Allogene Gets FDA Orphan Designation for ALLO-605 in Multiple Myeloma

By Colin Kellaher

Allogene Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its ALLO-605 product candidate for the treatment of multiple myeloma.

The South San Francisco, Calif., clinical-stage biotechnology company said a Phase 1 study evaluating ALLO-605 is ongoing.

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 last year granted fast-track designation to ALLO-605 based on its potential to address an unmet need for patients who have failed other standard therapies for multiple myeloma, an incurable blood cancer that starts in the bone marrow.

Shares of Allogene, which closed Tuesday at $8.46, rose 6.2% to $8.98 in premarket trading Wednesday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

04-27-22 0839ET