United States — Food and Drug Administration & Atara Biotherapeutics

Atara Biotherapeutics: Atara Biotherapeutics is the defendant in a class action lawsuit alleging false and misleading statements regarding its business, operations, and prospects, specifically concerning the regulatory approval of its lead product candidate, tabelecleucel. Its stock price experienced significant declines following FDA decisions.

Atara Biotherapeutics: Atara Biotherapeutics received Orphan Drug Designation from the United States — Food and Drug Administration for its autologous islet transplantation (AIT) for the prevention of diabetes due to total pancreatectomy. This designation provides potential market exclusivity and development incentives, enhancing the company's position in regenerative medicine.

Atara Biotherapeutics: Atara Biotherapeutics is the defendant in multiple securities fraud class action lawsuits due to alleged misleading statements about its manufacturing issues and the regulatory prospects of its drug tabelecleucel, leading to investor losses.