MDCX Medicus Pharma Ltd.

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...

Medicus Pharma (NASDAQ:MDCX) said it will focus future internally sponsored clinical development of SkinJect exclusively on Gorlin syndrome patients with multiple basal cell carcinoma lesions and will conclude further development in sporadic/nodular basal cell carcinoma. The decision builds...

Medicus Pharma Ltd. (NASDAQ:MDCX) on Monday announced it will concentrate all future internally sponsored clinical development for its SkinJect asset exclusively on Gorlin syndrome patients presenting with multiple basal cell carcinoma lesions, concluding further development in sporadic nodular basal cell carcinoma. Gorlin syndrome, also called nevoid basal cell carcinoma syndrome, is a rare inherited genetic disorder that causes the body to form multiple cancerous and non-cancerous tumors. Gorl

Pfizer (NYSE:PFE) has signed a co-development and license deal with Medicus Pharma for an early clinical-stage CD228-targeting antibody-drug conjugate. The agreement grants Medicus exclusive global rights to develop and commercialize the CD228V candidate across multiple human disease areas. Pfizer retains economic participation through financial milestones, royalties and ongoing involvement in the CD228V development program. This new Pfizer Medicus CD228V antibody-drug conjugate partnership...

Medicus Pharma (NASDAQ:MDCX) earlier this week outlined progress across its SkinJect program and a co-development and licensing opportunity with Pfizer, with CEO Raza Bokhari highlighting clinical, partnership and funding developments as the company sharpens its focus on precision oncology and...

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss a transformative agreement with Pfizer that significantly strengthens the company’s position in precision oncology and provides key resources to advance its lead cancer program. Under the development and licensing agreement, Medicus has secured rights to a CD228-targeted antibody-drug conjugate (ADC) program, while Pfizer is contributing approximately $2 million in development funding, along with inventory and infrastructure support. Bokhari described the transaction as a major milestone that effectively provides the company with the resources needed to continue development from where Pfizer concluded its Phase 1 dose-escalation work. The CD228-targeted ADC is being developed for the treatment of solid tumors, including refractory melanoma, and now represents the centerpiece of Medicus’ evolving oncology strategy. Bokhari said the agreement allows the company to move forward with a capital-efficient approach while leveraging the extensive scientific and clinical groundwork already completed by Pfizer. Beyond oncology, Medicus continues to make progress with its SkinJect program, which is focused on the treatment of basal cell carcinoma and related conditions. Bokhari noted that final clinical trial results recently published on ClinicalTrials.gov identified the 200-microgram patch as the optimal dose for future registrational studies. The company is now concentrating its efforts on advancing SkinJect in patients with Gorlin syndrome, a rare genetic condition that can lead to the development of multiple basal cell carcinomas throughout a patient’s lifetime. Medicus is preparing to move forward with the FDA-approved pivotal SkinJect 005 study while simultaneously recruiting patients for the trial. At the same time, Bokhari said the company is positioning the broader nodular basal cell carcinoma opportunity for potential out-licensing, allowing Medicus to focus internal resources on the areas where it sees the strongest risk-adjusted return. To support the commercial potential of SkinJect, Medicus commissioned an independent reimbursement analysis that suggests the treatment could potentially achieve reimbursement levels of $25,000 or more per patient. Bokhari noted that the rare disease and potential pediatric disease characteristics associated with Gorlin syndrome could provide attractive regulatory and commercial advantages. He described SkinJect as “partner-ready” and indicated that the company is actively exploring opportunities to unlock additional value through strategic partnerships. Bokhari characterized the Pfizer agreement as a paradigm shift for Medicus, transforming the company into a precision oncology-focused biotechnology business while maintaining a disciplined approach to capital allocation. He compared the strategy to a Berkshire Hathaway-style model for drug development, where resources are selectively deployed into programs with the highest potential returns. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #SkinJect #Pfizer #PrecisionOncology #Biotech #CancerResearch #ADC #Melanoma #DrugDevelopment #ClinicalTrials #SkinJect #GorlinSyndrome #Biotechnology #HealthcareInnovation #Oncology #LifeSciences

The completed SKNJCT-003 study is shaping Medicus Pharma’s next clinical strategy, with the 200 µg dose moving into an FDA-authorized Gorlin syndrome program while the company considers partnerships for nodular basal cell carcinoma. Key Investor TakeawaysMedicus Pharma (NASDAQ:MDCX) selected the 200 µg SkinJect patch as its proposed pivotal dose following the final analysis of its 90-patient Phase 2 SKNJCT-003 study.

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,...

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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...

Medicus Pharma Ltd. (MDCX) has outlined a revised development strategy that makes CD228V, its second-generation antibody-drug conjugate targeting melanotransferrin/CD228, the company’s principal clinical programme.

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...

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...

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...

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...

Medicus Pharma Ltd. (NASDAQ:MDCX) on Friday secured regulatory clearance from the United Arab Emirates Department of Health – Abu Dhabi for its PRECISION-E2 Phase 2a clinical study. The trial evaluates Teverelix in women with moderate-to-severe symptomatic endometriosis, an estrogen-dependent disease affecting roughly 10% of reproductive-age women globally. The trial marks a significant milestone in advancing a prospective genomics-guided precision medicine program designed to identify patients

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA), authorizing the start of its NDA-enabling Phase 2b clinical trial for SkinJect® in patients with Gorlin Syndrome. The FDA clearance follows the company's submission of the SKNJCT-005 study protocol and its response to the agency's June 2026 information requests, completing the safety review of the Investigational New Drug (IND) application. The Phase 2b, open-label, multicenter trial will evaluate SkinJect® 200 mcg in up to 50 patients with Gorlin Syndrome who develop multiple basal cell carcinomas (BCCs) requiring repeated surgical treatment. The study is designed to generate the efficacy and safety data needed to support a future New Drug Application (NDA). Gorlin Syndrome is a rare inherited genetic disorder linked to abnormalities in the Hedgehog signaling pathway, causing patients to develop numerous basal cell carcinomas beginning in childhood or early adulthood. Many patients undergo repeated surgeries throughout their lives, often resulting in scarring, functional impairment, and significant quality-of-life challenges. Bokhari said the FDA authorization marks a major regulatory milestone, allowing Medicus to advance SkinJect® into a registrational study that could provide a less invasive treatment option for patients living with this rare disease. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #SkinJect #ClinicalTrials #FDA #Biotech #RareDisease #GorlinSyndrome #BasalCellCarcinoma #DrugDevelopment #HealthcareInnovation

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...

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...

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive Medicus Pharma CEO Dr. Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of written FDA feedback and central Institutional Review Board (IRB) approval, with modifications, for its optimized Phase 2 clinical trial evaluating Teverelix® in men following a first episode of acute urinary retention (AUR). Bokhari said the randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, will enroll approximately 126 patients to evaluate the effects of Teverelix DP, a long-acting GnRH antagonist, on prostate volume and urinary function after an initial episode of AUR. The FDA provided seven recommendations related to protocol implementation, safety monitoring, and study documentation, including updates to contraception reporting, injection-site blinding, alpha-blocker therapy tracking, race data collection, and clarification of a secondary endpoint. Importantly, Bokhari said the company believes the FDA's comments are operational in nature and can be addressed through protocol amendments without changing the study's scientific rationale, patient population, treatment arms, primary endpoint, or planned interim analysis. Medicus is now working with its regulatory, clinical, and contract research partners to incorporate both the FDA and IRB recommendations, finalize participating clinical sites, and complete the remaining start-up activities ahead of patient enrollment. Management believes the regulatory feedback represents another important milestone in advancing Teverelix as a potential treatment for men experiencing acute urinary retention associated with enlarged prostate disease. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Teverelix #ClinicalTrials #FDA #Biotech #Phase2 #Urology #DrugDevelopment #HealthcareInnovation #PharmaNews

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...