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Investing.com -- Cidara Therapeutics Inc (NASDAQ:CDTX) stock surged 13.7% following the company’s announcement of updates to its planned Phase 3 registrational trial for CD388 after an End-of-Phase 2 meeting with the FDA.
The biotechnology company revealed that based on FDA feedback, it will expand its study population to include adults over 65 years of age with no specific co-morbidities, in addition to subjects over 12 years of age with high-risk comorbidities or immune compromised status. This expansion substantially increases the initial number of patients potentially eligible to receive CD388 from approximately 50 million to well over 100 million people in the U.S.
Cidara also announced an accelerated timeline for the Phase 3 trial, with enrollment now expected to begin by the end of September 2025 in the Northern Hemisphere, six months earlier than previously planned. The company intends to enroll 6,000 subjects in the global, multicenter, randomized, double-blind, placebo-controlled study.
"The FDA’s input on our Phase 3 study design was invaluable and we welcome the opportunity to expand the trial to include adults over 65 years of age who are among the most vulnerable to serious complications from influenza," said Jeffrey Stein, President and CEO of Cidara.
The study will evaluate a single 450-milligram dose of CD388 administered via subcutaneous injection at the beginning of the flu season, with a primary endpoint based on laboratory-confirmed influenza with specific temperature and symptom criteria.
Cidara believes its planned Phase 3 development program will be fully funded through completion following its successful financing earlier this summer.
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