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Segal Trials Contributes to Breakthrough Flu Prevention Study Led by Cidara Therapeutics

1. CD388 met all efficacy endpoints in Phase 2b NAVIGATE trial. 2. Study included over 5,000 unvaccinated adults, showing significant flu protection. 3. CD388 is a promising option for those unable to receive vaccines. 4. Cidara plans to discuss Phase 3 trial design with FDA. 5. This could redefine seasonal flu prevention strategies significantly.

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Why Bullish?

The successful trial results for CD388 could drive investor confidence, leading to price appreciation, similar to past FDA approvals for novel treatments that confirmed record efficacy rates, such as the COVID-19 vaccines which saw significant market impacts. Positive clinical trial results generally trigger a favorable response in stock prices of companies like Cidara.

How important is it?

The article discusses a successful trial of a novel antiviral (CD388) which could significantly influence Cidara's market performance and valuation. Its innovative approach to flu protection highlights the potential for broad applications, making it a topic of interest for current and potential investors.

Why Short Term?

Immediate investor interest is likely due to the successful trial results, with potential robust movement following the FDA meeting and subsequent trial phases. In the past, successful Phase 2 results have led to short-term stock surges as investors speculate on future approval.

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CIDR
MIAMI LAKES, Fla.--(BUSINESS WIRE)--Segal Trials proudly announces its participation in the successful Phase 2b NAVIGATE clinical trial conducted by Cidara Therapeutics, evaluating CD388—a novel, non-vaccine, long-acting antiviral—for the prevention of seasonal influenza. Dr. Steven Chavoustie served as the Principal Investigator for the study at Segal Trials.“We are honored to have been part of a study that marks a potential paradigm shift in how we approach flu prevention,” said Dr. Steven Chavoustie, Principal Investigator at Segal Trials.Share The NAVIGATE trial enrolled over 5,000 healthy, unvaccinated adults and met both its primary and secondary efficacy endpoints, showing that single doses of CD388 conferred 76%, 61%, and 58% protection, respectively, across three dosage levels. Participants were monitored for symptomatic, laboratory-confirmed influenza over a 24-week period. CD388 was well-tolerated at all doses with no unexpected safety signals reported. “We are honored to have been part of a study that marks a potential paradigm shift in how we approach flu prevention,” said Dr. Steven Chavoustie, Principal Investigator at Segal Trials. “A once-per-season antiviral could significantly improve access to flu protection, especially among individuals for whom vaccines may not be effective.” Unlike vaccines, CD388 does not rely on the body’s immune response, making it a promising option for those with compromised immunity or heightened risk for severe flu. This innovative approach represents a potential new standard of care for broad seasonal influenza protection. Following the trial’s success, Cidara Therapeutics has submitted an End of Phase 2 meeting request to the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 trial design. About Segal Trials Founded in 1998, Segal Trials is a privately held clinical research network with multiple sites across South Florida. Specializing in psychiatry, neurology, women’s health, and general medicine, Segal Trials is committed to advancing medical research through high-quality Phase I–IV trials while helping sponsors meet enrollment goals.

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