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Medicus Pharma gets FDA clearance to start Gorlin Syndrome study

Mon, 27 Jul 2026 08:17:53 -0400

Medicus Pharma Ltd. (NASDAQ: MDCX) announced that the U.S. Food and Drug Administration has issued a "Study May Proceed" letter for the company's SKNJCT-005 registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome who present with multiple basal cell carcinomas.

The FDA completed its safety review of the company's Investigational New Drug application and issued the letter on July 23, 2026, following Medicus' submission of the SKNJCT-005 protocol and its response to the agency's June 18, 2026, information requests.

The Phase 2b open-label, multicenter study is designed to enroll up to 50 patients and is intended

Medicus Pharma gets FDA clearance to start Gorlin Syndrome study

Mon, 27 Jul 2026 08:17:53 -0400

The Phase 2b open-label, multicenter study is designed to enroll up to 50 patients and is intended

Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

Mon, 27 Jul 2026 08:17:00 -0400

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

PHILADELPHIA, July 27, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its safety review of the Company's Investigational New Drug ("IND") application for SKNJCT-005 and issued a "Study May Proceed" letter authorizing the initiation of the Company's NDA-enabling registrational Phase 2b clinical

Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

Mon, 27 Jul 2026 08:17:00 -0400

Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

Mon, 27 Jul 2026 08:17:00 -0400

Medicus Pharma Receives FDA “Study May Proceed” Letter for NDA-Enabling Registrational SkinJect® Study in Patients with Gorlin Syndrome

Mon, 27 Jul 2026 08:17:00 -0400

Medicus Pharma gets FDA feedback and IRB nod for smaller Phase 2 trial

Thu, 16 Jul 2026 07:30:14 -0400

Medicus Pharma Ltd. (NASDAQ: MDCX) said it received written feedback from the U.S. Food and Drug Administration and central Institutional Review Board approval for a redesigned Phase 2 clinical study of its drug Teverelix in men who have experienced a first episode of acute urinary retention.

The study, designated ANT-2111-02, is a randomized, double-blind, placebo-controlled, multicenter trial evaluating Teverelix DP, a long-acting gonadotropin-releasing hormone antagonist, for the prevention of recurrent acute urinary retention associated with benign prostatic hyperplasia. The redesigned protocol is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients under the

Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention

Thu, 16 Jul 2026 07:30:00 -0400

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

PHILADELPHIA, July 16, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced that it has received written feedback from the U.S. Food and Drug Administration ("FDA") and central Institutional Review Board ("IRB") approval, with modifications, for its optimized Phase 2 clinical study of Teverelix® in men following a first episode of

Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention

Thu, 16 Jul 2026 07:30:00 -0400

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

Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention

Thu, 16 Jul 2026 07:30:00 -0400

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

Medicus Pharma Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention

Thu, 16 Jul 2026 07:30:00 -0400

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

New to The Street Show #760 Airs Tonight on Bloomberg Television Across the U.S. on Independence Day Featuring Sullivan & Cromwell’s Frank Aquila, Medicus Pharma, PetVivo, FreeCast and YY Group

Sat, 04 Jul 2026 12:25:00 -0400

Honoring Economic Freedom and American Capitalism Through Television That Connects Markets, Entrepreneurs, and Investors