Omeros Stock Price, News & Analysis

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.

Omeros Corporation (NASDAQ: OMER) has received an interim response from the FDA regarding its dispute resolution request concerning the biologics license application for narsoplimab, aimed at treating HSCT-TMA. The FDA's Office of New Drugs is collecting additional information before issuing a final decision within 30 days. Narsoplimab is the first drug candidate submitted for HSCT-TMA and holds Breakthrough Therapy and Orphan Designations. Omeros continues to develop narsoplimab for other conditions, including IgA nephropathy and COVID-19.

Omeros Corporation (Nasdaq: OMER) reported a net loss of $30.9 million or $0.49 per share for Q2 2022, which includes $3.7 million in non-cash expenses. This is a slight increase from a net loss of $28.6 million in Q2 2021. The company earned $17.2 million in royalties on net sales of OMIDRIA, reflecting a record high from Rayner Surgical's sales. Omeros has $122.6 million in cash and short-term investments as of June 30, 2022. Key upcoming milestones include a decision on narsoplimab's FDA approval expected in August 2022 and significant clinical trials for other promising therapies.

Omeros Corporation (NASDAQ: OMER) will release its second quarter financial results for the period ending June 30, 2022, on August 9, 2022, after market close. A conference call will follow at 4:30 p.m. Eastern Time to discuss the results and recent developments. Omeros focuses on developing therapeutics for immunologic disorders, with a lead candidate, narsoplimab, awaiting FDA approval for HSCT-TMA. The company is also advancing other programs targeting complement-mediated disorders.

Omeros Corporation announced that its investigational drug OMS906 has received orphan drug designation from the FDA for treating paroxysmal nocturnal hemoglobinuria (PNH). The drug targets MASP-3, a key protein in the alternative complement pathway, providing potential advantages in dosing and safety. Clinical enrollment in PNH patients is set to begin this summer, following a successful Phase 1 trial. Orphan designation offers benefits such as seven years of market exclusivity and tax credits. Omeros aims to position OMS906 as a first-line therapy for PNH.

Omeros Corporation (NASDAQ: OMER) is hosting its Annual Meeting of Shareholders virtually on June 17, 2022, at 10:00 a.m. Pacific Time. Only shareholders of record as of April 14, 2022, can vote during the meeting. Shareholders can attend the meeting and submit questions online using their control number. A recording will be available for those unable to attend. Omeros develops therapeutics for immunologic diseases and has various programs, including the lead compound, narsoplimab, which targets complement-mediated disorders.

Omeros Corporation (Nasdaq: OMER) reported first-quarter 2022 financial results, showing a net loss of $33.0 million or $0.53 per share, improved from a loss of $35.1 million a year earlier. The company earned $13.8 million in royalties from OMIDRIA sales by Rayner Surgical, reflecting a $6.6 million increase year-over-year. Cash reserves decreased to $142.2 million. Following an FDA meeting regarding its biologics license application for narsoplimab, Omeros plans to submit a formal dispute resolution request, confident in its data. Key upcoming events include trial data for OMS906 and OMS1029.

Omeros Corporation (NASDAQ: OMER) is set to release its first quarter financial results for the period ending March 31, 2022, on May 10, 2022, post-market. A conference call will follow at 4:30 p.m. ET to discuss the financial results and recent developments. Omeros focuses on developing therapeutics for immunologic diseases, with a lead product, narsoplimab, under FDA review for a specific disorder. The company has multiple late-stage clinical programs addressing various complement-mediated conditions.