Omeros Stock Price, News & Analysis

Omeros Corporation (NASDAQ: OMER) has scheduled its second quarter 2025 financial results announcement for Thursday, August 14, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the quarterly results and recent developments.

Investors can access the live webcast through Omeros' website at investor.omeros.com/upcoming-events. For phone participation, registration is required to receive a PIN. The call replay will be available at investor.omeros.com/archived-events.

Omeros (NASDAQ:OMER) has announced a registered direct offering of common stock to raise approximately $22 million through an agreement with Polar Asset Management Partners. The company will sell 5,365,853 shares at $4.10 per share, representing a 14% premium to the closing price on July 24, 2025.

The offering is expected to close around July 28, 2025, with D. Boral Capital LLC serving as the exclusive placement agent. The offering is made pursuant to an effective S-3 shelf registration statement previously filed with the SEC.

Omeros (NASDAQ:OMER) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The submission showcases impressive clinical results, including a 61% response rate and a three-fold improvement in overall survival compared to a matched external control group.

The application includes data from over 130 TA-TMA patients treated under Omeros' expanded access program. With orphan drug designation, the review will follow a centralized procedure, potentially leading to marketing authorization across EU member states and EEA countries. A final decision is expected by mid-2026. Additionally, the FDA is reviewing the resubmitted BLA with a PDUFA date of September 25, 2025.

Omeros Corporation (Nasdaq: OMER) has announced details for its virtual Annual Meeting of Shareholders scheduled for June 27, 2025, at 10:00 a.m. Pacific Time. The meeting will be accessible through the virtual shareholder meeting website.

Shareholders of record as of May 23, 2025 will be able to attend, vote, and submit questions using their 16-digit control number. The meeting will include a business portion followed by a general corporate overview and Q&A session. A recording will be available on Omeros' corporate website after the event.

Omeros Corporation (OMER) reported Q1 2025 financial results with a net loss of $33.5 million ($0.58/share), improving from Q1 2024's loss of $37.2 million. Cash position stands at $52.4 million, down $37.7M from December 2024. Key developments include FDA's acceptance of narsoplimab BLA resubmission for TA-TMA with a PDUFA date of September 25, 2025. The company restructured debt by exchanging $70.8M of 2026 Convertible Notes for new 2029 notes and converting $10M to equity. OMIDRIA royalties were $6.7M on $22.3M sales. To conserve capital, Omeros suspended several programs, including the Phase 3 PNH program for zaltenibart, while prioritizing narsoplimab's commercial launch preparations.

Omeros Corporation (NASDAQ: OMER) has scheduled the release of its Q1 2025 financial results for Thursday, May 15, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on the same day. Management will discuss financial results, recent developments, and highlights. Investors can access the live webcast through Omeros' website at investor.omeros.com/upcoming-events. For phone access, participants must pre-register to receive a PIN. A replay will be available at investor.omeros.com/archived-events.

Omeros Corporation (OMER) has announced significant debt restructuring agreements to manage its $80.5 million of Convertible Senior Notes due 2026. The company will exchange $70.5 million of its 5.25% notes for new 9.50% Convertible Senior Notes due 2029, and convert $10 million into common stock. The new notes feature a 35% premium conversion rate and will mature on June 15, 2029. Following these transactions, only $17.4 million of the 2026 notes will remain outstanding. This restructuring eliminates the need for a $20 million term loan prepayment due in November 2025 and reduces potential debt repayment obligations over the next 12 months from $117.9 million to $17.4 million. The Equitization Transaction is expected to complete by September 15, 2025.

Omeros Corporation (OMER) announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for narsoplimab, targeting the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The FDA has assigned a PDUFA date in late September 2025.

The Class 2 resubmission includes crucial data showing statistically significant and clinically meaningful improvements in survival for narsoplimab-treated patients compared to an external control group. Additional data from the company's expanded access program, treating both adult and pediatric TA-TMA patients, was also included. Omeros is currently responding to FDA information requests and plans to submit a marketing authorization application to the European Medicines Agency later this quarter.

Omeros (OMER) has established an Oncology Clinical Steering Committee to advance its OncotoX biologics program targeting acute myeloid leukemia (AML). The committee comprises distinguished clinical experts from leading National Comprehensive Cancer Network Centers, chaired by Dr. Naval Daver from MD Anderson Cancer Center.

The OncotoX-AML program features engineered molecules that deliver toxic payloads to cancer cells. In animal studies, the therapeutic has demonstrated superior efficacy to current standard treatments, showing effectiveness against tumors with mutations found in nearly 90% of AML patients. The treatment targets both AML blasts and leukemia stem cells, while preliminary studies indicate good tolerability at doses well above efficacious levels.

AML, affecting over 20,000 U.S. patients annually with 11,000+ deaths, represents a significant market opportunity. The global AML therapeutic market is projected to reach over $6 billion by 2030, within a broader leukemia therapeutic market forecast of $29 billion.