secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2021-10-18T23:59:59+00:00
Accession:  0001558370-21-013245
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 5.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros receives FDA Complete Response Letter for narsoplimab BLA; director Ray Aspiri retires
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- Ray Aspiri retired from Omeros board effective Oct 14, 2021, with no disagreement with the company.
- FDA issued a Complete Response Letter for narsoplimab BLA for HSCT-TMA, citing difficulty estimating treatment effect.
- FDA stated additional information is needed to support regulatory approval of narsoplimab for HSCT-TMA.
- No CMC, safety, or non-clinical issues precluding approval were raised in the FDA Complete Response Letter.
- Omeros plans to request a Type A meeting with FDA to discuss the most expeditious path for narsoplimab approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/0001558370-21-013245-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/omer-20211014x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-21-013245

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