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

Rhea-AI Summary

Annovis (NYSE: ANVS) announced the FDA scheduled a Type C meeting in January 2026 to discuss the clinical development pathway for buntanetap in Parkinson's disease dementia (PDD). The company said the meeting will cover trial design, patient population, and a potential approval route.

Annovis also reaffirmed that its Phase 3 Alzheimer's disease trial is enrolling on plan with full FDA alignment on study design, endpoints, and population following an End-of-Phase 2 meeting in 2024. Management said the Phase 3 design could support two NDAs: one for symptomatic treatment and one for disease-modifying treatment.

Positive

• FDA Type C meeting scheduled for January 2026 on PDD pathway
• Phase 3 AD trial enrolling on plan with full FDA alignment
• Phase 3 design positioned to support two NDAs (symptomatic and disease-modifying)

Negative

• No approved PDD indication for buntanetap yet; clinical pathway still under discussion
• Program pre-approval stage requires successful meetings and trial outcomes before regulatory clearance

Insights

Clinical-Regulatory Analyst

Scheduled FDA Type C meeting in January 2026 and confirmed Phase 3 alignment signal constructive regulatory progress for buntanetap.

Annovis Bio has secured a formal Type C meeting with the FDA to discuss a Parkinson's disease dementia (PDD) development pathway and reports full FDA alignment on its Phase 3 Alzheimer’s study design after an End‑of‑Phase‑2 interaction in 2024. A Type C meeting is an explicit regulatory touchpoint to clarify trial design, endpoints, and approval routes, and the company lists concrete agenda items including clinical trial design, patient population, and potential approval pathway for PDD.

The principal dependency is continued, documented regulatory agreement on specific trial elements during the January 2026 meeting; until those minutes or follow‑up correspondence are disclosed, the practical effect remains future‑facing. Key risks include the possibility that FDA feedback requires protocol changes or additional data that could alter timelines. The announcement cites cognitive benefit signals but does not disclose specific Phase 3 metrics or confirm primary endpoint alignment beyond general agreement.

Watch for the FDA meeting outcome and any written minutes or minutes‑equivalent shortly after January 2026, plus concrete Phase 3 readouts or protocol documents that specify primary endpoints and statistical plans. Nearer term, monitor enrollment progress and any regulatory correspondence that alters the stated plan; expect material clarity or changes within a 3–12 month window following the meeting.

MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its ongoing Phase 3 AD clinical trial continues to progress with full regulatory alignment on study design, endpoints, and patient population.

"We are pleased with such proactive engagement with the FDA on our PDD program, which represents a significant opportunity to address an underserved patient population," said Maria Maccecchini, Ph.D., President and CEO. "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."

Parkinson's Disease Dementia Program

The upcoming meeting will focus on the clinical development pathway for buntanetap in PDD, a debilitating condition affecting approximately 30% of PD patients, with some reports suggesting that up to 80% develop dementia over the long term. Dementia in Parkinson’s profoundly affects quality of life for both patients and caregivers, with limited approved treatment options currently available. The meeting agenda will include discussions on clinical trial design, patient population, and a potential approval route.

"Parkinson's disease dementia represents a natural extension of both our Alzheimer's and Parkinson's programs," added Cheng Fang, Senior VP, Research & Development. "Across both indications, we have generated strong data demonstrating meaningful cognitive improvement with buntanetap. Despite being a serious problem, cognitive decline in Parkinson's patients has received limited attention in the field. Our integrated data across multiple studies has opened a unique opportunity to address this unmet need and alleviate the cognitive burden in the Parkinson's population."

Phase 3 Alzheimer's Disease Study Progress

Annovis also confirmed that its Phase 3 clinical trial in early AD continues to enroll patients according to plan, with full FDA agreement on all critical study parameters. The agency provided comprehensive feedback during the End-of-Phase 2 meeting in 2024, confirming its alignment on the study design, which is set to support two potential NDAs: one for symptomatic treatment and one for disease-modifying treatment with buntanetap.

"The FDA's continued engagement across our clinical programs underscores the regulatory clarity we have established," said Maria Maccecchini, Ph.D. "We remain focused on executing our pivotal Phase 3 AD study while advancing opportunities in complementary indications like PDD, where our drug candidate may provide a truly meaningful benefit to patients."

About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.

Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com‍

FAQ

What did Annovis (ANVS) announce about the FDA meeting in January 2026?

Annovis announced a Type C FDA meeting in January 2026 to discuss the clinical development pathway for buntanetap in Parkinson's disease dementia.

How does the January 2026 FDA meeting affect ANVS's Parkinson's disease dementia program?

The meeting will cover trial design, patient population, and a potential approval route for buntanetap in PDD.

Is Annovis's Phase 3 Alzheimer's trial proceeding with FDA agreement (ANVS)?

Yes; Annovis said the Phase 3 AD trial is enrolling on plan with full FDA alignment on design, endpoints, and population.

What regulatory feedback did ANVS receive during the End-of-Phase 2 meeting in 2024?

The company reported comprehensive FDA feedback in 2024 and said there is alignment on the Phase 3 study design to support two potential NDAs.

Could Annovis file more than one NDA for buntanetap (ANVS)?

Annovis stated the Phase 3 design is set to support two potential NDAs: one for symptomatic treatment and one for disease-modifying treatment.

What patient population is the January 2026 FDA meeting focused on for ANVS?

The meeting will focus on Parkinson's disease dementia (PDD), a condition affecting a substantial portion of Parkinson's patients.