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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 received FDA clearance for a Phase 2a clinical trial of PCS12852 in patients with moderate to severe gastroparesis. This condition currently has limited treatment options, primarily relying on metoclopramide, which has significant side effects. PCS12852, a selective 5-HT4 receptor agonist, shows promise due to its minimal off-target effects, potentially offering a safer alternative. The trial aims to evaluate PCS12852's efficacy in improving gastric emptying rates, targeting a market worth up to $1.6 billion. The first patient is expected to be dosed in Q1 2022.
Processa Pharmaceuticals (NASDAQ: PCSA) announced participation in two upcoming investor conferences. The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit is scheduled for September 22, 2021, at 9:05 AM (ET), with a subsequent Cantor Fitzgerald Healthcare Conference on September 29, 2021, at 10:40 AM (ET). Management plans to host one-on-one investor meetings at both events. CEO Dr. David Young emphasized the importance of proactive corporate communications and aligned goals with shareholders, as they approach key milestones in drug development.
Processa Pharmaceuticals (NASDAQ: PCSA) announced its participation in two upcoming investor conferences. The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit is scheduled for September 22, 2021, at 9:05 AM (ET), with a webcast available here. The Cantor Fitzgerald Healthcare Conference will follow on September 29, 2021, at 10:40 AM (ET), with a webcast accessible here. One-on-one investor meetings will also be hosted during these events.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) is set to present at the World Orphan Drug Congress USA 2022 from August 25-27, 2022. Dr. David Young, CEO, will discuss 'Balancing the Benefit-Risk of an Orphan Drug: Case Studies' on August 25 at 1:30 PM ET. The company's mission focuses on developing treatments for patients with unmet medical needs, showcasing three drugs in clinical development targeting various cancers and other conditions. For more details, visit www.ProcessaPharma.com.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) reported significant advancements in its clinical programs, including the addition of RX-3117 as a fourth asset. Financial results for Q2 2021 show cash reserves of $20.8 million, up from $15.4 million in December 2020. The company announced a net loss of $3.2 million for the quarter, compared to $733,000 in Q2 2020. Key milestones ahead include filing an IND for PCS12852 and interim data for PCS6422 by Q4 2021. Processa targets markets worth $500 million to $1.5 billion with its clinical programs.
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) will hold a conference call on August 12, 2021, at 5:30 p.m. EST to discuss second quarter results and updates on its clinical pipeline. The company focuses on developing treatments for patients with high unmet medical needs, currently advancing three drugs: PCS499 for Ulcerative Necrobiosis, PCS3117 for metastatic pancreatic and non-small cell lung cancers, and PCS6422 for metastatic colorectal and breast cancers. An IND for PCS12852 targeting gastroparesis is expected in 3Q2021.
Processa Pharmaceuticals has initiated its Phase 1b clinical trial for PCS6422, targeting patients with advanced, refractory gastrointestinal cancer. The first patient has been dosed in this multicenter study, which aims to assess the safety and pharmacokinetics of PCS6422 in combination with capecitabine. Interim results are expected by the end of 2021, with further studies planned for 2022 to establish maximum tolerated doses and biomarkers. The trial represents a significant step in developing therapies for patients with unmet needs in cancer treatment.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) will present at the "Zooming with LD Micro" virtual investor event on July 29, 2021, at 12:00 PM ET. Investors can register for the event on the company's website. Processa focuses on developing treatments for unmet medical needs and has a team experienced in over 30 FDA drug approvals. The company emphasizes improving patient survival and quality of life through its innovative products.
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) will present at the Access to Giving Virtual Conference on July 14, 2021, at 10:30 a.m. ET. The presentation will be led by CEO Dr. David Young. The conference targets a range of companies and facilitates one-on-one meetings with qualified investors, who will donate to participate. Processa focuses on developing treatments for unmet medical needs, supported by a team with extensive FDA approval experience. For registration, visit here.
Processa Pharmaceuticals (NASDAQ: PCSA) has entered into a licensing agreement with Ocuphire Pharma (NASDAQ: OCUP) for RX-3117, an oral anticancer agent with FDA Orphan Designation for pancreatic cancer. The agreement grants Processa an exclusive worldwide license (excluding China) to develop and commercialize RX-3117. A Phase 2b trial is set to begin in 2022 to evaluate biomarker correlations and clinical effectiveness in patients with pancreatic and non-small cell lung cancer. The program aims to improve treatment options for patients needing better survival rates.
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