Medicus Pharma Seeks FDA Rare Pediatric Disease Status for Skinject

Medicus Pharma (NASDAQ: MDCX) announced the submission of a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration (FDA) for Skinject, its investigational doxorubicin-containing microneedle array patch. The therapy is being developed for the treatment of basal cell carcinoma in patients with Gorlin syndrome, a rare inherited disorder associated with recurring skin cancers.

The RPDD request follows the company’s previously announced orphan drug designation application and registrational study plans, which remain under FDA review. Medicus says its development strategy has been shaped through collaboration with clinical experts and the Gorlin Syndrome Alliance, helping ensure the program addresses the unique needs of this patient population.

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