secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2025-12-29T23:59:59+00:00
Accession:  0001437749-25-038758
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/0001437749-25-038758-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000143774925038758/omer20251218_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-038758

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