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) announces the CDC's approval of an ICD-10 code for hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). This code, effective October 1, 2021, will enhance diagnosis accuracy and reporting of HSCT-TMA cases. Additionally, CMS approved two ICD-10-PCS codes for administering narsoplimab, an investigational therapy for HSCT-TMA, aimed at improving billing and reimbursement processes. Narsoplimab is under FDA priority review and has received several designations, including breakthrough therapy status.
Omeros Corporation (Nasdaq: OMER) has begun dosing patients with narsoplimab in the I-SPY COVID-19 Trial, which aims to identify effective treatments for critically ill COVID-19 patients. This adaptive trial, sponsored by Quantum Leap Healthcare Collaborative, focuses on reducing mortality and minimizing mechanical ventilation duration. Narsoplimab, targeting MASP-2, is the only complement inhibitor in the trial, with positive outcomes in compassionate use cases. Omeros anticipates valuable data from this collaboration, especially as SARS-CoV-2 variants continue to spread.
Omeros Corporation (Nasdaq: OMER) reported its fourth quarter and full year 2020 financial results, with Q4 revenues of $10.6 million, down from $26.1 million in Q3. The decline is attributed to the expiration of pass-through reimbursement for OMIDRIA on October 1, 2020. Total revenues for 2020 were $73.8 million, compared to $111.8 million in 2019, largely due to reduced cataract surgeries amid the COVID-19 pandemic. The company had $135.0 million in cash and equivalents at year-end. Narsoplimab’s Biologics License Application was accepted with a PDUFA date of July 17, 2021.
Omeros Corporation (NASDAQ: OMER) will announce its fourth quarter and year-end financial results for 2020 on March 1, 2021, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results and recent company developments. Investors can join via phone or through a webcast on Omeros' website. The company focuses on developing therapeutics for various medical conditions, with products like OMIDRIA gaining market share in cataract surgery. Key developments include the rolling biologics license application for narsoplimab.
Omeros Corporation (Nasdaq: OMER) has appointed Nadia Dac as Chief Commercial Officer, responsible for all commercial operations, including the launch of narsoplimab, a MASP-2 inhibitor currently under FDA Priority Review for treating thrombotic microangiopathy. Dac brings nearly 30 years of experience from companies like Alder Pharmaceuticals and AbbVie. Omeros anticipates growth from the restoration of OMIDRIA reimbursement and the upcoming narsoplimab launch, enhancing its commercial prospects.
Omeros Corporation (Nasdaq: OMER) announced that the FDA has accepted its Biologics License Application (BLA) for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The application has been granted Priority Review status, with a decision expected by July 17, 2021. Narsoplimab targets MASP-2, an enzyme crucial for the lectin pathway of the complement system, and has previously received breakthrough and orphan drug designations. There are currently no FDA-approved therapies for HSCT-TMA, marking narsoplimab's potential significance.
Omeros Corporation (Nasdaq: OMER) announced that Gregory A. Demopulos, M.D., CEO, will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:50 a.m. EST. The presentation will be available via webcast, accessible for 30 days on the company’s website. Omeros is focused on developing therapeutics for inflammation, complement-mediated diseases, and CNS disorders. Its lead product, OMIDRIA, continues to gain market share. The company is advancing in various clinical stages with drugs targeting significant health issues, including cancer.
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.
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