AZURRX BIOPHARMA, INC. (NASDAQ:AZRX) Files An 8-K Regulation FD Disclosure
Item 9.01. Regulation FD Disclosure.
AZURRX BIOPHARMA, INC. (NASDAQ:AZRX) Files An 8-K Regulation FD Disclosure
See Item 9.01 below.
Item 9.01. Other Events.
On September 25, 2019, AzurRx BioPharma, Inc. (the “Company”) issued a press release announcing positive results from its Phase 2 clinical trial with MS1819, the Company’s lead product candidate, for the treatment of exocrine pancreatic insufficiency in cystic fibrosis (the “Phase 2 Trial”). A copy of the press release is attached hereto as Exhibit 99.1.
The Company’s management also hosted a conference call on September 25, 2019 to discuss the results of the Phase 2 Trial. A copy of the presentation utilized during the conference call is attached hereto as Exhibit 99.2.
The information in this Item 9.01 of this Current Report onForm8-K,including the information set forth in Exhibits99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibits 99.1 or 99.2 filed herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
In addition, this Current Report on Form 8-K and the exhibit(s) attached hereto may contain, among other things, certain forward-looking statements ∆within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company\’s plans, objectives, expectations and intentions; and (ii) other statements identified by words such as \”may\”, \”could\”, \”would\”, \”should\”, \”believes\”, \”expects\”, \”anticipates\”, \”estimates\”, \”intends\”, \”plans\” or similar expressions. These statements are based upon the current beliefs and expectations of the Company\’s management and are subject to significant risks and uncertainties.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits
AzurRx BioPharma, Inc. Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE Blueprint Exhibit 99.1 AzurRx BioPharma Announces Positive Results from Phase 2 Trial with MS1819 in Cystic Fibrosis Patients Excellent safety results seen in CF patients,…
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EX-99.1 2 ex99-1.htm PRESS RELEASE Blueprint Exhibit 99.1 AzurRx BioPharma Announces Positive Results from Phase 2 Trial with MS1819 in Cystic Fibrosis Patients Excellent safety results seen in CF patients,…
To view the full exhibit click
here
About AZURRX BIOPHARMA, INC. (NASDAQ:AZRX)
AzurRx BioPharma, Inc. is a clinical development-stage biopharmaceutical company. The Company is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal (GI) disorders. The Company’s product pipeline consists of two therapeutic proteins, such as MS1819 and AZX1101. MS1819 is an acid-resistant secreted lipase produced by Yarrowia lipolytica, known as LIP2, that the Company is developing through recombinant deoxyribonucleic acid (DNA) technology for the treatment of exocrine pancreatic insufficiency (EPI), associated with chronic pancreatitis (CP) and cystic fibrosis (CF). AZX1101 is a recombinant-lactamase combination of bacterial origin under development for the prevention of hospital-acquired infections by resistant bacterial strains induced by parenteral administration of b-lactam antibiotics (known as nosocomial infections), as well as the prevention of antibiotic-associated diarrhea (AAD).