Clene Inc. (CLNN) has two meetings scheduled with the FDA this quarter, related to its lead drug candidate CNM-Au8.
CNM-Au8 is a gold nanocrystal suspension currently in development as a disease-modifying treatment for people living with Amyotrophic Lateral Sclerosis, Multiple Sclerosis, and Parkinson's Disease.
The two meetings scheduled with the FDA this quarter are:
1. The ALS Survival Data Type C Meeting: This meeting will review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized controls from another Healey ALS Platform Trial Regimen, assessing whether these data support filing of an NDA under an accelerated approval pathway.
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September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.