CLNN - FDA Refuses Neurology-Focused Clene's Accelerated Approval For Amyotrophic Lateral Sclerosis Treatment Shares Fall | Benzinga
Clene Inc (NASDAQ: CLNN) provided an amyotrophic lateral sclerosis (ALS) regulatory update from its recent meeting with the FDA to discuss CNM-Au8 for ALS, presenting initial clinical and Neurofilament Light Chain (NfL) biomarker results from the completed Phase 2 ALS studies.
The FDA determined that the initial findings on biomarker NfL reduction from the Phase 2 programs were insufficient to support accelerated approval.
Clene looks forward to providing supplemental data for further engagement with ...