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.
Omeros Corporation develops and commercializes protein and small-molecule therapeutics for large-market and orphan indications, with emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Its news centers on YARTEMLEA (narsoplimab-wuug), an FDA-approved MASP-2 lectin pathway inhibitor for hematopoietic stem cell transplant-associated thrombotic microangiopathy in adult and pediatric patients aged two years and older.
Recurring updates also cover U.S. commercialization, reimbursement coding, transplant-medicine presentations, operating and financial results, and pipeline work including OMS1029, a long-acting MASP-2 inhibitor, and OncotoX-AML, an oncology therapeutic platform targeting acute myeloid leukemia.
Omeros Corporation (Nasdaq: OMER) announced that the Centers for Medicare & Medicaid Services (CMS) will provide separate payment for its cataract surgery drug, OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. Effective retroactively from October 1, 2020, this decision supports non-opioid pain management in ambulatory surgery centers (ASCs). The drug is noted for preventing pupil constriction and reducing postoperative pain in cataract surgeries, thereby improving outcomes and decreasing opioid dependency.
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.