Omeros Corporation - OMER STOCK NEWS

Omeros Corporation (Nasdaq: OMER) recently presented pivotal trial results for narsoplimab at the 26th European Hematology Association Congress, highlighting its effectiveness in treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The trial included a high-risk patient cohort, where 61% of participants showed improvement in laboratory and clinical markers. Notably, 74% of eligible patients experienced organ function improvement. A Biologics License Application is under Priority Review by the FDA, with a decision date set for October 17, 2021.

Omeros Corporation (Nasdaq: OMER) announced the publication of a study in the Journal of Neuroscience, highlighting the effects of phosphodiesterase 7 (PDE7) inhibitors on nicotine consumption. The research demonstrated that these inhibitors, including Omeros' OMS527, significantly reduced nicotine use in rodent models without abuse potential. PDE7 inhibition potentially offers a new avenue for treating addiction, including smoking cessation. Omeros holds global rights to PDE7 inhibitors for addiction disorders and continues to advance its therapeutic pipeline.

Omeros Corporation (Nasdaq: OMER) announced that Gregory A. Demopulos, M.D., CEO, will present at the BofA 2021 Napa BioPharma Virtual Conference on June 15, 2021, at 4:30 p.m. EDT. The presentation will be a fireside chat with analyst Geoff Meacham, PhD. Interested parties can access the live and archived webcast at Omeros Upcoming Events, available for 30 days post-event.

Omeros is focused on developing therapeutics for inflammation and immunologic diseases, with products like OMIDRIA and lead candidate narsoplimab under FDA review.

Omeros Corporation (Nasdaq: OMER) announced preliminary results from its Phase 1 trial of MASP-3 inhibitor OMS906. The study, involving healthy volunteers, demonstrates that OMS906 is well tolerated at all tested doses with no safety concerns. Key findings include a significant suppression of mature CFD for up to 4 weeks following administration of the drug. The trial supports the potential for once-monthly subcutaneous dosing. Omeros aims to advance OMS906 to Phase 2 trials, reinforcing its commitment to developing therapies for complement-mediated diseases.

Omeros Corporation (Nasdaq: OMER) has released preliminary results from a compassionate use study of its lead drug, narsoplimab, in critically ill COVID-19 patients in Bergamo, Italy. The cohort included ten patients, all with significant comorbidities and severe acute respiratory distress syndrome (ARDS). Notably, 80% of the patients recovered and were discharged. The drug is designed to target endothelial damage in COVID-19. Narsoplimab also holds Breakthrough Therapy designation and is under review by the FDA for other serious conditions. Further clinical trial data is expected.

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.