Achieve Life Sciences Announces Publication in Nicotine & Tobacco Research Linking Cytisinicline's Receptor Selectivity to Low Nausea Rates and Favorable Tolerability Achieve Life Sciences (Nasdaq: ACHV) reported a Nicotine & Tobacco Research publication linking cytisinicline’s receptor selectivity to favorable tolerability. Key preclinical findings: 99% displacement at the α4β2 nicotinic receptor and -8% displacement at the 5-HT3 serotonin receptor. The paper and one‑year open‑label safety data together support a biological explanation for low nausea rates seen in clinical studies.

#ACHV Achieve Life Sciences Announces Publication in Nicotine & Tobacco Research Linking Cytisinicline's Receptor Selectivity to Low Nausea Rates and Favorable Tolerability

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Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Achieve Life Sciences, Inc. (Achieve) (Nasdaq:

#ACHV Achieve Life Sciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

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Achieve Life Sciences to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call and Webcast on March 24, 2026 Achieve Life Sciences (Nasdaq: ACHV) will report fourth quarter and full year 2025 financial results and provide a corporate update on its cytisinicline development program on March 24, 2026 at 8:30 AM EDT.Investors can access a live webcast, join the conference call (877-269-7756 U.S. & Canada; 201-689-7817 International; conference ID 13758715), and view a replay posted about three hours after the call that will be archived for 90 days.

#ACHV Achieve Life Sciences to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call and Webcast on March 24, 2026

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Achieve Life Sciences Confirms Promotion of Dr. Mark Rubinstein to Chief Medical Officer Achieve Life Sciences (Nasdaq: ACHV) confirmed the promotion of Dr. Mark Rubinstein from Interim Chief Medical Officer to permanent Chief Medical Officer, effective Jan. 12, 2026.Dr. Rubinstein served as Interim CMO since September 2025 and joined Achieve as Head of Medical Affairs in October 2024. The company said clinical and regulatory milestones were achieved during his interim tenure; he co‑authored a paper in Thorax reporting data on cytisinicline’s potential efficacy and tolerability for smoking cessation in people with COPD. Management highlighted his experience as the company advances toward FDA review for cytisinicline.

#ACHV Achieve Life Sciences Confirms Promotion of Dr. Mark Rubinstein to Chief Medical Officer

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Achieve Life Sciences Announced Granting of New Hire Inducement Awards 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).

#ACHV Achieve Life Sciences Announced Granting of New Hire Inducement Awards

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#ACHV Achieve Life Sciences Reports Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program

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Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation 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.

#ACHV Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation

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Achieve Life Sciences Announces Granting of New Hire Inducement Awards 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.

#ACHV Achieve Life Sciences Announces Granting of New Hire Inducement Awards

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#ACHV: Preparations Continue as PDUFA Date Assigned buff.ly/gdiRxiI

Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline’s Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD 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.

#ACHV Achieve Life Sciences Announces Publication in Thorax of Data Demonstrating Cytisinicline’s Potential Efficacy and Tolerability for Smoking Cessation in Individuals with COPD

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Smoking Cessation Biotech Achieve Life Sciences Appoints New COO for First Treatment in 20 Years Biotech veteran Craig Donnelly promoted to COO at Achieve Life Sciences, leading commercial preparation for cytisinicline launch in 2026. First new smoking cessation treatment in nearly 20 years.

#ACHV Achieve Life Sciences Promotes Craig Donnelly to Chief Operations Officer

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First New Smoking Cessation Drug in Two Decades: FDA to Review Achieve's Cytisinicline Treatment FDA sets PDUFA date of June 2026 for cytisinicline, backed by Phase 3 trials with 2,000+ participants. Targets $600B annual smoking impact, potential first new cessation drug in 20 years.

#ACHV Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation

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#ACHV: Second Quarter Results buff.ly/Km3BSq4

Achieve Life Sciences Reports Second Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program 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.

#ACHV Achieve Life Sciences Reports Second Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program

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#ACHV: Achieve’s Busy Day buff.ly/ruA2pm4

Achieve Life Sciences Announces Pricing of $45.0 Million Underwritten Public Offering Achieve Life Sciences (NASDAQ:ACHV) has announced the pricing of an underwritten public offering of 15 million shares of common stock and accompanying warrants at $3.00 per share, aiming to raise approximately $45.0 million in gross proceeds.The offering includes common warrants to purchase up to 15 million additional shares, exercisable at $3.00 per share or for pre-funded warrants at $2.999, valid for five years. Underwriters have a 30-day option to purchase up to 2.25 million additional shares and/or warrants. The company plans to use the proceeds to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital purposes.

#ACHV Achieve Life Sciences Announces Pricing of $45.0 Million Underwritten Public Offering

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Achieve Life Sciences Seeks FDA Approval Funding Through New Public Offering: What Investors Should Know New public offering aims to advance smoking cessation drug cytisinicline through FDA approval process. Citizens Capital Markets, Raymond James lead underwriting. Get details.

#ACHV Achieve Life Sciences Announces Proposed Underwritten Public Offering

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Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation Achieve Life Sciences (NASDAQ: ACHV) has submitted a New Drug Application (NDA) to the FDA for cytisinicline, a novel treatment for nicotine dependence in adult smoking cessation. If approved, cytisinicline would become the first new FDA-approved pharmacotherapy for nicotine dependence in 20 years.The NDA submission is supported by data from two Phase 3 trials (ORCA-2 and ORCA-3), involving over 2,000 clinical trial participants. Both studies demonstrated significantly higher abstinence rates with cytisinicline compared to placebo at both 6 and 12-week treatment durations. Additional safety data from the ORCA-OL long-term trial, involving over 300 participants with six months of exposure, showed no new safety concerns.

#ACHV Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation

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(1/3)

#ACHV: Kicking Butts to Achieve June NDA Filing buff.ly/T4oqm56

Achieve Life Sciences Reports First Quarter 2025 Financial Results and Highlights Updates in Cytisinicline Program Achieve Life Sciences (NASDAQ: ACHV) reported its Q1 2025 financial results and provided updates on its cytisinicline program for smoking cessation. The company plans to submit a New Drug Application (NDA) to the FDA in June 2025. Key highlights include: publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine involving 792 U.S. adults, completion of long-term exposure requirements with ≥300 participants receiving six months and 100+ participants receiving one year of treatment, and a favorable third safety review by the Data Safety Monitoring Committee. Financial results show cash position of $23.2 million, operating expenses of $12.9 million, and a net loss of $12.8 million for Q1 2025. The company's cytisinicline could become the first new FDA-approved smoking cessation treatment in nearly 20 years.

#ACHV Achieve Life Sciences Reports First Quarter 2025 Financial Results and Highlights Updates in Cytisinicline Program

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Breakthrough Smoking Cessation Drug Outperforms Existing Treatments in Major Phase 3 Trial, JAMA Reports New clinical data reveals superior efficacy and tolerability in 792-patient smoking cessation trial. FDA submission planned for 2025. See complete results.

#ACHV Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine

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