Shares of Omeros Corporation (OMER) are up over 45% at $11.74, following compelling results of primary analysis of its drug candidate Narsoplimab in treating hematopoietic stem cell transplant-associated thrombotic microangiopathy.
In a pivotal trial, dubbed OMS721-TMA-001, Narsoplimab-treated patients had a 3-fold reduction in the risk of mortality compared to high-risk transplant-associated thrombotic microangiopathy (TA-TMA) patients in an external control cohort, the company said.
As part of the primary analysis, 28 Narsoplimab-treated patients from OMS721-TMA-001 were compared with more than 100 similarly high-risk patients from a stem cell transplant registry who did not receive narsoplimab.
Additional analyses are also being conducted by the independent statistical group.
The findings from these analyses, along with the primary analysis results, will be included in the narsoplimab BLA for TA-TMA, which is planned for resubmission at the earliest.
The company is also preparing for a European marketing authorization application in mid-2025.
The FDA had declined to approve Narsoplimab for the proposed indication of hematopoietic stem cell transplant-associated thrombotic microangiopathy in October 2021 and requested additional information to support its regulatory approval.
If approved, Narsoplimab would become the first approved therapeutic for TA-TMA, a life-threatening complication of hematopoietic stem cell transplantation.
Cash Position
The company ended September 30, 2024, with $123.2 million of cash and short-term investments.
We featured OMER on our site on Nov.22, 2024, when it was trading at $9.70. The stock is currently at $11.74, up 57.37%.
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