AcelRx Pharmaceuticals, Inc.

Investigation
06/08/2021

Initial Lawsuit
06/08/2021

Lawsuit Progression
12/16/2021

Investigation

Continous Holding
March 17, 2020 to February 12, 2021
Proposed Claim
Securities Violation

AcelRx’s received a warning letter from the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) about misleading claims and representations of the risks and efficacy of DSUVIA in submitted promotional material.

This investors investigation is opened for investors to gather facts, findings and track related lawsuits. We invite investors and shareholders to contribute to investigations for their own benefit, add events to the factual timeline below and vote on events’ pertinence.

A lawsuit was subsequently filed. We will update this post as it unfolds.

Main Event

FDA Warning Letter - Misleading Claims

02/16/2021

SEC Filing

AcelRx announces the receipt of a warning letter from the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) relating to promotional materials submitted in accordance with requirements that sponsors submit all promotional materials to the FDA at the time of their initial dissemination or publication. The materials included a banner advertisement the Company submitted to the OPDP on December 6, 2019, and a tabletop display the Company submitted on February 28, 2020. AcelRx summited the materials

The company reports that the “FDA’s concerns identified in the Letter include its view that the Promotional Material makes misleading claims and representations about the risks and efficacy of DSUVIA^® because the Promotional Material does not reveal facts that are material in light of the representations made.”

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
$2.3	$2.51	$-0.21	-8.37%

See more on Factual Timeline

Initial Lawsuit

First Complaint - 06/08/2021

A shareholders filed this federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired AcelRx securities between March 17, 2020 and February 12, 2021, both dates inclusive.

Filing Date
06/08/2021
Class Period
03/17/2020 to 02/12/2021
Transgression
Securities Violation
Filing Firms
Pomerantz LLP
Case Title
Sneed Jr. v. AcelRx Pharmaceuticals, Inc. et al
Docket Number
5:21-cv-04353
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) AcelRx had deficient disclosure controls and procedures with respect to its marketing of DSUVIA;
(ii) as a result, AcelRx had been making false or misleading claims and representations about the risks and efficacy of DSUVIA in certain advertisements and displays;
(iii) the foregoing conduct subjected the company to increased regulatory scrutiny and enforcement;
(iv) as a result, the company’s public statements were materially false and misleading at all relevant times.

Defendants

Company
AcelRx
Chief Executive Officer
Vincent J. Angotti
Chief Financial Officer
Raffi Asadorian

Lawsuit progression

Docket Number
5:21-cv-04353
Court
California Northern District Court

Lead Counsel

12/16/2021

The court issued an order appointing the lead plaintiff and lead counsel.

Lead Counsel
Pomerantz LLP
Lead Plaintiff
Group of Individuals
Free File
Order for lead

Amended Complaint

03/07/2022

This is a federal securities class action on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired AcelRx securities between March 20, 2019 and February 12, 2021, both dates inclusive.