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

Omeros Corporation 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.