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Cytisinicline

Updated ยทnext FDA decision on the calendar

Cytisinicline is a Achieve Life Sciences Inc. program in Smoking cessation of cigarettes. The FDA issued a Complete Response Letter on Jun 22, 2026. 1 FDA decision on record below. Every date links its source.

ACHV catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Smoking cessation of cigarettes. Sponsor: Achieve Life Sciences Inc. (ACHV). Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jun 20, 2026ACHVPDUFA · Jun 22, 2026 CRLACHV

Questions

When is Cytisinicline's next FDA decision or readout?

No upcoming catalyst is on our calendar for Cytisinicline; 1 FDA decision is on record below.

What happened at Cytisinicline's most recent FDA decision?

On Jun 22, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.

What is Cytisinicline used for?

In our records Cytisinicline is under review or in development for Smoking cessation of cigarettes.

Who makes Cytisinicline?

Achieve Life Sciences Inc. (ACHV).

Has Cytisinicline been approved by the FDA?

Not in our records. The FDA issued a Complete Response Letter on Jun 22, 2026.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.