(Reuters) -Atara Biotherapeutics said on Tuesday the U.S. health regulator has placed a clinical hold on its trials for cancer cell therapies, sending the drug developer’s shares down more than 4% in premarket trading.
The clinical hold applies to the studies of Atara’s experimental treatment tabelecleucel for a rare cancer, and ATA3219, which is being tested for a type of blood cancer and an autoimmune disease.
Last week, the U.S. Food and Drug Administration had declined to approve tabelecleucel, which the company said was based on the observations made during an inspection of a third-party manufacturing facility for the therapy.
Atara said the clinical hold was related to the issues observed at the third-party manufacturing facility.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar)
Source link : https://www.medscape.com/s/viewarticle/us-fda-puts-clinical-hold-ataras-trials-cancer-cell-2025a10001ea?src=rss
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Publish date : 2025-01-21 12:42:26
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