Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting
Clene Inc. (CLNN)
Company Research
Source: GlobeNewswire
The FDA has granted an in-person Type C meeting during the first quarter of 2026 New independent analyses across large observational ALS cohorts demonstrate that modest (~10%) NfL reductions are significantly associated with lower mortality risk, supporting NfL reduction as a candidate surrogate endpoint for accelerated approvalNew exploratory findings demonstrate that in responders with IGFBP7 biomarker decline, CNM-Au8 30mg was strongly associated with 78% reduced mortality risk (HR 0.22, p=0.01) in the HEALEY ALS Platform Trial, consistent with emerging genetic evidence linking lower IGFBP7 to ALS reversals SALT LAKE CITY, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis
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News
- Clene to Present at the Emerging Growth ConferenceGlobeNewswire
- Clene announces registered direct offering of over $28M [Seeking Alpha]Seeking Alpha
- Clene (NASDAQ:CLNN) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
- Clene Announces Registered Direct Offering of Over $28 MillionGlobeNewswire
- Clene (NASDAQ:CLNN) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
CLNN
Sec Filings
- 1/16/26 - Form 4
- 1/13/26 - Form 4
- 1/13/26 - Form 8-K
- CLNN's page on the SEC website