SEATTLE - Omeros (NASDAQ:OMER) Corporation (NASDAQ: OMER), a biotechnology company with a market capitalization of $515.75 million, today reported results from sensitivity analyses confirming the effectiveness of its investigational drug narsoplimab in treating thrombotic microangiopathy (TA-TMA) after hematopoietic stem cell transplantation. The company's stock has shown remarkable strength, delivering a 155.75% return over the past year, according to InvestingPro data. The independent statistical group's analysis supports the primary endpoint results previously announced on December 19, 2024, indicating a significant reduction in the risk of mortality for patients treated with narsoplimab compared to an external control group.
The sensitivity analyses demonstrated hazard ratios ranging from 0.24 to 0.42, with p-values between less than 0.00001 to 0.0124, underscoring the robustness of the primary analysis that showed a more than threefold decrease in mortality risk. While InvestingPro analysis indicates the company is quickly burning through cash, its current ratio of 2.96 suggests strong short-term liquidity to support ongoing operations. These results are based on various statistical models, including overall survival with treatment as the only factor and testing proportional hazards assumptions over different time frames.
Omeros plans to resubmit a Biologics License Application (BLA) to the FDA later this quarter, aiming for narsoplimab to become the first approved therapeutic for TA-TMA. Additionally, a submission to European regulators for a Marketing Authorization Application (MAA) is targeted by mid-year.
Narsoplimab, also known as OMS721, is a monoclonal antibody targeting MASP-2, a key player in the lectin pathway of the complement system. The drug has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA and is pending approval for the same indication. The European Medicines Agency (EMA) has also granted orphan drug designation for narsoplimab in hematopoietic stem-cell transplant treatment.
TA-TMA is a life-threatening complication of stem cell transplantation, affecting both adults and children. With no approved therapy currently available, the condition has a high mortality rate, particularly in severe cases.
The findings from the sensitivity analyses are part of Omeros's ongoing efforts to provide a treatment for TA-TMA, with additional results from the expanded access program anticipated soon. The company is moving forward with regulatory submissions based on the strength of the data collected.
This news is based on a press release statement from Omeros Corporation. With analysts setting a target price of $36.00, significantly above the current trading price of $8.90, investors seeking detailed analysis can access comprehensive financial metrics and 14 additional ProTips through InvestingPro's exclusive research reports, available for over 1,400 US stocks.
In other recent news, Omeros Corporation has been making significant strides in its drug development programs and financial health. The biopharmaceutical company's lead product candidate, Narsoplimab, is nearing potential approval in the United States and Europe. The recent initiation of coverage by D. Boral (OTC:BOALY) Capital with a Buy rating and a price target of $36.00 reflects a positive outlook for the company.
Narsoplimab has shown a significant over three-fold reduction in the risk of mortality for patients treated with it, according to independent statistical analysis. Omeros is preparing to resubmit a Biologics License Application for Narsoplimab to the FDA, marking a major milestone for the company. The company is also planning to initiate Phase 3 trials for another promising drug, Zaltenibart, in early 2025.
Omeros reported a decrease in its net loss for the third quarter of 2024 to $32.2 million, compared to the previous quarter's loss of $56 million. The company's cash reserves were reported at $123.2 million. These recent developments reflect Omeros' ongoing efforts to improve its financial health and advance its key drug programs.
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