Omeros: FDA Finds Deficiencies In BLA For Narsoplimab; Resolution Unlikely Before PDUFA Action Date

(RTTNews) - Regarding FDA's ongoing review of the company's BLA for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, Omeros Corp. (OMER) said the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments. Omeros stated that it does not currently expect any resolution to occur by the October 17, 2021 target action date under PDUFA.

The Biologics License Application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy was accepted for filing in January 2021.

The company noted that FDA did not provide specific details of the deficiencies in its notification.

Shares of Omeros Corp. were down 30% in pre-market trade on Friday.