Fennec Pharmaceuticals Announces Positive Phase 2 PEDMARK Results in Japan

What Happened

• On September 17, 2026, Fennec Pharmaceuticals (FENC) filed an 8-K to report positive results from an investigator‑initiated Phase 2 clinical study (STS-J01) of PEDMARK® in Japan. The study met its primary endpoint and "demonstrated significant hearing protection" in patients receiving cisplatin, with no evidence of interference with cisplatin antitumor activity. A press release describing the results was furnished as Exhibit 99.1 to the filing.

Key Details

• Study: Investigator-initiated Phase 2 STS-J01 in Japan.
• Primary outcome: Met primary endpoint; reported significant hearing protection.
• Safety/efficacy note: No evidence of interference with cisplatin's antitumor activity was observed.
• Filing date: Current Report on Form 8-K filed September 17, 2026 (press release Exhibit 99.1).

Why It Matters

• Positive Phase 2 data support PEDMARK’s clinical profile for prevention of cisplatin‑induced hearing loss, which is central to the drug’s intended use.
• For investors, these results may be a step toward further development or regulatory discussions in Japan and elsewhere, but the study was investigator‑initiated and additional company‑sponsored or regulatory‑required trials may still be needed.
• This disclosure updates the market on clinical progress without presenting new financial results or corporate leadership changes.