FAQ on Clene Inc.'s Regulatory Advances for CNM-Au8 in ALS and MS Treatment

Summary
What is Clene Inc. focusing on with its CNM-Au8 therapy?
Clene Inc. is focusing on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS) with its investigational therapy CNM-Au8.
What recent regulatory developments has Clene Inc. announced?
Clene Inc. announced feedback from a Type C meeting with the FDA on its statistical analysis plan for ALS, plans to resubmit a revised SAP, and scheduled FDA meetings in Q3 2025 to discuss ALS survival data and MS Phase 2 trial results.
Why is the feedback from the FDA Type C meeting important for Clene Inc.?
The feedback is crucial as it guides Clene Inc. in refining its statistical analysis plan for evaluating neurofilament light biomarker data, supporting a potential NDA submission under the accelerated approval pathway for ALS treatment.
When does Clene Inc. anticipate FDA acceptance of its revised SAP?
Clene Inc. anticipates FDA acceptance of its revised statistical analysis plan this summer, with neurofilament light analyses scheduled for early Q4 2025.
What are the upcoming FDA meetings Clene Inc. has confirmed?
Clene Inc. has confirmed two FDA meetings in Q3 2025: one to assess long-term ALS survival data for accelerated approval consideration and another End-of-Phase 2 Type B meeting to review Phase 2 MS trial results and discuss a Phase 3 study.
How does CNM-Au8 work in treating neurodegenerative diseases?
CNM-Au8 improves central nervous system cells’ survival and function by targeting mitochondrial function and the NAD pathway while reducing oxidative stress.
Where is Clene Inc. based and where are its operations located?
Clene Inc. is based in Salt Lake City, Utah, with research and development and manufacturing operations in Maryland.
What is the significance of the accelerated approval pathway for Clene Inc.?
The accelerated approval pathway could allow Clene Inc. to bring CNM-Au8 to market more quickly for ALS and MS patients, based on biomarker data and survival benefits, before completing full clinical trials.
How can investors stay updated on Clene Inc.’s developments?
Investors can stay updated by visiting the company’s newsroom at https://ibn.fm/CLNN for the latest news and updates relating to Clene Inc.

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