aTyr Pharma Gets Fast Track Designation for Efzofitimod
11 August 2022 - 1:54PM
Dow Jones News
By Chris Wack
ATyr Pharma Inc. said Thursday that the U.S. Food and Drug
Administration has granted the company Fast Track designation for
its lead therapeutic candidate efzofitimod for the treatment of
pulmonary sarcoidosis.
Efzofitimod is an immunomodulator that downregulates innate and
adaptive immune responses in uncontrolled inflammatory disease
states via selective modulation of neuropilin-2.
The biotechnology company is currently investigating efzofitimod
in a global pivotal phase 3 study. Efzofitimod previously received
FDA orphan drug designation for the treatment of sarcoidosis.
The FDA's Fast Track designation helps facilitate development
and expedite the review of drugs to treat serious or
life-threatening diseases with unmet need. Fast Track designation
provides certain benefits, including more frequent interactions
with the FDA throughout the development program, as well as
eligibility for accelerated approval, priority review and rolling
review.
ATyr shares were up 6%, to $3.95, in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
August 11, 2022 08:39 ET (12:39 GMT)
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