Omeros wins FDA breakthrough designation for novel biologic
Washington, USA-based Omeros (Nasdaq: OMER) has been granted Breakthrough Therapy designation for its candidate OMS721, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients.
Shares in the firm jumped 7% in mid-afternoon trading yesterday, as news of the US Food and Drug Administration’s decision was announced. The decision means Omeros will benefit from expedited development and review treatment from the FDA.
It is the second Breakthrough drug designation for OMS721, which last year received the designation from FDA for the treatment of Immunoglobulin A (IgA) nephropathy.
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