Medicus Pharma gets positive FDA feedback on Skinject microneedle therapy for basal cell carcinoma

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce that the company has received encouraging feedback from its recent Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development pathway of its innovative microneedle-based therapy, Skinject™ (D-MNA), for the treatment of basal cell carcinoma (BCC). The Type C meeting focused on reviewing key elements of the protocol, including study design, endpoints, and patient population definitions for upcoming clinical trials. According to Dr. Bokhari, the FDA provided clarity and alignment on several critical points. Specifically, the agency indicated that a relative bioavailability study with D-MNA, administered under certain conditions, could serve as a basis for establishing a regulatory bridge while addressing bioavailability requirements for the product. Importantly, the FDA offered constructive and supportive guidance on multiple aspects of the proposed development program, including the appropriate primary endpoint for the next clinical study. The company must define the patient population, such as tumor size limits, lesion location restrictions, and histological confirmation requirements and design a randomized, double-blind, placebo-controlled trial to demonstrate efficacy in treating BCC. This regulatory clarity is expected to further strengthen Medicus Pharma’s ongoing clinical program. The company is currently conducting its Phase 2 trial across nine clinical sites in the United States. Patient randomization began in August 2024. In March 2025, Medicus Pharma announced results from an interim analysis of the Phase 2 study, showing a positively trending clinical clearance rate exceeding 60%. The interim data, based on more than half of the targeted 60 patients randomized at the time, were highly encouraging, although final results may vary once the study is fully completed. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Biotech #CancerTreatment #ClinicalTrials #FDAApproval #SkinCancer #HealthcareInnovation #Investing #MedicalResearch #SkinCancer #BasalCellCarcinoma #BiotechNews #CancerResearch #UAEHealth #NonInvasiveTherapy #Doxorubicin #ClinicalTrials #HealthcareInnovation