- 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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