Atara Biotherapeutics Sees Tabelecleucel FDA Meeting in 1Q
January 10 2022 - 9:37AM
Dow Jones News
By Chris Wack
Atara Biotherapeutics Inc. said its Tabelecleucel tab-cel for
Post-Transplant Lymphoproliferative Disease is having continued
progress with the U.S. Food and Drug Administration, including
productive engagement with CBER and a Type B CMC meeting scheduled
for the first quarter of 2022.
The company said it plans to complete the Biologics License
Application submission for patients with EBV+ PTLD in the second
quarter of 2022, and U.S. approval of BLA for patients with EBV+
PTLD anticipated in the first half of 2023.
Atara submitted a Marketing Authorization Application for
tab-cel in patients with EBV+ PTLD, the first ever for an
allogeneic, off-the-shelf T-cell therapy, in November. With the
granting of Accelerated Assessment, the company is looking for a
decision regarding EU approval in the fourth quarter.
The company also said the FDA has granted Fast Track designation
for ATA188 in non-active primary progressive multiple sclerosis and
non-active secondary progressive multiple sclerosis.
Atara said it is continuing to make good progress enrolling the
Phase 2 study evaluating the efficacy and safety of ATA188 in
patients with progressive MS. The company plans to conduct Phase 3
studies at the conclusion of the Phase 2 study and is actively
exploring partnership opportunities.
Atara said it is continuing to advance its CAR T programs in
liquid and solid tumors, which include a differentiated approach to
allogeneic cell therapy, with no gene editing of the T-cell
receptor and next generation CAR technologies to enhance expansion
and persistence of functional T cells.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 10, 2022 09:22 ET (14:22 GMT)
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