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
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。