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Stock impact report

Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights

Clene Inc. (CLNN) 
Company Research Source: GlobeNewswire
Initiated discussions with FDA regarding accelerated approval pathway for CNM-Au8® for the treatment of ALS with the objective of submitting an NDA in 2024Released long-term data from the open-label extension of the HEALEY ALS Platform Trial in which CNM-Au8 demonstrated statistically significant reductions of plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomization, p=0.023) as well as a 60% decreased risk of long-term all-cause mortality using rank-preserving structural failure time model analysis (18 months, p=0.0167)Demonstrated a statistically significant survival benefit (p=0.0001) in Expanded Access Program (EAP) participants (n=220) treated with CNM-Au8 compared to historical ALS disease progression controls with decreased risk of all-cause mortality ranging from 57%-68% Reported additional long-term data from the Phase 2 VISIONARY-MS trial in which CNM-Au8 treatment was associated with vision improvement as measured by low co Show less Read more
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