Medicus Pharma Focusing SkinJect® on Gorlin Syndrome Patients

PHILADELPHIA, Sept. 21, 2026 /CourierPR/ -- Medicus Pharma Ltd., a precision-guided biotech/life sciences company, has announced a strategic shift in its clinical development focus for its SkinJect® product. The company will now concentrate its efforts exclusively on patients with Gorlin syndrome, a rare autosomal dominant disease characterized by the development of multiple and recurrent basal cell carcinoma (BCC) lesions. This decision was made following a comprehensive assessment that included findings from an independent third-party commercial assessment, clinical input from Babar K. Rao, MD, FAAD, and feedback from the U.S. Food and Drug Administration’s Office of Orphan Products Development (OOPD).

According to Medicus Pharma, the company’s September 8, 2026, strategic update established a clear principle: to concentrate capital where focused clinical development can create the greatest risk-adjusted value. The decision to focus on Gorlin syndrome is a direct application of this principle. The company believes that SkinJect® has the potential to offer a localized lesion-directed treatment option for patients with Gorlin syndrome, who may face a lifetime of recurrent BCC and repeated procedures.

The FDA has authorized the initiation of the SKNJCT-005, NDA-enabling Phase 2b study of SkinJect® in patients with Gorlin syndrome. The study builds upon the completed SKNJCT-003 Phase 2 program, which identified the 200-µg doxorubicin-loaded dissolvable microneedle array (D-MNA) patch as the proposed pivotal development dose. The company estimates that approximately 11,000 patients in the United States with Gorlin syndrome have active BCC, representing about 50,000 Gorlin-associated BCC procedures annually.

Medicus Pharma’s strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. The company’s current therapeutic assets include CD228V ADC, an investigational antibody-drug conjugate molecule, and Teverelix®, an investigational next-generation GnRH antagonist.

The Gorlin-focused strategy may also potentially support a differentiated reimbursement profile. A company-commissioned 2026 independent commercial assessment, incorporating interviews with physicians and payers, modeled rare-disease-anchored net pricing of approximately $25,800 per treatment, an implied U.S. total addressable market of approximately $1.1 billion, and potential peak U.S. revenue of approximately $383 million. These estimates are non-risk-adjusted and dependent upon successful clinical development, regulatory approval, reimbursement, and commercial adoption.

In its ongoing engagement with the FDA, Medicus Pharma is working to address the issues identified by the OOPD regarding the company’s prior development of D-MNA in BCC outside of Gorlin syndrome. The OOPD has not closed either regulatory pathway and has provided the company an opportunity to respond. If Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) are ultimately granted and applicable requirements are satisfied, potential benefits may include certain clinical-development tax incentives, exemption from certain FDA application user fees, and up to seven years of U.S. orphan-drug exclusivity following approval. If SkinJect ultimately receives a qualifying approval and satisfies all statutory requirements under the RPDD program, the sponsor could potentially receive a transferable Rare Pediatric Disease Priority Review Voucher.

The company’s strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory, and operational datasets, the company seeks to create opportunities for strategic collaborations, regional licensing transactions, and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.