Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
The FDA's own letter · Complete Response Letter, NDA 218995 (PDF), dated June 20, 2026, released under FDA's CRL transparency program. The company announced the decision on June 22, 2026; the FDA acted on June 20, 2026.
What the letter says has to be fixed (the letter's own section headings; read against the PDF, not openFDA's OCR text):
Facility inspections. Following a CGMP inspection of a facility listed in the application (name redacted), FDA conveyed deficiencies to the facility; the facility's satisfactory responses to its Form 483, and possibly re-inspection and a pre-approval inspection, are required before the application can be approved.
Prescribing information. Submit draft labeling responsive to FDA's electronic communication of June 4, 2026, as part of the resubmission.
Clinical pharmacology (the letter says this is not an approvability issue): The proposed dosing regimen in end-stage renal disease is not adequately supported by the available pharmacokinetic data; FDA asks for modelling across a range of dialysis scenarios. The letter labels this a comment, not an approvability issue.
The letter names no clinical efficacy or safety deficiency. Postmarketing studies on pregnancy and lactation exposure would be required if the application is approved.
✕ COMPLETE RESPONSE LETTER
Achieve Life Sciences Inc., Cytisinicline · Smoking cessation of cigarettes.
Run-up into the decision (T-120 → T+5)
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). Announced 6/22/26 (FDA action 6/20/26). Historical price action, not a forecast.
FDA record of the action: the FDA issued a Complete Response Letter on June 20, 2026, per CRL letter CRL_NDA218995_20260620_Redacted (FDA letter). The sponsor announced it on June 22, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Questions
Was Cytisinicline approved by the FDA?
Not in this review cycle. On June 20, 2026 the FDA issued a Complete Response Letter, declining to approve the application for Cytisinicline in its current form. The company announced it on June 22, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind Cytisinicline?
Cytisinicline is an Achieve Life Sciences Inc. (ACHV) program. The FDA decision came on June 20, 2026; the company's own announcement is linked on this page.
How did ACHV stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), ACHV moved +8.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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