AcelRx Pharmaceuticals, Inc.

AcelRx is a pharmaceutical company that develops therapies for the treatment of acute pain. One of its lead product candidates is DSUVIA, which has been approved by the U.S. Food and Drug Administration (“FDA”) for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings.

On February 16, 2021, AcelRx disclosed that it had received a warning letter from the FDA concerning promotional claims for DSUVIA. Specifically, the FDA concluded that certain of AcelRx’s promotional communications “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.”

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, thereby injuring investors. 

The complaint filed alleges that throughout the Class Period, 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 failed to disclose to investors that: (1) AcelRx had deficient disclosure controls and procedures with respect to its marketing of DSUVIA; (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, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.