Medicus Pharma (NASDAQ:MDCX) said on Monday it has applied for a US Food and Drug Administration Commissioner's National Priority Voucher (CNPV) to accelerate review of SkinJect, its investigational microneedle patch designed to non-invasively treat basal cell carcinoma (BCC).
The application includes a Statement of Interest outlining how SkinJect’s Doxorubicin Microneedle Array (D-MNA) aligns with the FDA’s national priorities, which focus on improving cancer care access, affordability and options for patients with rare diseases, the company said.
The FDA introduced the voucher pathway in June, offering a sharply shortened one- to two-month review timeline compared to roughly 10–12 months for drugs deemed aligned with national health priorities such as unmet medical needs, innovation, and domestic manufacturing.
“We believe that SkinJect’s D-MNA is uniquely positioned to expand access to effective non-melanoma skin cancer treatment… while dramatically reducing healthcare costs and surgical dependence,” Medicus CEO Dr Raza Bokhari said. He added that the therapy could significantly benefit patients with Gorlin syndrome, a rare genetic disorder that causes recurrent BCCs and requires repeated surgeries.
SkinJect is a biodegradable, single-use microneedle patch that delivers doxorubicin directly into skin lesions, offering what the company describes as a low-cost, office-based alternative to Mohs micrographic surgery. More than 5 million new BCC cases are diagnosed in the US each year, Medicus said, citing over seven million patients waiting for treatment.
The company is running a Phase 2 US study, SKNJCT-003, across nine sites, and reported an interim trend showing more than 60% clinical clearance after more than half of the targeted 60 patients were randomized. The study has since been expanded to 90 participants and recently received regulatory approval to broaden recruitment to the United Kingdom.
A second clinical study, SKNJCT-004, began in the United Arab Emirates in September, with Cleveland Clinic Abu Dhabi serving as principal investigator. The company treated the first UAE patient in October.
Medicus also highlighted recent expansion moves, including an August memorandum of understanding with Helix Nanotechnologies to explore co-development of thermostable infectious-disease vaccines, and the acquisition of Antev Ltd, a UK biotech developing the next-generation prostate-cancer candidate Teverelix. Medicus said Teverelix could offer cardiovascular risk advantages over existing hormone-therapy options.
The company is working with the Gorlin Syndrome Alliance to pursue an Expanded Access IND program for compassionate use of SkinJect in patients with multiple or inoperable BCC lesions.
Separately, the company reported third-quarter financial results showing cash and equivalents rose to $8.7 million from $5.3 million a year earlier, supported by $10.4 million in proceeds from financings and warrant exercises. Operating expenses increased to $15.4 million from $2.3 million a year earlier as Medicus accelerated clinical development across the US, Europe and the Middle East and integrated its Antev acquisition. The quarterly net loss widened to $16 million from $2.3 million.
“The clinical development program of SkinJect… is now active across the United States, Europe and the Middle East,” Bokhari said, adding that Antev provides strategic depth to the pipeline along with “a potential market opportunity” of about $6 billion for Teverelix.