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Posted On: 03/24/2025 4:33:43 PM
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NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Plans 2025 NDA Submission Following Positive ALS Trial Data
Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, reported a full-year 2024 net loss of $39.4 million, or $5.67 per share, compared to a loss of $49.5 million in 2023. Revenue remained limited, but Clene highlighted regulatory progress and survival data supporting CNM-Au8, its gold nanocrystal suspension for ALS. The company expects to meet with the FDA in Q2 2025 to finalize analysis plans for biomarker data, with a potential accelerated NDA submission in the second half of 2025. Clene ended the year with $12.2 million in cash and expects to begin enrollment for its confirmatory Phase 3 RESTORE-ALS trial in mid-2025.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, reported a full-year 2024 net loss of $39.4 million, or $5.67 per share, compared to a loss of $49.5 million in 2023. Revenue remained limited, but Clene highlighted regulatory progress and survival data supporting CNM-Au8, its gold nanocrystal suspension for ALS. The company expects to meet with the FDA in Q2 2025 to finalize analysis plans for biomarker data, with a potential accelerated NDA submission in the second half of 2025. Clene ended the year with $12.2 million in cash and expects to begin enrollment for its confirmatory Phase 3 RESTORE-ALS trial in mid-2025.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://nnw.fm/CLNN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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