Omeros Stock Price, News & Analysis

Omeros (NASDAQ: OMER) announced FDA approval of YARTEMLEA (narsoplimab-wuug) for treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children ≥2 years.

Key clinical results: CR 61% in the pivotal study (N=28) and 68% in evaluable expanded access patients; 100-day survival 73% in the pivotal study and 74% in evaluable EAP patients. Approval is based on a single-arm pivotal trial plus EAP data. U.S. launch is planned for January 2026, with dedicated ICD-10 diagnosis and procedure codes and a patient support program expected Q1 2026.

Omeros (Nasdaq: OMER) closed the asset purchase and license agreement with Novo Nordisk for the clinical-stage MASP-3 antibody zaltenibart (formerly OMS906).

Omeros received $240.0 million upfront and is eligible for up to $340.0 million in upfront/near-term milestones and up to $2.1 billion total including development/commercial milestones plus tiered royalties. Omeros retained rights to its MASP-3 small-molecule program.

At closing Omeros prepaid the $67.1 million senior secured term loan principal and related amounts, terminating that credit agreement and releasing liens and the $25.0 million minimum liquidity covenant. Remaining proceeds are expected to repay a $17.1 million 2026 convertible note balance and fund more than 12 months of operations, including an anticipated U.S. launch of narsoplimab for TA-TMA.

Omeros (Nasdaq: OMER) reported third-quarter 2025 results and strategic transactions on November 13, 2025. Q3 net loss was $30.9M ($0.47/share); 9-month net loss was $89.8M ($1.47/share). Cash and short-term investments at Sept 30 were $36.1M and Q3 cash burn (ex-financing) was $22.0M.

On October 10, 2025, Omeros signed an Asset Purchase and License Agreement with Novo Nordisk for zaltenibart (OMS906) yielding up to $2.1B in payments including a $240M upfront at closing and tiered royalties. The upfront is expected to fund repayment of senior secured debt (~$67.1M) and the remaining $17.1M 2026 convertible principal and provide >12 months of post-closing cash.

Omeros (NASDAQ: OMER) will release financial results for the quarter ended September 30, 2025 on Thursday, November 13, 2025 after market close. Management will host a conference call and webcast the same day at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results, recent developments, and highlights.

Live audio will be available via the company investor website and by phone with a required registration PIN; a replay will be posted online at the archived events page.

Omeros (Nasdaq: OMER) announced a peer‑reviewed manuscript in Blood Advances reporting survival outcomes in adults with high‑risk transplant‑associated thrombotic microangiopathy (TA‑TMA) treated with narsoplimab across a pivotal trial and the global expanded access program (EAP).

The analysis found significant, multifold reductions in mortality risk for narsoplimab versus a well‑matched external control group, with consistent results across individual cohorts and pooled data. No new safety signals were observed. Narsoplimab, a MASP‑2 inhibitor targeting the lectin complement pathway, is currently under review by the U.S. FDA and the European Medicines Agency. The full manuscript is available online.

Omeros (NASDAQ:OMER) announced the publication of a peer-reviewed manuscript in the American Journal of Hematology highlighting survival outcomes for patients treated with narsoplimab through a global expanded access program. The study focused on both adult and pediatric patients with transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening condition.

The drug, which inhibits MASP-2 (the effector enzyme of the lectin pathway of complement), demonstrated excellent survival outcomes in patients receiving it as first-line therapy and in those who failed prior treatments, including C5 inhibitors. The treatment showed no concerning safety signals, consistent with previous clinical studies. Notably, narsoplimab is currently under review for marketing approval by both the U.S. FDA and European Medicines Agency.

Omeros Corporation (Nasdaq: OMER) reported Q2 2025 financial results with a reduced net loss of $25.4 million ($0.43/share), compared to $56.0 million ($0.97/share) in Q2 2024. The company secured $20.6 million through a registered direct offering with Polar Asset Management Partners at a 14% premium.

Key developments include FDA's review of narsoplimab for TA-TMA with a PDUFA date extended to December 26, 2025, and EMA's acceptance of the marketing authorization application. The company significantly improved its balance sheet by reducing near-term debt by over $100 million through note exchanges and conversions.

Omeros is in advanced discussions for potential asset deals, including one with a multi-billion dollar potential value. The company ended Q2 with $28.7 million in cash and investments, while earning $8.6 million in OMIDRIA royalties on Rayner's $28.6 million U.S. net sales.

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.