secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2021-10-01T23:59:59+00:00
Accession:  0001558370-21-012911
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros receives FDA deficiency notice for narsoplimab BLA; PDUFA date expected to be missed
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- FDA identified deficiencies in narsoplimab BLA for HSCT-TMA, precluding labeling/post-marketing discussions.
- Resolution not expected by Oct 17, 2021 PDUFA target action date; FDA expressed intent to work with Omeros.
- No specific deficiencies disclosed; Omeros evaluating next steps for HSCT-TMA, a lethal condition with no approved therapy.
- Narsoplimab has Breakthrough Therapy and Orphan designations; first BLA submitted for HSCT-TMA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000155837021012911/0001558370-21-012911-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000155837021012911/omer-20211001x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-21-012911

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