Annovis Bio announced that the U.S. Food and Drug Administration has scheduled a Type C meeting in January 2026 to discuss the development pathway for its oral drug candidate buntanetap in the treatment of Parkinson’s disease dementia (PDD). The upcoming meeting will focus on trial design parameters, patient population definition and a potential regulatory approval route.
The company also reaffirmed that its ongoing Phase 3 study in early Alzheimer’s disease remains aligned with FDA-agreed endpoints, patient inclusion criteria and overall study design, supporting potential submission of two New Drug Applications—one for symptomatic relief and another for disease modification.
Annovis emphasised that the regulatory engagement in PDD represents a natural extension of its Alzheimer’s and Parkinson’s programmes and underscores its belief in buntanetap’s potential across neurodegenerative indications. While the Phase 3 Alzheimer’s trial is proceeding as planned, the PDD pathway remains contingent on the outcomes of the January meeting and subsequent clinical activities.
