Clene Advances CNM-Au8 Toward Accelerated ALS Approval

An announcement from Clene ( (CLNN) ) is now available.

On May 4, 2026, Clene announced it had received final minutes from a Type C meeting in which the U.S. Food and Drug Administration said the company’s data may be capable of supporting an accelerated approval New Drug Application for CNM-Au8 in amyotrophic lateral sclerosis. The FDA indicated that neurofilament light could potentially serve as a surrogate endpoint and asked Clene to further substantiate the link between reductions in this biomarker and clinical benefit, as the company prepares a third-quarter 2026 NDA filing backed by Phase 2 trial and expanded access data and plans a Phase 3 confirmatory study in 2027, underscoring both the urgency of ALS treatment and a potentially pivotal regulatory opportunity for Clene.

The planned NDA will rely on neurofilament light biomarker and clinical results from the HEALEY ALS Platform Trial, its open-label extension, the RESCUE-ALS trial and an NIH-sponsored expanded access protocol. These data, including observed reductions in plasma neurofilament light associated with longer survival, together with CNM-Au8’s prior Orphan Drug Designation, highlight Clene’s bid to advance what it describes as a first-in-class ALS therapy within a flexible regulatory framework that reflects the disease’s high unmet medical need.

The most recent analyst rating on (CLNN) stock is a Buy with a $30.00 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.

The score is held down primarily by very weak financial performance (large losses, sustained cash burn, and negative equity). Offsetting factors include improving technical momentum and supportive corporate developments (financing/runway extension and regulatory steps), while valuation remains unfavorable due to losses and no dividend.

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

More about Clene

Clene Inc., based in Salt Lake City, is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease and multiple sclerosis. Its lead investigational therapy, CNM-Au8, is an oral suspension of gold nanocrystals designed to enhance cellular energy production, promote neuroprotection and remyelination, and support central nervous system cell survival and function.

Average Trading Volume: 78,578

Technical Sentiment Signal: Buy

Current Market Cap: $72.32M

See more insights into CLNN stock on TipRanks’ Stock Analysis page.