FDA Signs Off on aTyr’s Revised Phase 3 Plan in Pulmonary Sarcoidosis
After EFZO-FIT missed, aTyr has FDA alignment on a narrower Phase 3 using FVC. Cash funds operations into 2028, but not the new trial.
After EFZO-FIT missed, aTyr has FDA alignment on a narrower Phase 3 using FVC. Cash funds operations into 2028, but not the new trial.
Efzofitimod for pulmonary sarcoidosis showed clinical benefits despite missing its primary endpoint. More patients stopped steroids and improved quality of life. It was well-tolerated, maintaining lung function. aTyr Pharma will now discuss these results with the FDA.