AzurRx BioPharma

First Wave Biopharma, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

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Entero Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the research and development of non-systemic therapies for the treatment of gastrointestinal diseases. The firm is involved in a therapeutic development pipeline populated with multiple clinical stage programs built around its proprietary technologies, such as Niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties, and the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. Its programs include FW-UP, FW-UC, FW-CD, FW-COV, FW-ICI-AC, MS1819, COVID-19 GI infections, and FW-EPI. The company was founded on January 30, 2014 and is headquartered in Boca Raton, FL.

DELRAY BEACH, Fla., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chief Executive Officer, will present at the BIO CEO & Investor Digital Conference taking place February 16-18, 2021. The presentation will be available on demand during the virtual event for all registered attendees.

AzurRx BioPharma to Present at BIO CEO & Investor Digital Conference

$8 Million Offering to Fuel Acquisitions and Clinical Studies Leading Therapeutic for COVID-19 Related Gastrointestinal Infections. MS1819 a Better Mousetrap vs Porcine Competitors.

AzurRx Officially A COVID-19 Play - The Right Dose For Your Portfolio

DELRAY BEACH, Fla., Jan. 28, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted non-systemic, recombinant therapies for gastrointestinal (GI) diseases, today announced the completion of patient enrollment in the first cohort of the Phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

AzurRx BioPharma Announces Completion of Enrollment in First Cohort of Phase 2b OPTION 2 Extension Study of MS1819

AzurRx BioPharma (NASDAQ: AZRX) shares are trading higher Friday amid a surge in session volume for the day. On Thursday, the company announced it has started dosing in the mid-stage cystic fibrosis study of MS1819.

Why AzurRx BioPharma Is Trading Sharply Higher Today

AzurRX (AZRX) is developing its pipeline candidate, MS1819, as monotherapy as well in combination with standard of care for treating exocrine pancreatic insufficiency in patients with cystic fibrosis.

AzurRx (AZRX) Starts Dosing in Pancreatic Insufficiency Study

DELRAY BEACH, Fla., Jan. 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, and First Wave Bio, Inc., (“First Wave Bio”) a clinical-stage biotechnology company developing novel gut-targeted small molecules for inflammatory bowel disease and other serious conditions, today jointly announced the United States Patent and Trademark Office (USPTO) has provided a notice of allowance for issuance of a patent (U.S. patent application number 16/835,307) that covers use of niclosamide as a treatment for COVID-19-associated GI disease.

AzurRx BioPharma and First Wave Bio Announce Allowance of U.S. Patent Application for Niclosamide as Treatment for COVID-19 Gastrointestinal Infections

DELRAY BEACH, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that the Company will be participating in the virtual H.C. Wainwright BioConnect 2021 Conference.

AzurRx BioPharma to Participate in H.C. Wainwright BioConnect 2021 Virtual Conference

DELRAY BEACH, Fla., Jan. 04, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a company specializing in the development of non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has signed an exclusive worldwide licensing agreement with First Wave Bio, Inc. (“First Wave”) for the use of their patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and COVID-19 GI infections.

AzurRx BioPharma Announces Exclusive Worldwide License Agreement with First Wave Bio for Use of Proprietary Niclosamide Formulations to Treat Immune Checkpoint Inhibitor-Associated Colitis and COVID-19 Gastrointestinal Infections

DELRAY BEACH, Fla., Nov. 30, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

AzurRx BioPharma Announces First Patients Dosed in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

Potential to add additional study arm utilizing immediate release capsules

AzurRx BioPharma Requests Protocol Amendment to Phase 2b OPTION 2 Study of MS1819 in Cystic Fibrosis Patients

DELRAY BEACH, Fla., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has signed a binding letter of intent with Asymchem, a leading global contract development and manufacturing service (CDMO) provider, for the development and production of MS1819 for the treatment of exocrine pancreatic insufficiency.

AzurRx BioPharma Identifies Asymchem as Potential Partner of Choice for MS1819 Phase 3 Clinical Trial Drug Production

NEW YORK, Oct. 29, 2020 (GLOBE NEWSWIRE) -- via InvestorWire -- AzurRx BioPharma, Inc. ( NASDAQ: AZRX ) (“AzurRx” or the “Company”), a New York-based biopharmaceutical company specializing in the development of therapeutic proteins for the treatment of patients with gastrointestinal disorders, today provides insight on the usage of porcine products in producing pharmaceuticals and medicinals and the inherent downsides associated with this usage, as well as updates regarding its own efforts to develop synthetic alternatives to porcine ingredients.

AzurRx BioPharma Provides Insight into Drawbacks of Using Porcine Products in Production of Pharmaceuticals and Medicinals, Offers Update on Efforts to Produce Synthetic Alternatives

NEW YORK, Oct. 21, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced the formation of a Scientific Advisory Board (SAB) including three of the leading global experts in exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis.

AzurRx BioPharma Announces Formation of Scientific Advisory Board

NEW YORK, Oct. 14, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has activated two trial sites in Turkey for its Phase 2 Combination Therapy clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with severe exocrine pancreatic insufficiency (EPI). A total of eight of the expected twelve sites in Europe are now active and recruiting patients.

AzurRx BioPharma Activates Additional Clinical Trial Sites in Turkey for Phase 2 Combination Therapy Trial of MS1819 in Cystic Fibrosis

AzurRx BioPharma Announces Two Abstracts Accepted for Presentation at the 2020 North American Cystic Fibrosis Virtual Conference

NEW YORK, Aug.  31, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be making company presentations at two upcoming investor conferences: the 2020 H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14th at 4:30 p.m. Eastern Time and the 2020 LD 500 Virtual Conference on Friday, September 4th at 11:40 a.m. Eastern Time.

AzurRx BioPharma to Present at the 2020 H.C. Wainwright 22nd Annual Global Investment Conference (September 14) and the LD 500 Virtual Conference (September 4)

NEW YORK, Aug.  17, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its initial European trial sites are active and screening patients for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). A total of nine of the expected fifteen sites globally are now active and recruiting patients. Top line data from the study are anticipated in Q1 2021.

AzurRx BioPharma Initiates European Arm of Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis

NEW YORK, Aug.  13, 2020  (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that is has enrolled the first three patients in its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial will enroll approximately 30 CF patients with top line data from the study anticipated in 1H 2021.

AzurRx BioPharma Announces First Patients Dosed in Phase 2b OPTION 2 Clinical Trial of MS1819 in Cystic Fibrosis

NEW YORK, Aug.  12, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

AzurRx BioPharma CEO Issues Clarifying Statement to Shareholders

Management to discuss the interim results on call scheduled for today, August 11, 2020, at 4:30 p.m. Eastern Time

AzurRx BioPharma Announces Positive Interim Data From First Patient Cohort in Phase 2 Clinical Trial of MS1819 in Combination with PERT Therapy in the Treatment of Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency

NEW YORK, July 22, 2020 /PRNewswire/ -- Purcell Julie & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of AzurRx BioPharma, Inc. (NASDAQ: AZRX).

SHAREHOLDER ALERT: Purcell Julie & Lefkowitz LLP Is Investigating AzurRx BioPharma, Inc. for Potential Breaches of Fiduciary Duty By Its Board of Directors

NEW YORK, July  22, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has initiated its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI) with the activation of three clinical sites and initial screening of the first patient.  Top line data from the study are anticipated in Q1 2021.

AzurRx BioPharma Initiates Phase 2b Clinical Trial of MS1819 in Cystic Fibrosis – with First Patient Screened and Three Clinical Trial Sites Activated

NEW YORK, July  20, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma (NASDAQ:  AZRX ), (“AzurRx” or the “Company”), today announced that on July 16, 2020, it entered into a Convertible Preferred Stock and Warrant Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited and institutional investors relating to the private placement (the “Private Placement”) of certain shares of convertible preferred stock and warrants for cash and in exchange for certain outstanding promissory notes as described below.

AzurRx BioPharma Closes $15.2 Million Private Placement and $6.9 Million Convertible Note Exchange

NEW YORK, May  07, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX ) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has entered into an agreement with Creapharm Clinical Supplies (“Creapharm”), a leader in clinical trial supply services, for the packaging, labelling and distribution of Phase 2 clinical trial drug product supply of its MS1819 therapy for the treatment of exocrine pancreatic insufficiency (EPI). 

AzurRx BioPharma Announces Entry into Packaging, Labeling and Distribution Agreement with Creapharm Clinical Supplies for MS1819 Clinical Trial Drug Product

NEW YORK, April  21, 2020  (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

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