ACHV
Achieve Life Sciences, Inc.·Healthcare
4.78
4.825%(+0.22)
Close PriceLast Updated: — ET
52W L: $2.0052W H: $6.15
ACHV NEWS
globenewswire.com
May 19
Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment
ORCA-OL data complete the clinical evidence package supporting the cytisinicline smoking cessation NDA No new safety signals identified by the independent Data Safety Monitoring Committee over 52 weeks of continuous exposure Nausea — a common barrier to treatment adherence with smoking cessation therapies — was reported in only 2.5% of participants over 52 weeks of continuous exposure¹ SEATTLE and VANCOUVER, British Columbia, May 19, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced the presentation of comprehensive long-term safety data from the ORCA-OL study at the American Thoracic Society (ATS) 2026 Annual Meeting. Additional cytisinicline data will be presented at ATS on May 20.
globenewswire.com
May 19
Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment
ORCA-OL data complete the clinical evidence package supporting the cytisinicline smoking cessation NDA No new safety signals identified by the independent Data Safety Monitoring Committee over 52 weeks of continuous exposure Nausea - a common barrier to treatment adherence with smoking cessation therapies - was reported in only 2.
seekingalpha.com
May 13
Achieve Life Sciences: 'Hold' On Expected CRL Cytisinicline And Q4 2026 NDA Resubmission
Achieve Life Sciences (ACHV) is downgraded to 'Hold' due to anticipated CRL of cytisinicline for smoking cessation and NDA resubmission in Q4 2026. FDA inspection issues at a third-party manufacturer will trigger a Complete Response Letter on or before June 20,2026, pushing NDA resubmission to Q4 2026 and potential launch H1 2027. Company has shifted cytisinicline supply to Adare, but future FDA inspections at Adare's facility remain a key risk for approval timelines.
seekingalpha.com
May 12
Achieve Life Sciences, Inc. (ACHV) Q1 2026 Earnings Call Transcript
Achieve Life Sciences, Inc. (ACHV) Q1 2026 Earnings Call Transcript
marketbeat.com
May 12
Achieve Life Sciences Q1 Earnings Call Highlights
Achieve Life Sciences NASDAQ: ACHV used its first-quarter 2026 earnings call to outline a transition period marked by new leadership, a major financing, manufacturing changes tied to its cytisinicline regulatory timeline and preparations for a potential commercial launch in 2027.
globenewswire.com
May 12
Achieve Life Sciences Strengthens Board and Commercial Leadership with Three Senior Appointments from Team Previously at Verona Pharma
Christopher Martin joins the Board of Directors, with Mark Zappia and Jim Willis joining as Senior Vice President of Commercial and Vice President of Sales, reuniting the team behind the launch of Ohtuvayre®, one of the most successful specialty pharmaceutical launches in recent industry history Christopher Martin joins the Board of Directors, with Mark Zappia and Jim Willis joining as Senior Vice President of Commercial and Vice President of Sales, reuniting the team behind the launch of Ohtuvayre®, one of the most successful specialty pharmaceutical launches in recent industry history
