secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2022-11-09T23:59:59+00:00
Accession:  0001558370-22-017140
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros reports Q3 2022 net loss $17.5M; FDA denies narsoplimab appeal, provides resubmission path
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- Net loss $17.5M ($0.28/share) vs $22.7M loss in 3Q21; cash and equivalents $221M at Sept 30.
- FDA denied Formal Dispute Resolution for narsoplimab BLA; proposes resubmission with survival vs historical control.
- Sold interest in OMIDRIA royalties to DRI for $125M cash; max DRI payout $188.4M at 9.4% effective rate.
- CMS final rule confirms separate OMIDRIA payment in ambulatory surgical centers for 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000155837022017140/0001558370-22-017140-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000155837022017140/omer-20221109x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-22-017140

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