secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2025-02-20T23:59:59+00:00
Accession:  0001437749-25-004505
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros reports robust narsoplimab EAP survival data in TA-TMA; BLA resubmission planned Q1 2025
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- Combined EAP + pivotal trial vs external control: HR 0.34-0.46, p-values <0.00001 to 0.00002.
- Previously untreated high-risk adults: 1-year survival 58%; children: 79% in EAP.
- Refractory patients (failed complement inhibitors): 1-year survival 44% vs historical <20%.
- No safety signals; BLA resubmission expected later Q1 2025, MAA submission by mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000143774925004505/0001437749-25-004505-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000143774925004505/omer20250212_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-004505

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