Current Report Filing (8-k)
11 January 2023 - 10:51PM
Edgar (US Regulatory)
0001710340
false
0001710340
2023-01-11
2023-01-11
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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
January
11, 2023
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 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 ☒
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
January 11, 2023, Eton Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has accepted
for review the Company’s New Drug Application (NDA) response for dehydrated alcohol injection for the proposed
indication of methanol poisoning. The FDA has
assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2023.
Eton’s
application has previously been granted orphan drug designation for the indication of methanol poisoning and if approved, the Company
expects the FDA to grant the application seven years of orphan drug exclusivity. Based on IQVIA data, trailing twelve month sales for
dehydrated alcohol injection were $74 million.
A
copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01 Financial Statements and Exhibits
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:
January 11, 2023 |
By:
|
/s/
James R. Gruber |
|
|
James
R. Gruber |
|
|
Chief
Financial Officer and Secretary |
|
|
(Principal
Financial Officer) |
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Feb 2024 to Mar 2024
Eton Pharmaceuticals (NASDAQ:ETON)
Historical Stock Chart
From Mar 2023 to Mar 2024