Welcome to our dedicated page for Omeros news (Ticker: OMER), a resource for investors and traders seeking the latest updates and insights on Omeros stock.
Omeros Corporation develops and commercializes protein and small-molecule therapeutics for large-market and orphan indications, with emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Its news centers on YARTEMLEA (narsoplimab-wuug), an FDA-approved MASP-2 lectin pathway inhibitor for hematopoietic stem cell transplant-associated thrombotic microangiopathy in adult and pediatric patients aged two years and older.
Recurring updates also cover U.S. commercialization, reimbursement coding, transplant-medicine presentations, operating and financial results, and pipeline work including OMS1029, a long-acting MASP-2 inhibitor, and OncotoX-AML, an oncology therapeutic platform targeting acute myeloid leukemia.
Omeros (Nasdaq: OMER) reported first-quarter 2026 results, driven by the January U.S. launch of YARTEMLEA. Gross product sales were $11.1 million, with net sales of $9.9 million. Reported net income was $56.1 million ($0.78/share), including a $73.1 million non-cash gain from 2029 note derivatives; non-GAAP adjusted net loss was $17.1 million ($0.24/share). Cash and short-term investments totaled $135.3 million. The company fully repaid its 2026 notes and now has $70.8 million of 2029 notes outstanding. CMS assigned a permanent J-code for YARTEMLEA effective July 1, 2026, and proposed NTAP status, with a final decision expected in August and potential effectiveness October 1, 2026. EMA review of the YARTEMLEA MAA continues with a mid-2026 decision expected.
Omeros (NASDAQ: OMER) will release its first quarter 2026 financial results on Wednesday, May 13, 2026, after market close.
Management will host a conference call and webcast at 4:30 p.m. ET to review recent developments and financial results, with a replay available for 90 days.
Omeros (NASDAQ: OMER) said CMS assigned a permanent HCPCS J-code (J1289) for YARTEMLEA, effective July 1, 2026. The product-specific code aims to simplify billing and reimbursement for Medicare, other U.S. government programs and commercial payors, and to align with ICD-10-CM M31.11 for TA-TMA.
The company highlighted that the J-code should reduce administrative burden, support faster patient access, and provide more predictable reimbursement for providers; patient support is available via YARTEMLEAssist and a dedicated phone line.
Omeros (Nasdaq: OMER) reported Q4 and full-year 2025 results on March 31, 2026, driven by a $237.6M net gain from the sale of zaltenibart to Novo Nordisk and an FDA approval.
Q4 net income was $86.5M ($1.22/share); 2025 net loss was $3.4M ($0.05/share). Cash and short-term investments: $171.8M; debt principal: $87.9M.
Omeros (NASDAQ: OMER) will report fourth-quarter and full-year 2025 financial results on March 31, 2026 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). A replay will be available for 90 days. The company is transitioning to a new Q4 Inc. earnings platform; allow extra login time.
Omeros (NASDAQ: OMER) will host an industry session at the 52nd EBMT Annual Meeting on March 22, 2026, from 2:30pm–4:00pm CET in Madrid, Spain. The session, “Advances in TA-TMA Treatment: Evaluating the Role of a Novel Targeted Therapy,” will be co‑chaired by Rafael Duarte, MD, PhD, and Mohamad Mohty, MD, PhD, and will feature speakers Miguel‑Angel Perales, MD, and Michelle L. Schoettler, MD, MS.
The presentation targets clinicians and researchers in transplantation and cellular therapy and aims to discuss developments in treatment approaches for TA‑TMA.
Omeros (NASDAQ: OMER) reported successful nonhuman primate results for its OncotoX-AML therapeutic, showing up to 99% dose-related, reversible reduction in myeloid progenitor cells after one treatment course and preservation of hematopoietic stem cells. No meaningful safety signals or adverse blood-chemistry changes were observed.
In murine-human xenograft models, OncotoX-AML eradicated disseminated tumors and extended survival beyond 100 days versus an 8-day median improvement with venetoclax plus azacitidine. Omeros is initiating IND-enabling studies and targeting a first-in-human trial in late 2027.
Omeros (NASDAQ: OMER) announced first commercial shipments of YARTEMLEA (narsoplimab-wuug) to distributors and initial orders fulfilled to transplant centers, with administration begun in both adult and pediatric TA-TMA patients.
YARTEMLEA, approved by the U.S. FDA on December 23, 2025, selectively inhibits MASP-2 to block lectin-pathway activation while preserving other complement functions, and is approved for ages two years and older. The company reports use in hospital and outpatient settings, including patients who failed prior off-label C5 inhibitors. A European Medicines Agency decision on a marketing authorization application is expected in mid-2026. The release notes ~30,000 annual allogeneic transplants in the U.S. and Europe and literature estimates TA-TMA in up to 56% of allogeneic recipients.
Omeros (NASDAQ: OMER) revised its investor conference call to discuss the FDA approval of YARTEMLEA® (narsoplimab-wuug), the first therapy indicated for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The call will be held on Wednesday, January 7, 2026 at 4:30 p.m. ET. The company noted a U.S. market launch of YARTEMLEA on January 2, 2026.
Webcast access and registration procedures remain unchanged: investors must register to receive a unique PIN for the phone conference or use the live webcast. A replay will be available on the company’s investor site.
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.