ACHV Stock — Achieve Life Sciences Inc. Common Shares: Cash, EV, Pipeline

Share price

$7.98

Market cap

$821.2M

Cash

$187.3M

Enterprise value

$633.9M

Balance sheet

Cash	$187.3M
Debt	$0.0M
Net cash	$187.3M
Enterprise value	$633.9M
Basic shares	102.7M shares
Fully diluted shares	133.8M shares
Fully diluted market cap	$1,067.9M
Cash per share	$1.82

Cash figures as of 2026-06-30. Database snapshot: 2026-09-21.

Price history

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Upcoming catalysts

Expected	Drug	Phase	Indication	Mgmt guide
Dec 27, 2026 - Feb 7, 2027	Cytisinicline	Phase 3	Vaping Cessation	—

Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.

Full readout calendar →

Pipeline assets

Cytisinicline

Phase 3 · Active

Aliases cytisine, Tabex

Target nicotinic acetylcholine receptor

Partnerships Sopharma AD: license + supply agreements (mid-single digit royalties on Tabex-branded net sales in territory; $2.0M deferred consideration contingent on FDA/EMA approval via 2015 Extab share purchase); Adare Pharma Solutions: U.S.-based finished drug product manufacturer named for NDA resubmission and commercial supply (~$3.2M development agreements; Adare CEO Thomas Sellig is an Achieve board member)

Indications

Smoking cessation (Phase 3)
Nicotine e-cigarette (vaping) cessation (Phase 2)

Catalysts

— Q4 2026
— first half of 2027

Status note NDA for smoking cessation submitted Jun 2025, accepted Sep 2025 with PDUFA Jun 20, 2026. FDA issued Complete Response Letter Jun 2026 citing manufacturing-related observations at a third-party facility (OAI classification + warning letter) and incomplete final labeling; no efficacy or safety deficiencies identified. NDA resubmission planned Q4 2026 naming Adare; potential approval H1 2027. Filing states cytisinicline is the company's sole product candidate. Commissioner's National Priority Voucher (CNPV) awarded Oct 2025 for nicotine e-cigarette cessation. Sopharma filed an arbitration demand Jul 2026 alleging breach of the supply agreement over use of third-party manufacturers; company disputes it.

Per-asset detail extracted from the 10-Q filed 2026-08-11. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.

Pipeline

Lead drug	Cytisinicline
Lead indication	Vaping Cessation
Lead phase	Phase 3
Active trials	1

Active clinical trials

Trial	Phase	Status	Role	Sponsor	BP	Condition(s)	Mgmt guide
NCT07392125	Phase 3	Not yet recruiting	Sponsor	Achieve Life Sciences	—	Vaping Cessation	—

Sponsor-matched active trials from ClinicalTrials.gov (1 as sponsor, 0 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.

View all 1 active trials for Achieve Life Sciences on ClinicalTrials.gov

Institutional holders

Fund	Shares	Q/Q change	% of portfolio	Filing
Frazier Life Sciences	7,614,836	+7,614,836	1.08%	2026-08-14
Logos Global Management	5,425,000	+5,425,000	1.53%	2026-08-14
ADAR1 Capital Management	53,800	+6,000	0.02%	2026-08-14

Institutional holder positions from 13F filings. Q/Q change is vs the prior quarter's filing; % of portfolio is the fund's own reported portfolio weight.

ACHV — Achieve Life Sciences Inc. Common Shares