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
October 22, 2019
Date of Report (Date of earliest event reported)
ETON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | | 001-38738 | | 37-1858472 |
| (State of | | (Commission | | (I.R.S. Employer |
| incorporation) | | File Number) | | Identification Number) |
21925 W. Field Parkway, Suite 235
Deer Park, Illinois 60010-7208
(Address of principal executive offices) (Zip code)
(847) 787-7361
(Registrant’s telephone number, including area code)
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:
| [ ] | 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 $0.001 per share | | ETON | | NASDAQ Global Select Market |
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 October 22, 2019, Eton Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food & Drug Administration (“FDA”) has approved Biorphen®, the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Eton acquired the U.S. marketing rights to Biorphen® from Sintetica SA in February 2019. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Separately, Sintetica also notified Eton that the NDA for ET-203, Eton’s second ready-to-use injectable product, was not yet accepted for review by the FDA due to questions surrounding the potency of ET-203 relative to the reference product. Sintetica plans to hold an FDA meeting within the next 30 days to discuss the topic and believes the FDA’s concerns can be adequately addressed with a resubmitted NDA in the near future.
Item 9.01 Financial Statements and Exhibits
Exhibit 99.1Press Release dated October 22, 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.
| Date: October 22, 2019 | By: | /s/ W. Wilson Troutman |
| | | W. Wilson Troutman |
| | | Chief Financial Officer and Secretary |
| | | (Principal Financial Officer) |
