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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