CLNN Stock Falls After Roth Labels Accelerated Approval For ALS Drug A ‘Long Shot’

• Clene said earlier on Thursday that it plans to submit a New Drug Application for its lead ALS candidate CNM-Au8 in the third quarter of 2026 under the FDA’s accelerated approval pathway.
• Roth Capital analyst dismissed the chances of the drug getting approval on a surrogate endpoint. 
• The analyst, however, reiterated a ‘Buy’ rating on the stock and a $30 price target.

Shares of Clene Inc. (CLNN) fell 3% after hours on Thursday after a Roth Capital analyst dismissed the chances of the U.S. Food and Drug Administration approving its application for the investigational therapy CNM-Au8 in the treatment of amyotrophic lateral sclerosis on an accelerated basis as a “long shot.”

Shares of the company rose 8% during regular trading hours but fell after hours following the analyst note.

Clene’s Plans For Its Investigational Therapy

Clene said earlier on Thursday that it plans to submit a New Drug Application for its lead ALS candidate CNM-Au8 in the third quarter of 2026 under the FDA’s accelerated approval pathway. The FDA's Accelerated Approval pathway allows earlier approval of drugs treating serious or life-threatening conditions with unmet medical needs based on surrogate endpoints reasonably likely to predict clinical benefit, with mandatory confirmatory trials required post-approval to verify benefit.

The company’s submission will rely on data showing statistically significant reductions in neurofilament light chain — a key biomarker of neuronal damage — following a constructive meeting with the FDA in the first quarter. Regulators signaled that the NfL results, along with correlations to improved survival and clinical outcomes, may support accelerated approval for ALS, the company said.

“We were encouraged by the constructive dialogue during our recent Type C meeting with the FDA,” said Clene CEO Rob Etherington. “People living with ALS continue to need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function, leading to improved survival.” The company also said on Thursday that it intends to launch a confirmatory late-stage trial in Q1 2027, with overall survival as the primary endpoint.

Analyst Weighs In On Plans

Roth Capital analyst Jonathan Aschoff said that the FDA's agreement to receive Clene's accelerated approval NDA for CNM-Au8 in treating ALS is a positive development, but the firm does not believe that the magnitude of change in neurofilament light will drive approval.

The firm added that despite the dire ALS medical need, the much smaller NfL reduction with CNM-Au8 versus Biogen’s Qalsody stokes its pessimism. Qalsody is a prescription, FDA-approved medication specifically for adults with ALS, a progressive, fatal neurodegenerative disorder.

Roth, however, reiterated a ‘Buy’ rating on the stock and a $30 price target.

How Did CLNN Retail Traders React?

On Stocktwits, retail sentiment around CLNN stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘extremely low’ levels.

CLNN stock has gained over 165% over the past 12 months.

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