Omeros Corp. Reschedules Conference Call for YARTEMLEA® Approval and Upcoming U.S. Launch
SEATTLE – Omeros Corporation (NASDAQ: OMER) has announced a revised date for its conference call to discuss the recent U.S. Food and Drug Administration (FDA) approval of YARTEMLEA® (narsoplimab-wuug). This groundbreaking therapy is the first and only treatment indicated for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
The call will now take place on Wednesday, January 7, 2026, at 4:30 p.m. Eastern Time. This adjustment aims to ensure broad participation from shareholders and investors, particularly to accommodate holiday schedules following the significant milestone of FDA approval and to align with the planned January 2, 2026, U.S. market launch of YARTEMLEA.
Omeros expressed enthusiasm for kicking off the new year by sharing details about this landmark approval and the forthcoming U.S. market introduction of YARTEMLEA.
Conference Call and Webcast Details:
Date: Wednesday, January 7, 2026
Time: 4:30 p.m. Eastern Time
Live Webcast:
The live webcast can be accessed at https://investor.omeros.com/upcoming-events.
Conference Call (Phone):
Participants wishing to join by phone must register at https://register-conf.media-server.com/register/BI860d4c7c1e5d4bb1a77988a530e78171 to receive a unique PIN. Following registration, participants can either dial in using the provided conference line and PIN, or opt for the “Call Me” feature to receive an automated call. Re-registration is required if the PIN or confirmation email is lost.
Replay:
A replay of the call will be available at https://investor.omeros.com/archived-events.
About YARTEMLEA®:
YARTEMLEA® (narsoplimab-wuug) is a fully human monoclonal antibody and represents the first and only approved inhibitor of the lectin pathway of complement. By inhibiting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway, YARTEMLEA addresses TA-TMA. In this condition, MASP-2 inhibition mitigates lectin pathway-mediated cellular injury, including endothelial damage and thrombus formation in small blood vessels. Crucially, YARTEMLEA selectively blocks the lectin pathway, preserving the activity of the classical and alternative pathways, which are vital for adaptive immune responses.
The U.S. FDA has approved YARTEMLEA for the treatment of TA-TMA in adults and children aged two years and older. A marketing authorization application for YARTEMLEA for TA-TMA is currently under review by the European Medicines Agency (EMA), with a decision anticipated in mid-2026. YARTEMLEA has received both breakthrough therapy and orphan drug designations from the FDA for TA-TMA, and the EMA has granted it orphan drug designation in hematopoietic stem-cell transplantation.
About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA):
TA-TMA is a serious and frequently fatal complication following hematopoietic stem cell transplantation in both adult and pediatric patients. The condition is characterized by systemic endothelial injury, often triggered by conditioning regimens, immunosuppressants, infections, graft-versus-host disease, and other transplant-related factors. The activation of the complement lectin pathway plays a critical role in the pathogenesis of TA-TMA.
TA-TMA can occur after both autologous and allogeneic transplants, with a higher incidence observed after allogeneic procedures. Approximately 30,000 allogeneic transplants are performed annually in the U.S. and Europe. Recent estimates suggest that TA-TMA develops in up to 56 percent of allogeneic transplant recipients. Mortality rates in severe TA-TMA can exceed 90 percent, and survivors often experience long-term renal complications, including a dependence on dialysis.
About Omeros Corporation:
Omeros is a biotechnology company focused on the discovery, development, and commercialization of novel therapeutics for both large-market and rare diseases. The company has a particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead product, YARTEMLEA® (narsoplimab), an inhibitor of the lectin pathway’s effector enzyme MASP-2, is FDA-approved for TA-TMA and is slated for a U.S. launch in January 2026. The EMA is also reviewing a marketing authorization application for YARTEMLEA for TA-TMA, with a decision expected mid-2026. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.
In a recent asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor for cocaine use disorder, and a portfolio of novel molecular and cellular oncology programs.
Forward-Looking Statements:
This press release contains forward-looking statements subject to risks and uncertainties, as defined by the Securities Act of 1933 and the Securities Exchange Act of 1934. These statements, often identified by words like “anticipate,” “believe,” “expect,” and “plan,” reflect management’s current beliefs and assumptions. Actual results may differ materially due to various factors, including regulatory uncertainties, clinical trial outcomes, manufacturing and supply challenges, reimbursement policies, intellectual property disputes, and competitive developments. Omeros assumes no obligation to update these statements, except as required by law.
Contact:
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
[email protected]
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