Why Are Omeros Shares Plunging On Friday?

  • 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.
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