Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce that the company has formally submitted an FDA Commissioner’s National Priority Voucher (CNPV) application on behalf of its partner SkinJect, seeking expedited regulatory review for the Doxorubicin Microneedle Array (D-MNA) a novel, non-invasive treatment for basal cell carcinoma (BCC) of the skin.

The submission includes a detailed Statement of Interest setting out how SkinJect aligns with the FDA’s highest national priorities, including improved cancer-care accessibility, reduced treatment costs, and the urgent unmet needs in rare diseases such as Gorlin Syndrome, where no approved therapies currently exist.
Dr. Bokhari explained that, if granted, the CNPV voucher would allow Medicus and SkinJect to participate in a commissioner-led FDA review process that dramatically reduces regulatory timelines. Under this program, a drug developer’s final application could be evaluated in 1–2 months, compared to the traditional 10–12-month review cycle.

Unlike the standard review pathway—where an application is routed through multiple FDA divisions—the new CNPV pilot brings together specialists from across the agency into a single cross-functional expert team, enabling faster, more coordinated decision-making.

The FDA intends to award only a limited number of vouchers in the program’s first year, specifically to products that directly support U.S. national health priorities. In addition to the time-saving benefits, qualifying therapies may also be eligible for accelerated approval, provided they meet applicable legal and clinical criteria.

Medicus Pharma believes SkinJect is well positioned for inclusion. The Doxorubicin Microneedle Array offers a localized, cost-effective, and non-surgical alternative to current BCC treatments. Basal cell carcinoma is the most common cancer in the United States, with more than five million new cases annually, representing a substantial public-health burden.

The company views the CNPV program as an important opportunity to advance a U.S.-developed cancer therapy that strengthens national goals of accessibility, safety, affordability, and quality of care. Dr. Bokhari emphasized that gaining entry into the pilot would help accelerate the delivery of a much-needed medical innovation to both general BCC patients and underserved rare-disease communities.

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