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| UNITED STATES |
| SECURITIES AND EXCHANGE COMMISSION |
| Washington, D.C. 20549 |
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FORM 8-K
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| CURRENT REPORT |
| Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Date of Report (Date of earliest event reported): January 14, 2022
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| Revance Therapeutics, Inc. |
| (Exact name of registrant as specified in its charter) | |
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| 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)
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| 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): |
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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| 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 January 18, 2022, Revance Therapeutics, Inc. (the “Company”) announced that it received the official Type A meeting minutes from the United States (U.S.) Food and Drug Administration (the “FDA”) regarding the Complete Response Letter (“CRL”) previously issued with respect to the Company’s Biologics License Application (the “BLA”) for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines. The Type A meeting was held on December 15, 2021.
Based on the meeting minutes, received by the Company on January 14, 2022, a complete response to address the outstanding observations related to the working cell bank (“WCB”) and the drug substance manufacturing process will require the Company to qualify its new WCB by producing three consecutive drug substance lots and one drug product lot. The qualification of the new WCB has been underway, and the Company plans to submit the new WCB qualification package as part of its BLA resubmission as soon as possible. A reinspection of the Company’s manufacturing facility will be required once the resubmission is accepted by the FDA.
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.
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| Date: | January 18, 2022 | Revance Therapeutics, Inc. |
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| | By: | /s/ Tobin C. Schilke |
| | | Tobin C. Schilke |
| | | Chief Financial Officer |
