AYA market represents a substantial opportunity with approximately 20,000 patients annually receiving Cisplatin, significantly larger than the 2,000 pediatric patients. In 2024, quarterly net product sales grew from approximately $7 million to $12.5 million, primarily driven by the AYA market.
  • PEDMARK maintains strong payer access with 100% reimbursement across major U.S. carriers and has a WAC price of $11,000 per vial. Its intellectual property includes orphan drug exclusivity until September 2029 and six Orange Book patents through July 2039.
  • Internationally, recent investigator-initiated trial data from Japan demonstrated PEDMARK's efficacy and safety, with plans to pursue approval and seek a partner. In Europe, PEDMARK has launched in the UK and Germany through a partnership with Norgine, which includes $43 million upfront and $200 million in milestones, with the first milestone anticipated in Q1 2026.
Dec 3, 2025, 6:00 PM
Fennec Pharmaceuticals Discusses PEDMARK Market Expansion and International Strategy
FENC
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • PEDMARK, the first and only FDA-approved product for cisplatin-induced ototoxicity in pediatric patients, has expanded its addressable market from 2,000 to 20,000 annual U.S. patients with NCCN 2A Guidelines approval for adolescent and young adult (AYA) use. This expansion contributed to quarterly product sales growth from approximately $7 million to $12.5 million.
  • Fennec Pharmaceuticals holds orphan drug exclusivity for PEDMARK until September 2029 and six Orange Book patents until July 2039. The product also benefits from 100% reimbursement across major U.S. carriers, with a WAC price of $11,000 per vial and a 20% gross-to-net step down.
  • Internationally, PEDMARK demonstrated efficacy and safety in a recent Japanese trial, supporting potential approval and partnership in Japan. The company has also launched in the UK and Germany via a partnership with Norgine, which includes $43 million upfront and $200 million in milestones, with the first milestone expected in Q1 2026.
Dec 3, 2025, 6:00 PM
Fennec Pharmaceuticals Discusses PEDMARK Growth and Market Expansion
FENC
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
  • PEDMARK is the first and only FDA-approved product to prevent Cisplatin-induced ototoxicity, initially indicated for ages 1-18, but NCCN 2A Guidelines now recommend its use for ages 15-39, expanding the addressable market from ~2,000 to ~20,000 patients annually.
  • The company has experienced four consecutive quarters of growth, with net product sales increasing from approximately $7 million to $12.5 million quarterly, primarily driven by the adolescent and young adult (AYA) market.
  • PEDMARK has a WAC price of $11,000 per vial, with strong payer access, achieving 100% reimbursement across major carriers last quarter.
  • Intellectual property includes orphan drug exclusivity until September 2029 and six Orange Book patents through July 2039.
  • Recent positive trial data from Japan supports plans for regulatory approval and partnering, while European launches have begun in the UK and Germany through a partnership with Norgine.
Dec 3, 2025, 6:00 PM