EU Regulator Rejects Narsoplimab Again, Closing Off European Market for Omeros
OMER has more than doubled off its 52-week low of $6.24.
Summary
EMA's CHMP upheld its negative opinion on narsoplimab for TA-TMA after re-examination, blocking EU approval and removing a potential international revenue stream; the negative opinion was originally adopted in June. The drug is already FDA-approved and sold in the U.S. as YARTEMLEA, so the hit is contained to the European rollout rather than the core commercial story. Omeros shares fell 12% to $16.60 after the re-examination upheld the negative opinion, and the committee did not give the expert group the patient-level data Omeros submitted in August. Omeros will terminate its EU compassionate use program due to U.S. demand and lean on named-patient access for limited European revenue. This lands while U.S. YARTEMLEA sales are surging — Q2 net revenue jumped 190% quarter-over-quarter and the company posted positive net income — so the setback concentrates growth in a single market. A new EU submission or additional data would be needed to reopen the path.
Updated with a Dow Jones Newswires report · What changed
Updates
· Dow Jones Newswires — Omeros shares fell 12% to $16.60 after the EMA re-examination upheld the negative opinion; the committee did not give the expert group the patient-level data Omeros submitted in August.
- CHMP negative opinion originally adopted in June
At the time of this announcement, OMER was trading at $17.05 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.4B. The 52-week trading range was $6.24 to $21.24. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: Wiseek News.