Annovis Announces FDA Meeting to Discuss Parkinson's Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer's Disease Study

Core Insights - Annovis Bio, Inc. is advancing its clinical programs for neurodegenerative diseases, particularly focusing on Parkinson's disease dementia (PDD) and Alzheimer's disease (AD) [1][4] Parkinson's Disease Dementia Program - The FDA has scheduled a Type C meeting in January 2026 to discuss the clinical development pathway for Annovis' drug candidate, buntanetap, in treating PDD, which affects approximately 30% of Parkinson's patients, with some estimates suggesting up to 80% may develop dementia over time [2][3] - The meeting will address clinical trial design, patient population, and potential approval routes, highlighting the significant opportunity to serve an underserved patient population [2][3] Alzheimer's Disease Study Progress - Annovis confirmed that its Phase 3 clinical trial for early Alzheimer's disease is progressing as planned, with full FDA agreement on critical study parameters [4][5] - The FDA provided comprehensive feedback during the End-of-Phase 2 meeting in 2024, confirming alignment on study design to support two potential New Drug Applications (NDAs): one for symptomatic treatment and another for disease-modifying treatment with buntanetap [4] Company Commitment - Annovis is dedicated to developing innovative therapies aimed at improving patient outcomes and quality of life for those suffering from neurodegenerative diseases [5]