Achieve Life Sciences Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
10analysts covering
FY EPS (est.)
-$0.68next fiscal year
Reporting Calendar
| Event | Expected Date |
|---|---|
| Third Quarter 2026 Financial Results and Corporate Update | 9 Nov 2026 |
| NDA Resubmission for Cytisinicline (Smoking Cessation) | 31 Dec 2026 |
Monitoring Framework
Key Performance Indicators
Cash, Cash Equivalents, and Marketable Securities Quarterly29.3MTarget: Sufficient to fund operations through key clinical and regulatory milestones, bolstered by up to $354 million in private placement financing
Quarterly Net Loss Quarterly-10.2MTarget: Manageable burn rate aligned with pre-commercialization and clinical trial progression
Quarterly Operating Expenses Quarterly10.5MTarget: Optimized R&D and G&A spend during the manufacturing transition phase
Watch Items
- FDA Complete Response Letter (CRL) ReceiptTrigger: Expected on or before June 20, 2026Action: Review FDA feedback regarding the prior contract manufacturer's OAI classification and ensure no cytisinicline-specific issues are raised.
- NDA Resubmission for CytisiniclineTrigger: Targeted for Q4 2026Action: Compile and submit the updated NDA package naming Adare Pharma Solutions as the primary commercial manufacturer, including completed technology transfer and engineering batch data.
- ORCA-V2 Phase 3 Trial ProgressTrigger: Initiation of Phase 3 trial for e-cigarette/vaping cessationAction: Monitor patient enrollment, clinical site activation, and trial execution timelines funded by the April 2026 private placement.
- U.S. Commercial Launch ReadinessTrigger: Targeted for 1H 2027Action: Establish commercial infrastructure, finalize marketing strategies, and secure payor coverage under the Affordable Care Act.
Research as of 20 Jun 2026