Achieve Life Sciences Inc Stock Price, News & Analysis

Achieve Life Sciences (Nasdaq: ACHV) announced inducement stock option awards for new hires, effective Dec. 4, 2025. The board granted Chief Legal Officer Erik Atkisson options to purchase 250,000 shares and granted two other new employees options for an aggregate of 45,000 shares.

All options vest over four years: 25% on the first anniversary of employment and the remainder vesting monthly over the following 36 months, subject to continued employment. Grants are governed by the 2024 Equity Inducement Plan and individual option agreements and were made in accordance with Nasdaq Listing Rule 5635(c)(4).

Achieve Life Sciences (Nasdaq: ACHV) reported third quarter 2025 results and provided program updates for cytisinicline. The FDA accepted the cytisinicline NDA for smoking cessation and set a PDUFA target date of June 20, 2026. The company received an inaugural Commissioner’s National Priority Voucher for vaping cessation, potentially shortening future FDA review to 1–2 months once materials are submitted. ORCA-OL long-term trial concluded with 334 participants completing one year; safety database includes 411 with ≥6 months exposure and 214 with ≥1 year. New post hoc Thorax data showed improved quit rates in COPD subgroups. Cash and equivalents totaled $48.1M at September 30, 2025; Q3 net loss was $14.4M (nine months: $40.0M).

Achieve Life Sciences (Nasdaq: ACHV) announced key regulatory and clinical milestones for its cytisinicline New Drug Application for smoking cessation on Nov 3, 2025. The company submitted a 120-day safety update to the FDA containing long-term safety data.

The ORCA-OL trial completed treatment in October 2025 with 334 participants finishing one year of treatment, exceeding FDA requests of ≥100 one-year and ≥300 six-month participants. As of the June 4, 2025 cutoff, the update includes 411 participants with ≥6 months exposure and 214 participants with ≥1 year exposure. The DSMC completed its final review, reported mostly mild adverse events, found no treatment-related serious adverse events, and identified no drug safety concerns.

Achieve Life Sciences (Nasdaq: ACHV) will report its third quarter 2025 financial results and provide a corporate update on the cytisinicline development program on Thursday, November 6, 2025 at 8:30 AM EST. Investors can join a live webcast or a conference call and hear management discuss Q3 results and program progress.

To join: use the 3Q25 Earnings Webcast link or dial 888-396-8049 (U.S. & Canada) or 416-764-8646 (International) and reference conference ID 13756406. A replay will be posted about three hours after the call and archived on the company website for 90 days.

Achieve Life Sciences (Nasdaq: ACHV) announced on October 20, 2025 the appointment of Erik Atkisson as Chief Legal Officer. Mr. Atkisson will lead legal strategy, corporate governance, compliance, and risk management as Achieve advances cytisinicline through regulatory review toward a potential launch.

He brings more than 25 years of legal experience in pharmaceutical and biotech companies, including prior roles as General Counsel and Chief Compliance Officer at multiple clinical- and commercial-stage firms, and holds a J.D. from Georgetown, an M.Sc. from the University of Edinburgh, and a B.A. from Harvard.

Achieve Life Sciences (NASDAQ: ACHV) received a U.S. FDA Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment for nicotine dependence for e-cigarette or vaping cessation on October 17, 2025. The CNPV, one of nine awards in the program's inaugural year, offers enhanced FDA communications and an expedited review window of 1–2 months versus the standard 10–12 months after complete materials are submitted. Cytisinicline showed efficacy in the Phase 2 ORCA-V1 trial (published in JAMA Internal Medicine), with treated participants 2.6 times more likely to quit vaping versus placebo. The drug has FDA Breakthrough Therapy designation and an agreed Phase 3 ORCA-V2 design; an NDA for smoking cessation was accepted with a PDUFA date of June 20, 2026. The company cited ~17 million U.S. adult e-cigarette users and ~60% expressing desire to quit.

Achieve Life Sciences (Nasdaq: ACHV) announced that on October 1, 2025 its board approved inducement stock option grants totaling 161,000 shares for five new employees under the 2024 Equity Inducement Plan.

The options have an exercise price equal to the closing price on October 1, 2025, a 10‑year term, and vest 25% after one year with the remaining 75% vesting in 36 equal monthly installments, subject to continued service. Grants were made as inducements in accordance with Nasdaq Listing Rule 5635(c)(4) and are governed by the 2024 Equity Inducement Plan and individual option agreements.

Achieve Life Sciences (NASDAQ:ACHV) announced the publication of new data in Thorax demonstrating cytisinicline's effectiveness for smoking cessation in patients with chronic obstructive pulmonary disease (COPD). The post hoc analysis of two Phase 3 trials (ORCA-2 and ORCA-3) showed that cytisinicline significantly improved quit rates compared to placebo in both COPD and non-COPD participants.

The study revealed statistically significant increases in continuous smoking abstinence with cytisinicline versus placebo, demonstrating comparable quit rates between COPD and non-COPD groups despite COPD patients having more severe tobacco use histories. The treatment showed a favorable safety profile with no serious treatment-related adverse events.

The FDA has accepted Achieve's New Drug Application for cytisinicline with a PDUFA target date of June 20, 2026. This development is particularly significant as nearly 6 million COPD patients in the U.S. currently smoke, with smoking attributed to 80% of COPD deaths.

Achieve Life Sciences (NASDAQ:ACHV) has promoted Craig Donnelly to Chief Operations Officer. Donnelly, who joined Achieve in 2022 as Executive Vice President of Chemistry, Manufacturing, and Controls (CMC) and Regulatory CMC, brings over 25 years of biopharmaceutical expertise.

In his new role, Donnelly will lead the integration of supply chain and manufacturing activities with commercial strategy as the company prepares for the anticipated launch of cytisinicline in mid-late 2026. The drug candidate represents the first potential smoking cessation treatment approval in nearly two decades.

Prior to Achieve, Donnelly held senior positions at NuCana, ICON, F. Hoffman-La Roche, and began his career at Pfizer. He holds a Bachelor's with Honors in Chemical and Pharmaceutical Sciences from the University of Sunderland.