Welcome to our dedicated page for Processa Pharmaceuticals news (Ticker: PCSA), a resource for investors and traders seeking the latest updates and insights on Processa Pharmaceuticals stock.
Processa Pharmaceuticals, Inc. (symbol: PCSA) is a clinical-stage biopharmaceutical company, founded in October 2017 and headquartered in Hanover, Maryland. The company's mission is to develop products that can significantly improve the survival and quality of life for patients with high unmet medical needs, particularly in the field of oncology.
Processa Pharmaceuticals specializes in the development of Next Generation Chemotherapy (NGC) oncology drug products using a unique 'regulatory science' approach. The company's primary focus is to advance its pipeline of proprietary small molecule oncology drugs. These NGC products are new chemical entities designed to alter the metabolism, distribution, and/or elimination of already FDA-approved cancer drugs or their active metabolites, while preserving the original mechanisms of action that kill cancer cells.
The company's current pipeline includes three promising NGC treatments:
- NGC-Capecitabine (NGC-Cap): This therapy involves Capecitabine administered with PCS6422, aiming to enhance efficacy and reduce side effects.
- PCS3117 (NGC-Gemcitabine or NGC-Gem): A novel formulation intended to improve the therapeutic profile of Gemcitabine.
- PCS11T (NGC-Irinotecan or NGC-Iri): Another innovative treatment designed to optimize the benefits of Irinotecan.
Processa Pharmaceuticals is committed to leveraging its expertise in regulatory science to bring these next-generation treatments to market. The company's strategic partnerships and ongoing clinical trials play a crucial role in advancing its mission and providing hope to patients battling cancer. For the latest updates and more information, investors can contact Patrick Lin at plin@processapharma.com.
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.
On May 5, 2022, Processa Pharmaceuticals (NASDAQ: PCSA) announced a conference call scheduled for May 12, 2022, at 4:30 p.m. EST to review Q1 results and update its clinical pipeline. Interested participants can join via phone or a live webcast. The company focuses on developing treatments for unmet medical needs, with active programs in metastatic colorectal cancer, breast cancer, and gastroparesis. The call will provide insights into the company's progress and future goals.
Processa Pharmaceuticals has initiated dosing for the first patient in its amended Phase 1B trial for Next Generation Capecitabine, targeting advanced gastrointestinal cancer. The trial tests the combination of PCS6422 and capecitabine, aiming to enhance capecitabine's potency significantly. Preliminary data suggest PCS6422 can make capecitabine approximately 50 times more potent per mg administered. The company aims to finalize the maximum tolerated dose (MTD) by the end of 2022 and plans to advance to Phase 2B or Phase 3 trials in 2023.
Processa Pharmaceuticals (NASDAQ: PCSA) has initiated a Phase 2A clinical trial for its drug PCS12852 aimed at treating moderate to severe gastroparesis, a serious gastric motility disorder affecting many patients. The study, involving 24 patients across 8 U.S. centers, seeks to demonstrate PCS12852's efficacy in improving gastric emptying rates and alleviating associated symptoms. This trial follows positive results from previous studies and is expected to provide pivotal data for future trials, targeting a market potentially exceeding $1B. The topline data is anticipated by the end of 2022.
Processa Pharmaceuticals (Nasdaq: PCSA) announced its financial results for 2021 and provided a corporate update. Despite challenges from COVID-19, the company progressed in clinical trials for PCS499 (uNL treatment), PCS6422 (GI cancer), and PCS12852 (gastroparesis). In 2021, Processa managed to raise its cash balance to $16.5 million, reporting a reduced net loss of $11.4 million. The upcoming milestones for 2022 include clinical trials and a focus on personalized medicine approaches, highlighting potential markets exceeding $1 billion.
Processa Pharmaceuticals (Nasdaq: PCSA) has announced a conference call scheduled for March 30, 2022, at 4:30 p.m. EST. The purpose of the call is to discuss the fourth quarter 2021 results and provide an update on its clinical pipeline. Interested participants can join via live webcast or by dialing in. Notable pipeline programs include PCS6422 for cancer and PCS499 for ulcerative necrobiosis lipoidica. The company focuses on developing treatments for patients with unmet medical needs.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) announced that CEO Dr. David Young will present at the Oppenheimer 32nd Annual Healthcare Conference on March 17, 2022, at 10:00 AM Eastern. The live webcast will be available in the Investor Relations section of Processa's website, with a replay to follow. Processa focuses on developing treatments for patients with unmet medical needs, including programs for metastatic colorectal and breast cancer, ulcerative necrobiosis lipoidica, and GI motility disorders. The company has a team with extensive FDA drug approval experience.
Processa Pharmaceuticals (Nasdaq: PCSA) shared a letter to shareholders detailing its accomplishments in 2021 and future plans for 2022. The company aims to initiate multiple Phase 3 trials and has a pipeline targeting unmet medical needs. Despite challenges in patient enrollment due to COVID-19, Processa successfully in-licensed PCS3117 for pancreatic cancer and progressed on several trials including PCS499 for ulcerative necrobiosis lipoidica and PCS12852 for gastroparesis. The company emphasizes its 'Regulatory Science' approach to de-risk drug development. Cash reserves are sufficient for upcoming clinical trials.
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