Annovis Bio Inc. (NYSE: ANVS) Receives FDA Clearance to Initiate Pivotal Phase 3 Alzheimer’s Studies, Paving the Way for NDA Filings
Annovis Bio received FDA clearance to move forward with Phase 3 trials for buntanetap following an End-of-Phase 2 meeting on October 10, 2024. The pivotal trials will investigate buntanetap’s short-term symptomatic effects and potential long-term disease-modifying benefits in early-stage Alzheimer’s disease (“AD”) patients. Annovis Bio is targeting potential NDA submission within one year of the study’s initiation for symptomatic treatment, based on the results of a well-executed 6-month trial. The FDA raised no safety concerns regarding buntanetap and supported the use of its new crystal form in development. Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on…