Following the recent regulatory approval, Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) is witnessing a remarkable increase in its stock value. As per the latest market update, the shares of PCSA have surged by 22.06%, reaching $2.08.
FDA Grants Approval for Next Generation Capecitabine
Today, Processa Pharmaceuticals announced that its primary product candidate, Next Generation Capecitabine (NGC-Cap), has received the U.S. Food and Drug Administration (FDA) authorization for its Investigational New Drug (IND) application. With recruitment expected to begin this quarter, this clearance opens the door for a Phase 2 clinical trial that will enroll patients with advanced or metastatic breast cancer.
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Promising Outcomes and Future Expectations
Processa has reached a pivotal milestone with NGC-Cap, which will now advance to clinical trials aimed at treating advanced or metastatic breast cancer—a condition where capecitabine is a standard treatment. The company has previously demonstrated in a Phase 1b study that NGC-Cap offers up to 5-10 times more 5-fluorouracil exposure to cancer cells compared to standard capecitabine therapy.
This enhanced exposure has resulted in superior efficacy while maintaining a safety profile comparable to or better than existing monotherapy options. Processa predicts that the initial results of the Phase 2 study will be available by mid-2025.
More effective chemotherapy medications with fewer severe side effects are constantly needed, even though capecitabine is widely used to treat solid tumors. Processa believes that this unmet demand will be addressed by NGC-Cap.
PCSA Fulfilling a Critical Need
Breast cancer is still a major cause of cancer-related mortality as the second most prevalent kind of cancer. PCSA is in plans of an international, multicenter, adaptive design, open-label, research in the next Phase 2 trial. It aims to compare two different doses of NGC-Cap against FDA-approved monotherapy capecitabine in about 60 to 90 patients with advanced or metastatic breast cancer.
The study will evaluate the safety and efficacy of NGC-Cap, determine optimal dosage regimens in accordance with the FDA Project Optimus Initiative, and explore potential personalization of NGC-Cap therapy. Processa plans to begin patient enrollment for this trial in the third quarter of 2024.
