LIFE - aTyr Pharma gains with FDA Fast Track status for lead asset
- The shares of clinical-stage biotech aTyr Pharma, Inc. ( NASDAQ: LIFE ) jumped ~7% in the pre-market Thursday after the company announced that the FDA issued Fast Track designation for its lead candidate efzofitimod for immune-mediated disease, pulmonary sarcoidosis.
- An immunomodulator, efzofitimod, is designed to downregulate humans' innate and adaptive immune responses.
- The candidate, also known as ATYR1923, is currently undergoing a global pivotal phase 3 study involving patients with pulmonary sarcoidosis.
- Sarcoidosis is a leading form of interstitial lung disease, and about 200K Americans are estimated to suffer from pulmonary sarcoidosis.
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at severe conditions with unmet medical needs. It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies.
- If certain criteria are met, such programs will also be able to win the Accelerated Approval, Priority Review, and Rolling Review, allowing the drugs to reach patients sooner.
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aTyr Pharma gains with FDA Fast Track status for lead asset