Processa Pharmaceuticals develops clinical-stage therapies centered on Next Generation Cancer (NGC) drug products. Company news commonly covers NGC-Cap, its lead oncology asset combining PCS6422 with capecitabine, including clinical updates in advanced or metastatic breast cancer and disclosures on metabolite exposure, safety profile and therapeutic-index objectives.
Updates also address the company's broader pipeline and business priorities, including PCS499 for focal segmental glomerulosclerosis, partnership activity for non-oncology assets, capital actions, conference participation, governance matters and operating or financial results tied to its development-stage biotechnology model.
Processa Pharmaceuticals (PCSA) announced positive outcomes from its ongoing Next Generation Capecitabine (NGC) Phase 1B trial. The NGC dosage regimens demonstrated significantly higher potency than existing FDA-approved capecitabine, with a 5-FU systemic exposure approximately 50 times greater. The trial showed reduced conversion of 5-FU into side-effect-causing metabolites, with less than 10% being converted compared to 80% for traditional capecitabine. In 2023, Processa plans to engage the FDA regarding its Phase 2B trial design to evaluate improved efficacy-safety profiles.
Processa Pharmaceuticals (Nasdaq: PCSA) announced significant advancements in its clinical trials, including the early completion of enrollment for PCS12852 for gastroparesis, with data expected by year-end. The company is expanding its trial sites for PCS6422 and PCS499, enhancing patient awareness and enrollment efforts. These initiatives are aimed at improving treatment options for conditions with unmet medical needs. Critical data on DPD formation and safety profiles will be available soon, with further development anticipated in 2023.
Processa Pharmaceuticals, a clinical stage biopharmaceutical company (Nasdaq: PCSA), announced that CEO Dr. David Young will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2022. A live webcast of the presentation will be available on the company’s investor relations page. Processa focuses on developing treatments for patients with unmet medical needs, with an active pipeline including PCS6422 for metastatic cancers, PCS499 for ulcerative necrobiosis lipoidica, and PCS12852 for GI motility disorders. For more information, visit www.processapharma.com.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) has appointed Khoso Baluch and James Neal as Independent Directors to its Board, effective August 2022. Current board member Justin Yorke has been named Chairman. Yorke emphasized the board's focus on three ongoing clinical trials and five pipeline products. Baluch brings over 36 years of biopharmaceutical experience, while Neal has over 25 years in business and technology collaborations. CEO Dr. David Young expressed confidence in their backgrounds to enhance the company’s trajectory as it aims to address unmet medical needs.
Processa Pharmaceuticals (Nasdaq: PCSA) reported financial results for the quarter ended June 30, 2022, highlighting a net loss of $8.4 million ($0.53 per share), up from $5.3 million in the same period last year. The company has a cash balance of $12.1 million, sufficient to fund operations into Q3 2023. Key developments include anticipated completion of enrollment for PCS12852 and progress in trials for PCS6422 and PCS499, with enrollment efforts yielding positive patient activity. Increased clinical trial costs are expected due to ongoing developments.
Processa Pharmaceuticals (PCSA) will hold a conference call on August 11, 2022, at 4:30 p.m. ET to discuss its Q2 2022 results and the status of its clinical pipeline. Interested participants should join 5-10 minutes early. The call will be available via toll-free numbers and live webcast. Processa focuses on advancing innovative treatments for patients with unmet medical needs, with active programs addressing conditions like metastatic colorectal cancer and gastroparesis. Further details can be found on their official website.
Processa Pharmaceuticals (NASDAQ: PCSA) has launched a new website to raise awareness about the rare skin condition ulcerative Necrobiosis Lipoidica (uNL) and its ongoing Phase 2 study of PCS499, a potential treatment. This condition, affecting an estimated 22,000 to 50,000 individuals in the U.S., currently has no FDA-approved therapy. The randomized, double-blind trial aims to evaluate the safety and efficacy of PCS499 compared to placebo, with 20 patients set to enroll. The company’s mission is to develop treatments for unmet medical needs.
Processa Pharmaceuticals (NASDAQ: PCSA) has launched a new website for ulcerative Necrobiosis Lipoidica (uNL), aimed at raising awareness and informing patients about its ongoing Phase 2 study of PCS499. This condition, affecting 22,000-50,000 people in the U.S., has no FDA-approved treatments. The randomized, double-blind study will evaluate the efficacy and safety of PCS499 in 20 patients with uNL. The Chief Development Officer stated the study aims to provide options for those suffering from this chronic skin condition.
Processa Pharmaceuticals (Nasdaq: PCSA) will present at the World Orphan Drug Congress USA 2022 on July 13, 2022, at 3:25 pm EDT. CEO Dr. David Young will discuss effective development strategies for rare disease therapies. Processa has a pipeline of five drugs, three with FDA Orphan Designation. PCS499 targets ulcerative necrobiosis lipoidica and is in Phase 2B trials, while PCS3117 is focused on pancreatic cancer. Both drugs aim to address serious unmet medical needs, with analyses expected in early 2023.
Processa Pharmaceuticals (PCSA) reported Q1 2022 financial results, showing a net loss of $3.2 million or $0.20 per share, up from $2.1 million or $0.14 per share in Q1 2021. The company had a cash balance of $14.4 million, expected to sustain operations through Q3 2023. The company is expanding patient enrollment and on track with clinical trials, including the amended Next Generation Capecitabine study, which aims to provide insights by mid-summer. Clinical trials are anticipated to yield important data by year-end, supporting a market potential exceeding $1 billion.