Medicus Pharma Clears FDA 'Study May Proceed' Letter for SkinJect Phase 2b Registrational Trial in Gorlin Syndrome

Medicus Pharma Ltd. (NASDAQ: MDCX) received a 'Study May Proceed' letter from the FDA on July 27, 2026, clearing the company to launch SKNJCT-005 — an NDA-enabling, open-label, multicenter Phase 2b registrational study of SkinJect® (D-MNA) 200 micrograms in up to 50 patients with Gorlin Syndrome presenting with multiple basal cell carcinomas.

The FDA authorization followed Medicus' submission of the SKNJCT-005 protocol and the company's comprehensive response to information requests the agency issued on June 18, 2026, per the company's July 27, 2026 news release on GlobeNewswire.

Gorlin Syndrome is a rare inherited disorder that causes patients to develop multiple basal cell carcinomas over a lifetime, with many patients undergoing repeated surgeries that result in scarring, functional impairment, and quality-of-life challenges. Per the July 27 release, there are currently no FDA-approved lesion-directed therapies specifically developed for Gorlin Syndrome patients.

The Phase 2b program builds on prior data from the completed SKNJCT-003 Phase 2 study in nodular basal cell carcinoma. In the 200 mcg D-MNA cohort, results at Day 57 showed 55% histological clearance, dose-dependent therapeutic activity, and a favorable safety profile with no treatment-related serious adverse events, per the same release.

CEO Dr. Raza Bokhari said in the July 27 release that the FDA authorization "marks a major regulatory milestone, allowing Medicus to advance SkinJect® into a registrational study that could provide a less invasive treatment option for patients living with this rare disease."

Per the July 27 release, Orphan Drug Designation — if granted — could provide eligibility for exemption from FDA NDA fees that currently exceed $5 million and seven years of U.S. market exclusivity following approval. A Rare Pediatric Disease Priority Review Voucher, if granted following approval, could shorten the FDA NDA review period by several months, per the same release.

On the financial side, per StockTitan's company overview, the trailing twelve months net income is -$47.3 million and operating cash flow is -$22.8 million. A $22 million secured promissory note facility is in place, with $12 million funded and $10 million held in a milestone collateral account. The stock was priced at $0.40 as of July 1, 2026, against an approximate market cap of $25.3 million, per the same overview.

Also on July 31, 2026, Medicus announced a separate regulatory authorization: the UAE Department of Health – Abu Dhabi granted IND authorization for the PRECISION-E2 Phase 2a study evaluating Teverelix® in women with moderate-to-severe symptomatic endometriosis, a condition that affects approximately one in ten women of reproductive age worldwide, per the company's July 31, 2026 GlobeNewswire release. Both programs remain early-stage.

What is immediately next for SKNJCT-005, per the July 27 release, is trial initiation at multiple centers enrolling up to 50 Gorlin Syndrome patients under the now-cleared IND.