UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 17, 2019
AZURRX BIOPHARMA, INC.
(Exact name of Registrant as specified in its Charter)
| Delaware | 001-37853 | 46-4993860 |
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
760 Parkside Avenue Downstate Biotechnology Incubator, Suite 304 Brooklyn, New York | | 11226 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code:(646) 699-7855
(Name, address, including zip code, and telephone number, including area code, of agent for service of process)
NOT APPLICABLE
(Former Name or Former Address, if Changes Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share | AZRX | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2) ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐
Item 8.01. Other Events.
On October 17, 2019, AzurRx BioPharma, Inc. (the “Company”) issued a press release announcing that the Cystic Fibrosis Foundation Data Safety Monitoring Board has completed its review of the Company’s final results of the Phase 2 OPTION trial and has found no safety concerns for MS1819-SD, the Company’s lead product candidate for the treatment of exocrine pancreatic insufficiency in cystic fibrosis, and that the group supports the Company’s plan to proceed to a higher 4-gram dose of MS1819-SD in its next planned Phase 2 clinical trial. A copy of the press release is attached hereto as Exhibit 99.1
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | | Description |
| | |
| | Press Release, dated October 17, 2019 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.
| | AzurRx BioPharma, Inc. | |
| | | | |
| Date: October 17, 2019 | By: | /s/ James Sapirstein | |
| | | Name: James Sapirstein
| |
| | | Title: Chief Executive Officer | |
