Medicus Pharma

MDCX

Market cap $17.2M

Medicus Pharma (NASDAQ:MDCX) announced it has put its chief medical officer in charge of UK subsidiary Antev Limited, consolidating leadership of the Teverelix clinical programme ahead of regulatory, late-stage development and partnering work. Dr Faisal Mehmud will become Antev's chief executive on August 30, while retaining his positions as Medicus chief medical officer and co-chairman of the subsidiary.

Dr. Mehmud's appointment further aligns the scientific, clinical, regulatory and operational leadership of Antev Dr. Mehmud's appointment further aligns the scientific, clinical, regulatory and operational leadership of Antev

Medicus Pharma (NASDAQ:MDCX) earlier this week announced that the US Food and Drug Administration (FDA) has cleared the company's Phase 2b registration-enabling clinical trial for SkinJect in patients with Gorlin syndrome, representing an important regulatory milestone for its lead investigational asset. Speaking with Proactive, CEO Raza Bokhari said the FDA had approved the company's proposed study following discussions and feedback, allowing Medicus Pharma (NASDAQ:MDCX) to move ahead with a crossover registration study involving up to 50 patients.

Medicus Pharma (NASDAQ:MDCX) announced that the United Arab Emirates Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) authorization for its Phase 2a PRECISION-E2 clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis. The authorization follows the DOH's review of the company's chemistry, manufacturing and controls, non-clinical, clinical and safety documentation.

Randomized Phase 2a PRECISION-E2 study designed to evaluate a predefined panel of genes to advance personalized medicine in women's health Randomized Phase 2a PRECISION-E2 study designed to evaluate a predefined panel of genes to advance personalized medicine in women's health

Medicus Pharma (NASDAQ:MDCX) said the US Food and Drug Administration (FDA) has issued a "Study May Proceed" letter authorizing the company to begin its NDA-enabling Phase 2b registrational study of SkinJect in patients with Gorlin syndrome who develop multiple basal cell carcinomas. The authorization follows the FDA's review of the company's investigational new drug (IND) application for the SKNJCT-005 study and Medicus' response to information requests issued by the agency in June.

SKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up SKNJCT-005 registrational clinical study protocol strengthened through planned implementation of FDA recommendations, including combined clinical and histological clearance endpoints and extended patient follow-up

Medicus Pharma (NASDAQ:MDCX) earlier this week provided an update on its redesigned clinical study for Teverelix, reporting that the revised protocol had received Institutional Review Board approval and had been accepted by the US Food and Drug Administration subject to operational observations. CEO Raza Bokhari told Proactive that the company had acquired the Teverelix development programme through its purchase of UK-based Antev.

Medicus Pharma (NASDAQ:MDCX) said it has received US FDA feedback and central Institutional Review Board approval for its optimized Phase 2 study of Teverelix in men following a first episode of acute urinary retention. The redesigned study, designated ANT-2111-02, is expected to enroll approximately 126 patients across the United States and Europe, down from roughly 390 patients contemplated under the company's previously disclosed development plan.

Regulatory and ethical-review milestones advance a capital-efficient Phase 2 study expected to enroll ~126 patients versus ~390 under the previously disclosed development plan Regulatory and ethical-review milestones advance a capital-efficient Phase 2 study expected to enroll ~126 patients versus ~390 under the previously disclosed development plan