FDA-confirmed accelerated approval path for ALS hinges on NDA acceptance and whether NfL qualifies as a surrogate — runway expires the same quarter the filing lands

Clene is a clinical-stage company developing a targeted neurological drug for amyotrophic lateral sclerosis (ALS), a fatal disease, which is not yet approved.

Clene is racing a near-empty balance sheet to file a CNM-Au8 NDA for ALS, a fatal disease with few options, under an accelerated approval pathway FDA confirmed in writing using neurofilament light chain as a surrogate endpoint. The thesis resolves on whether FDA accepts the NDA and grants approval on biomarker data alone, without a completed Phase 3. The central risk is structural: single-arm and external-control biomarker data supporting approval is an unconventional evidentiary standard, and cash runs out in late Q4 2026, the same window as the planned filing.