Omeros advancing OMS721 marketing applications for HSCT-TMA

Omeros (OMER +0.9%) is up modestly in early trade, albeit on light volume, on the heels of its update on marketing applications for lead candidate narsoplimab (OMS721) for the potential treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

In Europe, the EMA has signed off on its pediatric investigation plan (PIP), a prerequisite for acceptance of a marketing application, although it has received a deferral for its completion until after the EMA nod for adult use. Once the PIP is completed, narsoplimab will be eligible for up to two additional years of marketing exclusivity in the EU.

It recently initiated the rolling submission of its U.S. application for HSCT-TMA and will work with the FDA to sign off on the same study plan outlined in the PIP.

Narsoplimab has Orphan Drug status in the U.S. and Europe and Breakthrough Therapy status in the U.S. for HSCT-TMA.

https://seekingalpha.com/news/3510724-omeros-advancing-oms721-marketing-applications-hsct-tma