Welcome to our dedicated page for Omeros news (Ticker: OMER), a resource for investors and traders seeking the latest updates and insights on Omeros stock.
The Omeros Corporation (NASDAQ: OMER) news page on Stock Titan aggregates company announcements, clinical updates, regulatory milestones, and financial disclosures in one place. Omeros is a biopharmaceutical company focused on first-in-class small-molecule and protein therapeutics for complement-mediated diseases, cancers, and addictive or compulsive disorders, and its news flow reflects this broad development agenda.
A major theme in recent Omeros news is YARTEMLEA (narsoplimab-wuug), the company’s fully human monoclonal antibody that inhibits MASP-2 in the lectin pathway of complement. The U.S. FDA has approved YARTEMLEA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children two years of age and older. News items detail the approval decision, clinical data on complete response and survival, safety information, and plans for the U.S. market launch, as well as conference calls discussing this milestone.
Investors and clinicians following OMER news will also find updates on regulatory reviews in Europe, peer-reviewed publications on TA-TMA outcomes with narsoplimab, and developments in Omeros’ broader pipeline. These include progress with OMS1029, the long-acting MASP-2 inhibitor; OMS527 for cocaine use disorder, supported by a grant from the National Institute on Drug Abuse; and oncology and Targeted Complement Activating Therapy (T-CAT) programs.
Another recurring news topic is Omeros’ strategic transactions and financing. Releases describe the asset purchase and license agreement with Novo Nordisk for the MASP-3 inhibitor zaltenibart (OMS906), including upfront and milestone payment structures and retained rights, as well as registered direct offerings, at-the-market equity sales, and quarterly financial results. Bookmark this page to review OMER headlines, official press releases, and related commentary as they are issued.
Omeros Corporation (Nasdaq: OMER) has completed the rolling submission of its Biologics License Application (BLA) to the FDA for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The submission includes clinical sections based on a pivotal trial where the drug met its primary endpoint. Omeros has requested priority review, with the FDA having up to 60 days to determine the application’s filing and review designation. Narsoplimab has received both breakthrough therapy and orphan drug designations from the FDA.
Omeros Corporation (Nasdaq: OMER) reported third-quarter 2020 revenues of $26.1 million, impacted by an $8.7 million return reserve after the expiration of OMIDRIA's pass-through reimbursement on October 1, 2020. This marks a decrease from $29.9 million in Q3 2019. The company posted a net loss of $38.5 million or $0.66 per share, compared to $16.5 million in the same quarter the previous year. Despite challenges, Omeros is advancing its pipeline, including the submission of a Biologics License Application for narsoplimab and a Phase 1 trial for OMS906.
Omeros Corporation (Nasdaq: OMER) presented its OMS906 program data at the 4th Complement-based Drug Development Summit. OMS906 targets MASP-3, a key activator in the complement system's alternative pathway, aiming to inhibit its activation. The animal study data revealed that a single dose reduced mature complement factor D levels while increasing pro-complement factor D levels. Omeros targets paroxysmal nocturnal hemoglobinuria (PNH) as the first indication, with OMS906 showing greater potency than current C5 and C3 inhibitors. A Phase 1 clinical trial for OMS906 began last month.
Omeros Corporation (Nasdaq: OMER) will present final results from its pivotal trial of narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) in a webcast on October 22, 2020, at 8:30 a.m. ET. The data will support their Biologics Licensing Application (BLA) to the FDA, detailing primary and secondary efficacy endpoints including complete response rate and overall survival. The trial also incorporates data from a compassionate-use program, affirming the safety profile. Interested parties can access the webcast or dial in via phone for participation.