Clene concludes ALS biomarker data, plans NDA submission in Q1 2026.
ByAinvest
Thursday, Nov 13, 2025 8:10 am ET1min read
CLNN--
• 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
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
Comments
No comments yet