Omeros Stock Price, News & Analysis

Omeros (OMER) has initiated site activation for its Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). The program spans 120 clinical sites across 30 countries, with data for BLA submission expected in Q4 2026.

Zaltenibart, administered intravenously once every eight weeks, demonstrates advantages over current treatments that require more frequent dosing. The Phase 3 program includes two trials comparing zaltenibart to C5 inhibitors eculizumab and ravulizumab, targeting both treatment-naive patients and those with inadequate response to existing therapies.

Phase 2 data showed zaltenibart effectively inhibits both intravascular and extravascular hemolysis, achieving normal hemoglobin levels with no significant safety concerns. The global PNH market is valued at $3.8 billion in 2023, with projections reaching $11.7 billion by 2034.

Omeros (OMER) has secured a $4.02 million funding commitment from the National Institute on Drug Abuse (NIDA) for the clinical development of OMS527, their oral phosphodiesterase 7 inhibitor targeting cocaine use disorder (CUD).

The funding was triggered by successful drug-drug-interaction safety studies where OMS527 showed no enhancement of cocaine's detrimental effects and demonstrated beneficial outcomes in cocaine-administered animals. The grant will support a Phase 1b clinical trial to assess OMS527's safety and efficacy, with initial data expected in Q4 2025.

OMS527 has shown promising results in animal models across various addictions including cocaine, opioids, nicotine, and alcohol, reducing both craving and relapse. A previous Phase 1 trial demonstrated favorable safety and pharmacokinetics supporting once-daily dosing. With approximately 1.3 million Americans affected by CUD and over 27,000 cocaine-related deaths in 2022, OMS527 aims to address a significant unmet medical need as there are currently no approved treatments for CUD.

Omeros (NASDAQ: OMER) announced robust statistical analysis results for narsoplimab's Expanded Access Program (EAP) in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analysis showed that narsoplimab significantly reduced mortality risk in high-risk TA-TMA patients by 2-3 fold (hazard ratio = 0.34-0.46) with highly significant p-values (<0.00001).

The EAP included 136 TA-TMA patients, with impressive survival rates: 62% one-year survival for previously untreated patients (58% adults, 79% children) and 44% for treatment-refractory patients - more than double the historical survival rate of <20%. The results will be included in narsoplimab's BLA resubmission to FDA this quarter and MAA submission to European regulators by mid-year.

No safety concerns were identified, and the data consistently demonstrated narsoplimab's effectiveness in treating TA-TMA, a life-threatening complication with no currently approved treatment.

Omeros (OMER) has made available on its website materials from two presentations delivered at the 2025 Tandem Meetings, focusing on narsoplimab treatment outcomes. The presentations include survival data from Dr. Michelle Schoettler's study of 128 allogeneic transplant patients with TA-TMA treated under the expanded access program, and Dr. Piyatida Chumnumsiriwath's poster on outcomes from adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment.

Omeros (NASDAQ: OMER) has announced two upcoming presentations at the 2025 Tandem Meetings in Honolulu, Hawaii, focusing on narsoplimab treatment outcomes for TA-TMA patients under an expanded access program. The first presentation, by Dr. Michelle Schoettler from Emory University School of Medicine, will discuss overall survival rates among 128 allogeneic transplant patients treated with narsoplimab.

The second presentation, by Dr. Piyatida Chumnumsiriwath from UC Irvine, will showcase findings from a single-center study of adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment. Both presentations are scheduled for February 13, 2025, with Dr. Schoettler's podium presentation at 3:15 PM HST and Dr. Chumnumsiriwath's poster session at 6:45 PM HST.

Omeros (NASDAQ: OMER) announced positive statistical sensitivity analysis results for narsoplimab in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analyses validate previously reported primary endpoint results showing 2-fold to 4-fold reduction in mortality risk (hazard ratios 0.24-0.42) with p-values ranging from 0.0124 to <0.00001.

The primary endpoint analysis demonstrated an over 3-fold reduction in mortality risk (hazard ratio = 0.32) in narsoplimab-treated patients compared to external control. The company plans to resubmit its Biologics License Application (BLA) to FDA this quarter and targets Marketing Authorization Application (MAA) submission to European regulators by mid-year. Narsoplimab aims to become the first approved treatment for TA-TMA, a life-threatening complication in stem cell transplantation.

Omeros (OMER) announced successful results from its narsoplimab pivotal trial for treating transplant-associated thrombotic microangiopathy (TA-TMA). The primary statistical analysis showed that patients treated with narsoplimab had an over 3-fold reduction in mortality risk (hazard ratio = 0.32) compared to untreated patients in an external control group.

The study compared 28 narsoplimab-treated TA-TMA patients against more than 100 similar high-risk patients from a stem cell transplant registry. The results were highly statistically significant (p < 0.00001). Based on these positive outcomes, Omeros will resubmit its Biologics License Application (BLA) to FDA, aiming to make narsoplimab the first approved treatment for TA-TMA.

Omeros (OMER) presented two posters about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the ASH Annual Meeting. The presentations focused on Phase 2 clinical data and clinical pharmacology analyses for treating paroxysmal nocturnal hemoglobinuria (PNH).

The Phase 2 'switch-over' study showed that zaltenibart monotherapy achieved sustained improvements in hemoglobin and absolute reticulocyte count in PNH patients who had inadequate response to ravulizumab. The treatment was well-tolerated with no concerning safety signals.

Pharmacokinetic/pharmacodynamic modeling identified 8mg/kg as the optimal intravenous dose administered every 8 weeks, achieving >98% suppression of alternative pathway activation. Phase 3 clinical trials are expected to begin enrollment in early 2025.

Omeros (NASDAQ: OMER) has announced two upcoming presentations about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, December 7-10, 2024. The presentations focus on treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.

The presentations include interim results from a Phase 2 proof-of-concept study showing improved hematologic parameters in PNH patients, and a pharmacokinetics/pharmacodynamics study. Phase 3 clinical trials for zaltenibart in PNH are scheduled to begin in early 2025.