ACHIEVE LIFE SCIENCES, INC.
ACHV evidence brief
What we can confirm
- BioSniper Score:
- 3.2 / 10
- Market Cap:
- $726.5M
What it means
What to watch
Prepared research question
What matters most for ACHV—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ACHV
ACHIEVE LIFE SCIENCES is a late-stage clinical specialty pharmaceutical company focused solely on developing and commercializing cytisinicline to treat nicotine dependence, with a PDUFA target date for smoking cessation in the first half of 2027.
Key risk: Regulatory approval delay
BioSniper Score
Based on 2 of 6 signals
Limited data coverage
Market Cap
$726.5M
Cash Runway
—
Lead Asset
—
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 3 clinical trials for ACHIEVE LIFE SCIENCES, INC..
ACHIEVE LIFE SCIENCES is a late-stage clinical specialty pharmaceutical company focused solely on developing and commercializing cytisinicline to treat nicotine dependence, with a PDUFA target date for smoking cessation in the first half of 2027.
- ACHIEVE LIFE SCIENCES is a late-stage clinical specialty pharmaceutical company with the sole mission to address the global nicotine dependence epidemic through the development and commercialization of cytisinicline [sec_mda · as of 2026-08-11].
- The company anticipates potential FDA approval of cytisinicline for smoking cessation in the first half of 2027, followed by U.S. commercial launch [sec_mda · as of 2026-08-11].
- As of 2026-06-30, the company reported cash & equivalents of $48.0M, net income of -$74.8M, and shareholders' equity of -$14.7M [sec].
- A private placement of up to $354 million was closed, with $180 million upfront and up to $174 million from warrants exercisable prior to and up to 20 trading days following FDA approval [news · published 2026-08-11].
- The company has partnered with U.S.-based manufacturer Adare Pharma Solutions for commercial supply of cytisinicline, aiming to reduce risks related to international importation and potential tariffs [news · published 2026-03-24].
What works
- The company has secured a substantial private placement of up to $354 million, providing financial runway to support development and potential commercialization [news · published 2026-08-11].
- Cytisinicline is differentiated from existing smoking cessation treatments by its combination of efficacy, well-tolerated safety profile, and dosing flexibility with a 6 or 12-week regimen [sec_mda · as of 2026-08-11].
- The company has strengthened its organization with a new CEO, experienced commercial, CMC, and quality leaders, and six new Board appointments [news · published 2026-08-11].
- A U.S.-based manufacturing partnership with Adare Pharma Solutions reduces reliance on international supply chains and potential tariff exposure [news · published 2026-03-24].
What to weigh
- The company has no current sources of revenue and is dependent on raising funds to support ongoing clinical development and commercialization activities [sec_mda · as of 2026-03-24].
- As of 2026-06-30, the company reported negative shareholders' equity of -$14.7M and a net loss of -$74.8M [sec].
- There is potential for delay in FDA approval beyond the PDUFA target date due to observations from an FDA cGMP inspection at a third-party manufacturer [sec_mda · as of 2026-03-24].
- The company faces substantial competition, and competitors may discover, develop, or commercialize products faster or more successfully [sec_mda · as of 2026-03-24].
From the filings
Quoted directly from source documents.
The company's sole mission is to address the global nicotine dependence epidemic through cytisinicline.
“We are a late-stage clinical specialty pharmaceutical company with the sole mission to address the global nicotine dependence epidemic through the development and commercialization of cytisinicline.”
SEC MD&A · August 11, 2026
Anticipated FDA approval and commercial launch timeline.
“anticipate the potential approval of cytisinicline for smoking cessation in the first half of 2027, followed by U.S. commercial launch.”
SEC MD&A · August 11, 2026
Potential delay in FDA approval due to manufacturing observations.
“While unclear, there is potential for a delay in FDA approval beyond the PDUFA targeted action date of June 20, 2026.”
SEC MD&A · March 24, 2026
Catalyst timeline
- 2020-10-13 · Phase3_Start — A multicenter, double-blind, randomized, placebo-controlled Phase 3 trial evaluating cytisinicline in adult smokers began.
- 2026-04-16 · PDUFA — PDUFA target date for cytisinicline; note that a potential delay beyond this date has been flagged.
Risks & what to watch (4)›
Key risks
- Regulatory approval delay — Potential delay in FDA approval beyond PDUFA target due to cGMP observations at a third-party manufacturer [sec_mda · as of 2026-03-24].
- No current revenue — Company has no current sources of revenue and depends on fundraising to support operations [sec_mda · as of 2026-03-24].
- Negative equity and net loss — Shareholders' equity of -$14.7M and net loss of -$74.8M as of 2026-06-30 [sec].
- Competitive pressure — Substantial competition from other smoking cessation products that may be developed or commercialized faster [sec_mda · as of 2026-03-24].
What to watch
- FDA decision on cytisinicline NDA, now anticipated in the first half of 2027 [sec_mda · as of 2026-08-11].
- Initiation of Phase 3 vaping trial for cytisinicline [news · published 2026-03-24].
- Execution of commercial launch strategy and manufacturing scale-up with Adare [news · published 2026-03-24].
- Company's ability to raise additional capital given negative equity and no revenue [sec_mda · as of 2026-03-24].
Sources: Catalysts · News · SEC MD&A · Generated October 7, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 2 of 6 signals · derived from public data
Pipeline inputs are unavailable for this score. It uses only the available signals shown below.
Cash runway data unavailable
Net income -$75M
No tracked pipeline phase
No tracked pipeline candidates
No upcoming catalysts tracked
0 buys · 1 sell (180d)
Regulatory
Financials
Short Interest
as of Apr 30, 2026- % of float
- 15.0%
- Days to cover
- 7.7
- Shares short
- 6,845,606
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ACHV short interestGovernance
Frequently asked questions
What is the AI investment thesis for ACHIEVE LIFE SCIENCES, INC.?
ACHIEVE LIFE SCIENCES is a late-stage clinical specialty pharmaceutical company focused solely on developing and commercializing cytisinicline to treat nicotine dependence, with a PDUFA target date for smoking cessation in the first half of 2027.
Who is the CEO of ACHIEVE LIFE SCIENCES, INC.?
Dr. Andrew D. Goldberg M.D. is the chief executive officer of ACHIEVE LIFE SCIENCES, INC. (ACHV).
Where is ACHIEVE LIFE SCIENCES, INC. headquartered?
ACHIEVE LIFE SCIENCES, INC. (ACHV) is headquartered in Bothell, WA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.