Annovis Stock Rises After Company Confirms Meeting With Regulators To Discuss Drug In Treating Parkinson's Disease Dementia

• The January meeting is intended to discuss the clinical trial design, patient population, and a potential approval route for Buntanetap in PDD. 
• According to Annovis, PDD affects approximately 30% of Parkinson’s patients. 
• The company also said that its late-stage Alzheimer’s Disease study is ongoing with full regulatory alignment.

Annovis Bio, Inc. (ANVS) on Tuesday said the U.S. Food and Drug Administration (FDA) has scheduled a January 2026 meeting to discuss the company's pathway to developing Buntanetap for the treatment of Parkinson's disease dementia.

Parkinson's disease dementia (PDD) is a type of dementia that occurs in people who already have Parkinson's disease, characterized by cognitive decline, such as memory problems and slowed thinking, along with the movement issues of PD. According to Annovis, PDD affects approximately 30% of Parkinson’s patients.

What Will Be Discussed At The Meeting?

The meeting in January is aimed at discussing the clinical trial design, patient population, and a potential approval route for Buntanetap in PDD, the company said. According to Annovis executive Cheng Fang, PDD is a natural extension of the company’s Alzheimer's and Parkinson's programs, wherein the company generated data demonstrating meaningful cognitive improvement with Buntanetap.

"The scheduled January meeting marks a key milestone for our pipeline, underscoring buntanetap's potential across multiple neurodegenerative indications and the strength of our scientific approach."
Maria Maccecchini, CEO, Annovis

Alzheimer’s Trial Progress

The Malvern, Pennsylvania-headquartered company also said that its late-stage Alzheimer’s Disease study is ongoing with full regulatory alignment on study design, endpoints, and patient population.

The study is set to support applications for the drug in symptomatic treatment and disease-modifying treatment with Buntanetap.

How Did Stocktwits Users React?

ANVS shares traded 16% higher at the time of writing. On Stocktwits, retail sentiment around ANVS remained in the ‘extremely bullish’ territory, while message volume remained at ‘extremely high’ levels.

ANVS stock fell 31% this year and by 49% over the past 12 months. 

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