Clene Inc. CLNN
Clene Inc. (Nasdaq: CLNN) is a CNS/neurology/psychiatry drug developer. Its lead program, CNM-Au8, is in Phase 2 for Amyotrophic lateral sclerosis (ALS). Its next catalyst on record is CNM-Au8 (ALS): NDA submission seeking accelerated approval (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: CNM-Au8 (ALS) — NDA submission seeking accelerated approval (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| CNM-Au8 | ALS (completed Phase 2 HEALEY and RESCUE-ALS; NDA for accelerated approval planned; Phase 3 RESTORE-ALS planned as confirmatory) | small molecule | Phase 2 |
| CNM-Au8 | Multiple sclerosis (Phase 2 VISIONARY-MS/REPAIR-MS completed; Phase 3 design pending) | small molecule | Phase 2 |
| CNM-Au8 | Parkinson's disease | small molecule | Pre-clinical |
Recent results and decisions
- May 4, 2026n/a FDA Type C meeting minutes state Clene's proposed NfL-based data may support an accelerated approval NDA in ALS.
the FDA stated that Clene’s “proposed data may be capable of supporting the submission and review of an [New Drug Application (NDA)] under the accelerated approval pathway for the treatment of 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 2 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.