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Omeros, FDA Agree On Endpoint For Pivotal Trial Of Small Blood Vessel Damage Treatment

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Omeros, FDA Agree On Endpoint For Pivotal Trial Of Small Blood Vessel Damage Treatment

Shares of the thinly traded small-cap biotech Omeros Corporation (NASDAQ: OMER) were advancing strongly Thursday.

What Happened

Omeros announced Thursday ahead of the market open that it has reached an agreement with the FDA on the response-based primary endpoint of its pivotal trial to support the biologic license application for narsoplimab.

Narosoplimab, codenamed OMS721, is Omeros' lead human monoclonal antibody candidate for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA.

HSCT-TMA is a severe complication of HSCT, affecting about 20-30% of recipients. TMA is a condition where small blood vessels are damaged due to an endothelial injury, which in turn affects key organs such as the brain, kidney and heart. 

Why It's Important

HSCT-TMA has no approved treatment, and narsoplimab is the only drug in development for the condition. The investigational asset has been granted Breakthrough Therapy Designation.

Omeros expressed confidence that the study will meet the primary endpoint.

What's Next

Omeros said it will now complete the ongoing data collection from medical records of patients already treated with narosplimab either in the clinical trial or under compassionate use for inclusion in the clinical sections of the BLA.

It also plans to meet with the European Medicines Agency's rapporteurs this summer to pave the way for European approval.

The company hopes to complete and submit the BLA, as well as the MAA for European approval.

Omeros has the leeway to make a rolling submission to the FDA, which allows it to submit the completed portions without having to wait for all the sections to be completed.

Omeros shares were up 7.23% at $16.31 at the time of publication Thursday. 

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Photo courtesy of Omeros

Posted-In: Biotech News FDA Trading Ideas General Best of Benzinga

 

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