Medicus Pharma Ltd (MDCX)
NASDAQ (CM) NASDAQ (CM) Primary 
Medicus Pharma CMO to lead Antev's Teverelix clinical programme
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.
Medicus Pharma targets Gorlin Syndrome with SkinJect - ICYMI
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 receives FDA clearance to begin registrational SkinJect study for Gorlin syndrome
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.
Medicus Pharma CEO details Teverelix progress – ICYMI
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 advances Teverelix Phase 2 study after FDA feedback, IRB approval
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.
Medicus Pharma advances Teverelix in prostate cancer - ICYMI
Medicus Pharma (NASDAQ:MDCX) earlier this week announced the submission of a key European regulatory package designed to support the launch of a Phase 2b clinical study of Teverelix in advanced prostate cancer patients with elevated cardiovascular risk. Speaking with Proactive, chief medical officer Dr Faisal Mehmud said the filing represents an important regulatory milestone for the programme and marks a significant step toward advancing the company's development strategy in an underserved patient population.
Medicus Pharma seeks rare pediatric disease tag for SkinJect in Gorlin Syndrome
Medicus Pharma (NASDAQ:MDCX) said Monday it has submitted a Rare Pediatric Disease Designation request to the US Food and Drug Administration for SkinJect, its investigational microneedle patch for treating basal cell carcinoma in patients with Gorlin Syndrome. The submission follows an Orphan Drug Designation application and a registrational study design currently under FDA review for SkinJect, a dissolvable patch that delivers the chemotherapy drug doxorubicin directly into skin cancer lesions.
Medicus Pharma files IND for genomics-enabled endometriosis trial in UAE
Medicus Pharma (NASDAQ:MDCX) has submitted an Investigational New Drug application to Abu Dhabi's Department of Health for PRECISION-E2, a Phase 2a clinical trial evaluating its Teverelix drug candidate in women with symptomatic endometriosis in the United Arab Emirates. The study will enroll approximately 84 women across multiple sites in the UAE and test three different Teverelix dosing regimens, delivered by injection, to determine which dose and method best controls estrogen levels while minimizing side effects.
Medicus Pharma submits EU clinical trial modification for prostate cancer drug Teverelix
Medicus Pharma (NASDAQ:MDCX) has filed a substantial modification application through the European Union Clinical Trials Information System to advance a Phase 2b study of its prostate cancer treatment Teverelix, the company said on Monday. The planned trial will focus on patients with advanced prostate cancer and elevated cardiovascular risk who require androgen deprivation therapy (ADT), a segment the company estimates represents roughly $4 billion in annual market opportunity across major pharmaceutical markets.
Medicus Pharma advances SkinJect for Gorlin syndrome – ICYMI
Medicus Pharma (NASDAQ:MDCX) earlier this week announced the filing of a registration study with the US Food and Drug Administration (FDA) for its SkinJect program targeting patients with Gorlin syndrome, marking a potentially important step toward commercialization of the technology. Speaking with Proactive, chief executive Raza Bokhari said the company has continued to advance SkinJect, a non-invasive treatment platform designed for non-melanoma skin diseases, particularly basal cell carcinoma.
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Medicus Pharma advances SkinJect program with FDA submission targeting Gorlin Syndrome
Medicus Pharma (NASDAQ:MDCX) announced that it has submitted Protocol SKNJCT-005 to the US Food and Drug Administration (FDA) under its existing Investigational New Drug (IND) application for SkinJect, advancing the therapy into registrational development for patients with Gorlin Syndrome, also known as Nevoid Basal Cell Carcinoma Syndrome (NBCCS). The company said the protocol outlines a Phase 2b, open-label study intended to generate efficacy and safety data that could support a future New Drug Application (NDA) for SkinJect in the rare inherited disorder.
