Omeros Corporation - OMER STOCK NEWS

Omeros Corporation (NASDAQ: OMER) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The FDA expressed challenges in evaluating the treatment's effect and requested additional information for regulatory approval. Omeros remains confident in narsoplimab's efficacy and plans to engage in discussions with the FDA to outline the path forward. Narsoplimab is the first drug candidate submitted for HSCT-TMA with Breakthrough Therapy and Orphan designations.

Omeros Corporation (Nasdaq: OMER) announced that the FDA identified deficiencies in its Biologics License Application (BLA) for narsoplimab, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). This notification prevents discussions on labeling and post-marketing commitments at this time. The company does not expect these issues to be resolved by the October 17, 2021 target action date. Narsoplimab is the first drug submitted for HSCT-TMA approval and holds Breakthrough Therapy and Orphan Drug designations.

Omeros Corporation (Nasdaq: OMER) reported strong financial results for Q2 2021, with OMIDRIA revenues reaching $28.8 million, a 37% increase from Q1 2021. The net loss narrowed to $28.6 million ($0.46 per share), improving from a loss of $35.1 million in the prior quarter. The company's cash position stood at $73.7 million. A priority review of Omeros' Biologics License Application for narsoplimab is set for October 17, 2021. Recent positive clinical data supports ongoing development of OMS906, a MASP-3 inhibitor, marking significant progress in Omeros' pipeline.

Omeros Corporation (NASDAQ: OMER) is set to announce its Q2 financial results for the period ending June 30, 2021, on August 9, 2021, after market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and recent developments. Omeros is focused on developing therapeutics for inflammation and immunologic diseases, with its product OMIDRIA® gaining market traction. The company’s lead drug, narsoplimab, is under review by the FDA for a key indication related to hematopoietic stem cell transplants, while other drugs are in late-stage trials.

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.