Omeros transplant therapy snubbed in EU again

Omeros (OMER) fell in premarket trading on Friday after an expert panel of the EU drug regulator, the European Medicines Agency, declined to endorse the company’s transplant therapy narsoplimab for the second time this year.

In a statement, the Seattle, Washington-based biotech said that EMA’s Committee for Medicinal Products for Human Use adopted a negative opinion on its marketing authorization application for narsoplimab during its October meeting. The decision follows a reevaluation of its original negative opinion adopted in June 2026.

Omeros (OMER) added that patient-level data it submitted to CHMP in August as part of that process hasn’t been provided to an eight-member expert panel called the ad hoc expert group (AHEG) that conducted the reevaluation.

However, according to the final meeting minutes, AHEG recommends a review of individual patient-level data by external experts.

Narsoplimab is already marketed in the U.S. under the brand name Yartemlea for hematopoietic stem cell transplant-associated thrombotic microangiopathy, a complication of stem cell transplantation.

“As YARTEMLEA continues to progress toward becoming the standard of care in the U.S., it is disheartening that patients in Europe will not have routine access to its potentially life-saving benefits,” CEO Gregory Demopulos said.

Separately, the company said that it has informed CHMP regarding plans to terminate the Yartemlea compassionate-use program due to rising demand for the drug in the U.S. Patients already undergoing the therapy as part of the compassionate-use program will be provided adequate supplies to complete their treatment courses.

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