Omeros Stock Price, News & Analysis

Omeros Corporation (NASDAQ: OMER) announced positive interim results from its Phase 1b trial of OMS906, a MASP-3 inhibitor for treating paroxysmal nocturnal hemoglobinuria (PNH). The study showed significant improvements in hemoglobin (Hgb) and lactate dehydrogenase (LDH). Notably, all patients treated with OMS906 experienced an increase in Hgb of at least 4.0 g/dL after two doses, with a mean increase of 4.75 g/dL (p < 0.001). After three doses, the mean increase reached 6.27 g/dL (p = 0.005). Importantly, all patients remained transfusion-free throughout the observation period. OMS906 demonstrated good tolerability with no safety concerns reported. Omeros aims to expand its clinical trials and anticipates preliminary results from additional studies in the coming months.

Omeros Corporation (Nasdaq: OMER) has secured a $6.69 million grant from the National Institute on Drug Abuse to advance its proprietary PDE7 inhibitor, OMS527, aimed at treating cocaine use disorder (CUD). The funding, awarded on April 7, 2023, will be utilized for both preclinical studies and a clinical trial assessing OMS527's safety and efficacy in patients suffering from CUD, particularly those using cocaine concurrently. The research objectives include interaction studies in animal models and a randomized clinical study comparing OMS527 to placebo. This initiative arises from the growing societal crisis of substance use disorders, with 1.4 million Americans estimated to have CUD. Omeros’ drug has previously demonstrated tolerability in Phase 1 trials, showcasing its potential in combating addiction-related conditions.

Omeros Corporation (Nasdaq: OMER) reported a net income of $128.7 million, or $2.05 per share, for Q4 2022, reversing a prior loss of $17.5 million in Q3 2022. However, the net loss from continuing operations narrowed to $46.0 million, down from $54.8 million. The company earned $17.9 million in royalties from OMIDRIA in Q4, with total cash resources at $194.9 million. A pivotal milestone was the $200 million payment from Rayner, triggered by OMIDRIA sales. Additionally, Omeros plans to resubmit its BLA for narsoplimab and expects crucial data from ongoing trials in 2023.

Omeros Corporation (NASDAQ: OMER) has confirmed a lack of financial relationships with Silicon Valley Bank, addressing investor concerns. The company previously held a line of credit with the bank, which expired in August 2022. Currently, Omeros has no assets deposited with Silicon Valley Bank nor any other financial ties. Omeros is focused on developing pharmaceutical therapies for immunologic disorders, with its lead drug, narsoplimab, under a pending FDA biologics license application for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company is advancing multiple late-stage clinical programs targeting various complement-mediated disorders.

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.