Achieve Life Sciences submits 120-day safety update to FDA for cytisinicline.
ByAinvest
Monday, Nov 3, 2025 8:44 am ET1min read
ACHV--
Achieve Life Sciences has submitted a 120-day safety update to the FDA as part of the NDA review for cytisinicline, a treatment for nicotine dependence. The ORCA-OL long-term safety trial has concluded successfully, with no drug safety concerns found by the Data and Safety Monitoring Committee. The trial includes data on 411 participants with at least six months of cumulative exposure to cytisinicline.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
ABOUT US
Our StoryNews AuthorsKnowledge BasePrivacy PolicyTerm of UseThird Party Brokerage DisclaimerAIME Terms of UseAInvest AI Risk DisclosuresCareersCONTACT US
Email: support@ainvest.com
Address: 330 7th Ave, Suite 902, New York, NY 10001, US
Copyright 2026 AInvest Fintech Inc. All rights reserved.
Comments
No comments yet