Annovis schedules FDA meeting to review PDD program
FDA Meeting Scheduled: Annovis Bio has announced a Type C meeting with the FDA set for January 2026 to discuss its pathway for treating Parkinson's disease dementia (PDD).
Ongoing Clinical Trial: The company confirmed that its Phase 3 clinical trial for Alzheimer's disease (AD) is progressing well, with full regulatory alignment on study design, endpoints, and patient population.
Trade with 70% Backtested Accuracy
Analyst Views on ANVS
About ANVS
About the author
Healthcare Stocks with Strong Earnings Momentum Earn A+ EPS Revision Grades
- Investor Attention: As the earnings season unfolds, mid to low market capitalization healthcare stocks are drawing investor attention due to their strong earnings momentum, indicating growing market confidence in this sector.
- Analyst Expectations: The EPS Revision Grade reflects the trend in analyst earnings estimates, with A+ ratings indicating optimistic projections for future performance, potentially driving stock prices higher.
- List of A+ Rated Stocks: Currently, companies such as Aldeyra Therapeutics, Altimmune, Annovis Bio, and Assertio Holdings have received A+ EPS Revision Grades, showcasing their strong performance in the eyes of analysts.
- Market Strategy Impact: These A+ rated healthcare stocks are likely to attract more investor interest, potentially triggering positive sentiment towards the healthcare sector as a whole, thereby enhancing the performance of related ETFs.
Annovis to Conduct 36-Month Extension Study for Further Assessment of Buntanetap in Parkinson's Disease
Long-term Study Launch: Annovis Bio, Inc. is set to begin a long-term open-label extension study in January 2026 to evaluate the effects of Buntanetap on Parkinson's disease patients over three years, aiming to enroll 500 participants across multiple U.S. sites.
Cohorts and Objectives: The study will include two cohorts: former participants from earlier studies and patients receiving deep brain stimulation, focusing on the long-term safety, efficacy, and potential disease-modifying properties of Buntanetap.
Regulatory Preparation: This extension study is part of Annovis' strategy to support a future New Drug Application, as it aims to meet FDA requirements for total patient numbers and treatment duration, building on previous studies involving over 1,200 patients.
Market Performance: Annovis' stock has fluctuated between $1.11 and $5.60 over the past year, closing at $3.67 and rising to $3.79 in overnight trading, reflecting investor interest in the company's developments in Parkinson's disease treatment.
Annovis Initiates 36-Month Study for Parkinson's Drug Buntanetap
- Study Launch: Annovis Bio announced the initiation of a 36-month Open-Label Extension study starting January 2026, aiming to enroll 500 Parkinson's patients to evaluate the long-term safety and efficacy of the drug buntanetap, thereby providing continued treatment access for patients.
- Patient Populations: The study will include former clinical trial participants and patients receiving deep brain stimulation, aiming to assess the effects of buntanetap in different treatment contexts, addressing a significant gap in clinical research for underserved populations.
- Biomarker Collection: Throughout the study, skin and plasma biomarkers will be collected to deepen the understanding of disease progression and treatment effects, aiding the company in comprehending buntanetap's potential as a disease-modifying therapy.
- NDA Readiness: This study will assist Annovis in meeting FDA patient exposure requirements, with total patient participation expected to reach approximately 1,500, ensuring the company is well-prepared for future New Drug Application submissions.
Annovis Bio to Host Webinar on Clinical Progress and Future Directions
- Webinar Announcement: Annovis Bio will host a corporate update webinar on January 28, 2026, featuring CEO Maria Maccecchini, who will discuss recent progress and ongoing clinical programs, likely attracting significant interest from investors and patients.
- Clinical Progress Momentum: The company has made notable advancements in treating neurodegenerative diseases, driving strong market momentum, with additional milestones expected in early 2026, which will further bolster investor confidence.
- Interactive Engagement Opportunity: The webinar will include a live Q&A session, encouraging participants to submit questions in advance, aimed at enhancing direct dialogue with the community and increasing transparency and trust.
- Mission Reaffirmation: Annovis Bio is dedicated to developing innovative therapies that improve the quality of life for patients with Alzheimer's and Parkinson's diseases, underscoring its long-term commitment in the neurodegeneration space.
Insider Buying Update for Friday, December 12: ANVS, ECL
Annovis Bio Insider Purchase: Director Michael B. Hoffman bought 45,000 shares of ANVS at $4.31 each, totaling $193,794, while the stock is currently trading lower at $3.70, 14.1% below his purchase price.
Ecolab Insider Purchase: David Maclennan purchased 750 shares of Ecolab for $257.60 each, amounting to $193,198, and has previously invested $398,786 in ECL at an average price of $265.86 per share.
Stock Performance: Annovis Bio's stock is up about 6.9% on Friday, while Ecolab is trading up approximately 0.5%, with Maclennan seeing a 2.5% gain at the peak of the trading session.
Disclaimer: The views expressed in the report are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
Annovis Bio Presents Parkinson's Disease Therapy Data at PSG Annual Meeting
- Clinical Data Presentation: Annovis Bio will present Phase 3 data at the 2025 Parkinson Study Group Annual Meeting, revealing that patients with amyloid co-pathology experience more pronounced cognitive decline, which is effectively countered by buntanetap, indicating its potential in treating Parkinson's disease.
- Biomarker Improvement: The study shows that buntanetap not only reverses cognitive decline but also reduces tau biomarkers associated with disease severity, further validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins.
- Cross-Study Comparison: The presentation will debut a cross-study comparison of completed trials, providing a comprehensive analysis of cognitive outcomes across all tested indications by Annovis, highlighting that patients with amyloid pathology benefit the most from the treatment.
- Support for Strategic Steps: These findings support Annovis's next strategic steps, reinforcing its leadership position in neurodegenerative disease treatment and are expected to drive future R&D investments and market expansion.
Healthcare Stocks with Strong Earnings Momentum Earn A+ EPS Revision Grades
- Investor Attention: As the earnings season unfolds, mid to low market capitalization healthcare stocks are drawing investor attention due to their strong earnings momentum, indicating growing market confidence in this sector.
- Analyst Expectations: The EPS Revision Grade reflects the trend in analyst earnings estimates, with A+ ratings indicating optimistic projections for future performance, potentially driving stock prices higher.
- List of A+ Rated Stocks: Currently, companies such as Aldeyra Therapeutics, Altimmune, Annovis Bio, and Assertio Holdings have received A+ EPS Revision Grades, showcasing their strong performance in the eyes of analysts.
- Market Strategy Impact: These A+ rated healthcare stocks are likely to attract more investor interest, potentially triggering positive sentiment towards the healthcare sector as a whole, thereby enhancing the performance of related ETFs.
Annovis to Conduct 36-Month Extension Study for Further Assessment of Buntanetap in Parkinson's Disease
Long-term Study Launch: Annovis Bio, Inc. is set to begin a long-term open-label extension study in January 2026 to evaluate the effects of Buntanetap on Parkinson's disease patients over three years, aiming to enroll 500 participants across multiple U.S. sites.
Cohorts and Objectives: The study will include two cohorts: former participants from earlier studies and patients receiving deep brain stimulation, focusing on the long-term safety, efficacy, and potential disease-modifying properties of Buntanetap.
Regulatory Preparation: This extension study is part of Annovis' strategy to support a future New Drug Application, as it aims to meet FDA requirements for total patient numbers and treatment duration, building on previous studies involving over 1,200 patients.
Market Performance: Annovis' stock has fluctuated between $1.11 and $5.60 over the past year, closing at $3.67 and rising to $3.79 in overnight trading, reflecting investor interest in the company's developments in Parkinson's disease treatment.
Annovis Initiates 36-Month Study for Parkinson's Drug Buntanetap
- Study Launch: Annovis Bio announced the initiation of a 36-month Open-Label Extension study starting January 2026, aiming to enroll 500 Parkinson's patients to evaluate the long-term safety and efficacy of the drug buntanetap, thereby providing continued treatment access for patients.
- Patient Populations: The study will include former clinical trial participants and patients receiving deep brain stimulation, aiming to assess the effects of buntanetap in different treatment contexts, addressing a significant gap in clinical research for underserved populations.
- Biomarker Collection: Throughout the study, skin and plasma biomarkers will be collected to deepen the understanding of disease progression and treatment effects, aiding the company in comprehending buntanetap's potential as a disease-modifying therapy.
- NDA Readiness: This study will assist Annovis in meeting FDA patient exposure requirements, with total patient participation expected to reach approximately 1,500, ensuring the company is well-prepared for future New Drug Application submissions.
Annovis Bio to Host Webinar on Clinical Progress and Future Directions
- Webinar Announcement: Annovis Bio will host a corporate update webinar on January 28, 2026, featuring CEO Maria Maccecchini, who will discuss recent progress and ongoing clinical programs, likely attracting significant interest from investors and patients.
- Clinical Progress Momentum: The company has made notable advancements in treating neurodegenerative diseases, driving strong market momentum, with additional milestones expected in early 2026, which will further bolster investor confidence.
- Interactive Engagement Opportunity: The webinar will include a live Q&A session, encouraging participants to submit questions in advance, aimed at enhancing direct dialogue with the community and increasing transparency and trust.
- Mission Reaffirmation: Annovis Bio is dedicated to developing innovative therapies that improve the quality of life for patients with Alzheimer's and Parkinson's diseases, underscoring its long-term commitment in the neurodegeneration space.
Insider Buying Update for Friday, December 12: ANVS, ECL
Annovis Bio Insider Purchase: Director Michael B. Hoffman bought 45,000 shares of ANVS at $4.31 each, totaling $193,794, while the stock is currently trading lower at $3.70, 14.1% below his purchase price.
Ecolab Insider Purchase: David Maclennan purchased 750 shares of Ecolab for $257.60 each, amounting to $193,198, and has previously invested $398,786 in ECL at an average price of $265.86 per share.
Stock Performance: Annovis Bio's stock is up about 6.9% on Friday, while Ecolab is trading up approximately 0.5%, with Maclennan seeing a 2.5% gain at the peak of the trading session.
Disclaimer: The views expressed in the report are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
Annovis Bio Presents Parkinson's Disease Therapy Data at PSG Annual Meeting
- Clinical Data Presentation: Annovis Bio will present Phase 3 data at the 2025 Parkinson Study Group Annual Meeting, revealing that patients with amyloid co-pathology experience more pronounced cognitive decline, which is effectively countered by buntanetap, indicating its potential in treating Parkinson's disease.
- Biomarker Improvement: The study shows that buntanetap not only reverses cognitive decline but also reduces tau biomarkers associated with disease severity, further validating the drug's mechanism as a translational inhibitor of neurotoxic aggregating proteins.
- Cross-Study Comparison: The presentation will debut a cross-study comparison of completed trials, providing a comprehensive analysis of cognitive outcomes across all tested indications by Annovis, highlighting that patients with amyloid pathology benefit the most from the treatment.
- Support for Strategic Steps: These findings support Annovis's next strategic steps, reinforcing its leadership position in neurodegenerative disease treatment and are expected to drive future R&D investments and market expansion.
