Recent Quotes View Full List My Watchlist Create Watchlist Indicators DJI Nasdaq Composite SPX Gold Crude Oil Hydroworld Market Index Markets Stocks ETFs Tools Overview News Currencies International Treasuries InvestorNewsBreaks – Processa Pharmaceuticals Inc. (NASDAQ: PCSA) to Conduct NGC-Cap Trial Based on FDA Guidance and Project Optimus Oncology Initiative By: Investor Brand Network May 18, 2023 at 11:07 AM EDT Processa Pharmaceuticals (NASDAQ: PCSA) today announced its receipt of guidance from the U.S. Food and Drug Administration (“FDA”) regarding the company’s next trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”). The phase 2 safety-efficacy trial will study a combination of PCS6422 and capecitabine for colorectal cancer patients following the principles of FDA’s Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward. “Our communications with the FDA have been extremely productive,” said David Young, Pharm.D., Ph.D., Processa’s president and CEO. “One of the most important advantages of NGC-Cap and all our NGC drugs is that they have been designed to decrease the side effects associated with the treatment while increasing the exposure of cancer cells to proven cancer-killing molecules. These changes are expected to increase the number of patients who will benefit from each NGC drug given fewer side effects as well as have a significant impact on a patient’s response.” To view the full press release, visit https://ibn.fm/lKP0s About Processa Pharmaceuticals Inc. Processa is a clinical stage pharmaceutical company focused on developing Next Generation Chemotherapy (“NGC”) drugs intended to improve the safety, tolerability and efficacy of cancer treatment. Some of the key advantages of Processa’s NGCs are expected to be fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and an increase in the number of patients who will benefit from each NGC drug. The NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. By combining the proven cancer-killing active molecules and the Processa Regulatory Science Approach with FDA’s new Project Optimus Oncology Initiative, Processa can provide better therapeutic options to cancer patients more efficiently while increasing the probability of FDA approval. Using its Regulatory Science Approach, the Processa team has consistently demonstrated its ability to obtain FDA approvals as evidenced by over 30 approvals for indications across almost every division of the FDA. The company’s pipeline includes three Next Generation Chemotherapy oncology treatments: Next Generation Capecitabine (“PCS6422” and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (“PCS3117” to treat pancreatic, biliary duct, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (“PCS11T” to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers). For more information, visit the company’s website at www.ProcessaPharma.com. NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA About InvestorWire InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. As part of its service, InvestorWire provides coverage of noteworthy announcements. To further expand visibility of achievements being made throughout a multitude of sectors, InvestorWire’s syndication partners have extended the digital coverage to include individual broadcasts on financial websites and platforms visited by millions of investors daily. For more information, please visit https://www.InvestorWire.com Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://ibn.fm/Disclaimer InvestorWire (IW)8033 Sunset Blvd Suite 1037-IWLos Angeles, CA 90046310.299.1717 Officewww.InvestorWire.comEditor@InvestorWire.com InvestorWire is part of the InvestorBrandNetwork Data & News supplied by www.cloudquote.io Stock quotes supplied by Barchart Quotes delayed at least 20 minutes. By accessing this page, you agree to the following Privacy Policy and Terms and Conditions.
InvestorNewsBreaks – Processa Pharmaceuticals Inc. (NASDAQ: PCSA) to Conduct NGC-Cap Trial Based on FDA Guidance and Project Optimus Oncology Initiative By: Investor Brand Network May 18, 2023 at 11:07 AM EDT Processa Pharmaceuticals (NASDAQ: PCSA) today announced its receipt of guidance from the U.S. Food and Drug Administration (“FDA”) regarding the company’s next trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”). The phase 2 safety-efficacy trial will study a combination of PCS6422 and capecitabine for colorectal cancer patients following the principles of FDA’s Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward. “Our communications with the FDA have been extremely productive,” said David Young, Pharm.D., Ph.D., Processa’s president and CEO. “One of the most important advantages of NGC-Cap and all our NGC drugs is that they have been designed to decrease the side effects associated with the treatment while increasing the exposure of cancer cells to proven cancer-killing molecules. These changes are expected to increase the number of patients who will benefit from each NGC drug given fewer side effects as well as have a significant impact on a patient’s response.” To view the full press release, visit https://ibn.fm/lKP0s About Processa Pharmaceuticals Inc. Processa is a clinical stage pharmaceutical company focused on developing Next Generation Chemotherapy (“NGC”) drugs intended to improve the safety, tolerability and efficacy of cancer treatment. Some of the key advantages of Processa’s NGCs are expected to be fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and an increase in the number of patients who will benefit from each NGC drug. The NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. By combining the proven cancer-killing active molecules and the Processa Regulatory Science Approach with FDA’s new Project Optimus Oncology Initiative, Processa can provide better therapeutic options to cancer patients more efficiently while increasing the probability of FDA approval. Using its Regulatory Science Approach, the Processa team has consistently demonstrated its ability to obtain FDA approvals as evidenced by over 30 approvals for indications across almost every division of the FDA. The company’s pipeline includes three Next Generation Chemotherapy oncology treatments: Next Generation Capecitabine (“PCS6422” and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (“PCS3117” to treat pancreatic, biliary duct, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (“PCS11T” to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers). For more information, visit the company’s website at www.ProcessaPharma.com. NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA About InvestorWire InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. As part of its service, InvestorWire provides coverage of noteworthy announcements. To further expand visibility of achievements being made throughout a multitude of sectors, InvestorWire’s syndication partners have extended the digital coverage to include individual broadcasts on financial websites and platforms visited by millions of investors daily. For more information, please visit https://www.InvestorWire.com Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://ibn.fm/Disclaimer InvestorWire (IW)8033 Sunset Blvd Suite 1037-IWLos Angeles, CA 90046310.299.1717 Officewww.InvestorWire.comEditor@InvestorWire.com InvestorWire is part of the InvestorBrandNetwork
Processa Pharmaceuticals (NASDAQ: PCSA) today announced its receipt of guidance from the U.S. Food and Drug Administration (“FDA”) regarding the company’s next trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”). The phase 2 safety-efficacy trial will study a combination of PCS6422 and capecitabine for colorectal cancer patients following the principles of FDA’s Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward. “Our communications with the FDA have been extremely productive,” said David Young, Pharm.D., Ph.D., Processa’s president and CEO. “One of the most important advantages of NGC-Cap and all our NGC drugs is that they have been designed to decrease the side effects associated with the treatment while increasing the exposure of cancer cells to proven cancer-killing molecules. These changes are expected to increase the number of patients who will benefit from each NGC drug given fewer side effects as well as have a significant impact on a patient’s response.” To view the full press release, visit https://ibn.fm/lKP0s About Processa Pharmaceuticals Inc. Processa is a clinical stage pharmaceutical company focused on developing Next Generation Chemotherapy (“NGC”) drugs intended to improve the safety, tolerability and efficacy of cancer treatment. Some of the key advantages of Processa’s NGCs are expected to be fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and an increase in the number of patients who will benefit from each NGC drug. The NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. By combining the proven cancer-killing active molecules and the Processa Regulatory Science Approach with FDA’s new Project Optimus Oncology Initiative, Processa can provide better therapeutic options to cancer patients more efficiently while increasing the probability of FDA approval. Using its Regulatory Science Approach, the Processa team has consistently demonstrated its ability to obtain FDA approvals as evidenced by over 30 approvals for indications across almost every division of the FDA. The company’s pipeline includes three Next Generation Chemotherapy oncology treatments: Next Generation Capecitabine (“PCS6422” and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (“PCS3117” to treat pancreatic, biliary duct, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (“PCS11T” to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers). For more information, visit the company’s website at www.ProcessaPharma.com. NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA About InvestorWire InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. As part of its service, InvestorWire provides coverage of noteworthy announcements. To further expand visibility of achievements being made throughout a multitude of sectors, InvestorWire’s syndication partners have extended the digital coverage to include individual broadcasts on financial websites and platforms visited by millions of investors daily. For more information, please visit https://www.InvestorWire.com Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: http://ibn.fm/Disclaimer InvestorWire (IW)8033 Sunset Blvd Suite 1037-IWLos Angeles, CA 90046310.299.1717 Officewww.InvestorWire.comEditor@InvestorWire.com InvestorWire is part of the InvestorBrandNetwork