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MALVERN, Pa. - Annovis Bio Inc. (NYSE: ANVS), a clinical-stage drug platform company with a market capitalization of $74 million focused on neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted an updated protocol for its pivotal Phase 3 Alzheimer's disease (AD) study. The study, which will assess the efficacy of the drug buntanetap, is set to commence this month. According to InvestingPro data, the company's stock has experienced significant volatility, declining over 50% in the past six months.
The FDA's acceptance follows the agency's clearance in October 2024 for Annovis to proceed with Phase 3 AD studies based on promising Phase 2/3 data, which showed cognitive improvement in early-stage AD patients. The revised protocol combines what were initially two separate trials—a 6-month symptomatic study and an 18-month disease-modifying study—into a single trial with a 6-month data readout for symptomatic effects and a subsequent 12-month evaluation for disease modification. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 2.66, indicating sufficient resources to fund its clinical programs.
Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, expressed the company's enthusiasm for the integrated trial approach, which aims to streamline the development process while ensuring scientific integrity. The 6-month symptomatic data could potentially support a New Drug Application (NDA) filing, while the study continues to investigate long-term disease-modifying outcomes.
Annovis Bio, headquartered in Malvern, Pennsylvania, is committed to tackling neurodegeneration in diseases such as AD and Parkinson's disease (PD). The company's approach targets multiple neurotoxic proteins with the goal of restoring brain function and improving patient quality of life.
The FDA's acceptance of the updated protocol is based on information from the company's press release statement. It should be noted that forward-looking statements are subject to various risks and uncertainties, and there can be no assurance that the anticipated results will be achieved. Annovis Bio's progress in the development of buntanetap will continue to be closely monitored by investors and stakeholders in the biopharmaceutical sector. Analyst targets for the stock range from $21 to $72, reflecting diverse views on the company's potential. Get deeper insights into Annovis Bio's financial health and access 8 additional exclusive ProTips with InvestingPro.
In other recent news, Annovis Bio has been making significant strides in its clinical trials and corporate leadership. The U.S. Food and Drug Administration (FDA) has approved the company's updated protocol for its pivotal Phase 3 Alzheimer's disease study. The updated trial integrates two previously separate studies, aiming to streamline the development process for Annovis Bio's investigational drug, buntanetap.
The company also recently appointed William Fricker as its interim Chief Financial Officer. Fricker brings extensive experience in the finance sector, particularly within the biotech industry, to the role.
In addition, Annovis Bio's lead drug candidate, buntanetap, has received clearance to advance into Phase 3 trials for the treatment of Alzheimer's disease. The decision was based on Phase 2/3 data showing symptomatic improvement in patients with early Alzheimer's.
Furthermore, analyst firms Canaccord Genuity, EF Hutton, and H.C. Wainwright have all maintained a Buy rating on the company, with price targets ranging from $21 to $30. These are recent developments in Annovis Bio's ongoing operations, and the company's current cash reserves are adequate to fund operations through the anticipated meetings with the FDA and until the start of two pivotal studies.
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