Clene Inc. (NASDAQ: CLNN) has made significant strides in its regulatory strategy for CNM-Au8, a promising treatment for neurodegenerative diseases, following a productive Type C meeting with the FDA. The company has resubmitted a revised statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for amyotrophic lateral sclerosis (ALS), with FDA acceptance anticipated this summer. This development is crucial as it paves the way for a potential New Drug Application (NDA) submission under the accelerated approval pathway, with NfL analyses scheduled for early Q4 2025.
In addition to the progress in ALS treatment, Clene has confirmed two further FDA meetings in Q3 2025. One meeting will assess long-term ALS survival data for accelerated approval consideration, while another, an End-of-Phase 2 Type B meeting, will review Phase 2 multiple sclerosis (MS) trial results and discuss a Phase 3 study aimed at cognitive improvement. These meetings underscore the company's commitment to addressing unmet needs in neurodegenerative diseases, offering hope to patients and stakeholders in the biopharmaceutical industry.
The advancements in Clene's regulatory strategy for CNM-Au8 represent a significant step forward in the treatment of ALS and MS, diseases that currently have limited therapeutic options. The potential for accelerated approval and the focus on cognitive improvement in MS patients highlight the innovative approach Clene is taking to tackle these challenging conditions. For more information on Clene's developments, visit https://ibn.fm/iLzgr.
