Clene Receives Final Meeting Minutes from FDA, Plans to Submit ALS NDA in 2026

Clene announced receipt of final meeting minutes following its recent Type C meeting with the FDA. During the meeting and confirmed in the final meeting minutes, the FDA stated that Clene's "proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of ALS." The FDA reminded the company that the submission should demonstrate the effectiveness of an effect of CNM-Au8 on NfL and show that the magnitude of change in NfL is reasonably likely to predict clinical benefits in patients with ALS. Clene intends to submit its NDA in the third quarter of 2026, which will remain a matter of FDA review. The agency also noted that "NfL could potentially serve as a reasonably likely surrogate endpoint to support (an) accelerated approval." This submission would occur under the Subpart H accelerated approval pathway in ALS. The Agency has also requested that the company provide additional information in its NDA, including to support a connection between the reported magnitude of reduction in NfL and clinical benefit, which Clene has prepared and will include in the submission.