PEDMARK Phase 2 STS-J01: 24% Hearing Loss vs 56.4% Benchmark and 95.8% Tumor Response
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Summary
Phase 2 STS-J01 of PEDMARK in Japan met its primary endpoint, showing significant hearing protection (24.0% vs 56.4% historical benchmark) with no Grade 3/4 hearing loss and a 95.8% objective tumor response rate, supporting Japanese registration efforts.
Key Events · Product Development and Regulatory · FENC
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Primary Endpoint Met
ASHA-defined hearing loss occurred in 24.0% (6/25) of patients versus the prespecified historical benchmark of 56.4% (P=0.001).
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Hearing Protection Profile
84.0% of patients had Grade 0 hearing loss by Brock criteria; no Grade 3 or Grade 4 hearing loss was observed.
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Antitumor Activity Preserved
Objective tumor responses observed in 23 of 24 evaluable patients (95.8%), confirming delayed PEDMARK administration does not interfere with cisplatin efficacy.
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Japan Registration Strategy
Fennec is pursuing registration in Japan and actively exploring partnering or licensing opportunities for PEDMARK in that market.
Analysis · FENC · Life Sciences
Detailed results from the investigator-initiated Phase 2 STS-J01 study of PEDMARK in Japan were presented at SIOP 2026. The primary endpoint was met: ASHA-defined hearing loss occurred in 24.0% of patients versus a prespecified historical benchmark of 56.4% (P=0.001). Critically, 84% of patients had Grade 0 hearing loss by Brock criteria with no Grade 3 or 4 hearing loss observed, and objective tumor responses were seen in 23 of 24 evaluable patients (95.8%), providing reassurance that delayed PEDMARK administration does not interfere with cisplatin antitumor activity. The company is pursuing registration in Japan and exploring partnering or licensing opportunities. This is the third study to demonstrate no interference with cisplatin antitumor activity, building on the pivotal COG ACCL0431 and SIOPEL 6 trials. The data strengthens the clinical rationale for PEDMARK's six-hour administration interval and supports expansion into the Japanese market, a significant commercial opportunity for a company with Q2 2026 net product sales of $17.1 million.
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At the time of this filing, FENC was trading at $10.78 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $378M. The 52-week trading range was $5.65 to $13.25. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.