Nasdaq

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

Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation FDA acceptance starts the review process and sets ...
Seeking Alpha

Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation

SEATTLE and VANCOUVER, British Columbia, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (ACHV), a late-stage specialty pharmaceutical company focused on the global development and ...
Business Insider

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the ...
Hosted on MSN

Achieve Life Sciences announces several milestones in its ORCA-OL trial

Achieve Life Sciences (ACHV) announced several milestones in its ORCA-OL long-term safety trial supporting the New Drug Application, NDA, review process of cytisinicline for smoking cessation. 120-Day ...