Clene to include ALS biomarker data in NDA for accelerated approval
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Clene Announces Biomarker Analyses To Be Included in NDA Submission Supporting ALS Accelerated Approval
August 10, 2026 8:00 AM EDTSurvival benefit is concentrated in participants with NfL biomarker response: CNM-Au8®-treated patients whose NfL declined or stabilized lived significantly longer than concurrently randomized controlsFunctional benefit concentrated in participants with NfL biomarker response: CNM-Au8-treated patients whose NfL declined or stabilized had significantly better outcomes on combined measures of survival and function, including daily function (ALSFRS-R) and breathing capacity (Slow Vital Capacity), than concurrently randomized controls
SALT LAKE CITY, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq:... More
