Achieve Life Sciences, Inc. ACHV
Achieve Life Sciences, Inc. (Nasdaq: ACHV) is a CNS/neurology/psychiatry drug developer. Its lead program, cytisinicline, is in Phase 3 for smoking cessation (nicotine dependence); also vaping cessation. Its next catalyst on record is cytisinicline (smoking cessation): Potential FDA approval (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: cytisinicline (smoking cessation) — Potential FDA approval (H1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| cytisinicline | smoking cessation in adults (NDA, CRL received June 2026) | small molecule | Phase 3 |
| cytisinicline | nicotine e-cigarette (vaping) cessation (Phase 2 completed; Breakthrough Therapy and CNPV) | small molecule | Phase 2 |
Recent results and decisions
- Aug 11, 2026positive 52-week ORCA-OL safety data (475 participants, median exposure 361 days) showed no new safety signals per the independent DSMC.
Among 475 participants dosed for up to 52 weeks (median cumulative exposure of 361 days), no new safety signals were identified by the independent Data Safety Monitoring Committee.
Filing - Jun 20, 2026CRL FDA issued a CRL on June 20, 2026 for the cytisinicline NDA over cGMP observations at the prior manufacturer and incomplete labeling; no efficacy or safety deficiencies identified (re-reported in Q2 results).
The FDA identified no deficiencies related to the clinical efficacy or safety of cytisinicline.
Filing - Nov 6, 2025accepted FDA accepted the cytisinicline NDA for smoking cessation with a PDUFA target action date of June 20, 2026 (previously announced, confirmed in Q3 results).
The FDA has accepted the cytisinicline NDA for treatment of nicotine dependence for smoking cessation in adults. The FDA has assigned a PDUFA targeted action date of June 20, 2026.
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.