ThZeal - The Zeal

rvnc-20220308


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): March 8, 2022



Revance Therapeutics, Inc.
			(Exact name of registrant as specified in its charter)


Delaware	001-36297	77-0551645
(State or other jurisdiction of incorporation)	(Commission File No.)	(I.R.S. Employer Identification No.)

1222 Demonbreun Street, Suite 2000, Nashville, Tennessee, 37203

(Address, including zip code, of principal executive offices)

(615) 724-7755

(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, par value $0.001 per share	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 March 8, 2022, Revance Therapeutics, Inc. (the “Company”) announced that it resubmitted its Biologics License Application to the U.S. Food and Drug Administration (the “FDA”) with respect to DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines (the “BLA”) in response to the Complete Response Letter previously issued by the FDA with respect to the BLA. The resubmission follows the Company’s Type A meeting, held in December 2021, and the subsequent completion of the production of three consecutive drug substance lots and one drug product lot as part of the qualification of a new working cell bank (“WCB”), which was required by the FDA to address the outstanding observations related to the WCB and the drug substance manufacturing process.

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:	March 8, 2022	Revance Therapeutics, Inc.

		By:	/s/ Tobin C. Schilke
			Tobin C. Schilke
			Chief Financial Officer