NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of investors that purchased AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) securities between March 17, 2020 and February 12, 2021, both dates inclusive (the “Class Period”). Investors have until August 9, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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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-to-severe 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.
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, 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 February 16, 2021, AcelRx disclosed that, on February 11, 2021, the Company received a warning letter from the FDA concerning promotional claims for DSUVIA. Specifically, having “reviewed an ‘SDS Banner Ad’ (banner) (PM-US-DSV-0018) and a tabletop display (PM-US-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."
On this news, AcelRx’s stock price fell $0.21 per share, or 8.37%, to close at $2.30 per share on February 16, 2021.
If you purchased ACRX securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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