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Omeros reports survival benefit with narsoplimab in TA-TMA

Published 12/19/2024, 10:22 PM
OMER
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Omeros (NASDAQ:OMER) Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing small-molecule and protein therapeutics for various diseases. The company is working towards broad accessibility of narsoplimab for TA-TMA patients and their physicians, following the anticipated regulatory approvals. With a current ratio of 2.96, the company maintains strong liquidity to support its operations, though InvestingPro analysis indicates the stock is slightly overvalued at current levels. For deeper insights into Omeros's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers. With a current ratio of 2.96, the company maintains strong liquidity to support its operations, though InvestingPro analysis indicates the stock is slightly overvalued at current levels. For deeper insights into Omeros's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

The independent statistical analysis, which was agreed upon with the FDA, showed that patients treated with narsoplimab had a more than threefold reduction in the risk of mortality compared to a cohort of over 100 TA-TMA patients who did not receive the treatment. The hazard ratio was reported as 0.32 with a 95% confidence interval of 0.23 to 0.44 and a p-value of less than 0.00001.

Omeros Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing small-molecule and protein therapeutics for various diseases. The company is working towards broad accessibility of narsoplimab for TA-TMA patients and their physicians, following the anticipated regulatory approvals. With a current ratio of 2.96, the company maintains strong liquidity to support its operations, though InvestingPro analysis indicates the stock is slightly overvalued at current levels. For deeper insights into Omeros's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

The analysis compared overall survival in 28 TA-TMA patients from Omeros's pivotal trial to that of more than 100 similarly high-risk TA-TMA patients in an external control registry who did not receive narsoplimab treatment. The patients in both cohorts had similar demographics and baseline characteristics.

TA-TMA is recognized as a devastating complication of stem cell transplantation that can lead to multi-organ failure and death. There is currently no approved therapy or standard of care for HSCT-TMA.

Narsoplimab, also known as OMS721, is a monoclonal antibody targeting MASP-2, a key enzyme in the lectin pathway of complement. The FDA has granted the drug breakthrough therapy and orphan drug designations for TA-TMA, and the European Medicines Agency (EMA) has also granted orphan drug designation for its use in hematopoietic stem-cell transplant.

Omeros Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing small-molecule and protein therapeutics for various diseases. The company is working towards broad accessibility of narsoplimab for TA-TMA patients and their physicians, following the anticipated regulatory approvals.

Additional analyses and sensitivity studies are being conducted and will be included in the narsoplimab BLA for TA-TMA. The data from this analysis is based on a press release statement from Omeros Corporation.

In other recent news, Omeros Corporation has reported significant progress in its drug development and financial health. The company revealed encouraging clinical data for its investigational drug zaltenibart, which is aimed at treating paroxysmal nocturnal hemoglobinuria (PNH). This data supports the planned initiation of Phase 3 clinical trials for zaltenibart in PNH, set to begin in early 2025.

Another promising drug, narsoplimab, designed to treat a rare complication of stem cell transplantation, is progressing towards the resubmission of its Biologics License Application, following feedback from the U.S. Food and Drug Administration.

In terms of financial health, Omeros reported a decrease in its net loss for the third quarter of 2024, standing at $32.2 million, a reduction from the previous quarter's loss of $56 million. The company's cash reserves were reported at $123.2 million.

Also, a deal with DRI Healthcare over OMIDRIA royalties is set to bring potential milestone payments, further bolstering Omeros' financial standing. These recent developments reflect Omeros' ongoing efforts to improve its financial health and advance its key drug programs.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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