- Omeros (NASDAQ:OMER +9.6%) is up more than double normal volume in response to the news that it has streamlined the work required for its U.S. marketing application seeking approval for OMS721 for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a Breakthrough Therapy and Orphan Drug indication.
- Response-based data will now be the primary endpoint of a Phase 3 trial. Overall survival and 100-day survival will be secondary endpoints. The new endpoint eliminates the need for a historical control so the company will cease its data collection in this area.
- A rolling BLA filing will be conducted, first with non-clinical sections.
- The FDA will consider both accelerated and full approval.
- It plans to meet with European regulators next quarter to advance its application there.