Clene announces NDA submission for CNM-Au8 planned for Q2 2026; cash runway into Q4 2026

Clene Inc.

Raised over $28M in January 2026 registered direct offering; cash runway into Q4 2026 sufficient through NDA acceptance.
In-person Type C FDA meeting scheduled by end of Q1 2026 to discuss data submitted late 2025.
NDA for CNM-Au8 via accelerated pathway planned for Q2 2026; PDUFA date possible in H2 2026.
Confirmatory Phase 3 RESTORE-ALS trial planned to begin later in 2026 after FDA feedback.
Over 800 patients treated; no CNM-Au8-related SAEs; favorable safety profile across 1,000+ patient-years.

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