AcelRx Pharmaceuticals, Inc.

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Case Summary
Company Name: AcelRx Pharmaceuticals, Inc.
Stock Symbol : NASDAQ: ACRX
Class Period Start: 03/17/2020
Class Period End: 02/12/2021
Lead Plaintiff motion: 08/09/2021
Date Filed: 06/09/2021
Type of Case: Securities Class Action
Court: U.S. District Court for the Northern District of California
Summary:

Thieler Law Corp advises investors with losses exceeding $100,000 of the June 18, 2021.lead plaintiff deadline in a class action lawsuit filed against AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) (AcelRx Pharmaceuticals, Inc. or “the Company”). The suit is pending in the U.S. District Court for the Northern District of California and investors, who purchased AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) securities between March 17, 2020 and February 12, 2021 (“Class Period”), have until August 9, 2021. to move for lead plaintiff. You do not need to move for lead plaintiff to be a member of the Class.

If you purchased AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) securities during the Class Period, and have losses over $100,000, you may contact Thieler Law Corp by calling at (619) 377 - 4324 or emailing mail@thielerlaw.com . No class has been certified in this case, and if your losses are less than $100,000 you are still a member of the class.

 

AcelRx 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-tosevere acute pain.

 

On November 2, 2018, AcelRx announced that the U.S. Food and Drug Administration (“FDA”) had approved DSUVIA for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

 

On February 16, 2021, AcelRx disclosed that, on February 11, 2021, the Company received a warning letter from the FDA concerning promotional claimsfor DSUVIA. Specifically, having “reviewed an ‘SDS Banner Ad’ (banner) (PM-US-DSV-0018) and a tabletop display (PMUS-DSV-0049) (display),” the FDA concluded that “[t]he promotional communications, the banner and display, make false or misleading claims and representations about the risks and efficacy of DSUVIA,” and “[t]hus . . . misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.” The warning letter “request[ed] that AcelRx cease any violations of the FD&C Act” and “submit a written response to th[e] letter within 15 days from the date of receipt.”

 

 According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) AcelRx had deficient disclosure controls and procedures with respect to its marketing of DSUVIA (the Company’s lead product candidate, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to severe acute pain); (2) 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; (3) the foregoing conduct subjected the Company to increased regulatory scrutiny and enforcement; and (4) as a result, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

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