aTyr Pharma Secures Pivotal FDA Meeting for 2026

aTyr Pharma US0021202025

Biopharmaceutical firm aTyr Pharma (ATYR) has scheduled a critical regulatory discussion with the U.S. Food and Drug Administration (FDA) for mid-April 2026. This planned Type C meeting represents a significant juncture for the company’s lead drug candidate, efzofitimod, which is being developed as a treatment for pulmonary sarcoidosis.

The upcoming dialogue with regulators follows a complex set of results from the EFZO-FIT Phase 3 trial. While the study, involving 268 participants, did not achieve its primary endpoint—reducing corticosteroid use after 48 weeks—it delivered promising outcomes on several secondary measures. These mixed results have placed heightened importance on the 2026 FDA meeting, which will determine the compound’s regulatory pathway forward.

@ boerse-global.de | US0021202025 PHARMA