- Omeros 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.
https://seekingalpha.com/news/3637588-omeros-jumps-7_5-after-completing-bla-submission-for-narsoplimab
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Wednesday, November 18, 2020
Omeros jumps after BLA submission for respiratory med
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