The Clinical Data Behind This FDA-Cleared Study

Author

Jeff Williams
August 03, 2026

*together with Medicus Pharma Ltd

The FDA just moved this rare-disease program from planning into an authorized registrational study. 🧪

MDCX is building a portfolio of precision-guided clinical programs, led by a dissolvable microneedle treatment designed to deliver therapy directly into basal cell carcinoma lesions during brief office visits.

The newest development is a “Study May Proceed” letter from the FDA, clearing an NDA-enabling Phase 2b trial after the agency completed its safety review.

The open-label, multicenter study will evaluate the 200-microgram regimen in up to 50 patients with Gorlin syndrome, a rare inherited condition that can cause repeated skin cancers and a lifelong surgical burden.

Why does this matter?

In the prior Phase 2 study, the 200-microgram cohort produced the strongest Day 57 response: 64% clinical clearance and 55% histological clearance. In plain English, 55% achieved clearance confirmed under microscopic review.

Those results remain early clinical data. They do not establish approval or commercial success.

The broader need is substantial. Company materials cite more than five million annual U.S. basal cell carcinoma cases, approximately 10,000 U.S. Gorlin patients and a $2 billion commercial field for the broader indication.

The FDA clearance does not finish the story. It gives the team permission to test whether the earlier signal can hold up in a registrational setting. 📊

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