Atara Biotherapeutics (ATRA) shares were down more than 40% in Thursday trading after the company reported "compliance issues" involving a third-party manufacturing facility for Ebvallo, a treatment for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease.
The US Food and Drug Administration issued a complete response letter for Atara's biologics license application for Ebvallo, with the letter solely focusing on pre-license "inspection findings" involving the manufacturing plant, the company said.
No additional clinical trials were sought for FDA approval of Ebvallo and the agency did not identify any deficiencies in the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, the company said.
Atara Chief Executive Cokey Nguyen said the BLA will be resubmitted once the third-party manufacturer issues have been addressed.
Price: 7.58, Change: -5.58, Percent Change: -42.43
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