BioMedNewsBreaks — Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance for Pivotal Phase 3 Alzheimer’s Trial, Launch Set for Early 2025
Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on developing therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), announced today that the U.S. Food and Drug Administration (“FDA”) has granted clearance to proceed with pivotal Phase 3 studies for buntanetap in early-stage Alzheimer’s patients. This decision follows a successful End-of-Phase 2 meeting held on Oct. 10, 2024, where Annovis and the FDA aligned on the next steps for advancing buntanetap toward New Drug Application (“NDA”) submissions. The Phase 3 program will consist of two trials: a 6-month study aimed at confirming…
