What’s going on with OMER?
Omeros Corp. (OMER) stock slid 11.61% after the biopharmaceutical company reported that the U.S. Food and Drug Administration would need more time to review its Biologics License Application for narsoplimab, an experimental treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new Prescription Drug User Fee Act date, or when the FDA’s decision is due, is now October 17, 2021.
Shares of OMER were trading at $15 per share on Thursday afternoon.
What does this mean for Omeros Corp.?
Narsoplimab is the first drug submitted to FDA for approval in HSCT-TMA, and has been designated with Breakthrough Therapy and Orphan designations in HSCT-TMA and IgA nephropathy. Omeros provided a response to an FDA information request as part of the FDA’s Priority Review for the BLA for narsoplimab, which was filed in January. However, the agency classified it as a major amendment that delayed the approval process, according to Omeros.
“Omeros views the information provided in response to FDA’s information request as further supporting the application, and we look forward to making narsoplimab available to HSCT-TMA patients and their physicians as soon as possible,” said Gregory A. Demopulos, M.D., chairman and CEO of Omeros.
OMER has an Overall Score of 57. Find out what this means to you and get the rest of the rankings on OMER!
Omeros Corp is a United States-based biopharmaceutical company. Its goal is to research, develop, and commercialize small-molecule and protein therapeutics targeting inflammation, coagulopathies, and disorders of the central nervous system. The company owns Omidria (phenylephrine and ketorolac injection), approved by the U.S. Food and Drug Administration and launched in the U.S. for use during cataract surgery and intraocular lens replacement. Its product pipeline is focused on complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders.
