Medicus Pharma Ltd. Common Stock

Pfizer 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, while Pfizer retains economic participation through financial milestones, royalties and ongoing involvement in the CD228V development program. Pfizer, a US-based pharmaceuticals group with a market value of about $158.0 billion, is handing Medicus day-to-day development and commercialization duties while keeping the patents, milestone rights and royalties, limiting its upfront spend on an early clinical asset and preserving a cut of future upside across indications. The next real test comes when Medicus moves CD228V toward a first pivotal trial and Pfizer must decide whether to exercise its option to fund later-stage development, a decision point that, alongside any detail shared at events such as the Morgan Stanley Global Healthcare Conference on 14 September 2026, will show how important Pfizer sees the asset within its oncology plans.

Medicus Pharma Ltd. has received Investigational New Drug authorization from the Department of Health – Abu Dhabi for its Phase 2a PRECISION-E2 trial of Teverelix in women with symptomatic endometriosis in the United Arab Emirates. The randomized, placebo-controlled study will enroll approximately 84 participants and evaluate three treatment regimens: 60 mg and 90 mg administered subcutaneously, and 90 mg intramuscularly. The primary goal is to identify the proportion of participants achieving and maintaining serum estradiol levels within the Barbieri therapeutic window of approximately 20 to 50 picograms per milliliter for at least 14 consecutive days. Teverelix, a gonadotrophin-releasing hormone antagonist developed by subsidiary Antev Ltd., is designed to suppress reproductive hormones without an initial hormonal flare. The authorization follows review of chemistry, manufacturing and controls, non-clinical, clinical, and safety documentation, with the study still subject to site-specific Institutional Review Board and ethics approvals.

Medicus Pharma has received a 'Study May Proceed' letter from the U.S. Food and Drug Administration for its NDA-enabling registrational Phase 2b clinical study of SkinJect in patients with Gorlin Syndrome. The open-label, multicenter study, designated SKNJCT-005, will evaluate the dissolvable microneedle-array patch delivering 200 mcg of doxorubicin in up to 50 patients who develop multiple basal cell carcinomas. The FDA authorization follows the company's comprehensive response to the agency's June 18, 2026 information requests and includes protocol amendments such as requiring baseline biopsy confirmation, a composite primary endpoint of both clinical and histological clearance, and extending patient follow-up to at least two years. SkinJect has shown 64% clinical clearance and 55% histological clearance in a prior 90-patient study, and if approved, it could become the first FDA-approved lesion-directed therapy for Gorlin Syndrome, a rare genetic disorder affecting an estimated 6,000 to 12,000 individuals in the U.S.

Medicus Pharma has received written feedback from the U.S. Food and Drug Administration and central Institutional Review Board approval for its optimized Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention. The randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients under the previously disclosed development plan. The FDA provided seven operational recommendations that the company believes do not require changes to the study's scientific rationale, patient population, treatment arms, primary endpoint or planned interim analysis. Central IRB Advarra approved the protocol with modifications on June 18, 2026, with the approval period extending through June 18, 2027. Medicus intends to incorporate the feedback and advance toward study initiation, aiming to generate decision-grade clinical evidence to support future regulatory discussions and strategic partnering opportunities.

Medicus Pharma Ltd. has filed a Rare Pediatric Disease Designation request with the U.S. Food and Drug Administration for SkinJect, its investigational doxorubicin-containing microneedle array patch, for the treatment of basal cell carcinoma in patients with Gorlin Syndrome. The submission follows the company's previously filed Orphan Drug Designation application and ongoing FDA review of its registrational study design. Recent Phase 2 results demonstrated encouraging clinical and complete response rates while maintaining a favorable safety profile. If granted, the designation could support the company's regulatory strategy and potentially provide eligibility for a Rare Pediatric Disease Priority Review Voucher, subject to future FDA approval. Separately, Medicus Pharma announced on June 8 that it had filed a substantial modification application through the European Union CTIS for the planned Phase 2b study of Teverelix in advanced prostate cancer.

Medicus Pharma will present updates on its SkinJect and Teverelix programs at the 2026 Bio International Conference in San Diego. Chief Medical Officer Dr. Faisal Mehmud will discuss the Phase 2 SKNJCT-003 study for SkinJect, an investigational dissolvable microneedle array delivering doxorubicin to treat basal cell carcinoma, which showed a 55% histological clearance and 64% clinical clearance in the 200 microgram cohort. The presentation will also cover preparations for an End-of-Phase 2 meeting with the FDA, a planned registrational development strategy, and regulatory initiatives for Gorlin Syndrome including orphan drug and rare pediatric disease designation requests currently under FDA review. For Teverelix, a next-generation GnRH antagonist, updates will include the advanced prostate cancer program, the acute urinary retention relapse program, and the recently initiated PRECISION-E2 Phase 2a study in endometriosis leveraging the UAE Genome Program to integrate genomic profiling with hormonal modulation.