secwatch.observer — SEC 8-K summary
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Issuer:     aTYR PHARMA INC (ATYR)
CIK:        0001339970
Form:       8-K
Filed at:   2025-09-15T23:59:59+00:00
Accession:  0001193125-25-202865
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

aTyr Pharma Phase 3 EFZO-FIT study misses primary endpoint in pulmonary sarcoidosis
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- Primary endpoint: change from baseline in mean daily OCS dose at week 48; p=0.3313 (2.79 mg efzofitimod vs 3.52 mg placebo).
- Nominal KSQ-Lung score improvement for 5.0 mg/kg vs placebo (p=0.0479); steroid withdrawal with KSQ-Lung improvement p=0.0199.
- FVC maintained; safety consistent with prior trials; company plans to engage FDA on path forward.
- Study enrolled 268 patients; hierarchical testing stopped after primary miss; all subsequent p-values nominal.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1339970/000119312525202865/0001193125-25-202865-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1339970/000119312525202865/atyr-20250915.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-202865

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer