PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) has submitted a federal priority-review request for its investigational SkinJect microneedle patch, a dissolvable doxorubicin-based therapy designed to non-invasively treat basal cell carcinoma, the most common cancer in the United States.
The application asks the U.S. Food and Drug Administration to grant a Commissioner’s National Priority Voucher, a newly launched program intended to accelerate reviews for drugs aligned with national public-health priorities. The voucher, announced this year under FDA Commissioner Marty Makary, allows selected therapies to undergo a condensed one- to two-month review, compared with the typical 10 to 12 months.
In its filing, Medicus argued that SkinJect meets all federal criteria, citing the enormous treatment backlog for basal cell carcinoma and the lack of nonsurgical curative options. More than five million new cases occur annually, and an estimated seven million patients remain in treatment queues nationwide. Current standard care relies on Mohs micrographic surgery, a procedure that can be costly, invasive, and difficult to access for older or medically fragile patients.
SkinJect is a single-use biodegradable microneedle patch that delivers doxorubicin directly into lesions. The company says the device is designed to eliminate the need for surgery while offering an office-based, low-cost alternative that could expand access across the country.
Dr. Raza Bokhari, Medicus Pharma’s executive chairman and CEO, said the patch represents “a non-surgical, low-cost innovation for America’s most common cancer” and highlighted its potential role for patients with Gorlin syndrome, a rare genetic disorder that causes hundreds of recurrent BCC lesions beginning in childhood.
The company is advancing a Phase 2 clinical program, SKNJCT-003, now expanded to 90 U.S. participants across nine sites. An interim analysis released earlier this year showed more than 60% clinical clearance, though the company cautioned that the findings are preliminary.
Medicus has continued to broaden the program internationally. In September, it launched SKNJCT-004 in the United Arab Emirates, with Cleveland Clinic Abu Dhabi serving as principal investigator. In November, U.K. regulators approved expansion of the Phase 2 study following a full scientific and ethical review.
The company has also pursued strategic development partnerships and pipeline growth. This year it entered a memorandum of understanding with Helix Nanotechnologies to explore thermostable vaccine co-development and completed its acquisition of Antev Limited, a U.K. biotech developing next-generation GnRH antagonist therapies for advanced prostate conditions.
In October, Medicus announced a collaboration with the Gorlin Syndrome Alliance to expand compassionate-use access to SkinJect. The groups will jointly pursue an Expanded Access IND with the FDA to support treatment of patients facing multiple or inoperable tumors.
The FDA’s national priority voucher program is expected to grant only a limited number of vouchers in its inaugural year. If selected, Medicus says the accelerated pathway could significantly shorten the regulatory timeline for SkinJect while supporting domestic drug manufacturing and advancing national goals in cancer care access and affordability.
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