Why Is Small-Cap Processa Pharmaceuticals Stock Rallying After Breast Cancer Trial Data?

Core Insights - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock surged by 130.95% to $6.94 following a clinical update on its Phase 2 study of NGC-Cap, a combination treatment for advanced or metastatic breast cancer [7]. Clinical Study Findings - The first 16 of 19 patients in the Phase 2 study showed that NGC-Cap significantly increases exposure to capecitabine metabolites without increasing side effects compared to standard Mono-Cap therapy [2]. - Patients were randomized to receive either NGC-Cap (150 mg twice daily) or standard-dose Mono-Cap (1,000 mg/m² twice daily), with preliminary findings suggesting NGC-Cap allows for greater exposure to effective cancer-killing components while avoiding increased severity of side effects [3]. Safety and Side Effects - Although patients receiving NGC-Cap experienced a higher total number of side effects related to capecitabine metabolites, the severity of these side effects was similar between the two treatment groups, indicating that increased activity did not lead to more severe toxicity [4]. - Patients on NGC-Cap had substantially lower exposure to FBAL, a catabolite metabolite associated with side effects like hand-foot syndrome (HFS), with exposure being up to ten times less than that of Mono-Cap [5]. - The incidence of HFS was similar between treatment groups, but symptoms in the NGC-Cap group were mild (Grade 1), while those on Mono-Cap experienced more severe symptoms (up to Grade 2) [6]. Future Plans - Processa anticipates completing enrollment for the final patient in the 20-patient interim analysis of the Phase 2 safety and efficacy study by the end of Q1 2026 [7].