NEW YORK, Nov. 16, 2022 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Accelerate Diagnostics, Inc. AXDX, and Veru Inc. VERU. Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices. Additional information about each case can be found at the link provided.
Accelerate Diagnostics, Inc. AXDX
After the market closed on October 21, 2022, Accelerate Diagnostics disclosed receiving a request from the U.S. Food and Drug Administration for the company to immediately discontinue marketing and distribution of its Accelerate Arc system and related BC Kit for a particular diagnostic use.
Previously, Accelerate Diagnostics had been marketing the Accelerate Arc products as Class I devices, exempting them from 510(k) clearance requirements. Recently, the FDA informed the company that marketing the products in the U.S. requires 510(k) clearance.
Shares of Accelerate Diagnostics stock dropped approximately 9% in premarket trading and were down more than 40% in intraday trading on October 24, 2022.
For more information on the Accelerate Diagnostics investigation go to: https://bespc.com/cases/AXDX
Veru Inc. VERU
On November 10, 2022, Veru issued a press release announcing that the U.S. Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (the “Advisory Committee”) voted against granting emergency use authorization for the Company’s product sabizabulin for treatment of hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome. Specifically, the Advisory Committee voted 8-5 that the known and potential benefits of sabizabulin do not outweigh its known and potential risks.
On this news, Veru’s stock price fell sharply during intraday trading on November 10, 2022.
For more information on the Instil investigation go to: https://bespc.com/cases/VERU
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.