Annovis Bio, Inc., a Malvern, Pennsylvania-based Phase 3 clinical-stage biotech, announced on September 23, 2026 a collaboration with Weave Bio, an AI platform for regulatory content and knowledge management, to support the planned New Drug Application (NDA) for buntanetap, its investigational oral therapy for Alzheimer’s disease (AD) and Parkinson’s disease (PD). Under the collaboration, Annovis will use Weave for drafting, reviewing, and managing NDA documents as it heads toward a 6-month top-line data readout from its pivotal Phase 3 AD trial — the data that will form the basis of the submission — while Annovis’ own regulatory and clinical teams retain full responsibility for content, verification, and final approval of everything submitted to the FDA.
Eve Damiano, Senior VP, Regulatory Operations at Annovis, said: “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. 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.”
A Trial That Overshot Its Enrollment Target
The collaboration follows completion of enrollment in Annovis’ pivotal Phase 3 AD study (NCT06709014), which enrolled 862 biomarker-confirmed patients — well above the original target of 760. The company aims to reach database lock for the 6-month treatment period in December 2026, with top-line symptomatic data expected in March 2027.
Brandon Rice, CEO and co-founder of Weave Bio, framed the partnership around the scale of the challenge: “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. 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.”
Built Around FDA’s Own AI Guidance
Annovis and Weave Bio say they’ve aligned their approach with FDA guidance on the use of AI in regulatory decision-making, issued in January 2025, which keeps regulatory professionals in control of AI-assisted drafting, extraction, traceability, and review.
About Annovis Bio
Headquartered in Malvern, Pennsylvania, Annovis Bio is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases including Alzheimer’s and Parkinson’s disease. Its lead candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits translation of multiple neurotoxic proteins — including APP and amyloid beta, tau, alpha-synuclein, and TDP-43 — through a specific RNA-targeting mechanism, with the goal of halting disease progression and improving cognitive and motor function.
