FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
Annovis Bio, Inc. (ANVS)
Company Research
Source: GlobeNewswire
MALVERN, Pa., Oct. 15, 2024 (GLOBE NEWSWIRE) -- via IBN – Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), announced today the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy. The Phase 3 program will investigate buntanetap in patients with early AD and will consist of two trials: a 6-month study aimed at confirming buntanetap’s symptomatic effects and an 18-month stud
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ANVS
News
- Annovis CEO Showcases Groundbreaking Advances in Neurodegenerative Disease Treatment on Today's Marketplace [Yahoo! Finance]Yahoo! Finance
- Annovis CEO Showcases Groundbreaking Advances in Neurodegenerative Disease Treatment on Today’s MarketplaceGlobeNewswire
- /C O R R E C T I O N -- Today's Marketplace/PR Newswire
- Annovis to Host Year-End Investor Webcast on December 11, 2024 [Yahoo! Finance]Yahoo! Finance
- Annovis to Host Year-End Investor Webcast on December 11, 2024GlobeNewswire
ANVS
Earnings
- 11/11/24 - Beat
ANVS
Sec Filings
- 12/11/24 - Form 8-K
- 12/11/24 - Form 8-K
- 12/11/24 - Form 424B5
- ANVS's page on the SEC website