Revance Therapeutics, Inc.

Investigation
12/10/2021

Initial Lawsuit
12/10/2021

Lawsuit Progression
02/08/2022

Investigation

Continous Holding
November 25, 2019 to October 11, 2021
Proposed Claim
Securities Violation

Investigation regarding Revance’s biologics license application (BLA) for DaxibotulinumtoxinA (DAXI) and following company receipt of Form 483 and complete response letter (CRL).

Main Event

CRL Received

10/15/2021

Company Statement

Revance announces the receipt of a complete response letter (CRL) by the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.

“In a communication received on October 15, the FDA has determined it is unable to approve the BLA in its present form, and indicated that there are deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility. Revance plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised. No other deficiencies were identified in the CRL.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close	Previous close	Price variation	Percentage variation
$13.81	$22.71	$-8.9	-39.19%

See more on Factual Timeline

Initial Lawsuit

First Complaint - 12/10/2021

Plaintiff brings this is federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Revance securities between November 25, 2019 and October 11, 2021, both dates inclusive.

Filing Date
12/10/2021
Class Period
11/25/2019 to 10/11/2021
Transgression
Securities Violation
Filing Firms
Bronstein, Gewirtz & Grossman, LLC
Pomerantz LLP
Case Title
Aramic LLC v. Revance Therapeutics, Inc. et al
Docket Number
5:21-cv-09585
Court
California Northern District Court
Free File
Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:

(i) quality control deficiencies existed at the company’s manufacturing facility for DAXI;
(ii) the foregoing deficiencies decreased the likelihood that the FDA would approve the DAXI BLA in its current form;
(iii) accordingly, it was unlikely that the DAXI BLA would obtain FDA approval within the timeframe the company had represented to investors; and
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.