Medicus Pharma submits Teverelix Phase 2b/3 registrational protocol to FDA
Medicus said it submitted an optimized seamless Phase 2b/3 registration-intent protocol to the FDA for Teverelix in advanced prostate cancer. The design starts with about 80 randomized patients and expands to about 608 if continuation criteria are met, targeting a registrational pathway in patients at increased cardiovascular risk and aiming to cut prior plans of about 1,500 patients. Medicus plans to seek a partner to fund execution, pending FDA feedback.
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11:37:14 AM UTC
SquawkNews
Sept 29 (Reuters) — Medicus Pharma Ltd: Medicus Pharma Submits Optimized Teverelix® Registrational Protocol To Fda To Create Partner Ready Program In Advanced Prostate Cancer Medicus Pharma - Anticipates Gmp Manufacturing And Study Readiness Completion Before Year-end 2026 Medicus Pharma - Intends To Seek Strategic Partner Or Out-license Teverelix Apc Program Source text:... Further company coverage: MDCX.O (Reuters.Briefs@thomsonreuters.com;;)