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Regulatory setback from EMA raises uncertainty around EU uptake and pricing; immediate price pressure observed (~18% drop). US reimbursement progress could mitigate some downside, but the net tone remains negative until clarity improves.
What happened, with direct paths to the underlying reporting
EMA CHMP cited trial design flaws and limited pediatric data for Yartemlea TA-TMA, limiting interpretability. Despite FDA approval and a US launch, EMA concerns could slow European uptake. CMS J-code set for July 1, 2026 and NTAP prospects support US reimbursement, but the EMA setback keeps OMER under pressure.
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