Omeros Stock Price, News & Analysis

Omeros Corporation (NASDAQ: OMER) is set to release its fourth quarter and year-end financial results for the period ending December 31, 2022, on March 13, 2023, after the market closes. Following the release, Omeros management will host a conference call at 4:30 p.m. ET to discuss the results and recent developments. Omeros specializes in developing therapeutics for immunologic disorders, with its lead candidate, narsoplimab, currently pending FDA approval for treating TA-TMA. The company is also pursuing multiple late-stage clinical programs for various complement-mediated disorders, including IgA nephropathy and COVID-19.

Omeros Corporation (Nasdaq: OMER) received a $200 million milestone payment from Rayner Surgical due to the Asset Purchase Agreement for OMIDRIA^®. This payment, received on February 3, 2023, is expected to support Omeros' operations well into 2025. U.S. net sales of OMIDRIA reached $131 million in 2022, with growth anticipated from regulatory changes ensuring separate payment for non-opioid pain management drugs. Omeros will continue earning royalties, with rates decreasing from 50% to 30% for U.S. sales post-milestone. The funds will be utilized for clinical studies, commercialization, and other strategic purposes.

Omeros Corporation (Nasdaq: OMER) reported third-quarter 2022 earnings, generating $16.5 million in royalties from the sales of OMIDRIA, accounting for 50% of Rayner's $33.0 million net sales. The company posted a net loss of $17.5 million ($0.28 per share), an improvement from $22.7 million in Q3 2021. A $125 million sale of future OMIDRIA royalties to DRI Healthcare Acquisitions was also completed. The FDA denied the resubmission request for narsoplimab but offered a path forward for its BLA based on survival data, which is critical for future development and approvals.

Omeros Corporation announced that the FDA's Office of New Drugs has denied its appeal for immediate labeling discussions regarding its biologics license application (BLA) for narsoplimab, aimed at treating thrombotic microangiopathy. However, the decision outlines a potential path for BLA resubmission based on survival data from completed trials compared to historical controls. The company plans to discuss the implications of this decision in its upcoming earnings call on November 9, 2022. Narsoplimab is the first drug candidate submitted to the FDA for this indication.

Omeros Corporation (NASDAQ: OMER) will release its third-quarter financial results on November 9, 2022, after market close. A conference call will be held at 4:30 PM ET on the same day to discuss the results and recent developments. The company is focused on developing therapeutics for immunologic disorders, with its lead product, narsoplimab, under a biologics license application for treating HSCT-TMA. This product is also part of ongoing clinical trials for other conditions, including IgA nephropathy and COVID-19.

Omeros Corporation (Nasdaq: OMER) will present two studies on its investigational complement inhibitors at the 64th American Society of Hematology Annual Meeting from December 10-13, 2022, in New Orleans. The first presentation focuses on the safety and pharmacokinetics of the MASP-3 inhibitor OMS906 (Abstract #2570), scheduled for December 11. The second presentation evaluates the MASP-2 inhibitor Narsoplimab for pediatric patients with HSCT-TMA (Abstract #3808) on December 12. Poster details will be available on Omeros' website post-meeting.

Omeros Corporation (NASDAQ: OMER) has successfully sold a portion of its projected royalty payments from OMIDRIA to DRI Healthcare Acquisitions LP, generating $125 million in gross proceeds. This sale, finalized under a Royalty Purchase Agreement dated September 30, 2022, allows DRI to receive royalty payments on net sales until December 31, 2030, capped at various amounts annually. Omeros retains a significant portion of future revenues from OMIDRIA and has no dilution of stockholders. The transaction positions Omeros to secure substantial funding without impacting its balance sheet.

Omeros Corporation (NASDAQ: OMER) announced significant findings from the I-SPY COVID Trial, indicating that the addition of narsoplimab reduces the mortality risk in critically ill COVID-19 patients (HR=0.81). The trial involved 91 patients in the narsoplimab group compared to 116 in the control group, with no new safety signals identified. However, narsoplimab did not expedite recovery times. Despite some treatment limitations, a substantial efficacy signal was observed, highlighting narsoplimab's potential in severe acute COVID-19 management.

Quantum Leap Healthcare Collaborative (QLHC) and Omeros Corporation (NASDAQ: OMER) announced the closure of enrollment and analysis of the narsoplimab arm in the I-SPY COVID Trial. The study revealed that narsoplimab, when added to standard care in critically ill COVID-19 patients, reduces mortality risk (HR=0.81, p<0.77). A total of 91 patients were randomized, showing no new safety signals for narsoplimab. The trial intends to enhance treatment outcomes for severely ill COVID-19 patients through innovative clinical trial designs.