LAVA Therapeutics Gets FDA Orphan Designation for LAVA-051
15 October 2021 - 11:03PM
Dow Jones News
By Colin Kellaher
LAVA Therapeutics N.V. on Friday said the U.S. Food and Drug
Administration granted orphan-drug designation to LAVA-051, the
most advanced product candidate from its Gammabody platform, for
the treatment of chronic lymphocytic leukemia.
The Utrecht, Netherlands, clinical-stage biotechnology company
said enrollment is underway in a Phase 1/2a clinical trial of
LAVA-051 for the treatment of relapsed and/or refractory chronic
lymphocytic leukemia, multiple myeloma and acute myeloid
leukemia.
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.
LAVA said it expects data from the Phase 1 dose escalation phase
of the study in the first half of 2022, with top-line clinical data
from the Phase 2a expansion cohorts expected in the second
half.
Shares of LAVA, which closed Thursday at $7.63, rose 7.6% in
premarket trading Friday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 15, 2021 07:48 ET (11:48 GMT)
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