Processa Pharmaceuticals Announces Results From Phase 1b Trial Of Next Generation Capecitabine For Stage III/IV GI Cancer, Establishing Maximum Tolerated Dose And Recommended Phase 2 Dose Range

6/11/24 8:21:09 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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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

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Recent Analyst Ratings for
$PCSA

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

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$PCSA
Leadership Updates

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Processa Pharmaceuticals Names Russell L. Skibsted as Chief Financial Officer
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
7/17/24 8:00:00 AM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer
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
1/19/24 7:45:00 AM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals Appoints Life Sciences Industry Veteran George Ng as Chief Executive Officer
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
8/8/23 8:15:00 AM ET
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Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results
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 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 nine months ended September 30, 2024. "We continued to make progres
10/30/24 4:15:00 PM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer
Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabineResults 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 company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. "Dosi
10/2/24 4:05:00 PM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals to Participate in Investor and Industry Conferences During September
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 26th 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 company presentation. The recorded presentation will be available on demand beginning Monday, September 9th at 7:00am Eastern time on the Investors section of Processa's website and here.European Society for Medical Oncology (ESMO) Congress 2024, September 13-17, 2024, in Bar
9/3/24 8:00:00 AM ET
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Financials

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Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results
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 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 nine months ended September 30, 2024. "We continued to make progres
10/30/24 4:15:00 PM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals Provides Product Pipeline and Financial Update
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
8/28/24 8:00:00 AM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care
Processa Pharmaceuticals to Host Conference Call to Discuss 2022 Year End Results and Provide Drug Development Update on March 30, 2023 at 4:30 p.m. EST
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
3/23/23 8:30:00 AM ET
$PCSA
Biotechnology: Pharmaceutical Preparations
Health Care

Processa Pharmaceuticals Announces Results From Phase 1b Trial Of Next Generation Capecitabine For Stage III/IV GI Cancer, Establishing Maximum Tolerated Dose And Recommended Phase 2 Dose Range

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Recent Analyst Ratings for $PCSA

$PCSA Leadership Updates

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Processa Pharmaceuticals Names Russell L. Skibsted as Chief Financial Officer

Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer

Processa Pharmaceuticals Appoints Life Sciences Industry Veteran George Ng as Chief Executive Officer

$PCSA Insider Purchases

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Young David bought $51,526 worth of shares (21,000 units at $2.45), increasing direct ownership by 36% to 79,387 units (SEC Form 4)

Young David bought $50,504 worth of shares (20,000 units at $2.53) (SEC Form 4)

Lin Patrick bought $9,525 worth of shares (4,000 units at $2.38), increasing direct ownership by 17% to 27,478 units (SEC Form 4)

$PCSA Press Releases

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Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results

Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer

Processa Pharmaceuticals to Participate in Investor and Industry Conferences During September

$PCSA Market Insights

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$PCSA Insider Trading

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Processa Pharmaceuticals Appoints Russell L. Skibsted As CFO

HC Wainwright & Co. Reiterates Buy on Processa Pharma, Maintains $8 Price Target

Processa Pharmaceuticals shares are trading higher after the company announced efficacy results from a preliminary evaluation of its Phase 1b dose-escalating trial with NGC-Cap in gastrointestinal cancer.

SEC Form 4 filed by Director Yorke Justin W

SEC Form 4 filed by Director Pannu Geraldine

SEC Form 4 filed by Director Neal James R

$PCSA Large Ownership Changes

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SEC Form SC 13G/A filed by Processa Pharmaceuticals, Inc. (Amendment)

SEC Form SC 13G filed by Processa Pharmaceuticals, Inc.

SEC Form SC 13G/A filed by Processa Pharmaceuticals, Inc. (Amendment)

$PCSA Financials

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Processa Pharmaceuticals Reports Third Quarter Business Highlights and Financial Results

Processa Pharmaceuticals Provides Product Pipeline and Financial Update

Processa Pharmaceuticals to Host Conference Call to Discuss 2022 Year End Results and Provide Drug Development Update on March 30, 2023 at 4:30 p.m. EST

$PCSA Analyst Ratings

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H.C. Wainwright initiated coverage on AirGate PCS with a new price target

Oppenheimer initiated coverage on Processa Pharmaceuticals with a new price target

Oppenheimer initiated coverage on Processa Pharmaceuticals with a new price target

$PCSA SEC Filings

Processa Pharmaceuticals Inc. filed SEC Form 8-K: Changes in Registrant's Certifying Accountant, Financial Statements and Exhibits

SEC Form 10-Q filed by Processa Pharmaceuticals Inc.

Processa Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

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