PEDMARK Phase 2 Cuts Hearing Loss to 24% vs 56% Benchmark
FENC sits 87% above its 52-week low of $5.65.
Summary
Fennec's Phase 2 STS-J01 data for PEDMARK shows ASHA-defined hearing loss in 24.0% of patients versus a 56.4% historical benchmark (P=0.001), with 84% Brock Grade 0 and no Grade 3/4 events. Objective response rate was 95.8% in 23/24 evaluable patients, indicating no interference with cisplatin efficacy. The company is pursuing registration and partnering in Japan, which could open a new market and bring milestone payments. This is the first disclosure of these results and materially strengthens the clinical profile of PEDMARK, supporting adoption and reimbursement arguments. The data extends prior COG and SIOPEL 6 findings with Japan-specific evidence. Watch for a formal Japan regulatory filing or partnership announcement, which would convert this into a revenue event.
At the time of this announcement, FENC was trading at $10.55 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $370M. The 52-week trading range was $5.65 to $13.25. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.