Shares of Processa Pharmaceuticals (NASDAQ: PCSA) skyrocketed over 2100% on Friday following the announcement of the expansion of its NGC-Cap Program into Advanced or Metastatic Breast Cancer.
Processa Pharmaceuticals (NASDAQ: PCSA) has revealed plans to expand the development of Next Generation Capecitabine (NGC-Cap) to combat advanced or metastatic breast cancer. This expansion is set to kick off with the initiation of its upcoming Phase 2 trial.
Following discussions with the FDA, Processa Pharmaceuticals concluded that its NGC-Cap Phase 2 trial will focus on breast cancer. Both parties agreed that targeting breast cancer would streamline the drug development process, increasing the chances of securing FDA approval. The FDA highlighted that existing data from past and ongoing studies could be directly applied to support the Phase 2 trial for breast cancer.
David Young, PharmD, Ph.D., President of Research and Development at Processa, said,
“We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrolment process for the Phase 2 and 3 trials.”
“Capecitabine is already approved as both monotherapy and combination therapy in breast cancer, which contributes to the logic and efficiency of our current direction. In addition, the FDA’s agreement that our present data would support a Phase 2 trial in breast cancer makes the expansion seamless. We believe our Phase 2 trial will provide the safety-efficacy data to preliminarily demonstrate the benefit of NGC-Cap over capecitabine and other treatment options.”
“Based on this expansion to breast cancer we have identified breast cancer key opinion leaders to join our scientific advisory board, have already determined the Phase 2 study design which we expect to share with the FDA soon, and plan to initiate our Phase 2 study in the third quarter of 2024.”
Breast cancer stands out as the most commonly diagnosed cancer, comprising approximately 15% of all new cancer cases in 2023. With a staggering 3.8 million patients affected and nearly 300,000 new diagnoses reported last year, the prevalence of this disease is alarming. Of particular concern is the fact that over 150,000 women are currently grappling with advanced or metastatic breast cancer.
Processa Pharmaceuticals (NASDAQ: PCSA) envisions a substantial market for NGC-Cap, extending beyond breast cancer to colorectal and other cancers. The potential reach of this next-generation treatment is estimated to benefit more than 250,000 patients annually.
PCSA stock was up 2116% as of Friday’s close. That comes with 51,899,286 (51.89 million) shares traded. The company’s daily average trading volume stands at 845.99K shares.