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ACHV FDA decision — Jun 22, 2026

✕ COMPLETE RESPONSE LETTER

Achieve Life Sciences Inc. — Cytisinicline - (ORCA-3) · Smoking cessation of cigarettes.

Run-up into the decision (T-120 → T+5)

PDUFA 6/22/26$5.99$2.651/5/26
Daily close, T-120 (1/5/26) 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 6/22/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-22
OutcomeCRL
Drug / candidateCytisinicline - (ORCA-3)
CompanyAchieve Life Sciences Inc.
120-day run-up (T-120→T-1)+8.0%