MALVERN, Pa. - Annovis Bio Inc. (NYSE: ANVS), a clinical-stage drug platform company focused on neurodegenerative diseases with a market capitalization of $74 million, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's updated protocol for its pivotal Phase 3 Alzheimer's disease (AD) study. The trial is set to begin this January. According to InvestingPro data, analysts maintain a bullish outlook with price targets ranging from $21 to $72.
The updated protocol integrates two previously separate trials into a single study, with a 6-month readout for symptomatic effects and an 18-month assessment for disease-modifying outcomes. This change is expected to streamline the development process for Annovis Bio's investigational drug, buntanetap, while still adhering to scientific standards. InvestingPro analysis reveals the company maintains strong liquidity with a current ratio of 2.66, though it remains unprofitable with significant R&D investments. Get access to 8 more exclusive InvestingPro Tips to better understand ANVS's financial health.
Annovis Bio's CEO, Maria Maccecchini, Ph.D., expressed optimism about the revised protocol's potential to accelerate the path toward a New Drug Application (NDA) filing. The company aims to leverage short-term data to support the NDA while simultaneously evaluating long-term effects within the same study.
The decision by the FDA follows clearance granted in October 2024, allowing Annovis to proceed with Phase 3 AD studies based on Phase 2/3 data that showed cognitive improvement in early-stage AD patients. The integrated trial design is intended to expedite the development of buntanetap, which targets multiple neurotoxic proteins in an effort to restore brain function for patients with AD.
Based in Malvern, Pennsylvania, Annovis Bio is committed to addressing neurodegeneration in diseases such as Alzheimer's and Parkinson's. While the stock has experienced a 52% decline over the past six months, trading near $5.35, the company maintains a solid balance sheet with cash exceeding debt. The company has encouraged interested investors and shareholders to sign up for press releases and updates via their website.
The press release also contained forward-looking statements, which involve risks and uncertainties that could cause actual results to differ from those projected. These statements are based on current expectations and assumptions, and the company cautions that future events could alter their plans.
This news is based on a press release statement from Annovis Bio Inc.
In other recent news, Annovis Bio, Inc. has announced significant developments. The pharmaceutical company recently appointed William Fricker as its interim Chief Financial Officer, a move that leverages Mr. Fricker's extensive background in the finance and biotech industries. Furthermore, Annovis Bio has filed three new patents for combination therapies using its lead compound, buntanetap, targeted at neurodegenerative diseases such as Alzheimer's and Parkinson's.
These therapies, combined with Trulicity or Viagra, have shown promise in early clinical trials and are set to advance to Phase 3 human trials. Additionally, the company's buntanetap has received clearance to advance into Phase 3 trials for the treatment of Alzheimer's disease, following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration. The decision was based on Phase 2/3 data that demonstrated symptomatic improvement in patients with early Alzheimer's.
In terms of financial development, Annovis Bio generated $7 million from the exercise of approximately 0.8 million warrants, marking a significant cash influx. Analyst firms Canaccord Genuity, EF Hutton, and H.C. Wainwright have maintained a Buy rating on the company, reflecting their continued confidence in Annovis Bio's prospects. These are some of the recent developments in the company's ongoing operations.
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