Clene Granted In-Person Meeting With FDA Senior Leadership to Discuss CNM-Au8 Biomarker and Related Clinical and Survival Data
Clene Inc. (CLNN)
Company Research
Source: GlobeNewswire
SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), announced today that it will meet in-person with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss CNM-Au8 development for ALS. The meeting will include the FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (DN1) review team, as well as recognized key opinion leaders in ALS, biostatistics, and biomarkers. Clene is appreciative of the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS. By way of background, days prior to DN1 gra
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CLNN
News
- Clene Inc. (NASDAQ: CLNN) had its price target lowered by analysts at Canaccord Genuity Group Inc. from $86.00 to $83.00. They now have a "buy" rating on the stock.MarketBeat
- Clene Inc. (NASDAQ: CLNN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $31.00 price target on the stock.MarketBeat
- Clene Inc. (CLNN) Reports Q3 Loss, Misses Revenue Estimates [Yahoo! Finance]Yahoo! Finance
- Clene Reports Third Quarter 2024 Financial Results and Recent Operating HighlightsGlobeNewswire
- Clene Inc. (NASDAQ: CLNN) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $31.00 price target on the stock.MarketBeat
CLNN
Earnings
- 11/13/24 - Beat
CLNN
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/13/24 - Form 8-K
- CLNN's page on the SEC website