secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2024-12-19T23:59:59+00:00
Accession:  0001437749-24-037898
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros narsoplimab meets TA-TMA pivotal trial primary endpoint; HR 0.32 for survival
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- Narsoplimab-treated TA-TMA patients had over 3-fold reduction in risk of death (HR 0.32, 95% CI 0.23-0.44, p<0.00001) vs >100 external control patients.
- Omeros will resubmit the narsoplimab BLA to FDA as soon as possible for first approved TA-TMA therapy.
- Expanded access program data: 46% of adults and 50% of children achieved TA-TMA resolution after failing C5 inhibitors.
- European marketing authorisation application planned for Q2 2025; additional sensitivity analyses and manuscripts expected early 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000143774924037898/0001437749-24-037898-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000143774924037898/omer20241210_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-037898

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