Omeros Announces Journal of Clinical Oncology Publication Detailing Pivotal Trial Results for Narsoplimab in HSCT-TMA

Rhea-AI Summary

Omeros Corporation (NASDAQ: OMER) announced the online publication of a manuscript detailing the results from its pivotal study on narsoplimab for treating HSCT-TMA, a severe complication following stem cell transplants. No approved treatment exists for this condition. The manuscript will appear in the Journal of Clinical Oncology and is currently available online. Narsoplimab is the subject of a biologics license application pending with the FDA. The company is also engaged in late-stage clinical programs for other complement-mediated disorders.

Positive

• Narsoplimab's pivotal study results for HSCT-TMA published online, indicating potential market approval.
• Narsoplimab is subject to a biologics license application pending with the FDA.

Negative

• None.

SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today announced the online publication of a manuscript detailing the results of its pivotal study assessing efficacy and safety of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved treatment. The manuscript – Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2 Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell Transplantation–Associated Thrombotic Microangiopathy – will be published in an upcoming volume of the Journal of Clinical Oncology (JCO) and yesterday was made available online by JCO, the flagship publication of the American Society of Clinical Oncology.

About Omeros Corporation

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic diseases, including complement-mediated diseases and cancers related to dysfunction of the immune system, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is initiating a Phase 1b clinical program in paroxysmal nocturnal hemoglobinuria (PNH). In addition to its complement franchise, Omeros has ongoing cutting-edge programs in addiction treatments, immuno-oncology therapeutics and human CAR-T and adoptive T cell therapy systems. More information about Omeros and its programs is available at www.omeros.com and in Omeros’ annual, quarterly and current reports filed with the U.S. Securities and Exchange Commission (SEC), which can be accessed at www.omeros.com under “Investors & News — Financial Information — SEC Filings” and on the SEC’s website at www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005459/en/

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Source: Omeros Corporation

FAQ

What are the results of the pivotal study on narsoplimab by Omeros Corporation?

The pivotal study results on narsoplimab for HSCT-TMA were published online, indicating its efficacy and safety for this severe condition.

When will the manuscript on narsoplimab be published?

The manuscript will appear in an upcoming volume of the Journal of Clinical Oncology.

What is HSCT-TMA and why is narsoplimab significant?

HSCT-TMA is a life-threatening complication of stem cell transplants; narsoplimab is significant as it may be the first approved treatment for this condition.

Is narsoplimab currently under FDA review?

Yes, narsoplimab is under a biologics license application pending with the FDA.

What other conditions is Omeros targeting with narsoplimab?

Omeros is developing narsoplimab for other complement-mediated disorders, including IgA nephropathy and atypical hemolytic uremic syndrome.