Clene's CNM-Au8 ALS NDA Path Advances with Survival Data from 2 Phase 2 Trials
Clene Inc. reports FDA meeting minutes confirm an accelerated approval pathway for CNM-Au8 in ALS. New biomarker analyses link NfL stabilization to longer survival and improved function. The company plans to submit an NDA, citing data from two completed Phase 2 trials.
Source: californiatelegraph.com · hawaiitelegraph.com