Roth says FDA approving Clene’s ALS treatment NDA a ‘long shot’

Roth Capital analyst Jonathan Aschoff reiterated a Buy rating and $30 price target on Clene (CLNN), noting that the company ended Q1 with $12.4M in pro forma cash, enough funding into Q4, with a potential additional $22M in milestone-based funding tranches able to fund operations well into 2027. The FDA agreeing 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, or NfL, will drive approval. The firm added that despite the dire ALS medical need, the much smaller NfL reduction with CNM-Au8 versus Qalsody stokes its pessimism.