OMEROS CORPORATION

Omeros Restructures $80.5 Million in Debt, Significantly Reducing Near-Term Financial Obligations

10 days ago

• Omeros Corporation has entered into agreements to exchange $70.5 million of its 2026 Convertible Notes for new 2029 Convertible Notes with a 9.50% interest rate, extending debt maturity by three years. • An additional $10 million of 2026 Convertible Notes will be converted into common stock through an "Equitization Transaction," reducing the company's outstanding debt by $10 million. • These strategic financial maneuvers will decrease Omeros' potential debt repayment obligations over the next 12 months from $117.9 million to approximately $17.4 million, preventing a required $20 million term loan prepayment.

Omeros Forms Elite Clinical Steering Committee to Advance Novel AML Therapeutic Program

a month ago

• Omeros Corporation has established an Oncology Clinical Steering Committee comprising eight distinguished leukemia experts from leading cancer centers to guide its OncotoX-AML program development. • The OncotoX-AML therapeutic has demonstrated superior efficacy to current standard treatments in preclinical studies, effectively targeting 90% of common AML mutations while showing excellent tolerability at high doses. • The novel engineered molecules, approximately half the size of antibodies, selectively kill dividing cancer cells including treatment-resistant leukemia stem cells, addressing a significant unmet need in AML treatment.

Omeros Advances Zaltenibart Phase 3 Trials for PNH with Potential Superiority Over Current Treatments

2 months ago

• Omeros Corporation has initiated site activation for its Phase 3 clinical trials of zaltenibart (OMS906) in paroxysmal nocturnal hemoglobinuria (PNH), with data for regulatory submission expected in Q4 2026. • Zaltenibart offers a significant advantage over current PNH therapies with convenient once-every-eight-weeks dosing and ability to inhibit both intravascular and extravascular hemolysis, potentially achieving normal hemoglobin levels. • The Phase 3 program includes head-to-head comparisons against C5 inhibitors eculizumab and ravulizumab across 120 clinical sites in 30 countries, targeting a global PNH market projected to reach $11.7 billion by 2034.

Narsoplimab Shows Promising Real-World Outcomes in TA-TMA Patients at 2025 Tandem Meetings

3 months ago

• Omeros Corporation will present real-world data from 128 transplant patients treated with narsoplimab for TA-TMA under an expanded access program at the 2025 Tandem Meetings in Honolulu. • Key findings include outcomes from patients who received narsoplimab after failing eculizumab treatment, highlighting potential new treatment options for refractory cases. • The investigational antibody, which targets MASP-2, maintains critical immune functions while awaiting FDA approval, with breakthrough therapy and orphan drug designations already secured.

Narsoplimab Shows Significant Survival Benefit in TA-TMA Patients, BLA Resubmission Planned

5 months ago

• Narsoplimab significantly reduced the risk of mortality in high-risk TA-TMA patients by over 3-fold compared to an external control group. • Sensitivity analyses further confirmed the robustness of narsoplimab's survival benefit, with p-values ranging from 0.00001 to 0.0124. • Omeros plans to resubmit the Biologics License Application (BLA) to the FDA for narsoplimab, seeking approval as the first therapy for TA-TMA. • The European marketing authorisation application (MAA) submission to European regulators is targeted by mid-year 2025.

Omeros Corporation's Narsoplimab Meets Primary Endpoint in Pivotal Trial for Stem Cell Transplant Patients

5 months ago

Omeros Corporation's stock surged approximately 55% following the announcement that its lead drug, narsoplimab, successfully met the primary endpoint in a pivotal trial for stem cell transplant patients. This significant development highlights the potential of narsoplimab in treating transplant-associated thrombotic microangiopathy (TMA), a serious complication in stem cell transplant recipients.

Zaltenibart Receives FDA Rare Pediatric Disease Designation for C3 Glomerulopathy

7 months ago

• Zaltenibart (OMS906) has been granted Rare Pediatric Disease Designation by the FDA for treating complement 3 glomerulopathy (C3G). • C3G, a progressive renal disorder affecting children and young adults, currently lacks approved treatments, highlighting the importance of this designation. • Zaltenibart inhibits mannan-binding lectin-associated serine protease-3 (MASP-3), a key activator of the alternative complement pathway. • A phase 3 clinical trial is anticipated to begin next year to assess zaltenibart's efficacy in treating C3G, expanding its potential therapeutic applications.

FDA Grants Rare Pediatric Disease Designation to Omeros' Zaltenibart for C3 Glomerulopathy

7 months ago

• The FDA has granted rare pediatric disease designation to Omeros' zaltenibart (OMS906) for treating complement 3 glomerulopathy (C3G). • C3G is an ultra-rare, progressive renal disorder primarily affecting children and young adults, with no approved treatments currently available. • Zaltenibart, a MASP-3 inhibitor, is the most proximal inhibitor of the alternative pathway and is set to enter Phase 3 clinical trials next year. • Omeros is also advancing zaltenibart for paroxysmal nocturnal hemoglobinuria (PNH) and anticipates initiating Phase 3 studies later this quarter.

Omeros' Zaltenibart Receives FDA Rare Pediatric Disease Designation for C3 Glomerulopathy

7 months ago

• The FDA has granted Rare Pediatric Disease designation to Omeros' zaltenibart (OMS906) for treating complement 3 glomerulopathy (C3G). • Zaltenibart, a MASP-3 inhibitor, is the most proximal inhibitor of the alternative pathway and aims to address the unmet need in C3G treatment. • Phase 3 clinical trials for zaltenibart in C3G are planned to commence next year, alongside ongoing studies in paroxysmal nocturnal hemoglobinuria (PNH). • This designation allows Omeros to receive a priority review voucher upon zaltenibart's approval, potentially accelerating market entry for other products.