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FDA Confirms Omeros’ Schedule for Rolling Review of the Company’s BLA for Narsoplimab in the Treatment of HSCT-TMA
– Omeros Remains On Track to Initiate the Submission Next Quarter – SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) announced that the United
About this update from Omeros Corporation
[{"type":"text","content":"\n– Omeros Remains On Track to Initiate the Submission Next Quarter –\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) announced that the United States Food and Drug Administration (FDA) agreed with the company’s proposed schedule for the rolling review of the Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).\n\n\nConsistent with the agreed schedule, the company is on track to submit the BLA’s first sections, which will include the nonclinical and clinical pharmacology data, in the first half of next quarter.\n\n\nUnder its rolling review process, FDA can review components of a marketing application as they are submitted rather than requiring all components to be received prior to initiating review, allowing faster review of the application. The BLA for narsoplimab, because of the drug’s breakthrough therapy designation from FDA for the treatment of HSCT-TMA, is also eligible for priority review, which shortens the standard FDA review cycle by four months.\n\n\nOmeros referenced FDA’s agreement with the company’s proposed schedule for its rolling BLA during a webcast presentation given yesterday by Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer, at the H.C. Wainwright 21st Annual Global Investment Conference. Omeros has received informational requests from investors regarding this agreement. In addition to the information contained in this release, an archived recording of the webcast presentation can be accessed on the Investors & News/Events section of Omeros’ website at www.omeros.com.\n\n\nAbout Omeros Corporation\n\n\nOmeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. The company’s drug product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Uni...