aTyr Pharma Shares Ascend As FDA Grants Fast Track Status To Lung Disease Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to aTyr Pharma’s LIFE lead therapeutic candidate, efzofitimod (ATYR1923), for the treatment of pulmonary sarcoidosis, a major form of interstitial lung disease.

A Clinical proof-of-concept was recently initiated for efzofitimod in a Phase 1b/2a study in patients with pulmonary sarcoidosis.

Efzofitimod is being evaluated in a global pivotal phase 3 study called EFZO-FIT.

Sanjay S. Shukla, President and CEO, said, "The Fast Track designation for efzofitimod underscores the significant need for a new therapy that provides clinically meaningful outcomes for patients living with pulmonary sarcoidosis. we look forward to the opportunity to work closely with the FDA to potentially expedite the delivery of a new treatment to patients in need."

Efzofitimod was previously granted FDA orphan drug designation for the treatment of sarcoidosis.

Sarcoidosis is an immune-mediated disease distinguished by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body, predominantly in the lungs.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : aTyr Pharma shares are trading around 4 percent higher at $3.86 on Thursday during pre-market session.