
MedicusâŊPharma Seeks FDA CompassionateâUse OK for Skinject in Gorlin Syndrome Patients
âĒBy ADMIN
Related Stocks:MDCX
Medicus Pharma (NASDAQ:âŊMDCX) is moving ahead with a plan to secure compassionateâuse approval from the Food and Drug Administration (FDA) for its flagship therapy, Skinject, targeting patients with Gorlin syndrome â a rare, genetic condition affecting about 1 inâŊ31,000 people worldwide and often resulting in lifelong basal cell carcinoma.
Medicus has teamed up with the Gorlin Syndrome Alliance (GSA), a patientâregistry organisation representing some 11,000 U.S.âbased patients and global connections, to pave the way for access to Skinject outside of traditional clinical trials.
CEO Raza Bokhari explained the strategy: Skinject is a nonâinvasive microneedle array therapy containing doxorubicin for nonâmelanoma skin diseases â aligning innovation with patient advocacy, regulatory momentum and unmet need.
The company is leveraging key supporters in Washington, including boardâmember and former congresswoman Cathy McMorris Rodgers, to advance its submission. If approved, select patients with Gorlin syndrome could begin using Skinject under compassionateâuse protocols while safety data are still gathered.
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