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ACHV PDUFA Date: Cytisinicline

FDA decision (PDUFA) target 2026-06-20 · Achieve Life Sciences Inc. · Smoking cessation of cigarettes

ACHV run-up into the PDUFA (last ~120 days)

$5.99$2.65
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-06-20
Drug / candidateCytisinicline
IndicationSmoking cessation of cigarettes
CompanyAchieve Life Sciences Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT05206370 · completed

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FAQ

When is the ACHV PDUFA date?
The FDA PDUFA target date for ACHV (Achieve Life Sciences Inc.) is 2026-06-20 for Cytisinicline. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is ACHV's drug Cytisinicline?
Cytisinicline is Achieve Life Sciences Inc.'s candidate under FDA review for Smoking cessation of cigarettes.
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.