NVDA
NVIDIA
-- 138.510 TSLA
Tesla
-- 389.505 RGTI
Rigetti Computing
-- 9.4950 PLTR
Palantir
-- 66.960 AMD
Advanced Micro Devices
-- 120.532 
NEWS
Achieve Life Sciences Announces Critical Milestone Successfully Reached in ORCA-OL Cytisinicline Clinical Trial Required for NDA Submission
Tuesday, 7th January at 8:30 am
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, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation as a treatment for nicotine dependence, today announced that its ongoing ORCA-OL clinical trial, designed to evaluate the long-term safety exposure of cytisinicline, has reached the goal of at least 300 participants completing six months of cumulative cytisinicline treatment. The U.S. Food and Drug Administration (FDA) requested six-month safety exposure data to be included in the company's planned New Drug Application (NDA). Further, based on ongoing Data Safety Monitoring Committee (DSMC) review, no safety concerns have been identified, and the study continues to proceed as planned with no modifications. Achieve remains on track for the planned NDA submission, expected to occur in the second quarter of 2025.
Tuesday, 7th January at 8:30 am
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, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline for smoking cessation as a treatment for nicotine dependence, today announced that its ongoing ORCA-OL clinical trial, designed to evaluate the long-term safety exposure of cytisinicline, has reached the goal of at least 300 participants completing six months of cumulative cytisinicline treatment. The U.S. Food and Drug Administration (FDA) requested six-month safety exposure data to be included in the company's planned New Drug Application (NDA). Further, based on ongoing Data Safety Monitoring Committee (DSMC) review, no safety concerns have been identified, and the study continues to proceed as planned with no modifications. Achieve remains on track for the planned NDA submission, expected to occur in the second quarter of 2025.
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment