Processa Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, focuses on the development of drug products for the treatment of patients with unmet medical needs in the United States. Its lead product candidate is PCS499, an oral tablet that is in Phase II clinical trials for the treatment of necrobiosis lipoidica, a chronic disfiguring condition. The company is also developing PCS12852, a novel selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist that is in Phase II clinical trials for the treatment of gastroparesis; and PCS6422, an oral, potent, selective, and irreversible inhibitor that is in Phase I clinical trials for treating metastatic colorectal and breast cancer. It has a license agreement with Akashi Therapeutics, Inc. to develop and commercialize PCS100, an anti-fibrotic and anti-inflammatory drug. The company was incorporated in 2011 and is based in Hanover, Maryland.
IPO Year:
Exchange: NASDAQ
Website: processapharmaceuticals.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
4/25/2024 | $8.00 | Buy | H.C. Wainwright |
8/3/2021 | $20.00 | Outperform | Oppenheimer |
8/2/2021 | $20.00 | Outperform | Oppenheimer |
Phase 2 trial with NGC-Cap in breast cancer underway NGC-Cap Phase 1b trial demonstrated a favorable safety profile with preliminary anti-tumor activity Preclinical studies demonstrated NGC-Iri delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde® HANOVER, Md., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and six mont
Delivers more cancer-killing SN-38 molecules to tumor than irinotecan and Onivyde® Studies support potential benefit as an improved treatment with fewer side effects HANOVER, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) announces positive data from preclinical studies that support the potential for NGC-Iri to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde® (the liposomal formulation of irinotecan). Next Generation irinotecan (NGC-Iri) is a prodrug of SN-38, which is the active anticancer metabolite of irinotecan. In two studies with the human melanoma xen
Open-label Phase 2 trial in breast cancer to begin this quarter Initial data expected mid-2025 HANOVER, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate. The IND supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is expected
HANOVER, Md., July 17, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, announces the appointment of Russell L. Skibsted as Chief Financial Officer (CFO), effective immediately. Mr. Skibsted succeeds James Stanker, who is retiring and staying on in an advisory role to assist in the transition. "We are delighted to welcome Russell to Processa's executive team. His proven record in finance and capital markets combined with a deep understanding of the complexities inherent in the life sciences make him a
Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 months At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD) For all NGC-Cap doses, 5-Fluorouracil (5-FU) exposure was greater and fluoro-beta-alanine (FBAL) exposure was lower with a better or similar side-effect profile than monotherapy capecitabine HANOVER, MD., June 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today
HANOVER, Md., May 06, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that management will be participating in the EF Hutton Annual Global Conference being held May 15, 2024 at The Plaza Hotel in New York City. Management will be holding one-on-one meetings with investors. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (NGC) drugs to improve the safety and efficacy of cancer treat
Brings extensive experience in all phases of oncology drug development HANOVER, Md., April 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that it has named Steven Cha, M.D. as Senior Vice President of Clinical Research. In this newly created position, Dr. Cha's experience as an oncologist as well as in oncology drug development will be important additions to Processa. "We are delighted to have Dr. Cha join our team to lead the clinical development of our three oncology progr
NGC-Cap demonstrated greater 5-FU exposure than monotherapy capecitabine at a significantly lower dose with a favorable clinical safety profile NGC-Cap holds potential for improved efficacy in more patients due to an increase in distribution of 5-FU to cancer cells Phase 1b study final results to be released upon database lock HANOVER, Md., April 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, presented two abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2024
HANOVER, MD, March 28, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces that George Ng, Chief Executive Officer, will present a corporate update at the MedInvest Biotech and Pharma Investor Conference. David Young, Processa's President of Research & Development, will participate virtually. The conference is being held on April 3 – 4, 2024 at Cooley Law, 55 Hudson Yards, New York, NY 10001. Presentation Date:Wednesday, April 3, 2024Time:10:55am E
HANOVER, MD, March 25, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces that the Company will have two posters at the American Association for Cancer Research Annual Meeting 2024 in San Diego from April 5-10, 2024. David Young, PharmD, Ph.D., President of Research and Development at Processa, will be available during the allotted times below and, along with Processa CEO George Ng, will be available for 1-on-1 meetings. The following posters will b
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H.C. Wainwright initiated coverage of AirGate PCS with a rating of Buy and set a new price target of $8.00
Oppenheimer initiated coverage of Processa Pharmaceuticals with a rating of Outperform and set a new price target of $20.00
Oppenheimer initiated coverage of Processa Pharmaceuticals with a rating of Outperform and set a new price target of $20.00
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HANOVER, Md., July 17, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, announces the appointment of Russell L. Skibsted as Chief Financial Officer (CFO), effective immediately. Mr. Skibsted succeeds James Stanker, who is retiring and staying on in an advisory role to assist in the transition. "We are delighted to welcome Russell to Processa's executive team. His proven record in finance and capital markets combined with a deep understanding of the complexities inherent in the life sciences make him a
FDA and Processa agree to expand NGC-Cap development into breast cancer providing a more efficient path to approval FDA agrees that existing data and studies can be used to support the Phase 2 breast cancer trial design HANOVER, MD, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces it plans to expand the development of Next Generation Capecitabine ("NGC-Cap") into the treatment of advanced or metastatic breast cancer beginning with its ne
HANOVER, MD, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical-stage pharmaceutical company focusing on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces today that industry veteran George Ng has been appointed to serve as the Company's Chief Executive Officer and as a Board Director as of August 8, 2023. Dr. David Young will focus his efforts on the development of the Next Generation Chemotherapy (NGC) drugs as President of Research and Development and as a board member. "We are thrilled to have George assume the leadership of ou
Board Appointments Designed to Position Company for Anticipated Milestones While Ensuring Adherence to the Highest Governance Standards HANOVER, MD, Aug. 16, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical stage biopharmaceutical company using its Regulatory Science process to more effectively develop products to improve the survival and/or quality of life for patients who have an unmet medical need condition announced today the appointment of Khoso Baluch and James Neal to its Board of Directors. In addition to the two new Independent Directors, current board member Justin Yorke has been named Chairman of the Board. Justin Yorke, Processa Chairman state
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Phase 2 trial with NGC-Cap in breast cancer underway NGC-Cap Phase 1b trial demonstrated a favorable safety profile with preliminary anti-tumor activity Preclinical studies demonstrated NGC-Iri delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde® HANOVER, Md., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, provides updates on its product pipeline, upcoming milestones and business activities, and reports financial results for the three and six mont
HANOVER, MD, March 23, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a developer of Next Generation Chemotherapy drugs that provide a better safety-efficacy profile than their widely used FDA-approved counterparts, today announced that it will host a conference call and live webcast on March 30, 2023 at 4:30 p.m. EST to discuss its 2022 results and provide an update on its clinical pipeline for 2023. Conference Call Information To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call. Date: March 30, 2023Time: 4:30 p.m. ETToll Free: 888-506-0062Internatio
PCS12852 successfully demonstrates a positive effect on the gastric emptying rate, clearing the path for a Phase 2B trial in 2023.Next Generation Capecitabine (a combination of PCS6422 and capecitabine) successfully identifies dosing regimens for a Phase 2B trial to be initiated in 2023 after a meeting with FDA to discuss the alignment of the trial design with the FDA's Project Optimus Oncology Initiative. HANOVER, Md., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient's
HANOVER, MD, Nov. 02, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on November 8, 2022, at 4:30 p.m. EST to discuss its third quarter 2022 results and provide an update on its clinical pipeline. Conference Call Information To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call. Date: November 8, 2022Time: 4:30 p.m. ESTToll Free: 888-506-0062International: 973-528-0011En
PCS12852 on target to complete enrollment by SeptemberExpanded efforts to increase enrollment in PCS499 and PCS6422 showing results HANOVER, Md., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient's survival and/or quality of life, today announced financial results for the quarter ended June 30, 2022, and provided an update on its clinical programs. Dr. David Young, President and CEO of Processa, commented, "Our efforts to enhance enrollment through adding new sites, extensive marke
HANOVER, MD, Aug. 05, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on August 11, 2022, at 4:30 p.m. EST to discuss its second quarter 2022 results and provide an update on its clinical pipeline. Conference Call Information To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call. Date: August 11, 2022Time: 4:30 p.m. ETToll Free: 877-545-0320International: 973-528-0002 Ent
Amended Next Generation Capecitabine study has restarted which will elucidate timelines for de novo formation of DPDExpanded efforts for enrollment in PCS499PCS12852 on target to complete enrollment by Q3 HANOVER, Md., May 12, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient's survival and/or quality of life, today announced financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs. Dr. David Young, CEO and chairman of Processa, commented
HANOVER, MD, May 05, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on May 12, 2022 at 4:30 p.m. EST to discuss its results for the first quarter and provide an update on its clinical pipeline. Conference Call Information To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call. Date: May 12, 2022Time: 4:30 p.m. ETToll Free: 877-545-0320International: 973-528-0002 Ent
Targeting Major Milestones 2022 HANOVER, Md., March 30, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient's survival and/or quality of life, today announced financial results for the year ended December 31, 2021, and provided a corporate update. Dr. David Young, CEO and chairman of Processa, commented, "Although COVID presented challenges for us and our industry in 2021, we commenced and enrolled patients in PCS499 for the treatment of uNL, PCS6422 (Next Generation Capecitabine) for the t
HANOVER, MD, March 23, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need condition announces today it will host a conference call and live webcast on March 30, 2022, at 4:30 p.m. EST to discuss its fourth quarter 2021 results and provide an update on its clinical pipeline. Conference Call Information To participate in this event, please log-on or dial-in approximately 5 to 10 minutes before the beginning of the call. Date: March 30, 2022Time: 4:30 p.m. ETToll Free: 888-506-0062 International: 973-528-0011Entr
HC Wainwright & Co. analyst Raghuram Selvaraju reiterates Processa Pharma (NASDAQ:PCSA) with a Buy and maintains $8 price target.
Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 monthsAt the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD)For all NGC-Cap doses, 5-Fluorouracil (5-FU) exposure was greater and fluoro-beta-alanine (FBAL) exposure was lower with a better or similar side-effect profile than monotherapy capecitabine
HC Wainwright & Co. analyst Raghuram Selvaraju reiterates Processa Pharma (NASDAQ:PCSA) with a Buy and maintains $8 price target.
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