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Case Status:    ONGOING    
On or around 03/28/2024 (Date of last review)

Filing Date: June 08, 2021

According to the Complaint, AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company that focuses on the development and commercialization of therapies for the treatment of acute pain. The Company’s lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain. DSUVIA is a potent opioid painkiller that is of particular use in certain special circumstances where adult patients may not be able to swallow oral medication and where access to intravenous pain relief is not possible.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose 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; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

On December 16, 2021, the Court issued an Order appointing Lead Plaintiffs and Counsel. Lead Plaintiffs filed an amended Complaint on March 7, 2022. Defendants filed a Motion to Dismiss the amended Complaint on May 6. On September 28, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to amend the Complaint.

On November 28, 2022, Lead Plaintiffs filed a second amended Complaint. Defendants filed a Motion to Dismiss the second amended Complaint on January 30, 2023. On July 7, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to amend all claims except Claim 2.

On September 5, 2023, Lead Plaintiffs filed a third amended Complaint.

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