Core Viewpoint - Annovis Bio, Inc. is set to launch an Open-Label Extension (OLE) study in January 2026 to assess the long-term safety and efficacy of its drug, buntanetap, in patients with Parkinson's disease [2][3] Study Overview - The OLE study aims to enroll 500 patients over a 36-month treatment period, with participants receiving a once-daily dose of 30mg oral buntanetap [9] - The study will include two cohorts: former participants of previous clinical trials and patients who have been receiving deep brain stimulation (DBS) for at least 12 months [9][10] Objectives and Methodology - The study will evaluate treatment persistence by examining how patient outcomes evolve after discontinuing treatment, providing insights into the long-term effects of buntanetap [5][6] - It will also assess patient responses when treatment is reintroduced, offering a comprehensive view of the drug's effects and durability [6] Addressing Underserved Populations - The inclusion of patients receiving DBS aims to address a gap in clinical research, as this population is often excluded due to complications in outcome assessments [8][10] - The study seeks to evaluate the interaction between buntanetap and DBS, potentially providing additional therapeutic benefits [7][10] Regulatory Advancement - The OLE study is a critical step toward a future New Drug Application (NDA) submission, helping the company meet FDA patient exposure requirements [11] - The study aims to ensure a total of approximately 1,500 treated patients, with specific targets for treatment duration and dosage [11]

Core Insights - Annovis Bio, Inc. is set to present at the 2025 Annual Meeting of the Parkinson Study Group, showcasing its advancements in therapies for neurodegenerative diseases like Alzheimer's and Parkinson's [1][5] Group 1: Presentation Highlights - The presentation will build on recent Phase 3 PD biomarker data, indicating that patients with amyloid co-pathology show significant cognitive decline, which is counteracted and reversed by the drug buntanetap [2] - A cross-study comparison of completed trials will be introduced, providing a comprehensive overview of cognitive outcomes across all tested indications, particularly highlighting the benefits for patients with amyloid pathology [3] - Findings suggest that individuals with biomarker-confirmed amyloid presence experience the greatest cognitive gains following treatment with buntanetap, validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins [3] Group 2: Company Overview - Annovis Bio is headquartered in Malvern, Pennsylvania, and focuses on developing innovative therapies aimed at improving outcomes and quality of life for patients suffering from neurodegenerative diseases [6] - The company is committed to advancing research and showcasing best practices in the field of Parkinson's disease [5]

MALVERN, Pa., Nov. 24, 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 two presentations at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place December 1-4, 2025 in San Diego, California. The presentations will highlight progress across the Alzheimer’s an ...

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 Pha ...

Small Cap Annovis Bio Inc. (NYSE:ANVS) stock is trading higher on Monday, with a session volume of 12.29 million compared to the average volume of 615.12 thousand as per data from Benzinga Pro.A late-stage clinical drug platform company focused on neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease, revealed new data demonstrating the impact of amyloid co-pathology on cognitive outcomes in Parkinson’s patients and the therapeutic efficacy of buntanetap.In the Phase 3 study in earl ...

Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical development MALVERN, Pa., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, I ...

Core Insights - Annovis Bio, Inc. is making significant progress in its pivotal Phase 3 Alzheimer's study, with all 84 clinical sites fully activated and participant recruitment ongoing [6][2] - The company has strengthened its intellectual property by transferring all patents to a new crystalline form of its drug, buntanetap, and published pharmacokinetic data supporting this transition [2][6] - Recent biomarker findings from a Phase 2/3 study indicate meaningful reductions in inflammation and neurodegeneration, suggesting the drug's potential as a disease-modifying therapy [2][6] Clinical Highlights - The pivotal Phase 3 study for early Alzheimer's disease is on track, with robust participation and a screen failure rate within expected projections [6] - The first patients have completed the 6-month treatment period, marking a key milestone for upcoming symptomatic readouts [6] - Biomarker results from the Phase 2/3 trial show significant reductions in neuroinflammation and neurodegeneration in patients treated with buntanetap compared to placebo [6] Business Highlights - The company appointed Mark Guerin as CFO, enhancing its leadership team during a critical phase [2][6] - Annovis presented four scientific posters at the AAIC 2025 conference, showcasing progress in its Alzheimer's trial and pharmacokinetics of buntanetap [6] Financial Results - As of September 30, 2025, Annovis reported cash and cash equivalents of $15.3 million, an increase from $10.6 million at the end of 2024 [6] - Research and development expenses for Q3 2025 were $6.3 million, up from $2.7 million in Q3 2024 [6] - The net loss per common share for Q3 2025 was $0.37, a decrease from $0.97 in Q3 2024 [7][15]

Core Insights - Annovis Bio, Inc. has fully activated all 84 clinical sites for its pivotal Phase 3 study in early Alzheimer's disease (AD), with patient enrollment and treatment underway [1][2] - The first group of participants has reached the 6-month treatment milestone, keeping the study on track for data readout in the second half of 2026 [1][2] - The Phase 3 trial aims to enroll a total of 760 patients with early AD and biomarker-confirmed amyloid pathology, featuring a dual design for evaluating symptomatic efficacy and potential disease-modifying response [2] Enrollment and Progress - The trial is currently 25% complete, demonstrating strong execution in patient enrollment and progression through the protocol [2][3] - The dedication of the team, site partners, and patient engagement has contributed to the momentum of the trial [3] Company Overview - Annovis is headquartered in Malvern, Pennsylvania, focusing on innovative therapies for neurodegenerative diseases such as AD and Parkinson's disease (PD) [4] - The company is committed to improving patient outcomes and quality of life through its drug development efforts [4]

Core Insights - Annovis Bio, Inc. announced new results indicating that its drug candidate, buntanetap, can reduce inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond just symptomatic relief [1][2]. Group 1: Clinical Study Results - The Phase 2/3 study analysis showed that buntanetap effectively targets key biomarkers of neuroinflammation and neurodegeneration, leading to reductions in inflammatory markers such as IL-5, IL-6, S100A12, IFN-γ, and IGF1R compared to placebo [2]. - Buntanetap also decreased levels of neurofilament light chain (NFL), a marker of neuronal damage, indicating improved cellular integrity and neuronal health, particularly in patients with positive pTau217 plasma levels [2][3]. Group 2: Mechanism and Therapeutic Potential - The drug's ability to target multiple neurotoxic proteins simultaneously is highlighted as a significant advantage, potentially interrupting the toxic cascade associated with Alzheimer's disease [3]. - Previous clinical benefits were noted in mild Alzheimer's patients, who experienced significant cognitive improvements, reinforcing the potential of buntanetap as a disease-modifying therapy [3]. Group 3: Ongoing Research and Future Outlook - Buntanetap is currently undergoing a pivotal Phase 3 trial in early Alzheimer's disease, with a 6-month readout focused on symptomatic improvement and an 18-month readout aimed at assessing disease modification [3][4]. - The full biomarker data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in December 2025, which is expected to provide further insights into the drug's efficacy [4].

Core Viewpoint - Annovis Bio, Inc. has appointed Mark Guerin as Chief Financial Officer to guide the company through a critical phase as its drug candidate, buntanetap, shows promise in late-stage clinical development for neurodegenerative diseases [1][5] Company Overview - Annovis Bio is a late-stage clinical drug platform company focused on developing transformative therapies for neurodegenerative diseases, including Alzheimer's disease and Parkinson's disease [1][6] - The company is headquartered in Malvern, Pennsylvania, and is dedicated to improving patient outcomes and quality of life through innovative therapies [6] Leadership Experience - Mark Guerin has extensive experience in financial operations within biopharma companies, having served as CFO at Onconova Therapeutics (now Traws Pharma) and facilitated critical financing transactions [2][3] - Prior to Onconova, Guerin held senior finance roles, including Vice President of Finance and CFO at Cardiokine, Inc., overseeing its New Drug Application filing and sale [3][4] Financial Strategy - During his tenure at Onconova, Guerin was instrumental in completing several financing transactions, including a $20 million financing in December 2024 [2] - His experience includes managing financial reporting, forecasting, and internal controls, which will be beneficial for Annovis as it advances its clinical programs [2][5]