Omeros receives FDA deficiency notice for narsoplimab BLA; PDUFA date expected to be missed

OMEROS CORP

FDA identified deficiencies in narsoplimab BLA for HSCT-TMA, precluding labeling/post-marketing discussions.
Resolution not expected by Oct 17, 2021 PDUFA target action date; FDA expressed intent to work with Omeros.
No specific deficiencies disclosed; Omeros evaluating next steps for HSCT-TMA, a lethal condition with no approved therapy.
Narsoplimab has Breakthrough Therapy and Orphan designations; first BLA submitted for HSCT-TMA.

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