Clene Inc. 8K

Clene Inc. reported new exploratory biomarker analyses showing CNM-Au8’s survival and functional benefits in ALS patients with NfL response, which it will use to support a planned NDA submission for accelerated FDA approval and a Phase 3 confirmatory trial.

On August 10, 2026, Clene Inc. announced new post hoc biomarker analyses from its Phase 2 ALS trials HEALEY and RESCUE-ALS showing that amyotrophic lateral sclerosis patients treated with its investigational therapy CNM-Au8 whose neurofilament light chain (NfL) levels declined or stabilized experienced significantly improved survival and functional outcomes compared to concurrently randomized controls, and that the magnitude of NfL reduction correlated with reduced risk of death across large external cohorts. The company conducted multiple analytical approaches, including an FDA-requested principal stratum causal analysis using only pre-treatment characteristics, which indicated that CNM-Au8’s survival benefit was concentrated in patients predicted to be NfL responders and appeared mechanistically linked to NfL changes, while negative-control biomarkers showed no such relationship. These exploratory, non-prespecified analyses, together with a favorable long-term safety and tolerability profile and plans for a prospective Phase 3 RESTORE-ALS confirmatory trial that will stratify by baseline NfL, are intended to support Clene’s planned New Drug Application submission in early Q4 2026 seeking FDA accelerated approval for CNM-Au8 in ALS and to respond to questions raised by the FDA at a March 2026 Type C meeting regarding the use of NfL as a reasonably likely surrogate endpoint.

Filing Facts

CIK

1822791

Ticker

-

Form

8K

Source Type

sec

Accession

0001437749-26-026653

Alert Tier

6