CRL for cytisinicline (Jun 22 2026) — third-party manufacturing (cGMP) + labeling; no efficacy/safety deficiencies
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/2/26) through T+5. Run-up high $5.99 on 5/14/26, low $2.65 on 4/1/26 (T-120 to T-1). FDA decision 6/20/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-06-20
OutcomeCRL
Drug / candidateCytisinicline - (ORCA-3)
IndicationSmoking cessation of cigarettes
CompanyAchieve Life Sciences
Market-cap tierSmall
120-day run-up (T-120→T-1)+20.2%
Cohort decision-day move (history)±3% median
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier — history, not a prediction.