---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-21-013245"
form_type: "8-K"
ticker: "OMER"
cik: "0001285819"
company_name: "OMEROS CORP"
filed_at: "2021-10-18T23:59:59+00:00"
generated_at: "2026-06-28T20:13:32.644294+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Omeros receives FDA Complete Response Letter for narsoplimab BLA; director Ray Aspiri retires

## Summary
- 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.

## SEC filing metadata
- accession: 0001558370-21-013245
- form_type: 8-K
- ticker: OMER
- cik: 0001285819
- company_name: OMEROS CORP
- filed_at: 2021-10-18T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 5.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/0001558370-21-013245-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/omer-20211014x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-21-013245
- JSON: https://secwatch.observer/filing/0001558370-21-013245.json
- Plain text: https://secwatch.observer/filing/0001558370-21-013245.txt

## Key facts
- Executive change
  Ray Aspiri retired as Director at OMEROS CORP.
  - Action: retired
  - Role: Director
  source text: Ray Aspiri has retired from the board of directors of Omeros Corporation (the “Company”).
  evidence_url: https://www.sec.gov/Archives/edgar/data/1285819/000155837021013245/0001558370-21-013245-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.