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Annovis Bio (ANVS) Stock Surges 38% in a Month: Here's Why

Annovis Bio ANVS is a clinical-stage drug platform company addressing neurodegenerative diseases, such as Alzheimer’s Disease (AD) and Parkinson’s Disease (PD).

The company’s lead product candidate is buntanetap (formerly ANVS402 or posiphen), an investigational, oral translational inhibitor of neurotoxic aggregating proteins. This mode of action is expected to lead to a lower level of neurotoxic proteins and, consequently, less toxicity in the brain.

Currently, buntanetap is being evaluated in a late-stage study in early PD patients. The drug is also being evaluated in a phase II/III study in mild-to-moderate AD patients.

Since last month, shares of Annovis Bio have soared 37.8% compared to the industry’s 0.2% rise.

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Zacks Investment Research


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This upside came after management reported that it exceeded complete enrolment in the phase II/III study evaluating the efficacy, safety, and tolerability of buntanetap in AD indication over a 12-week treatment period. This study, designed by Annovis to enroll 320 patients, has screened more than 700 patients and enrolled a total of 353 patients.

The study is designed to assess cognition and activities of daily living in AD patients receiving either three doses of buntanetap (7.5mg, 15mg or 30mg) or a placebo on top of their standard of care for 12 weeks. This will be measured by changesfrom baseline to the end of treatment in AD Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and AD Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC), the co-primary endpoints of the study.

Annovis expects to report data from this study by the end of March 2024.

Per management, unlike other AD drugs — which target only one neurotoxin protein and only have a minor effect — buntanetap is designed to reduce levels of multiple neurotoxic proteins, namely amyloid beta, tau, alpha-synuclein and TDP43. By attacking multiple neurotoxic proteins, the Annovis Bio drug is likely to demonstrate the ability to reverse the destructive effects that a neurodegenerative disease like AD has on thinking and memory.

Apart from AD, management also intends to report data from the phase III study in PD patients by next month. Annovis intends to submit regulatory filings to the FDA for buntanetap in AD and PD indications by 2026-end.

The AD target market is highly competitive as several other pharma companies like Biogen BIIB and Eli Lilly LLY have their drugs targeting the AD indication. The AD drugs of these companies have either recently been approved for use or are under regulatory review development.

This July, the FDA granted full approval to Biogen’s AD drug Leqembi (lecanemab). Following approval, the Biogen drug is the first and only approved anti-amyloid antibody treatment shown to reduce the rate of disease progression and slow cognitive impairment in the early and mild dementia stages of AD indication. Since Biogen’s Leqembi received full/standard approval from the FDA, it is eligible for broader Medicare coverage. Such coverage is crucial for a wider rollout of treatment.

Eli Lilly developed donanemab, its antibody therapy for AD. In June, Lilly reported positive data from the phase III TRAILBLAZER-ALZ 2 study that showed that treatment with donanemab significantly slowed cognitive and functional decline in people with early symptomatic AD. Based on this result, Eli Lilly has submitted regulatory applications with the FDA and EMA for the drug to treat AD. A final decision in the United States is expected in first-quarter 2024.

The successful development of the above AD drugs raised investors’ hopes for other companies with AD candidates in their pipeline.

With no marketed drugs in its portfolio, Annovis is entirely dependent on the successful development of buntanetap. Management is also evaluating a subcutaneous formulation of the candidate in preclinical studies for traumatic brain injury and stroke. Any pipeline/regulatory setbacks in buntanetap development will mar Annovis’ growth prospects. Apart from buntanetap, the company is evaluating ANVS301 in an early-stage study to treat advanced AD.

Annovis Bio, Inc. Price

 

Annovis Bio, Inc. Price
Annovis Bio, Inc. Price

Annovis Bio, Inc. price | Annovis Bio, Inc. Quote

 

Zacks Rank & A Key Pick

Annovis Bio currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is CytomX Therapeutics CTMX, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 13.1% in the year-to-date period.

CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.

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Biogen Inc. (BIIB) : Free Stock Analysis Report

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Annovis Bio, Inc. (ANVS) : Free Stock Analysis Report

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