Clene Files NDA for ALS Therapy CNM-Au8; FDA Filing Decision Expected by Early December

Clene Inc. (CLNN) has submitted a New Drug Application to the FDA seeking accelerated approval of CNM-Au8, its gold nanocrystal therapy for amyotrophic lateral sclerosis. The FDA typically rules within 60 days on whether to accept the application for review, putting a filing decision before early December. The stock closed at $3.73, up 13.73%. The NDA follows mixed clinical results: the Phase 2 RESCUE-ALS and Phase 2/3 HEALEY platform trials missed their primary efficacy endpoints, though exploratory analyses suggested potential survival and functional benefits. In 2023, the FDA declined an accelerated approval bid, finding initial evidence of neurofilament light chain (NfL) reduction insufficient; Clene cites subsequent observational analyses linking roughly 10% NfL reductions to lower mortality risk. Clene reported $13.7 million in cash as of September 30, 2026, with runway expected into mid-Q1 2027. It estimates the global ALS market could exceed $1.5 billion by 2032. Approved ALS drugs include riluzole, edaravone and tofersen; Relyvrio was withdrawn after its confirmatory trial failed.