Medicus Pharma (NASDAQ:MDCX) earlier this week outlined further progress in its Skinject program following the release of Phase 2 topline data, alongside independent validation from a leading dermatology expert.
The company’s CEO Raza Bokhari said Medicus Pharma is advancing a novel, noninvasive treatment using patent-protected microneedle arrays designed to treat non-melanoma skin diseases, particularly basal cell carcinoma. He noted that the company is “very pleased” with both development and commercialization progress.
A key catalyst for investors is the external endorsement of the data by principal investigator Dr. Babar Rao, who joined a recent company update call to provide an independent assessment. Bokhari indicated that the feedback and forward outlook “couldn’t be more encouraging and positive.”
The Phase 2 trial was structured as a three-arm study, comprising a device-only arm and two cohorts receiving micro-dosed doxorubicin at 100 micrograms and 200 micrograms. Bokhari highlighted that while clinical activity was observed across all arms, the company’s regulatory focus is now narrowing.
He explained that the relevant dataset for future development is derived from the doxorubicin cohorts, stating that “the focus of the data set… should be on those cohorts… micro dosed with doxorubicin.” In particular, the 200 microgram arm has emerged as the lead candidate for further advancement.
This positioning aligns with the company’s regulatory strategy under the FDA’s 505(b)(2) pathway, which allows for a more efficient approval process by leveraging an existing chemotherapeutic agent. Bokhari described this route as “the most fastest economical and relatively easy to achieve” compared to pursuing a fully novel drug approval pathway.
Looking ahead, Medicus Pharma plans to initiate an end-of-Phase 2 meeting with the FDA, focused specifically on the 200 microgram cohort. This represents a key near-term catalyst that could define the next stage of development and potential commercialization timelines.
Additionally, the company’s microneedle platform itself demonstrated biological activity, though Bokhari indicated this will not be central to the current regulatory approach.
Overall, Medicus Pharma appears to be refining its strategy around its most promising dataset, with regulatory alignment and external validation supporting its forward trajectory in the dermatology therapeutics space.