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ACHV PDUFA Date: Cytisinicline

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

The story

Cytisinicline is under FDA review to treat helping adults quit smoking (the plant-derived smoking-cessation drug cytisinicline). Balance sheet: about 8 months of cash, runway ~8 mo (estimated). ELEVATED — under 12 months
Full PDUFA calendar ->Every upcoming FDA decision date, by monthUNCY . 2026-06-29Same area: Nephrology . Oxylanthanum Carbonate (OLC)VERA . 2026-07-07Same area: Nephrology . AtaciceptGSK-tebipenem-hbr . 2026-06-18Same month decision . Tebipenem HBr (SPR994)
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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.