Achieve Life Sciences Inc Stock Price, News & Analysis

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.

Achieve Life Sciences (NASDAQ:ACHV) has appointed Dr. Mark Rubinstein as Interim Chief Medical Officer, succeeding Dr. Cindy Jacobs. Dr. Rubinstein, who joined Achieve as Head of Medical Affairs in October 2024, brings extensive experience in clinical development and medical affairs from his roles at Blip and Juul Labs.

The transition comes at a crucial time as the company recently received FDA acceptance of its cytisinicline New Drug Application for nicotine dependence treatment. Dr. Rubinstein, a Yale Medical School graduate and Professor Emeritus at UCSF, will lead the company's efforts to address nicotine dependence among the estimated 15 million American adults who attempt to quit smoking annually.

Achieve Life Sciences (NASDAQ:ACHV) announced the FDA's acceptance of its New Drug Application (NDA) for cytisinicline, a novel smoking cessation treatment. The FDA has set a PDUFA target date of June 20, 2026, marking a significant milestone in potentially introducing the first new FDA-approved smoking cessation pharmacotherapy in two decades.

The NDA is supported by comprehensive data from the ORCA-2 and ORCA-3 Phase 3 trials, involving over 2,000 participants. The trials demonstrated significantly higher smoking abstinence rates with cytisinicline compared to placebo, both at the end of treatment and through week 24. Safety data includes over 400 participants with six-month exposure and 200 with one-year exposure, showing no new safety concerns.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, has announced its participation in two upcoming investor conferences in New York. CEO Rick Stewart will present at the H.C. Wainwright Global Investment Conference on September 8, 2025, participating in a fireside chat at 11:00 AM ET. Additionally, the company will attend the Lake Street Best Ideas Growth Conference (BIG9) on September 11, 2025, for one-on-one meetings with investors.

Achieve Life Sciences (NASDAQ: ACHV) reported significant Q2 2025 milestones, including the submission of a New Drug Application (NDA) to the FDA for cytisinicline, their smoking cessation treatment. The company secured a strategic partnership with Omnicom for commercialization and raised $49.3 million through a public offering.

Key achievements include meeting FDA long-term exposure requirements in the ORCA-OL trial and publication of Phase 3 ORCA-3 results in JAMA Internal Medicine. The company reported $55.4 million in cash and equivalents as of June 30, with a net loss of $12.7 million for Q2 2025.

Achieve Life Sciences (NASDAQ:ACHV), a late-stage pharmaceutical company developing cytisinicline for smoking cessation, announced its participation in the BTIG Virtual Biotechnology Conference on July 29-30, 2025. CEO Rick Stewart will engage in a fireside chat with BTIG Biotechnology Analyst Julian Harrison on July 29 at 3:20 pm EDT.

The company focuses on developing treatments for nicotine dependence through its cytisinicline program. Interested parties can register for the conference by contacting BTIG directly.