Annovis Announces Open-Label Extension Study for Parkinson's Disease Patients

Rhea-AI Summary

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.

Positive

• Enrollment target of 500 patients
• 36-month treatment period for long-term data
• Once-daily 30 mg standardized dosing
• OLE contributes toward ~1,500 treated patients needed for NDA exposure

Negative

• None.

Key Figures

Planned enrollment 500 patients PD open-label extension study (NCT07284784)

Treatment duration 36 months Once-daily buntanetap in OLE PD study

Buntanetap dose 30 mg once daily Final intended dose in OLE PD study

Prior treated patients more than 1,200 patients Completed or enrolled across prior studies

Total treated for NDA approximately 1,500 patients FDA exposure requirement for buntanetap NDA readiness

One-year exposure at least 100 patients Patients treated for one year at 30 mg

Six-month exposure 300–600 patients Patients treated for six months at 30 mg

OLE start date January 2026 Enrollment start for PD open-label extension

Market Reality Check

$3.65 Last Close

Volume Volume 601,379 is below the 20-day average, with relative volume at 0.39 ahead of this news. low

Technical Shares at $3.67 are trading above the 200-day MA ($2.38) but sit 34.46% below the 52-week high.

Peers on Argus 1 Up 1 Down

Peers show mixed moves, with BRNS down 4.28% and RADX up 5.83%, suggesting ANVS’s -7.89% move is more stock-specific than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 16	Corporate webinar update	Positive	+4.0%	Announced Jan 28, 2026 corporate update webinar on late-stage programs and strategy.
Dec 03	Conference presentation	Positive	+5.4%	Presented Phase 3 PD biomarker data at Parkinson Study Group meeting highlighting cognitive benefit.
Nov 24	Conference presentations	Positive	+7.9%	Announced two CTAD 2025 talks on AD Phase 3 design and PD dementia biomarker findings.
Nov 18	FDA meeting update	Positive	+11.2%	Disclosed FDA Type C meeting for PDD program and confirmed alignment on Phase 3 AD trial.
Nov 17	Phase 3 biomarker data	Positive	+29.5%	Reported PD Phase 3 data showing halted cognitive decline and tau biomarker reductions.

Pattern Detected

Recent PD/AD program updates and data presentations have generally been followed by positive price reactions, indicating sensitivity to clinical and regulatory progress.

Recent Company History

Over the last month, Annovis has repeatedly highlighted buntanetap’s late-stage development in both Parkinson’s and Alzheimer’s disease. Events on Nov 17–24, 2025 focused on Phase 3 biomarker data and cognitive benefits, as well as FDA alignment on the pivotal Phase 3 AD trial and a Type C meeting for PDD. Subsequent conference presentations and a corporate update webinar announcement on Dec 3 and Dec 16 maintained this trajectory. Today’s OLE PD study announcement extends that storyline by emphasizing long-term safety, efficacy, and NDA-readiness exposure requirements.

Market Pulse Summary

This announcement outlines a long-term open-label extension in Parkinson’s disease, adding up to 500 patients on once-daily 30 mg buntanetap over 36 months. It expands safety and efficacy exposure toward roughly 1,500 treated patients, including defined one-year and six-month cohorts to meet NDA requirements. In context of recent positive biomarker and FDA-alignment updates, investors may track actual enrollment progress, durability of cognitive and motor benefits, and how new data integrate with the pivotal Phase 3 Alzheimer’s program.

Key Terms

open-label extension medical

"announced it will begin an Open-Label Extension (OLE) study in January 2026"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

deep brain stimulation medical

"Patients receiving deep brain stimulation (DBS) treatment"

A medical procedure that implants small electrodes into specific brain areas and uses a surgically placed pulse generator to send mild electrical signals that adjust abnormal brain activity—think of it as a pacemaker for the brain. Investors care because it represents a durable medical-device market with high development and regulatory hurdles, ongoing revenue from hardware and follow-up care, and clinical results or approvals that can materially affect company value and reimbursement prospects.

biomarker medical

"Collecting biomarker data will also help us deepen our understanding"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

plasma biomarkers medical

"For both cohorts, skin and plasma biomarkers will be collected"

Plasma biomarkers are measurable molecules in the liquid part of blood that signal the presence, severity, or progression of a disease and the body’s response to treatment. Think of them as dashboard lights for health—simple readings that help doctors and drug developers know whether a therapy is working or a condition is getting worse. For investors, reliable plasma biomarkers can speed clinical trials, reduce development costs, improve regulatory chances, and clarify a drug’s market potential.

new drug application regulatory

"step toward a future New Drug Application (NDA) submission"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

pivotal phase 3 medical

"currently enrolled in the ongoing pivotal Phase 3 AD trial"

A pivotal Phase 3 is a large, final clinical trial designed to show whether a new treatment actually works and is safe enough for regulatory approval. Think of it as the product’s final exam or full dress rehearsal: positive results are the main evidence regulators use to decide if the drug can be sold, while negative or ambiguous results can halt approval and value. Investors watch these trials closely because their outcomes strongly affect a company’s future sales prospects, regulatory risk, and stock value.

clinicaltrials.gov regulatory

"study information is available on the Company’s website and on ClinicalTrials.gov"

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

disease-modifying treatment medical

"buntanetap’s potential as a disease-modifying treatment"

A disease-modifying treatment is a therapy that changes the underlying course of a chronic illness rather than only easing symptoms, like repairing a leak in a roof instead of just mopping up the water. For investors it matters because such treatments can sustain patient benefits over time, command higher prices, shift long-term healthcare costs and create lasting market advantages or risks depending on how widely and quickly they are adopted and reimbursed.

AI-generated analysis. Not financial advice.

Enrollment will begin in January 2026

Participants will be treated with buntanetap for 36 months

The study aims to enroll 500 patients

MALVERN, Pa., Dec. 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 it will begin an Open-Label Extension (OLE) study in January 2026 to evaluate the long-term safety and efficacy of buntanetap in PD patients.

“Launching the OLE study is a natural next step for our Parkinson’s program,” said Maria Maccecchini, Ph.D., President and CEO. “In our previous PD trial, many patients shared they experienced noticeable improvements and were eager to stay on treatment. Being able to offer them continued access to buntanetap truly matters to us.”

“At the same time, this study will allow us to take a longer-term view of buntanetap,” she continued. “By following patients over an extended period, we will further measure buntanetap’s safety and evaluate its sustained benefits on both motor and cognitive functions. Collecting biomarker data will also help us deepen our understanding of buntanetap’s potential as a disease-modifying treatment.”

Study overview (NCT07284784)

• Enrollment: 500 patients across multiple sites in the U.S.
• Duration: 36-month treatment period
• Treatment: Once-daily 30mg oral buntanetap
• Patient populations:
  
  
  • Cohort 1: Former participants of buntanetap clinical studies (by invitation)
  • Cohort 2: Patients receiving deep brain stimulation (DBS) treatment

Examining treatment persistence (Cohort 1)

By inviting participants from prior studies, Annovis aims to evaluate how patient outcomes evolved after discontinuing treatment, an important factor in understanding buntanetap’s potential to alter the course of disease. This approach provides insight into whether treatment effects persist over time and how symptoms progress during a treatment-free interval.

In addition, the study will allow Annovis to assess how patients respond when treatment is reintroduced. Observing both the off-treatment and return-to-treatment phases offers a more complete, longitudinal view of buntanetap’s effects and durability, helping to characterize its long-term impact across different stages of disease management.

Addressing an underserved population (Cohort 2)

In addition to former Annovis clinical trial participants, the study will also include patients who did not take part in earlier trials but have been receiving DBS for at least 12 months following successful surgery. By doing so, Annovis aims to understand how buntanetap works alongside DBS and the interaction between the two treatments.

This population is frequently excluded from clinical research, as electrical stimulation can complicate outcome assessments and make it difficult to isolate treatment effects. Through this OLE study, Annovis aims to help address this gap by offering these patients access to buntanetap, while also evaluating its safety and the potential to provide a meaningful additional benefit.

“We remain deeply committed to addressing areas of significant unmet medical need,” said Melissa Gaines, Senior VP, Clinical Operations. “Patients receiving DBS have long been underserved in clinical research, and this study represents an important opportunity to better understand how a new therapeutic option may support them.”

For both cohorts, skin and plasma biomarkers will be collected to further deepen the understanding of the course and progression of the disease.

Advancing toward NDA readiness

The OLE PD study represents an important step toward a future New Drug Application (NDA) submission by helping Annovis meet the FDA’s patient exposure requirements. With more than 1,200 patients who have completed prior studies or are currently enrolled in the ongoing pivotal Phase 3 AD trial, the addition of the OLE study will allow the Company to satisfy all required criteria: a total of ~1,500 treated patients, at least 100 patients treated for one year, and 300-600 patients treated for six months at the final intended dose of 30 mg. By closing this gap, the OLE study reinforces the Company’s readiness and ensures Annovis is fully prepared to advance buntanetap toward an NDA submission.

Participation information

Comprehensive study information is available on the Company’s website and on ClinicalTrials.gov. For more questions, patients are encouraged to contact clinicaltrials@annovisbio.com.

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

When does Annovis start the Parkinson's OLE study (ANVS)?

Enrollment begins in January 2026.

How many patients will Annovis enroll in the OLE study (ANVS)?

The study aims to enroll 500 patients across multiple U.S. sites.

What is the buntanetap dosing and treatment duration in the ANVS OLE?

Participants receive once-daily 30 mg buntanetap for a 36-month treatment period.

Which patient groups are eligible for the Annovis OLE study (ANVS)?

Cohort 1: invited former buntanetap trial participants; Cohort 2: patients with deep brain stimulation for at least 12 months.

How does the OLE study support Annovis's NDA readiness (ANVS)?

The OLE adds patient exposure to meet targets of ~1,500 treated patients, ≥100 patients treated one year, and 300–600 patients treated six months at 30 mg.