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 Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies
Annovis Bio Inc. announced FDA clearance for Phase 3 studies of buntanetap for Alzheimer’s disease, following successful End-of-Phase 2 meeting. The Phase 3 program includes two trials to assess symptomatic and disease-modifying effects. Annovis aims for an expedited NDA submission, with trial initiation planned for early next year.
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FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer's Study
Annovis Bio Inc. announced FDA clearance for Phase 3 studies of buntanetap for Alzheimer’s disease, following a successful End-of-Phase 2 meeting. The Phase 3 program includes two trials to assess symptomatic and disease-modifying effects. The company aims for an expedited NDA submission, with trial initiation planned for early next year.
Annovis Bio, Inc. Latest Stock News & Market Updates
Annovis Bio (ANVS) is a clinical-stage pharmaceutical company developing therapies for neurodegenerative diseases like Alzheimer’s and Parkinson’s. Their lead compound, Buntanetap, targets multiple neurotoxic proteins and is in phase II/III trials. Recent achievements include a successful Phase II/III study and a patent application for Buntanetap in neuropsychiatric conditions. The company ended Q1 2024 with $3.1 million in cash.
Annovis Bio Inc. (NYSE: ANVS) Research Points to Potential Future Breakthroughs in AD
Annovis Bio Inc. (NYSE: ANVS) announces promising early research results for its lead drug, buntanetap, in combination with other approved Alzheimer's disease (AD) drugs, aiming to improve cognition, unlike current treatments like Leqembi and Kisunla that only slow decline. This positions Annovis Bio as a notable player in transforming AD treatment.
Annovis stock swells after Phase III Parkinson's subgroup shows improved cognition
Annovis Bio's share price surged 100% after positive Phase III trial results for buntanetap in Parkinson's disease, showing improved cognition. The trial involved 523 patients, with significant improvements in MDS-UPDRS scores for those diagnosed over three years ago and with PIGD. Despite a setback in Alzheimer's trial, Annovis plans a Phase III trial.
Vertex Begins Rolling NDA Filing for Acute Pain Drug
Vertex Pharmaceuticals announced FDA's rolling NDA submission for suzetrigine (VX-548) in moderate-to-severe acute pain, aiming for completion by Q2 2024. Supported by phase III results, suzetrigine showed significant pain reduction. Also, Vertex is advancing suzetrigine for neuropathic pain, with phase III DPN studies planned for H2 2024.
Biotech Stock Roundup: ALDX, EVLO Down on Setback, SRRK Offers Updates
Aldeyra's shares fell after FDA identified issues with its NDA for reproxalap, requiring additional studies. Annovis Bio's Alzheimer’s study on buntanetap showed positive interim results. Scholar Rock plans to expand into cardiometabolic disorders with SRK-439. Evelo's psoriasis study failed, halting EDP2939 development. Amylyx faces EU setback for ALS treatment AMX0035, focusing on phase III study results.
FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study
Annovis Bio Inc. announced FDA acceptance of an updated protocol for its pivotal 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.
Annovis Bio Announces Positive FDA Notice For Phase 3 Clinical Study of Buntanetap for Parkinson's Disease
Annovis Bio received FDA approval to proceed with a Phase 3 clinical study of buntanetap for Parkinson's disease, following a successful Type B meeting. The FDA accepted the study's protocol and development plan, allowing longer duration trials. Buntanetap, targeting neurodegenerative diseases, showed significant improvements in Phase 2a trials for Parkinson's and Alzheimer's patients.
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