Achieve Life Sciences (ACHV)
NASDAQ:ACHV
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Earnings Data
Report Date
Aug 06, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.16Last Year’s EPS
-0.37Same Quarter Last Year
Strong Buy
Based on 5 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong positive momentum: a substantial financing, experienced new leadership and commercial hires, U.S. manufacturing partnership with initial batches, robust Phase III efficacy (notably 32.4% vs 6% in hard-to-treat patients) and supportive mechanistic/tolerability data. The principal negatives are an anticipated FDA CRL tied to a third-party manufacturer OAI, requiring an NDA resubmission in Q4 2026 and introducing execution risk around the manufacturing tech transfer to Adare and timing uncertainty. Overall, the company appears well capitalized and operationally proactive to address the delays and pursue a planned H1 2027 launch, but near-term regulatory and manufacturing execution risks remain.Company Guidance
Transformational Financing
Completed a private placement providing $180 million in upfront capital plus up to $174 million in milestone-based warrants exercisable before and up to 20 trading days after FDA approval, supported by a syndicate of specialist healthcare investors (Frazier, TPG, venBio, Paradigm, Marshall Wace).
Experienced Leadership and Commercial Team Additions
Appointed Andrew Goldberg as CEO (physician, investor, commercialization experience) and added three new Board members (Chris Martin, Dr. Lucian Iancovici, Dr. Aaron Royston). Hired Mark Zappia (SVP Commercial) and Jim Willis (VP Sales & Enablement) to lead commercial launch planning.
U.S.-Based Manufacturing Partnership and Early Production
Partnered with Adare Pharma Solutions for U.S. drug product manufacturing and produced the first cytisinicline engineering batch in Q1, moving manufacturing onshore to reduce importation/tariff risk and support commercial supply.
Strong Phase III Clinical Efficacy in Difficult-to-Treat Subgroups
Analysis of >1,600 Phase III participants showed consistent efficacy across prior treatment histories; among participants with prior varenicline and bupropion use, 12 weeks of cytisinicline achieved continuous abstinence of 32.4% versus 6% for placebo (absolute difference +26.4 percentage points; odds ratio 7.5).
Favorable Mechanistic and Tolerability Data
Published mechanistic data indicating cytisinicline selectively interacts with the alpha4beta2 nicotinic receptor with minimal 5-HT3 interaction, providing a plausible explanation for observed low nausea rates and favorable tolerability profile.
Regulatory Progress and Designations
Received a Center for Nicotine and Tobacco Products (CNPV) priority voucher and Breakthrough Therapy designation; company has two Phase III positive courses (6- and 12-week) supporting the smoking NDA and expects to present 52-week safety/efficacy data later in the year.
Clear Timeline and Resubmission Plan
Company expects to resubmit the NDA in Q4 2026 with Adare named as primary manufacturer and targets a commercial launch in H1 2027, with plans to initiate the ORCA-V2 vaping Phase III trial potentially later this year.
Intellectual Property Confidence
Management reports due diligence supports IP protection for the product well into the late 2030s and 2040s, providing a durable franchise outlook.
ACHV Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
ACHV Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 12, 2026 | $5.59 | $5.99 | +7.16% |
Mar 24, 2026 | $4.05 | $2.90 | -28.40% |
Nov 06, 2025 | $4.93 | $4.74 | -3.85% |
Aug 07, 2025 | $2.64 | $2.64 | 0.00% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Achieve Life Sciences (ACHV) report earnings?
Achieve Life Sciences (ACHV) is schdueled to report earning on Aug 06, 2026, After Close (Confirmed).
What is Achieve Life Sciences (ACHV) earnings time?
Achieve Life Sciences (ACHV) earnings time is at Aug 06, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is ACHV EPS forecast?
ACHV EPS forecast for the fiscal quarter 2026 (Q2) is -0.16.