Clene to submit ALS NDA in Q1 2026, phase 3 trial to start H1 2026.
ByAinvest
Thursday, Nov 13, 2025 8:19 am ET1min read
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Clene Inc. is concluding ALS biomarker data analyses and expects to submit a New Drug Application in Q1 2026 under an accelerated approval pathway. The FDA advised Clene to request a Type C meeting to review further analyses. The Company plans to dose the first patient in the Phase 3 RESTORE-ALS trial in H1 2026. Clene's cash and cash equivalents stood at $7.9 million as of September 30, 2025, with a cash runway extended into Q2 2026.
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