Nasdaq

Chemomab Completes Successful End-of-Phase 2 Meeting and Aligns with FDA on Clear and Efficient Path to Potential Regulatory Approval for Nebokitug (CM-101) in Primary ...

Single Positive Phase 3 Trial Designed to Support Full Regulatory Approval, For the First Time Providing Regulatory Clarity in PSC and Positioning Nebokitug to Potentially Become the First ...
Nasdaq

Achieve Life Sciences announces outcome of End-of-Phase 2 meeting with FDA

Achieve Life Sciences (ACHV) announced the outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration. This meeting represents a key milestone in advancing cytisinicline’s ...
Benzinga.com

Cognition Therapeutics' End-Of-Phase 2 Trial Meeting With FDA Could Kick Off Phase 3 Trial For Its Alzheimer's Candidate Zervimesine

Cognition Therapeutics Inc. (NASDAQ:CGTX), a clinical stage company developing drugs to treat neurodegenerative disorders, is making progress toward submitting a new drug application (NDA) to the FDA ...
Nature

Analysis of phase II and phase III clinical trial terminations from 2013 to 2023

Success rates in phase II and phase III clinical trials are recognized as two of the most powerful drivers of overall efficiency in drug development (Nat. Rev. Drug Discov. 23, 656–657; 2024). With ...