PCSA Stock Soars on Upbeat Clinical Update From Breast Cancer Study

Core Insights - Processa Pharmaceuticals' shares surged 122.3% following a positive clinical update on its mid-stage study of NGC-Cap for advanced or metastatic breast cancer [1][6] Clinical Study Overview - NGC-Cap, a combination of PCS6422 and Roche's Xeloda (capecitabine), is the lead asset in Processa Pharmaceuticals' pipeline, with 19 patients enrolled in the phase II study [2] - The preliminary analysis includes data from the first 16 patients, indicating a pharmacokinetic advantage of NGC-Cap over Xeloda monotherapy [3][4] Efficacy and Safety Profile - Preliminary phase II data show significantly higher exposure to active metabolites in patients treated with NGC-Cap, suggesting improved antitumor activity [4] - The pharmacologic profile indicates that NGC-Cap allows for greater delivery of effective components of Xeloda without worsening tolerability [5][6] - Early results suggest that increased exposure to active metabolites did not lead to more severe toxicity compared to Xeloda, with manageable tolerability despite higher pharmacologic activity [7] Side Effects and Tolerability - Patients on NGC-Cap experienced about ten times lower exposure to the toxic metabolite FBAL, associated with dose-limiting toxicities, leading to similar incidence of hand-foot syndrome (HFS) across treatment groups, but with milder symptoms in the NGC-Cap arm [8] - These findings support a differentiated safety profile for NGC-Cap, which could be appealing if sustained in later analyses [9] Future Expectations - Processa Pharmaceuticals aims to complete enrollment of the 20-patient cohort for the phase II interim analysis by the end of Q1 2026, with full results expected in early 2026 [9] - The company also has another investigational candidate in mid-stage development for rare kidney diseases [10]