Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
Earnings Data
Report Date
May 07, 2026After Close (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
-0.3Last Year’s EPS
-0.37Same Quarter Last Year
Strong Buy
Based on 3 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed meaningful progress on multiple strategic fronts: regulatory advancement (NDA acceptance and clear PDUFA date), an accelerated pathway for the vaping indication (CNPV), strong clinical and long-term tolerability data including peer-reviewed publication, commercial build-out using AI/digital capabilities, and steps to onshore manufacturing. Major risks highlighted include a limited cash balance relative to the current annualized burn (implying roughly an eight-month runway at current spend), GMP observations at a named manufacturer that introduce supply uncertainty, and the need for additional financing and payer access work ahead of a potential 1H 2027 launch. Overall, achievements and momentum around approval, clinical validation, and commercial preparation are substantial, but near-term financial and manufacturing risks are material and will require active management.Company Guidance
NDA Submission and FDA Acceptance
New Drug Application (NDA) for smoking cessation submitted June 2025 and accepted by the FDA; PDUFA date set for June 20, 2026, putting the company on a clear regulatory path toward a potential approval that could be the first new FDA-approved nicotine dependence treatment in ~20 years.
Commissioner's National Priority Voucher for Vaping Indication
Cytisinicline received the FDA Commissioner's National Priority Voucher (CNPV) for vaping cessation, providing an accelerated review timeline of 1–2 months compared to the typical 10–12 months and positioning Achieve to potentially be first-to-market for e-cigarette cessation.
Robust Clinical Data and Publications
Pooled analysis of over 1,600 Phase III participants showed consistent efficacy across subgroups (prior treatments and quit-attempt histories); post-hoc Thorax publication demonstrated significantly improved quit rates in COPD patients; ORCA-OL 52-week long-term exposure trial confirmed strong tolerability and excellent patient satisfaction.
High Long-Term Adherence Observed
Long-term open-label data (ORCA-OL) reported adherence rates above 75% over up to 52 weeks, indicating strong real-world tolerability and feasibility of the TID dosing schedule in trials.
Commercial Infrastructure and Digital/AI Strategy
Built a launch-ready commercial infrastructure emphasizing an omnichannel, AI-powered digital platform and unified data ecosystem to target physicians and patients precisely; developed an 'AI-powered asset factory' and a marketing engine with Omnicom to accelerate compliant content creation and deployment.
Manufacturing Partnership and Supply-Chain Actions
Selected U.S.-based Adare Pharma Solutions for drug product manufacturing; technology transfer is underway to onshore production, increase redundancy, reduce import/tariff risk, and support a planned commercial launch in 1H 2027.
Raw Material Inventory and Supply Visibility
Company reports having stockpiled starting material and expects to have more than three years' supply of starting material for anticipated in-market needs, reducing immediate API supply-chain risk.
Operational Progress Toward Launch
3PL implementation in progress, administrative/logistical setup with specialty pharmacy hub completed, more than half of required state licenses secured, and ~40 payer touchpoints reached in Q1—positioning the company for payer conversations and launch readiness.
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 |
|---|---|---|---|
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% |
May 13, 2025 | $2.48 | $2.65 | +6.85% |
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 Inc (ACHV) report earnings?
Achieve Life Sciences Inc (ACHV) is schdueled to report earning on May 07, 2026, After Close (Confirmed).
What is Achieve Life Sciences Inc (ACHV) earnings time?
Achieve Life Sciences Inc (ACHV) earnings time is at May 07, 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 (Q1) is -0.3.