aTyr Pharma reaches FDA alignment on Phase 3 protocol for efzofitimod in sarcoidosis
aTyr Pharma said it has reached alignment with the FDA on the protocol for a planned Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The company expects to start study-related activities in the fourth quarter of 2026 and to focus on regulatory submissions in the U.S. and Europe, but the filing states that future development will require additional capital through equity or debt offerings, grant funding, collaborations, partnerships or licensing.
Key points
- Planned 54-week, randomized, double-blind, placebo-controlled study of up to approximately 372 patients
- Efzofitimod 5.0 mg/kg or placebo given intravenously once every 3 weeks for a total of 17 doses
- Primary endpoint is change from baseline in forced vital capacity at week 48; key secondary endpoint is King's Sarcoidosis Questionnaire-Lung score
- Study-related activities expected to begin in the fourth quarter of 2026
The filing
Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 24, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.