CHMP negative opinion on Yartemlea (narsoplimab) for TA-TMA hits OMER
CHMP negative opinion on Yartemlea (narsoplimab) for TA-TMA drives OMER -16% premarket drop
- EMA's CHMP issued negative opinion on Yartemlea for transplant-associated thrombotic microangiopathy after June 22-25 meeting
- Drug already FDA-approved and launched in US (Jan 2026) with strong early sales, but EU rejection is major setback
- Negative opinion also covered other meds but directly hits Omeros' lead asset European prospects
- Mid-2026 EMA decision had been anticipated; this follows positive US launch momentum and J-code reimbursement
- Stock closed at $10.72 on June 25; plummeted to ~$8.97-$8.50 range in premarket on high volume
- Company had reported Q1 net income boosted by launch and Novo partnership; no immediate US impact
- Analysts previously maintained buy ratings with high price targets tied to global expansion
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