Annovis Bio
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2008-01-01
- Employees
- 6
- Market Cap
- $119.1M
- Website
- http://www.annovisbio.com
- Introduction
Annovis Bio, Inc. is a clinical stage drug platform company, which engages in the development of drugs which aim to treat neurodegenerative diseases such as Alzheimer's (AD) and Parkinson's (PD). Its lead product candidate, Buntanetap, is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Its product pipeline also includes ANVS405 and ANVS301, which focus on the treatment of traumatic brain injury, stroke, and advanced AD. The company was founded by Maria Luisa Maccecchini in May 2008 and is headquartered in Malvern, PA.
FDA accepts Annovis' updated protocol for drug study
The FDA approved Annovis Bio's updated Phase 3 Alzheimer’s study protocol, combining two trials into one 6/18-month study to assess buntanetap's symptomatic and disease-modifying effects, aiming to expedite development and potential new drug application filing.
FDA accepts updated protocol for Annovis' phase 3 Alzheimer's disease study
The FDA approved Annovis Bio's updated protocol for a combined six/18-month Alzheimer’s disease study, aiming to assess buntanetap's symptomatic and disease-modifying effects. Buntanetap, targeting neurodegeneration, showed promise in improving cognitive function in early AD patients, potentially supporting a new drug application.
FDA Accepts Amended Protocol for Phase 3 Trial of Buntanetap in Alzheimer Disease
FDA accepted Annovis Bio's updated phase 3 AD study protocol for buntanetap, targeting neurodegeneration by inhibiting neurotoxic proteins. Phase 2/3 results showed cognitive improvements in AD patients, with the highest dose (30 mg) significantly outperforming placebo. Buntanetap also showed promise in Parkinson's disease, improving motor function and slowing cognitive decline.
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer's Study
Annovis Bio Inc. announced FDA acceptance of an updated protocol for its Phase 3 Alzheimer’s disease study, integrating a 6-month symptomatic and 18-month disease-modifying trial into one. This aims to accelerate development and potentially support a New Drug Application with 6-month data, while assessing long-term outcomes.
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway
Annovis Bio Inc. announced FDA acceptance of an updated protocol for its Phase 3 Alzheimer’s disease study, integrating a 6-month symptomatic and 18-month disease-modifying trial into one. This aims to accelerate buntanetap's development, potentially supporting an NDA filing with early data while assessing long-term outcomes.
Annovis Bio announces FDA acceptance of protocol for Phase 3 AD study
Annovis Bio's FDA-approved Phase 3 Alzheimer’s study, starting January 2025, combines a 6-month symptomatic and 18-month disease-modifying trial into one, with buntanetap's effects evaluated at 6 and 18 months.
FDA approves Annovis Bio's updated Alzheimer's trial protocol for Phase 3 study
Annovis Bio Inc. announced FDA acceptance of its updated Phase 3 Alzheimer's study protocol, integrating two trials into one for efficiency. The study, starting January, aims for a 6-month symptomatic and 18-month disease-modifying assessment. CEO Maria Maccecchini is optimistic about accelerating NDA filing. Despite a 52% stock decline, the company has a strong balance sheet.
Annovis Bio, Inc. Announces FDA Accepts Final Protocol for Pivotal Phase 3 AD Study
Annovis Bio, Inc. announced FDA acceptance of an updated protocol for a pivotal Phase 3 AD study, integrating a 6-month symptomatic and an 18-month disease-modifying study into a single trial, starting January 2025, with buntanetap's potential evaluated over 18 months.
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