Welcome to our dedicated page for Annovis Bio news (Ticker: ANVS), a resource for investors and traders seeking the latest updates and insights on Annovis Bio stock.
Annovis Bio Inc (ANVS) is a clinical-stage biopharmaceutical company developing multi-target therapies for neurodegenerative diseases, generating news primarily related to clinical trial progress, regulatory interactions, and corporate developments. The company's news flow reflects the distinct dynamics of early-stage biotech companies, where data releases, regulatory milestones, and financing activities drive investor interest.
News coverage for Annovis Bio typically includes announcements of clinical trial results and biomarker data from studies of ANVS401, the company's lead candidate for Alzheimer's disease and Parkinson's disease. Regulatory interactions with the FDA, including formal meetings and guidance discussions, represent significant news events that can impact development timelines and strategic direction. The company also generates news through scientific presentations at major medical conferences, peer-reviewed publications in scientific journals, and corporate updates on pipeline advancement.
Financing activities constitute another important category of Annovis Bio news, as the company regularly conducts registered direct offerings and other equity financings to fund clinical operations. Executive appointments, corporate governance changes, and strategic partnerships or licensing agreements also contribute to the company's news flow. Investors following Annovis Bio benefit from tracking these diverse news types to understand both the scientific progress of drug candidates and the financial health of the organization.
This news resource provides real-time updates on all material developments affecting Annovis Bio, from clinical data releases to regulatory submissions. The biotech sector demands careful attention to trial outcomes, regulatory decisions, and funding announcements, all of which can significantly impact company trajectory. Bookmark this page to stay informed about Annovis Bio's neurodegenerative disease programs and corporate developments.
Annovis (NYSE: ANVS) will begin an Open-Label Extension (OLE) study for Parkinson's disease in January 2026 to evaluate long-term safety and efficacy of buntanetap.
Key design: enrollment target 500 patients across U.S. sites, 36-month once-daily 30 mg treatment, two cohorts (invited former study participants and patients with deep brain stimulation). Skin and plasma biomarkers will be collected.
The OLE is intended to help meet FDA patient-exposure criteria toward NDA readiness by contributing to a ~1,500 treated-patient target and required multi-duration exposure thresholds.
Annovis (NYSE: ANVS) will host a corporate update webinar on January 28, 2026 at 4:30 p.m. ET featuring President and CEO Maria Maccecchini, Ph.D.. The presentation will review the company’s recent progress, ongoing late‑stage clinical programs in Alzheimer’s and Parkinson’s disease, strategic direction, and upcoming early‑2026 milestones, followed by a live Q&A.
The webinar is open to shareholders, patients, investigators, and other interested parties; participants are encouraged to register via the company registration link and may submit questions in advance to ir@annovisbio.com.
Annovis (NYSE: ANVS) will present at the 2025 Annual Meeting of the Parkinson Study Group in San Diego, Dec 4-6, 2025.
The company will present Phase 3 Parkinson's disease biomarker data showing that patients with amyloid co-pathology experienced greater cognitive decline that was counteracted and reversed by buntanetap; buntanetap also reduced tau biomarkers. The poster includes a cross-study comparison of completed trials and highlights that patients with amyloid pathology show the largest cognitive gains.
Presentation: Amyloid co-pathology, cognitive decline, and improvement in buntanetap-treated Parkinson’s disease dementia patients by Maria Maccecchini, Ph.D., on Dec 5 at 6:15 p.m. PST; data will be posted on the company website after the meeting.
Annovis (NYSE: ANVS) announced two scientific presentations at the 18th Clinical Trials on Alzheimer’s Disease (CTAD), December 1–4, 2025 in San Diego.
Presentation P073 covers amyloid co-pathology and cognitive decline in buntanetap-treated Parkinson’s disease dementia patients, presented by Cheng Fang, Ph.D. Presentation P007 describes a double 6/18-month Phase 3 study testing symptomatic and potential disease‑modifying efficacy of buntanetap in Alzheimer’s disease, presented by Maria Maccecchini, Ph.D., President and CEO. Both talks highlight recent biomarker data and cognition findings the company says support buntanetap’s potential disease‑modifying activity.
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.
Annovis (NYSE: ANVS) reported Phase 3 data in early Parkinson's disease (NCT05357989) showing buntanetap halted cognitive decline across the study population and produced the largest benefit in patients with mild dementia.
Approximately 25% of participants had amyloid co-pathology and experienced accelerated cognitive decline that was reversed by buntanetap. Treatment also produced measurable reductions in plasma pTau217, total tau, and brain-derived tau, biomarkers linked to Alzheimer’s pathology.
Full biomarker data will be presented at CTAD in San Diego, December 1–4, 2025.
Annovis Bio (NYSE: ANVS) provided corporate updates and third quarter 2025 financial results on November 12, 2025. Key clinical progress includes full activation of 84 Phase 3 AD sites, first patients completing 6-month treatment, and October biomarker data showing reductions in neuroinflammation and neurodegeneration versus placebo. The company published PK data for a new crystalline buntanetap form and transferred patents securing IP through 2046. Financially, cash totaled $15.3M as of September 30, 2025 (includes $6.0M and $3.4M offerings) funding operations to Q3 2026. Q3 R&D was $6.3M; G&A $1.1M; diluted net loss was $0.37 per share; shares outstanding were 20.2M.
Annovis (NYSE: ANVS) reported that all 84 Phase 3 sites for its pivotal early Alzheimer's trial are fully activated and enrolling across the U.S., with the first participants having completed the 6-month treatment milestone.
The study is now 25% complete toward a total enrollment target of 760 patients with biomarker-confirmed amyloid pathology. A symptomatic 6-month readout is on track for H2 2026, followed by an 18-month disease‑modifying assessment; participants completing 6 months continue blinded treatment for 12 more months.
Annovis Bio (NYSE: ANVS) announced a registered direct offering of 1,670,732 shares of common stock at $2.05 per share (closing price on Oct 24, 2025).
The offering is expected to close on or about October 28, 2025, with aggregate gross proceeds of approximately $3.4 million before placement agent fees and expenses. Michael Hoffman (board chair) and CEO Dr. Maria Maccecchini are participating in the purchase.
H.C. Wainwright & Co. is the exclusive placement agent. Net proceeds are intended for working capital and general corporate purposes. Securities are offered under a Form S-3 shelf registration (No. 333-276814) declared effective Feb 12, 2024.
Annovis (NYSE: ANVS) closed a registered direct offering on October 15, 2025 selling an aggregate of 4,000,000 shares (or pre-funded warrants) at $1.50 per share, generating approximately $6.0 million in gross proceeds before placement agent fees and offering expenses. H.C. Wainwright & Co. served as exclusive placement agent. The company intends to use net proceeds for working capital and general corporate purposes. The securities were offered under a Form S-3 shelf registration (No. 333-276814) declared effective Feb 12, 2024, and via a prospectus supplement filed with the SEC.
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