SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 17, 2018
ARCH THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction||(Commission||(I.R.S. Employer|
|of incorporation)||File Number)||Identification No.)|
|235 Walnut Street, Suite 6|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (617) 431-2313
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 (see General Instruction A.2. below):
|¨||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))|
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).
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 7.01||Regulation FD Disclosure.|
On December 17, 2018, Arch Therapeutics, Inc. (the “Company”) issued a press release announcing that the Company’s 510(k) premarket notification for AC5™ Topical Gel has been reviewed and cleared by the U.S. Food and Drug Administration. The text of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
|Item 8.01||Other Events.|
The disclosure under Item 7.01 (Regulation FD Disclosure) is incorporated herein by reference.
|Item 9.01||Financial Statements and Exhibits|
(d) The following exhibits are being filed herewith:
|99.1||Press Release issued by Arch Therapeutics, Inc. on December 17, 2018|
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.
|ARCH THERAPEUTICS, INC.|
|Dated: December 17, 2018||By:||/s/ Terrence W. Norchi, M.D.|
|Name: Terrence W. Norchi, M.D.|
|Title: President, Chief Executive Officer|