Allogene Gets FDA Orphan Designation for ALLO-715 in Multiple Myeloma
12 August 2021 - 11:12PM
Dow Jones News
By Colin Kellaher
Allogene Therapeutics Inc. on Thursday said the U.S. Food and
Drug Administration granted orphan-drug designation to ALLO-715 for
the treatment of the blood cancer multiple myeloma.
The South San Francisco, Calif., clinical-stage biotechnology
company, which previously reported encouraging initial clinical
experience in heavily pretreated patients in a Phase 1 study, said
it plans to give another update on the study by the end of the
year.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended marketing
exclusivity period against competition.
The agency in April granted ALLO-715
regenerative-medicine-advanced-therapy designation, which offers
eligibility for expedited development and regulatory review of
product candidates, including earlier and more frequent
consultation with the agency, and the potential for accelerated
approval.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 12, 2021 08:58 ET (12:58 GMT)
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