Fennec Pharmaceuticals Inc. FENC
Fennec Pharmaceuticals Inc. (Nasdaq: FENC) is an oncology drug developer. Its lead program, PEDMARK (sodium thiosulfate injection), is in Phase 3 for reduce risk of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. Its next catalyst on record is PEDMARQSI: Norgine launches in additional European markets (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: PEDMARQSI — Norgine launches in additional European markets (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| PEDMARK (US) / PEDMARQSI (EU/UK) | cisplatin-induced ototoxicity, pediatric | small molecule | Approved |
| PEDMARK Japan registration (STS-J01) | cisplatin-induced ototoxicity | small molecule | Phase 3 |
| PEDMARK adult testicular germ cell tumor (investigator-initiated, City of Hope) | cisplatin ototoxicity in adult men with metastatic testicular germ cell tumors | small molecule | Phase 2 |
Recent results and decisions
- May 21, 2026met Investigator-initiated Phase 2/3 STS-J01 (27 patients) met its primary endpoint, with hearing loss of 16-24% vs 56-63% historically reported with cisplatin alone, to be presented at ASCO 2026.
The study, which enrolled 27 patients, met its primary endpoint with a significant reduction in hearing loss in 3–18-year-old patients who received PEDMARK® when compared with historically reported rates of hearing loss in patients receiving cisplatin alone (16-24% versus 56-63%, respectively).
Filing - Feb 20, 2026positive Retrospective real-world review of 15 adults with head and neck cancer: PEDMARK given 6+ hours after cisplatin was feasible, with early hearing-preservation signals (MHNCS poster).
Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK® could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC.
Filing - Dec 2, 2025met Investigator-initiated single-arm Phase 2/3 STS-J01 (n=27 primary cohort) met primary endpoint: hearing loss 24% (ASHA) and 16% (Brock) vs historical 56-63% with cisplatin alone; ~95% tumor response.
The primary endpoint of the study was met and the data showed that 24% and 16% of evaluable patients who were treated with PEDMARK® experienced hearing loss (ototoxicity)
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.