Clene Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®
Clene Inc. (CLNN)
Company Research
Source: GlobeNewswire
FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activityCompany has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathwayClene is hosting an investor webcast today at 8:30 am ET SALT LAKE CITY, Dec. 03, 2025 (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 (MS), today announced completion of the FDA-recommended biomarker analyses for CNM-Au8® in people living with ALS. The res
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News
- Clene (NASDAQ:CLNN) had its "buy" rating reaffirmed by analysts at Benchmark Co..MarketBeat
- 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 (NASDAQ:CLNN) had its "buy" rating reaffirmed by analysts at UBS Group AG.MarketBeat
- Clene to Provide CNM-Au8® ALS Program UpdateGlobeNewswire
- Institutions own 17% of Clene Inc. (NASDAQ:CLNN) shares but individual investors control 56% of the company [Yahoo! Finance]Yahoo! Finance
CLNN
Sec Filings
- 12/3/25 - Form 8-K
- 12/3/25 - Form 8-K
- 11/14/25 - Form 4
- CLNN's page on the SEC website