By Stephen Nakrosis
Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration.
In Thursday afternoon trading, the stock had gained 47%, to $6.20. Earlier in the session, shares hit a high of $7.51.
Omeros said it held a presubmission meeting with FDA for its biologics license application for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy. The National Institutes of Health said the disorder, also known as TA-TMA, can be triggered by several mechanisms during transplants.
Following the meeting, the company said, it revised and resubmitted its statistical analysis plan, and now expects to receive a reply imminently. If the results support resubmission, the company said, it plans to finalize and resubmit the BLA as soon as possible.
The biopharmaceutical company also said preparations are underway for a European marketing authorization application for narsoplimab in TA-TMA, which it expects to submit in the first half of next year.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 14, 2024 13:33 ET (18:33 GMT)
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