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): May 26, 2021
|Revance Therapeutics, Inc.|
|(Exact name of registrant as specified in its charter)|
|(State or other jurisdiction of incorporation)||(Commission File No.)||(I.R.S. Employer Identification No.)|
1222 Demonbreun Street, Suite 1001, Nashville, Tennessee, 37203
(Address of principal executive offices and zip code)
(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 (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))|
|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, $0.001 par value||“RVNC”||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 May 26, 2021, Revance Therapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) plans to initiate its pre-approval inspection of the Company’s manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021.
In November 2020, the FDA deferred a decision on the Biologics License Application (“BLA”) for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines. The FDA reiterated that an inspection of the Company’s manufacturing facility is required as part of the BLA approval process, but the FDA was unable to conduct the required inspection due to the FDA’s travel restrictions associated with the COVID-19 pandemic.
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 26, 2021||Revance Therapeutics, Inc.|
|By:||/s/ Tobin C. Schilke|
|Tobin C. Schilke|
|Chief Financial Officer|