Medicus Pharma Ltd (MDCX)
NASDAQ (CM) NASDAQ (CM) Primary 
Medicus Pharma targets partnerships and clinical milestones as oncology pipeline advances
Medicus Pharma (NASDAQ:MDCX) is positioning its precision oncology-led pipeline for a series of clinical and regulatory milestones, with partnerships and licensing deals central to the next phase of development, the company said in a shareholder update marking its third anniversary. The Nasdaq-listed biotech said its priorities are to advance selected clinical and regulatory milestones, align organizational costs with those priorities, and pursue licensing and co-development opportunities.
Medicus Pharma files streamlined Phase 2b/3 prostate cancer trial design with FDA
Medicus Pharma (NASDAQ:MDCX) has submitted a seamless Phase 2b/3 registration-intent protocol to the US Food and Drug Administration for Teverelix, its long-acting GnRH antagonist for advanced prostate cancer patients at increased cardiovascular risk. The company said the stage-gated design starts with about 80 randomized patients, replacing a previously FDA-cleared, stand-alone 40-patient open-label dose-optimization study.
Medicus Pharma reports positive Phase 2 data for SkinJect in skin cancer treatment
Medicus Pharma (NASDAQ:MDCX) said a completed Phase 2 study of its SkinJect therapy showed all 90 enrolled patients finished treatment without discontinuations, data the company says will guide its next-stage registrational trial in a rare genetic skin cancer syndrome. The randomized, double-blind, multicenter trial enrolled patients across 10 US investigative sites, comparing two dose levels of SkinJect against a device-only microneedle comparator.
Medicus Pharma reorients around new cancer drug candidate, sharpens focus for other programs
Medicus Pharma (NASDAQ:MDCX) is repositioning itself as a precision oncology-led biotechnology company, centering its strategy on CD228V, a second-generation antibody-drug conjugate targeting CD228-expressing solid tumors, the company said Tuesday. CD228V is now the company's principal strategic priority, with initial development focused on establishing clinical proof-of-concept in a selected tumor population.
Medicus Pharma advances pipeline during Q2 with key milestones
Medicus Pharma (NASDAQ:MDCX) has reported second quarter financial results and regulatory and clinical progress across its SkinJect and Teverelix programs, while raising about $40 million through equity and debt financing during the first half of 2026. The company said it received FDA “Study May Proceed” authorization for its registrational SkinJect study in patients with Gorlin Syndrome.
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.
