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 (OMER) is a clinical-stage biopharmaceutical company pioneering therapies for immunologic disorders and complement-mediated diseases. This page provides investors and researchers with essential updates on the company's clinical trials, regulatory progress, and strategic developments.
Access timely announcements including FDA submissions, clinical trial results, partnership agreements, and financial reports. Our curated news collection helps stakeholders track Omeros' advancements in targeting the complement system and addressing unmet medical needs.
Bookmark this page for centralized access to verified updates about OMER's pipeline candidates, including its lead monoclonal antibody therapy. Stay informed about developments in hematologic, nephrologic, and central nervous system disorders through our comprehensive news monitoring.
Omeros Corporation (Nasdaq: OMER) announced that the FDA requires additional time to review the Biologics License Application (BLA) for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new PDUFA target action date is set for October 17, 2021. Omeros recently submitted a major amendment to the BLA in response to an FDA information request, demonstrating ongoing engagement with the agency. Narsoplimab has received Breakthrough Therapy and Orphan designations and is the first drug submitted for approval in HSCT-TMA.
Omeros Corporation (Nasdaq: OMER) announced that data from its pivotal trial of narsoplimab for HSCT-TMA will be presented at the 2021 EHA Virtual Congress. Dr. Miguel-Angel Perales will present findings on the drug's impact on organ function improvement in high-risk patients. Narsoplimab, a human monoclonal antibody, is currently under priority review by the U.S. FDA for HSCT-TMA treatment and has received numerous designations, including breakthrough therapy. The condition HSCT-TMA is serious, with up to 90% mortality in severe cases, and no approved therapies currently exist.
Omeros Corporation (Nasdaq: OMER) reported strong first-quarter 2021 results, with OMIDRIA revenues rising to $21.1 million from $10.6 million last quarter. The net loss decreased to $35.1 million (or $0.57 per share), compared to $37.3 million (or $0.60 per share) previously. As of March 31, 2021, cash and equivalents reached $100.5 million. Notably, the FDA is reviewing Omeros' Biologics License Application for narsoplimab, with a decision expected by July 17, 2021. The company is also advancing multiple clinical programs, including trials for COVID-19 therapies.
Omeros Corporation (NASDAQ: OMER) will release its first-quarter financial results for the period ending March 31, 2021, on May 10, 2021, post-market. A conference call is scheduled for the same day at 4:30 p.m. Eastern Time to discuss the results and recent developments. Omeros is a biopharmaceutical firm focused on therapeutics for inflammation and complement-mediated diseases. Its products include OMIDRIA and the investigational drug narsoplimab, which is under FDA priority review for thrombotic microangiopathy.
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.
