Achieve Life Sciences (ACHV) pipeline and stated timing

Name in SEC filings: ACHIEVE LIFE SCIENCES, INC.

Pipeline at a glance

Program	Event	Stage	Stated timing	Filing
cytisinicline	submission	—	fourth quarter of 2026	8-K · Aug 11, 2026

Source: ORION, orionbiotechai.com/company/ACHV, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/ACHV

Nearest upcoming stated timing: cytisinicline · NDA/BLA submission · fourth quarter of 2026

SEC sources last checked Oct 18, 2026.

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

cytisinicline

Matched

NDA/BLA submissionfourth quarter of 2026

Stage: —

Public float: $103,958,994 · as of Jun 30, 2025 · SEC filing

The Company intends to resubmit its NDA naming Adare as its finished drug product manufacturer for commercial supply in the fourth quarter of 2026

8-K · Filed Aug 11, 2026 · Last checked Oct 18, 2026

Source details

Accession 0001193125-26-344571

Alert me · Calendar: same stage and window-end month (2026-12)

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of Oct 19, 2026.

Program / event

Stated period and SEC wording

Disclosure in stated period

cytisiniclineSubmission

fourth quarter of 2026

“The Company intends to resubmit its NDA naming Adare as its finished drug product manufacturer for commercial supply in the fourth quarter of 2026”

Filed Aug 11, 2026 · EX-99.1

Still within period

As of Oct 19, 2026

cytisiniclineSubmission

fourth quarter of 2026

“The Company intends to resubmit its New Drug Application in the fourth quarter of 2026, naming Adare as its new and primary manufacturing partner for commercial supply.”

Filed May 12, 2026 · EX-99.1

Still within period

As of Oct 19, 2026

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

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Reading these records

First stated window: The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date: The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q: First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original: The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status: One of seven labels set by founder review of the original filings. Definitions: Methodology.

See ACHV in the calendar · Review labels and methodology