Shares of Omeros (NASDAQ: OMER) were 8.7% higher as of 3:21 p.m. EST on Thursday after rising as much as 12.7% earlier in the day. The biotech announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) that streamlines its path to filing for approval of experimental drug OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) -- a complication resulting from stem cell transplants.
Any time the FDA makes it easier for a biotech to submit a new drug for approval, it's good news for the biotech. That's definitely the case for Omeros.
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Probably the most important news from the agreement with the FDA is that Omeros will be able to use data from its current phase 3 clinical study of OMS721 in HSCT-TMA without having to use historical control data. This means less work for Omeros and a speedier route to filing the Biologics License Application (BLA) for OMS721.
Omeros chairman and CEO Greg Demopulos hit the nail on the head with his remarks about the FDA agreement. Demopulos said, "We now have an even clearer and more streamlined path to submitting our BLA, saving time and crucial resources as we advance toward regulatory review and approval."
The FDA now says that it won't just consider accelerated approval for OMS721 in HSCT-TMA; the agency will also consider full regular approval of the drug. An accelerated approval requires a confirmatory post-approval clinical study, so a full approval that didn't require this step would definitely be great for Omeros.
Omeros now plans to meet with European regulators to discuss aligning its submission for OMS721 with its FDA filing. The biotech will likely soon begin filing its rolling BLA submission for the drug in the U.S., beginning with the nonclinical section of the application that was completed in late 2018.
There's no guarantee that OMS721 will be approved. However, with no approved treatment for HSCT-TMA and promising clinical data so far, Omeros could be on track to launch its second product in the not-too-distant future.
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