US FDA puts clinical hold on Atara's trials for cancer cell therapies (updated)

Atara Biotherapeutics

21/01/2025 12:57

(Adds shares in paragraph 1, details in paragraphs 2,4)
       Jan 21 (Reuters) - Atara Biotherapeutics  ATRA.O  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)
 ((Kamal.Choudhury@thomsonreuters.com))