Annovis Announces Partnership with Weave Bio, AI Regulatory Platform, in Preparation of NDA for Buntanetap in Alzheimer’s Disease
Annovis will use Weave Bio’s AI platform to accelerate NDA preparation for buntanetap as its 862-patient Phase 3 Alzheimer’s trial nears key readouts.
Rhea-AI Summary
Annovis Bio (ANVS) has partnered with Weave Bio’s AI-powered regulatory platform to prepare the planned NDA for buntanetap in Alzheimer’s disease.
Under the collaboration, Annovis will use Weave to draft, review and manage NDA documents while its internal regulatory and clinical teams retain full responsibility for content, verification and final FDA submissions. The company aims to have most of the NDA assembled before a 6‑month top-line data readout from its pivotal Phase 3 AD trial, which will form the basis of the filing. The Phase 3 study (NCT06709014) has completed enrollment with 862 biomarker-confirmed patients, above the original target of 760. Annovis targets database lock for the 6‑month treatment period in December 2026, followed by a top-line symptomatic data announcement in March 2027. Annovis and Weave state that their approach aligns with FDA guidance on AI use in regulatory decision-making issued in January 2025.
Positive
- Phase 3 AD trial enrollment completed with 862 biomarker-confirmed patients vs 760 target
- Key milestones defined: database lock planned for December 2026, top-line symptomatic data in March 2027
- AI-enabled NDA workflow adopted to streamline drafting, review and management of FDA submission documents
Negative
- None.
Key Figures
- Patients enrolled
- 862 patients
- Pivotal Phase 3 AD study; original target was 760
- Database lock
- December 2026
- For the 6-month treatment period
- Top-line data announcement
- March 2027
- Symptomatic data from the 6-month treatment period
Key Terms
new drug application regulatory
database lock medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
MALVERN, Pa., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced a collaboration with Weave Bio, an AI platform for regulatory content and knowledge management, in support of the planned New Drug Application (NDA) for buntanetap.
Under the collaboration, Annovis will use Weave for drafting, reviewing and managing the NDA documents as the Company heads toward a 6-month top-line data readout from the pivotal Phase 3 AD trial – the data that will form the basis of the submission. Annovis’ regulatory and clinical teams will retain full responsibility for content, verification and final approval of every document submitted to the U.S. Food and Drug Administration (FDA).
"Our goal is to have most of the NDA ready before the data readout, so the path from the top-line results to filing is as short as possible," said Eve Damiano, Senior VP, Regulatory Operations at Annovis. "Weave will let our regulatory team spend time on scientific judgment and strategy while providing essential assistance on assembling documents in a faster and more organized way. That is a meaningful advantage as we prepare a submission for an investigational therapy we believe has the potential to help millions of patients still waiting for a treatment that can change their lives."
The collaboration follows the completion of enrollment in Annovis’ pivotal Phase 3 AD study (NCT06709014), which enrolled 862 biomarker-confirmed patients, exceeding the original target of 760. The Company aims to reach the database lock for the 6-month treatment period in December 2026, followed by the top-line symptomatic data announcement in March 2027.
“Annovis is exactly the kind of company our platform was built for – a team with deep scientific expertise, ambitious timelines, and a vision for the future of AI-driven drug development,” said Brandon Rice, CEO and co-founder of Weave Bio. “NDA submissions are not just about writing documents, they are about weaving years of scientific knowledge into a coherent, traceable narrative. We are privileged to help Annovis do that for a disease area that still has no effective treatment.”
Annovis and Weave Bio have aligned their approach around the FDA’s guidance on the use of AI to support regulatory decision-making, issued in January 2025, keeping regulatory professionals in control of AI-assisted drafting, extraction, traceability and review.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
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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
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How will responsibilities be divided between Annovis and Weave Bio for the buntanetap NDA?
Annovis will use Weave Bio’s AI platform for drafting, reviewing and managing NDA documents, while Annovis’ regulatory and clinical teams retain full responsibility for all content, verification and final approval of every document submitted to the FDA.
What are the key design features disclosed for Annovis’ pivotal Phase 3 Alzheimer’s study of buntanetap?
The pivotal Phase 3 Alzheimer’s disease study (NCT06709014) has completed enrollment of 862 biomarker-confirmed patients, above the original target of 760, and includes a 6‑month treatment period that will support the top-line symptomatic data readout.
How are Annovis and Weave Bio addressing regulatory expectations around AI use in submissions?
Annovis and Weave Bio have aligned their approach with FDA guidance on the use of AI to support regulatory decision-making, issued in January 2025, keeping regulatory professionals in control of AI-assisted drafting, extraction, traceability and review.