News
Tag: Clinical News
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Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation
Smoking, the leading cause of preventable death and disease, continues to affect nearly 29 million adults in the U.S. alone. If approved, cytisinicline will be the first new FDA-approved pharmacotherapy option for nicotine dependence in two decades. More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s…
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Achieve Life Sciences to Present New Data at the 2025 ATS International Conference Demonstrating that Cytisinicline Reduced Cravings and Nicotine Intake
Oral Presentation to Highlight Key Benefits of Cytisinicline’s Dual Mechanism of Action to Pulmonary Specialists. SEATTLE and VANCOUVER, British Columbia, May 20, 2025 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Nasdaq: ACHV) a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today…
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Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine
ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo. Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025. SEATTLE and VANCOUVER, British Columbia, April 21, 2025 (GLOBE NEWSWIRE) – Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the…
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Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial
No Safety Concerns Identified by DSMC in the ORCA-OL Long-Term Exposure Trial. Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025. SEATTLE and VANCOUVER, British Columbia, February 10, 2025 (GLOBE NEWSWIRE) – Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation…
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Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission
Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission. ORCA-OL Long-Term Exposure Timelines Remain on Track with No Safety Concerns Identified. Planned Cytisinicline NDA Submission on Target for Q2 2025. SEATTLE and VANCOUVER, British Columbia – January 7, 2025 Achieve Life…