Clene Inc. CLNN
Clene Inc. (Nasdaq: CLNN) is a CNS/neurology/psychiatry drug developer. Its lead program, CNM-Au8, is in Phase 3 for Amyotrophic Lateral Sclerosis (ALS). Its next catalyst on record is CNM-Au8 for ALS: FDA response on NDA acceptance for review (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CNM-Au8 for ALS — FDA response on NDA acceptance for review (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CNM-Au8 | Amyotrophic Lateral Sclerosis (ALS) | small molecule | Phase 3 |
| CNM-Au8 | Multiple Sclerosis (MS) | small molecule | Phase 2 |
| CNM-Au8 | Parkinson's Disease (PD) | small molecule | Pre-clinical |
Recent results and decisions
- submitted Clene submitted an NDA to the FDA in October 2026 seeking accelerated approval for CNM-Au8 in ALS.
Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October 2026 seeking accelerated approval for CNM-Au8® in amyotrophic lateral sclerosis (ALS)
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.