Omeros jumps after detailing FDA meeting on IgA nephropathy program
Shares of Omeros (OMER) are up 40% after the company last night reported financial results for the third quarter and announced recent highlights and developments.
Omeros said that it met with the FDA in follow-up to the FDA’s granting breakthrough designation for OMS721 in IgA nephropathy to discuss Phase 3 trial design.
“The Agency’s meeting minutes make clear that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint. Depending on the size of the effect on proteinuria, either full approval or accelerated approval is possible.
If full approval is granted based on reduction in proteinuria, estimated glomerular filtration rate will be followed as part of the safety assessment. Any effect of OMS721 on eGFR is likely to result in additional label claims for the product. If, based on the effect on proteinuria, accelerated rather than full approval is granted, marketing of OMS721 would be allowed during which time confirmatory data on long-term effects of OMS721 on eGFR would be collected. These eGFR data, if satisfactory, would then form the basis for full approval,” the company stated.
Gregory Demopulos, chairman and chief executive officer of Omeros, added, “We have also made substantial progress across our OMS721 programs – in addition to our Phase 3 aHUS program, we have a clear roadmap for the Phase 3 IgA nephropathy trial, including FDA confirmation of proteinuria as the primary efficacy endpoint, and compelling data to support our advancing to a Phase 3 program in stem cell transplant-associated TMA.”
Proteinuria is the presence of excess proteins in the urine. In healthy people, urine contains very little protein; an excess is suggestive of illness.
IgA nephropathy, also known as Berger’s disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues. IgA is an antibody—a protein made by the immune system to protect the body from foreign substances such as bacteria or viruses.
In Friday’s trading, Omeros shares are up $4.35, or 31%, to $18.44.
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