Annovis Bio (ANNV) Shares Surge 11.22% on FDA Meeting for Parkinson’s Drug Buntanetap

Shares of Annovis Bio surged 11.22% in pre-market trading on November 19, 2025, following news of a scheduled January 2026 meeting with the U.S. Food and Drug Administration (FDA) to discuss the development pathway for buntanetap in treating Parkinson’s disease dementia (PDD).

The FDA Type C meeting will focus on clinical trial design, patient population, and potential approval routes for buntanetap, a drug candidate targeting PDD, which affects 30% of Parkinson’s patients. The company emphasized regulatory alignment on its Phase 3 Alzheimer’s trial, which supports dual New Drug Applications (NDAs) for symptomatic and disease-modifying treatments. Maria Maccecchini, CEO, highlighted the meeting as a “key milestone” for addressing an underserved patient population.

Annovis also confirmed ongoing enrollment in its Alzheimer’s trial, with full FDA agreement on study design and endpoints. Cheng Fang, Senior VP of R&D, noted that cognitive improvement data from buntanetap across multiple studies strengthens its potential in neurodegenerative indications. The stock’s recent 43.6% weekly gain reflects investor optimism about regulatory progress and clinical outcomes.

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