Narsoplimab shows promise in TA-TMA survival rates

SEATTLE - Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company with a market capitalization of $534 million and notably volatile stock movements (Beta 1.98), has revealed results from statistical analyses indicating that narsoplimab, their investigational monoclonal antibody, may significantly improve survival rates in patients with thrombotic microangiopathy (TA-TMA) following stem cell transplantation. InvestingPro data shows the company’s stock has surged over 130% in the past six months, reflecting growing investor confidence in their pipeline. The analyses compared survival outcomes of high-risk adult and pediatric patients treated under an expanded access program (EAP) with those from an external control group.

The combined analysis of 49 untreated EAP patients and 28 from the OMS721-TMA-001 pivotal trial demonstrated a reduction in mortality risk by over two-fold, with hazard ratios ranging from 0.34 to 0.46 and p-values from less than 0.00001 to 0.00002. These results align with the primary and sensitivity analyses previously agreed upon with the FDA.

The EAP included 136 TA-TMA patients, with 102 identified as high-risk based on expert consensus criteria. Notably, 49 untreated adult EAP patients and 13 untreated pediatric patients exhibited impressive one-year survival rates of 58% and 79%, respectively. This contrasts with the historically low survival rates of less than 20% for patients who fail targeted therapy.

Narsoplimab’s safety profile remained consistent with no new safety concerns observed. These findings are set to be included in a resubmission of a biologics license application (BLA) to the FDA and a marketing authorization application (MAA) to European regulators expected later this year. According to InvestingPro analysis, while Omeros is quickly burning through cash in its development efforts, the company maintains a healthy current ratio of 2.96, indicating sufficient liquidity to fund its near-term operations. For deeper insights into Omeros’s financial health and 12 additional exclusive ProTips, consider exploring InvestingPro’s comprehensive research platform.

The robust data from the EAP further supports narsoplimab’s potential as a treatment for TA-TMA, a condition with no currently approved therapy. This news is based on a press release statement.

TA-TMA is a severe complication of hematopoietic stem cell transplantation, affecting both adult and pediatric patients. Narsoplimab, also known as OMS721, targets mannan-binding lectin-associated serine protease-2 (MASP-2), a key player in the lectin pathway of complement activation, which is implicated in TA-TMA.

Omeros Corporation, a biopharmaceutical company, is actively working towards the approval and launch of narsoplimab, aiming to provide a new therapeutic option for patients suffering from TA-TMA. With the company’s next earnings report due on February 26th and InvestingPro’s Fair Value analysis suggesting slight undervaluation, investors seeking detailed insights can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, covering all crucial aspects of OMER’s financial health and growth potential.

In other recent news, Omeros Corporation has announced promising results from its investigational drug, narsoplimab, in reducing mortality for patients with thrombotic microangiopathy (TA-TMA) following hematopoietic stem cell transplantation. The independent statistical analysis showed a significant over threefold reduction in mortality risk for patients treated with narsoplimab compared to a control group. Omeros is preparing to resubmit a Biologics License Application (BLA) to the FDA and plans to file for European marketing authorization later this year. D. Boral (OTC:BOALY) Capital has initiated coverage on Omeros with a Buy rating, emphasizing the potential approval of narsoplimab as the first therapy for TA-TMA. The firm set a price target of $36.00, reflecting confidence in the company’s strategic direction and pipeline. Additionally, Omeros has shared new clinical data on its drug zaltenibart for paroxysmal nocturnal hemoglobinuria (PNH), supporting the initiation of Phase 3 trials in early 2025. The Phase 2 study showed significant improvements in patients unresponsive to existing treatments, with an optimal dosing regimen established. These developments highlight Omeros’s ongoing efforts to advance its therapeutic offerings in critical medical areas.

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