Clene Inc. CLNN shares are trading lower by 25.90% to $2.09 during Monday's pre-market session after the company announced topline results in the Healey ALS Platform trial of CNM-Au8. The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeks.
Clene says the full analyses, including data on biomarkers of neurodegeneration and exploratory efficacy results, are expected later in 2022.
The open-label extension will continue to follow participants and provide data updates in the future. Clene is in discussions with the Healey & AMG ALS Center to offer a broader EAP of CNM-Au8 30 mg for eligible participants of closed regimens and others.
Based on these topline findings, Clene has selected the CNM-Au8 30 mg dose for continued development in ALS. The CNM-Au8 60 mg dose did not demonstrate a survival benefit.
Clene added that CNM-Au8 was well-tolerated, and there were no drug-related serious adverse events or significant safety findings reported.
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According to data from Benzinga Pro, Clene has a 52-week high of $7.98 and a 52-week low of $1.93.
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