ACHIEVE LIFE SCIENCES (ACHV) Company Report

Achieve Life Sciences received an FDA Commissioner's National Priority Voucher (CNPV) for cytisinicline for the e-cigarette or vaping indication, which is expected to reduce the potential NDA approval timeline to one to two months from the standard 10-12 months.
The FDA accepted the New Drug Application (NDA) for cytisinicline for smoking cessation, setting a PDUFA (approval) date of June 20, 2026, with a product launch anticipated in Q3 or Q4 2026.
As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $48.1 million, with the current cash runway expected to fund operations into the second half of 2026.
For Q3 2025, total operating expenses were $14.7 million and the net loss was $14.4 million.
The company announced management changes, including the promotion of Dr. Mark Rubenstein to Interim Chief Medical Officer and Craig Donnelly to Chief Operations Officer, and the hiring of Eric Atkinson as Chief Legal Officer.

Nov 6, 2025, 1:30 PM

Achieve Life Sciences Reports Q3 2025 Results and Key Cytisinicline Program Updates

ACHV

Earnings

New Projects/Investments

Achieve Life Sciences reported Q3 2025 financial results, with cash, cash equivalents, and marketable securities of $48.1 million as of September 30, 2025. Total operating expenses for the quarter were $14.7 million, resulting in a net loss of $14.4 million.
The FDA accepted the New Drug Application (NDA) for cytisinicline for smoking cessation, setting a PDUFA targeted action date of June 20, 2026.
The company was awarded the FDA Commissioner’s National Priority Voucher (CNPV) for cytisinicline for e-cigarette or vaping cessation, recognizing its potential as a first-in-class treatment for this growing public health need.

Nov 6, 2025, 12:10 PM

Achieve Life Sciences Details Cytisinicline's Market Opportunity and Regulatory Path

ACHV

Product Launch

New Projects/Investments

Guidance Update

Cytisinicline is positioned as the first potential new FDA-approved treatment for nicotine dependence in nearly 20 years, addressing an estimated market of up to 50 million Americans who use tobacco.
The PDUFA date for FDA approval of Cytisinicline for smoking cessation is expected on June 20, 2026, following a completed NDA submission and acceptance.
Clinical trials (ORCA-2 and ORCA-3) demonstrated robust efficacy and excellent tolerability for smoking cessation, with odds ratios exceeding available treatment options. Cytisinicline also holds Breakthrough Therapy designation for vaping cessation, with a Phase 3 ORCA-V2 trial planned.
Achieve Life Sciences estimates an $11 billion Rx opportunity for smoking cessation, supported by anticipated Affordable Care Act coverage and a focused launch strategy targeting high-volume prescribers.
The company reports a cash runway into the second half of 2026 and broad patent protection for Cytisinicline extending to 2040.

Nov 5, 2025, 12:00 PM

Achieve Life Sciences Updates on Cytisinicline NDA and ORCA-OL Safety Trial Completion

ACHV

Product Launch

New Projects/Investments

Achieve Life Sciences submitted the 120-day safety update to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) review for cytisinicline.
The ORCA-OL long-term safety trial concluded in October 2025, with 334 participants completing one full year of cytisinicline treatment, exceeding FDA requirements for cumulative safety data.
The Data Safety Monitoring Committee (DSMC) completed its final review for the ORCA-OL trial, finding no drug safety concerns.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026, for the cytisinicline NDA.

Nov 3, 2025, 1:30 PM

Achieve Life Sciences to Announce Q3 2025 Results and Provide Corporate Update

ACHV

Earnings

Product Launch

Guidance Update

Achieve Life Sciences will report its third quarter 2025 financial results and provide a corporate update on the cytisinicline development program on November 6, 2025, at 8:30 AM EST.
The company announced in September 2025 that its New Drug Application (NDA) for cytisinicline, submitted to the U.S. Food and Drug Administration (FDA) in June 2025, had been accepted for review.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 20, 2026, for cytisinicline as a treatment for nicotine dependence for smoking cessation in adults.
Achieve has also completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication.

Oct 29, 2025, 12:30 PM

Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher

ACHV

New Projects/Investments

Product Launch

Achieve Life Sciences (ACHV) has been awarded a Commissioner's National Priority Voucher (CNPV) by the FDA for cytisinicline, intended for the treatment of nicotine dependence for e-cigarette or vaping cessation.
This designation provides an expedited FDA review pathway, reducing the assessment time to one to two months from the standard 10-12 months.
Cytisinicline is a potential first-in-class treatment addressing a significant unmet medical need, with approximately 17 million adult e-cigarette users in the U.S., 60% of whom desire to quit.
Separately, the FDA accepted Achieve Life Sciences' New Drug Application (NDA) for cytisinicline for smoking cessation, with a Prescription Drug User Fee Act (PDUFA) target action date of June 20, 2026.

Oct 17, 2025, 11:30 AM

Achieve Life Sciences Names Interim CMO

ACHV

Management Change

Product Launch

Achieve Life Sciences announced a leadership transition, with Dr. Cindy Jacobs resigning as Chief Medical Officer and President, effective October 6, 2025, and Dr. Mark Rubinstein appointed Interim Chief Medical Officer.
The company recently received FDA acceptance of its New Drug Application for cytisinicline, a plant-based treatment for nicotine dependence, and is progressing toward commercialization.
Achieve Life Sciences faces financial challenges typical of early-stage biotechs, including zero revenue and ongoing losses, with a negative earnings per share of -1.46.
The stock (ACHV) has an analyst rating of 'Buy' with a $10.00 price target, although TipRanks’ AI Analyst rates it as 'Underperform'.