aTyr Pharma Outlines Efzofitimod Phase 3 Results, Plans FDA Meeting

Company to discuss path forward for lead program in pulmonary sarcoidosis with regulators in mid-April

Mar. 12, 2026 at 12:03pm

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aTyr Pharma CEO Sanjay Shukla provided an update on the company's lead program, efzofitimod, including results from a global Phase 3 study in pulmonary sarcoidosis and plans for an upcoming FDA Type C meeting in mid-April to determine the next steps for the program.

Why it matters

Efzofitimod is aTyr's lead candidate, a novel therapy targeting inflammation and fibrosis in interstitial lung diseases like pulmonary sarcoidosis. The Phase 3 results provide important insights, even though the primary endpoint was narrowly missed, and the upcoming FDA meeting will be critical in shaping the path forward for this program.

The details

The Phase 3 EFZO-FIT trial in pulmonary sarcoidosis enrolled 268 patients and compared efzofitimod at 5 mg/kg and 3 mg/kg doses versus placebo. While efzofitimod showed nearly 80% reductions in steroid use, the trial did not meet the primary endpoint of steroid reduction due to a higher-than-expected placebo response. However, the data showed statistically significant improvements in quality of life measures, and composite analyses combining steroid withdrawal with symptom improvement were also positive. Safety data was favorable, with low rates of serious adverse events and discontinuations. aTyr is now preparing for an FDA Type C meeting in mid-April to discuss the results and determine the next steps, which could include another late-stage study with a focus on quality of life and lung function endpoints.

  • The EFZO-FIT Phase 3 trial in pulmonary sarcoidosis completed in 2025.
  • aTyr has a FDA Type C meeting scheduled for mid-April 2026 to discuss the EFZO-FIT results.

The players

aTyr Pharma

A clinical-stage biotechnology company focused on developing novel protein-based therapies that modulate the extracellular matrix and immune pathways.

Sanjay Shukla

The CEO of aTyr Pharma who outlined the company's strategy and provided updates on the efzofitimod program.

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