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, Inc. (Nasdaq: PCSA) has announced significant advancements in its clinical trials and financial results for the year ending December 31, 2022. The company focuses on the development of Next Generation Chemotherapy drugs, particularly the Next Generation Capecitabine, which aims to reduce side effects experienced by patients on standard capecitabine. A successful Phase 2A trial for PCS12852 also opens avenues for out-licensing opportunities. Financially, Processa reported a net loss of $27.4 million and a cash balance of $6.5 million as of year-end. Funds raised post-year-end are expected to support operations into Q3 2024.
Processa Pharmaceuticals (Nasdaq: PCSA) has announced a conference call scheduled for March 30, 2023, at 4:30 p.m. EST. The call will cover the company’s 2022 results and updates on its clinical pipeline for 2023. Interested participants can join via teleconference or live webcast. The call aims to discuss the development of Next Generation Chemotherapy drugs aimed at improving the safety and efficacy profiles compared to existing treatments. Processa is currently developing three oncology treatments, including PCS6422 and PCS3117, targeting various cancers.
Processa Pharmaceuticals (Nasdaq: PCSA) has successfully dosed the first patient in its 300 mg group for the NGC-Capecitabine trial, a crucial step for assessing drug exposure against adverse events for FDA approval. This innovative chemotherapy aims to improve treatment outcomes without the severe side effects commonly associated with capecitabine, such as hand-foot syndrome and cardiotoxicity, which occur in 50-70% of current patients. The company anticipates FDA guidance on its Phase 2B trial in mid-April, enhancing collaboration under Project Optimus Oncology. The enrollment for the Phase 1B trial is expected to complete by mid-2023, with hopes of commencing the Phase 2B trial in the second half of the year.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announced that President & CEO, Dr. David Young, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 12:00 PM Eastern. The presentation will be available via a live webcast on the company’s Investor Relations website. Processa is focused on developing Next Generation Chemotherapy drugs with improved safety and efficacy compared to existing FDA-approved options. Their pipeline includes Next Generation Capecitabine, Gemcitabine, and Irinotecan, targeting various cancers like colorectal, breast, and pancreatic.
For more information, visit Processa's website.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) emphasizes its focus on Next Generation Chemotherapies (NGCs), which are modifications of existing FDA-approved cancer treatments to enhance safety and efficacy. Clinical studies suggest NGCs could benefit more patients compared to traditional chemotherapy options like capecitabine and gemcitabine. The company plans FDA meetings in 2023 to discuss development phases and the implementation of Project Optimus. Processa is also exploring partnerships for non-oncology assets while prioritizing clinical trials for three specific NGCs aimed at treating various cancers.
Processa Pharmaceuticals (Nasdaq: PCSA) has successfully closed a $6.25 million registered direct offering of 7,812,544 common shares at $0.80 each. The offering was facilitated by Spartan Capital Securities, LLC, providing funds intended for future clinical trials, research and development, and general corporate needs. This transaction is part of a shelf registration filed with the SEC, allowing efficient capital raising. Processa aims to enhance treatment options for patients with unmet medical needs through its next-generation chemotherapy drugs.
Processa Pharmaceuticals (Nasdaq: PCSA) has announced a registered direct offering of 7,812,544 common shares at $0.80 each, aiming to raise approximately $6.25 million. The offering is set to close around February 14, 2023, pending standard conditions. Proceeds will be allocated to future clinical trials, research and development, and general corporate purposes. Spartan Capital Securities, LLC is acting as the placement agent. The shares will be offered under a previously filed effective shelf registration statement with the SEC. Processa focuses on developing innovative chemotherapy drugs to address unmet medical needs.
Processa Pharmaceuticals (Nasdaq: PCSA) will present its strategic focus at the Biotech Showcase on January 11, 2023, at 10 AM. CEO Dr. David Young will detail the company's therapeutic direction and engage with potential investors during the J.P. Morgan Annual HealthCare Conference week. The firm aims to meet the needs of patients with unmet conditions through its clinical pipeline, including treatments for various cancers and gastrointestinal disorders. Forward-looking statements highlight possible risks and uncertainties in achieving future milestones.
Processa Pharmaceuticals (Nasdaq: PCSA) reported positive results from a Phase 2A study of PCS12852 for treating gastroparesis. The 0.5 mg daily dose over 28 days significantly improved symptoms, with a greater percentage of patients achieving clinically meaningful reductions compared to placebo. Notably, 100% of patients on the 0.5 mg dose saw improvements. The study also indicated that longer treatment durations may yield even better results. These findings support the initiation of a Phase 2B trial in 2023.
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