OMER - Omeros jumps 7.5% after completing BLA submission for narsoplimab
Omeros (OMER) shares climb 7.5% after the company completes its rolling submission of its Biologics License Application to the FDA for narsoplimab for the treatment of a complication associated with stem cell transplantation.The company has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application.If the stock's advance stays at that level, it will be Omeros's largest rise since Aug. 10, when it reported positive results from a compassionate use study evaluating narsoplimab in severely ill COVID-19 patients with acute respiratory distress syndrome requiring mechanical ventilation.The BLA is for the use of narsoplimab in treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.See OMER stock performance vs.
For further details see:
Omeros jumps 7.5% after completing BLA submission for narsoplimab