Medicus Pharma submits FDA rare pediatric disease designation request for SkinJect in Gorlin syndrome
PUBT · 06/15 11:30
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- Medicus Pharma submitted an FDA Rare Pediatric Disease Designation request for SkinJect to treat basal cell carcinoma in Gorlin syndrome patients.
- The filing follows an orphan drug designation application; the registrational study design remains under FDA review.
- Phase 2 data showed 64% clinical clearance, 55% complete response in the 200 ug arm.
- If granted and later approved, the designation could support eligibility for a rare pediatric disease priority review voucher.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Medicus Pharma Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606150730PRIMZONEFULLFEED9746756) on June 15, 2026, and is solely responsible for the information contained therein.
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