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Clene concludes ALS biomarker data, plans NDA submission in Q1 2026.
ByAinvest
Thursday, Nov 13, 2025 8:10 am ET1min read
• Clene to conclude ALS biomarker data analysis shortly • FDA advises Clene to request Type C meeting for further review • NDA submission planned for first quarter of 2026 • First patient dosed in RESTORE-ALS trial expected in H1 2026 • FDA and Clene discussed MS clinical development program in Type B meeting • Cash and cash equivalents at $7.9 million as of September 30
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