By Don Nico Forbes
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications.
The biotechnology company said the FDA put a hold on its Ebvallo and ATA3219 programs due to compliance issues at a third-party manufacturing facility. Ebvallo is a treatment candidate for Epstein-Barr virus positive post-transplant lymphoproliferative disease, or EBV+PTLD. ATA3219 is a candidate for the treatment of non-Hodgkin's lymphoma and systemic lupus erythematosus.
The company noted that the issues don't affect its Fujifilm Diosynth Biotechnologies third-party facility in Thousand Oaks, Calif.
Atara added that it has agreed with the FDA upon necessary actions to release the clinical holds.
"We intend to work closely with the FDA to address these issues as expeditiously as possible," said Chief Executive Cokey Nguyen.
Shares of Atara fell 4.3% to $6.29 in premarket trading Tuesday.
Write to Don Nico Forbes at don.forbes@wsj.com
(END) Dow Jones Newswires
January 21, 2025 08:14 ET (13:14 GMT)
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