Omeros' Lead mAb Granted Breakthrough Therapy Designation for IgA Nephropathy stat : GEN

The FDA granted breakthrough therapy designation to Omeros' lead human monoclonal antibody (mAb) OMS721 for the treatment of immunoglobulin A (IgA) nephropathy. There is no currently approved therapy for IgA nephropathy, Omeros points out. A Phase III study with OMS721 in patients with IgA nephropathy is now being planned. OMS721 has been granted FDA orphan drug status for preventing complement-mediated TMAs, and fast track designation for the aHUS indication. "We are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agency's recognition of the potential importance of OMS721 in the treatment of this disease," stated Gregory A. Demopulos, M.D., Omeros chairman and CEO.




OMER Receives Breakthrough Therapy DesignationAs mentioned above, Omeros Corporation is having a strong time in the market at the moment after the United States Food and addiction Administration granted breakthrough therapy designation. The breakthrough therapy designation was granted to OMER based on the solid data surrounding the Phase 2 clinical trial of OMS721. The company was just granted breakthrough therapy designation with regard to a key treatment candidate. The breakthrough therapy designation is overwhelmingly positive news for OMER. Omeros Corporation (NASDAQ: OMER) is having an incredibly strong day in today's trading session and for good reason.

Omeros' OMS721 a Breakthrough Therapy for kidney disorders; shares ahead 10% - Omeros Corporation (NASDAQ:OMER)

Omeros (OMER +10.4% ) follows through on yesterday's upmove on triple normal volume. Previously: Omeros announces additional positive data from mid-stage study of OMS721; facebook/" target="_blank">shares ahead 3% premarket (March 1) The catalyst appears to be the FDA's designation of Breakthrough Therapy (BTD) status to lead monoclonal antibody candidate OMS721 for the treatment of IgA nephropathy. BTD provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the marketing application. Phase 2-stage OMS721 binds to an enzyme called mannan-binding lectin-associated serine protease-2 (MASP-2) which plays a key role in the lectin pathway of the complement system, which is believed to contribute to significant tissue injury.


collected by :Lucy William

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