secwatch.observer — SEC 8-K summary
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Issuer:     OMEROS CORP (OMER)
CIK:        0001285819
Form:       8-K
Filed at:   2024-11-13T23:59:59+00:00
Accession:  0001437749-24-034900
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Omeros Q3 net loss $32.2M; narsoplimab BLA resubmission path cleared after FDA meeting
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- Net loss Q3 2024: $32.2M ($0.56/sh) vs $37.8M ($0.60/sh) in Q3 2023; nine-month loss $125.5M.
- Cash and investments $123.2M at Sept 30, down $48.7M from Dec 31, 2023, including $18.4M narsoplimab drug substance charge and $21.2M debt repurchase.
- Narsoplimab in TA-TMA: FDA presubmission in Sep 2024; minor feedback on statistical plan incorporated; BLA resubmission planned after efficacy analysis; European MAA in H1 2025.
- Zaltenibart (OMS906): FDA and EU regulators agree on Phase 3 design for PNH; enrollment expected early 2025; rare pediatric disease designation for C3G.
- OMIDRIA royalties $9.3M on Rayner’s U.S. sales $31.0M in Q3 2024 vs $10.0M on $33.3M in Q3 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1285819/000143774924034900/0001437749-24-034900-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1285819/000143774924034900/omer20240808_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-034900

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