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Clene plans NDA submission for ALS drug CNM-Au8 in Q3 2026 after positive FDA meeting and raises $35M in funding.

Company Fundamentals
14 May 2026
GlobeNewsWire
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Bullish
pluang ai news

Clene Inc. announced plans to submit a New Drug Application (NDA) for its ALS treatment CNM-Au8 in the third quarter of 2026 following a successful FDA Type C meeting that supported accelerated approval based on biomarker data. The company raised over $35 million through registered direct offerings and amended its debt facility to extend maturity and ease payments. Clene reported a net loss of $8.1 million for Q1 2026 but expects its cash runway to last into late 2026 or early 2027, supported by potential warrant exercises. The company also plans to start a confirmatory Phase 3 trial for CNM-Au8 in early 2027 to further evaluate survival benefits in ALS patients.

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