AcelRx Therapeutics, Inc. (ACRX) Made Misstatements in Advertising for its Lead Drug Candidate DSUVIA
During the relevant period, 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) this 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.
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 earning 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. The stock now trades at around $1.50.
If you purchased shares of AcelRx Therapeutics, Inc. (ACRX) between March 17, 2020 and February 12, 2021, you have until August 9, 2021, to ask the court to appoint you lead plaintiff for the class.
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