First patient dosed in Phase 2 clinical trial with NGC-Cap for metastatic breast cancer Positive data from preclinical studies support NGC-Iri’s ability to deliver more SN-38 to tumors compared with either irinotecan or Onivyde ® HANOVER, Md., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next... Read More

Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical... Read More

HANOVER, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announces that management will be participating in the following investor and industry conferences during the month of September: H.C. Wainwright 26 th Annual Global Investment Conference, September 9-11, 2024, at the Lotte New York Palace Hotel. Management will be holding one-on-one meetings with investors and will deliver a... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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,... Read More

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.... Read More

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... Read More

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)... Read More

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... Read More

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... Read More

HANOVER, MD, Feb. 21, 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 Chief Executive Officer George Ng will present a corporate update at the 2024 BIO CEO & Investor Conference... Read More

HANOVER, MD, Feb. 14, 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 that CEO George Ng will present a corporate update at The Winter Wrap-Up MicroCap Rodeo 2024 Virtual... Read More

HANOVER, MD, Feb. 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 to improve the efficacy and safety for more patients suffering from cancer, announces it has received notice from The Nasdaq Stock Market LLC (“Nasdaq”) informing the Company that it has regained... Read More

HANOVER, MD, Feb. 01, 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 the closing of its previously announced public offering consisting of 1,555,555 shares of common stock (or... Read More

HANOVER, Md., Jan. 26, 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 the pricing of a public offering consisting of 1,555,555 shares of common stock (or pre-funded warrants in... Read More

Next Generation Capecitabine (NGC-Cap) provides patients with 2-10 times greater exposure to its 5-FU cancer treatment metabolite than capecitabine administration NGC-Cap was better tolerated with positive preliminary efficacy results than FDA-approved capecitabine HANOVER, MD, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical... Read More

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... Read More

HANOVER, MD, Jan. 18, 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 in conjunction with stockholder approval of the reverse stock split on November 14, 2023, the Company’s Board... Read More

HANOVER, MD, Jan. 02, 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 overview at the Biotech Showcase 2024. The event... Read More

FDA acknowledges that NGC-Cap is a New Chemical Entity given the changes to metabolism and distribution of its major metabolite 5-FU Interim analysis of the NGC-Cap Phase 1b data shows improved safety, even with 5-FU exposure much greater than that from capecitabine Company to conduct Fireside Chat at 4:30PM ET on December 20, 2023 HANOVER, MD, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA)... Read More

FDA provides guidance on Phase 2 design and Processa to continue with pre-study activities for Phase 2 trial HANOVER, MD, Dec. 13, 2023 (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... Read More

HANOVER, MD, Nov. 30, 2023 (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 Dr. David Young, President of Research and Development, will present virtually at the MedInvest Oncology... Read More

HANOVER, MD, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces that CEO George Ng has issued a letter to shareholders. Dear Processa Pharmaceuticals Shareholders: Following... Read More

Hanover, MD., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announced today with great sadness that Virgil Thompson, Director, passed away unexpectedly on November 9, 2023. Mr. Thompson served on our Board of Directors since we were formed in 2017 and was previously on the Board of Directors of Promet Therapeutics, LLC, our predecessor. He was 83 years old. “We are all saddened by the sudden... Read More

HANOVER, MD, Nov. 09, 2023 (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 Dr. David Young, President of Research and Development, will present at the 20 th Orphan Drugs and Rare... Read More

Company To Leverage World-Class Oncology Advisory Board in the Design of Oncology Trial Protocols, Including the Anticipated Phase 2 Trial for NGC-Cap HANOVER, MD, Nov. 01, 2023 (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... Read More

HANOVER, MD, Oct. 13, 2023 (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 CEO George Ng will present an updated corporate overview at the ThinkEquity Conference. The conference is... Read More

HANOVER, MD, Sept. 06, 2023 (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 Chief Executive Officer George Ng will present a corporate overview at the at the H.C. Wainwright 25 th... Read More

Interim analysis of Phase 1B data suggests Processa’s novel chemotherapy treatment could improve safety and efficacy in more patients by individualizing the dosing regimen for each patient HANOVER, MD, Aug. 17, 2023 (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... Read More

HANOVER, MD, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces that David Young, President of Research and Development, will present a corporate overview at the Sidoti & Co.... Read More

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... Read More

HANOVER, MD, June 14, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, announces that CEO David Young, Pharm.D., Ph.D. will present at the MedInvest Oncology Investor Conference being held on... Read More

Company also to provide a corporate overview in a separate session HANOVER, MD, May 22, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, today announces CEO David Young, Pharm.D., Ph.D. will... Read More

HANOVER, MD, May 18, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”) today announces it has received guidance from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s next trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”). The trial for NGC-Cap, the combination of PCS6422 and capecitabine, will be a Phase 2 safety-efficacy trial in... Read More

PCS12852 Shown to be Safe and Efficacious in Phase 2 Proof-of-Concept Trial in Gastroparesis Patients PCS12852 Improved Both Gastroparesis Symptom Scores and Gastric Emptying Rate HANOVER, MD, April 28, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company now focused on developing the next generation of chemotherapeutic drugs to improve... Read More

Company focused on the development of Next Generation Chemotherapy drugs in 2023 and out-licensing/business development efforts for non-oncology assets. Dose escalations continue for Next Generation Capecitabine with no observed adverse events associated with the catabolites of capecitabine. FDA discussions mid-April on Next Generation Capecitabine Phase 2B trial and overall development following Project Optimus initiative.... Read More

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... Read More

The 300 mg dose group will provide more information on the drug exposure vs adverse event relationship which is critical to FDA approval given the FDA’s Project Optimus Oncology initiative. P atients treated with Next Generation Chemotherapy-Capecitabine have NOT ha d hand-foot syndrome or cardiotoxicity adverse events , typically seen in 50 -70% of patients presently on FDA-approved capecitabine . In mid-April Processa e... Read More

HANOVER, MD, March 07, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), the developer of the Next Generation Chemotherapy drugs that will provide a better safety-efficacy profile than their widely used FDA-approved counterparts, today announced that the Company’s President & CEO, Dr. David Young, will present virtually at the Oppenheimer 33rd Annual Healthcare Conference... Read More

Our Next Generation Chemotherapies ( NGC s ) are cancer treatments where the metabolism and/or distribution of an FDA-approved drug ha s been altered to provide potentially safer and more effective chemo t herapy to cancer patients . Based on preliminary clinical and pre-clinical studies, m ore cancer patients should benefit from o ur NGC s than their FDA- approved counterpart dr ugs . Our Regulatory Science approach,... Read More

HANOVER, MD., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing next generation chemotherapy 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 that it has closed its $6.25 million registered direct... Read More

HANOVER, MD., Feb. 10, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing next generation chemotherapy 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 that it has entered into definitive agreements with retail... Read More

HANOVER, MD, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), Dr. David Young, Processa Pharmaceuticals, CEO will present an update on Processa’s future therapeutic focus and strategy at the upcoming Biotech Showcase on January 11, 2023, at 10 am. This presentation will also be accessible here . Processa management is available for one-on-one meetings with potential investors and partners in... Read More

A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by greater than a 0.5 reduction in the ANMS GCSI-DD score compared to baseline. The percentage of patients who met the clinically meaningful change in symptom score was greater in the PCS12852 0.5 mg daily dose group than in the placebo or the PCS12852 0.1... Read More