Omeros Corporation (NASDAQ:OMER) – Omeros Submits Response To FDA Regarding Narsoplimab Application In HSCT-TMA


Omeros Submits Response To FDA Regarding Narsoplimab Application In HSCT-TMA

  • Omeros Corporation (NASDAQ: OMER) has submitted to the FDA its response to Complete Response Letter for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). 
  • The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory, and legal experts addressing the points raised by the FDA. 
  • Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.
  • Related Link: Omeros Stock Falls As FDA Asks For More Clinical Narsoplimab Data In HSCT-TMA.
  • 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: Omeros’ Narsoplimab Shows Improved, Stabilized Renal Function At Three Years.
  • Price Action: OMER shares are up 1.94% at $5.26 during after-hours trading on Wednesday.



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