Clene Reports Third Quarter 2025 Financial Results and Recent Operating Highlights
Clene Inc. (CLNN)
Company Research
Source: GlobeNewswire
As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analysesThe Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathwayThe Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company’s MS clinical development program and ongoing plans for MS development of CNM-Au8Cash and cash equivalents of $7.9 million as of September 30, 2025 Cash runway extended into the second quarter of 2026, including $1.2 million additionally raised following the third quarter close SALT LAKE CITY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its sub
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CLNN
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 Announces Statistically Significant ALS Biomarker Results Supporting Accelerated Approval Pathway for CNM-Au8®GlobeNewswire
- Clene to Provide CNM-Au8® ALS Program UpdateGlobeNewswire
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