Lawsuit Overview
June 8, 2021 - An investor in shares of AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by AcelRx Pharmaceuticals, Inc. in connection with certain allegedly false and misleading statements made between March 17, 2020 and February 12, 2021.
Redwood City, CA based AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company, 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 Pharmaceuticals, Inc. 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 Pharmaceuticals, Inc 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."
Shares of AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) declined to as low as $1.02 per share on May 13, 2021.
According to the complaint the plaintiff alleges on behalf of purchasers of AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) common shares between March 17, 2020 and February 12, 2021, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between March 17, 2020 and February 12, 2021, the defendants made false and/or misleading statements and/or failed to disclose that: AcelRx had deficient disclosure controls and procedures with respect to its marketing of DSUVIA, that 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, that the foregoing conduct subjected the Company to increased regulatory scrutiny and enforcement, and that as a result, the Company's public statements were materially false and misleading at all relevant times.