Class Action Lawsuits Filed Against Atara Biotherapeutics and Inovio Pharmaceuticals

Class action lawsuits have been filed against two biotechnology companies, Atara Biotherapeutics and Inovio Pharmaceuticals, alleging securities law violations related to their regulatory submissions to the U.S. Food and Drug Administration. The lawsuits claim both companies made materially false and misleading statements about their lead product candidates' regulatory prospects and manufacturing capabilities.

The class action against Atara Biotherapeutics was filed in the United States District Court for the Central District of California and is on behalf of persons who purchased or acquired Atara securities between May 20, 2024 and January 9, 2026. The complaint alleges that Atara failed to disclose that certain manufacturing issues, as well as deficiencies inherent in the ALLELE study, made it unlikely that the FDA would approve the tabelecleucel Biologics License Application (BLA). Atara's lead product candidate is tabelecleucel (also referred to as tab-cel or EBVALLO), a T-cell immunotherapy program for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease.

In May 2024, Atara announced its submission of a BLA to the FDA for tabelecleucel as a monotherapy for the treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy. The tabelecleucel BLA was purportedly supported by data from the Company's Phase 3 ALLELE study. The truth began to emerge on January 16, 2025, when Atara issued a press release announcing its receipt of a Complete Response Letter regarding the tabelecleucel BLA, stating that the CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. On this news, Atara's stock price fell $5.33 per share, or 40.5%, to close at $7.83 per share on January 16, 2025.

Then, on January 21, 2025, Atara issued a press release announcing that the FDA had placed a clinical hold on Atara's active Investigational New Drug applications due to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the CRL issued in connection with the tabelecleucel BLA.

Separately, the class action against Inovio Pharmaceuticals was filed in the United States District Court for the Eastern District of Pennsylvania and is on behalf of persons who purchased or acquired Inovio securities between October 10, 2023 and December 26, 2025. Inovio is a biotechnology company focused on the discovery, development, and commercialization of DNA medicines to treat and protect people from diseases associated with human papilloma virus. The Company's lead product candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis, a life-long, rare disease of the respiratory tract caused by HPV infection.

The complaint alleges that throughout the Class Period, Defendants touted the prospects of the FDA granting accelerated approval and/or priority review for the BLA of INO-3107 for the treatment of RRP. Defendants also touted their ability to complete rolling submission of the INO-3107 BLA by the second half of 2024. The truth began to emerge on August 8, 2024, when Inovio issued a press release reporting its financial results and recent business highlights for the second quarter of 2024, revealing that Inovio expected to submit the INO-3107 BLA to the FDA in mid-2025—representing an approximate full-year delay from Defendants' initially projected mid-2024 submission timeline—because of a manufacturing issue with a component of the CELLECTRA device. On this news, Inovio's stock price fell $0.27 per share, or 3.1%, to close at $8.44 per share on August 9, 2024.

Then, on December 29, 2025, Inovio issued a press release announcing that the FDA had accepted the INO-3107 BLA on a standard rather than accelerated review timeline. The lawsuits allege that manufacturing for Inovio's CELLECTRA device was deficient, and Inovio had insufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review.