Clene Inc. 8-K

What Happened
Clene Inc. (CLNN) issued a press release on January 12, 2026 announcing additional biomarker data for its experimental neuroprotective therapy CNM‑Au8. The company said the new data support a potential new drug application (NDA) filing and relate to an upcoming in‑person meeting with the U.S. Food and Drug Administration (FDA).

Key Details

• Press release announced on January 12, 2026 describing additional CNM‑Au8 biomarker data.
• The data are presented as supporting a potential NDA filing for CNM‑Au8.
• The announcement references an upcoming in‑person meeting with the FDA to discuss next steps.

Why It Matters
A potential NDA filing and an in‑person FDA meeting are material regulatory milestones; progress on biomarker evidence can be an important step toward formal regulatory review. For investors, this update signals Clene is advancing regulatory discussions for CNM‑Au8, but the filing and any approval remain contingent on further data and FDA decisions. The 8‑K is informational and does not include new financial results or guarantees of approval.