Medicus Pharma Narrows SkinJect Focus To Gorlin Syndrome, Drops Sporadic BCC Program
(RTTNews) - Medicus Pharma Ltd. (MDCX) announced that it will focus future internally sponsored clinical development of SkinJect exclusively on patients with Gorlin syndrome and multiple basal cell carcinoma (BCC) lesions, while concluding further development in sporadic/nodular BCC.
The decision follows a commercial, clinical, and regulatory assessment of the program. It also follows Medicus' capital-efficient portfolio strategy announced on September 8, 2026.
Under the strategy, the company is concentrating capital and organizational resources on selected clinical development programs.
Gorlin syndrome, also known as nevoid basal cell carcinoma syndrome, is a rare inherited disorder characterized by the development of multiple and recurrent BCCs, which can lead to repeated surgeries and other lesion-directed procedures over a patient's lifetime.
SkinJect is an investigational localized treatment that uses a dissolvable microneedle array (D-MNA) patch to deliver treatment directly to BCC lesions. The Gorlin program builds on the completed Phase 2 SKNJCT-003 study, which identified the 200-µg doxorubicin-loaded D-MNA patch as the proposed pivotal development dose.
The FDA issued a "Study May Proceed" letter in July 2026 for SKNJCT-005, an NDA-enabling, registrational Phase 2b study of SkinJect in patients with Gorlin syndrome and multiple BCC lesions.
The decision followed an assessment that included an independent commercial evaluation, clinical input from the Phase 2 program's principal investigator, and findings from the final Phase 2 Clinical Study Report.
It also considered feedback from the FDA's Office of Orphan Products Development (OOPD) on the company's requests for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD).
The OOPD said it considers BCC occurring in Gorlin syndrome to be the same disease as sporadic BCC and noted that the overall prevalence of BCC exceeds the statutory threshold applicable to the designation requests.
The OOPD also identified SkinJect's prior clinical development in BCC outside Gorlin syndrome as relevant to its assessment of the orphan-subset requirements.
The agency has kept further review of the ODD and RPDD requests in abeyance pending additional information from Medicus. The company said it plans to continue engaging with the FDA and submit additional information to the OOPD regarding the designation requests.
The company said that, 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 (PRV).
Raza Bokhari, Executive Chairman and CEO of Medicus, said the FDA-authorized, NDA-enabling SKNJCT-005 study provides a focused path to evaluate SkinJect as a lesion-directed treatment option for patients with Gorlin syndrome, while the company continues working with the FDA on its ODD and RPDD designation requests.
MDCX is trading down 2.57% at $0.16.
