Clene Advances CNM-Au8 ALS Program with FDA Meeting

Clene ( (CLNN) ) has shared an announcement.

On January 12, 2026, Clene Inc. announced that the U.S. Food and Drug Administration granted the company an in-person Type C meeting in the first quarter of 2026 to discuss biomarker data supporting a potential new drug application for CNM-Au8 in ALS. In preparation, Clene submitted a briefing package detailing statistically significant reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein from prior CNM-Au8 studies, along with new analyses across large ALS cohorts showing that modest NfL reductions of about 9–10% were associated with an 8–13% lower mortality risk, reinforcing NfL trajectory as a prognostic biomarker and potential surrogate endpoint. The company also reported exploratory findings from the HEALEY ALS Platform Trial indicating that CNM-Au8 30 mg treatment was associated with improved survival and that patients showing declines in the biomarker IGFBP7 experienced a 78% reduction in mortality risk compared with controls, aligning with emerging genetic evidence that lower IGFBP7 may protect against ALS progression; collectively, these data aim to strengthen Clene’s regulatory case and could enhance its positioning in the ALS treatment landscape if regulators ultimately accept these biomarkers as part of an approval framework.

The most recent analyst rating on (CLNN) stock is a Sell with a $5.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Spark’s Take on CLNN Stock

According to Spark, TipRanks’ AI Analyst, CLNN is a Neutral.

Clene’s overall stock score is primarily impacted by its poor financial performance and valuation, reflecting significant financial instability and ongoing losses. However, the positive corporate events related to promising clinical data provide a potential upside, offering hope for future growth and market positioning. The technical analysis indicates bearish momentum, further weighing down the score.

To see Spark’s full report on CLNN stock, click here.

More about Clene

Clene Inc., based in Salt Lake City with R&D and manufacturing operations in Maryland, is a late clinical-stage biopharmaceutical company developing therapies to improve mitochondrial health and protect neuronal function in neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease and multiple sclerosis. Its lead investigational product, CNM-Au8, is an oral suspension of gold nanocrystals designed to enhance cellular energy production, support neuroprotection and remyelination, and reduce oxidative stress via mechanisms targeting mitochondrial function and the NAD pathway.

Average Trading Volume: 171,276

Technical Sentiment Signal: Sell

Current Market Cap: $61.69M

Find detailed analytics on CLNN stock on TipRanks’ Stock Analysis page.