---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-038758"
form_type: "8-K"
ticker: "OMER"
cik: "0001285819"
company_name: "OMEROS CORP"
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:04:40.836338+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Omeros' YARTEMLEA as first therapy for TA-TMA; launch set for Jan 2026

## Summary
- YARTEMLEA (narsoplimab-wuug) approved for adults and children ≥2 years with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
- Pivotal trial CR rate 61%, EAP CR rate 68%; 100-day survival 73% and 74% respectively; all patients high-risk.
- No Boxed Warning or REMS; most common adverse reactions (≥20%) include viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, hypokalemia.
- U.S. launch planned for January 2026; dedicated ICD-10 and procedure codes in place; YARTEMLEAssist patient support program expected in Q1 2026.
- Marketing authorization application under EMA review with decision expected mid-2026.

## SEC filing metadata
- accession: 0001437749-25-038758
- form_type: 8-K
- ticker: OMER
- cik: 0001285819
- company_name: OMEROS CORP
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/0001437749-25-038758-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/omer20251218_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-038758
- JSON: https://secwatch.observer/filing/0001437749-25-038758.json
- Plain text: https://secwatch.observer/filing/0001437749-25-038758.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.