Why Are Omeros Shares Plunging On Friday? - Omeros (NASDAQ:OMER)

The FDA has identified deficiencies regarding Omeros Corporation's OMER marketing application of narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The application was accepted in January 2021 under FDA's Priority Review program.
The agency FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Related Link: Omeros' Narsoplimab Associated With Improvement In Organ Function In Stem Cell Transplant Patients.
FDA did not provide specific details of the deficiencies in its notification.
The Company does not currently expect any such resolution by the October 17, 2021 target action date. Omeros is evaluating potential next steps as it awaits additional information from FDA.
Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA.
It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.
Related content: Benzinga's Full FDA Calendar.
Price Action: OMER stock is down 45.20% at $7.56 during the market session on the last check Friday.