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): May 6, 2019
ZYNERBA PHARMACEUTICALS, INC.
(Exact Name of Issuer as Specified in its Charter)
Delaware |
| 001-37526 |
| 26-0389433 |
(State or Other Jurisdiction of |
| (Commission |
| (I.R.S. Employer |
80 W. Lancaster Avenue, Suite 300
Devon, PA 19333
(Address of Principal Executive Offices) (Zip Code)
(484) 581-7505
(Registrant’s Telephone Number, Including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 |
| ZYNE |
| The NASDAQ Global Market |
Check the appropriate box below if the Form 8–K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a–12 under the Exchange Act (17 CFR 240.14a–12)
o Pre—commencement communications pursuant to Rule 14d–2(b) under the Exchange Act (17 CFR 240.14d–2(b))
o Pre—commencement communications pursuant to Rule 13e–4(c) under the Exchange Act (17 CFR 240.13e–4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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. x
Item 8.01 Other Events
On May 6, 2019, Zynerba Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration granted Fast Track Designation for the Company’s lead development candidate Zygel™ (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
The following exhibits are being filed herewith:
(d) Exhibits
Exhibit |
| Document |
|
|
|
99.1 |
|
SIGNATURE
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.
Date: May 6, 2019
| ZYNERBA PHARMACEUTICALS, INC. | |
|
|
|
| By: | /s/ Suzanne Hanlon |
|
| Name: Suzanne Hanlon |
|
| Title: Secretary, Vice President and General Counsel |