OMEROS (OMER) Company Report

Yarcomlia (Narsoplimab) received FDA approval on December 23, 2025, as the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA).
The commercial launch of Yarcomlia began on January 2, 2026, with an initial per vial price of approximately $36,000.
Yarcomlia's label covers all TATMA patients (adult and pediatric, standard and high risk) and has a differentiated safety profile without a box warning, REMS, or vaccination requirement.
Omeros reported approximately $172 million in cash and short-term investments as of December 31, 2025, and anticipates a European marketing authorization decision by mid-year.

Jan 7, 2026, 9:30 PM

Transcript

Omeros receives FDA approval for YARTEMLEA, initiates commercial launch

OMER

Product Launch

New Projects/Investments

Omeros' YARTEMLEA (narsoplimab) received FDA approval on December 23, 2025, as the first and only approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), with commercial launch initiated on January 2, 2026.
The drug is priced at approximately $36,000 per vial, with a median treatment course of 8 to 10 vials, targeting a U.S. market of approximately 11,000 allogeneic transplants annually where TA-TMA can develop in up to 56% of recipients.
YARTEMLEA demonstrated a 61% complete response rate and 73% 100-day survival in its pivotal study, offering a differentiated safety profile with no box warning, no REMS, and no vaccination requirement.
As of December 31, 2025, Omeros held approximately $172 million in cash and short-term investments and expects a New Technology Add-on Payment (NTAP) for YARTEMLEA to become effective in October 2026.

Jan 7, 2026, 9:30 PM

Transcript

Omeros Announces FDA Approval and Commercial Launch of Yarcomlia

OMER

Product Launch

New Projects/Investments

Omeros Corporation's drug, Yarcomlia (Narsoplimab), received FDA approval on December 23, 2025, as the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA), and its commercial launch commenced on January 2, 2026.
The initial per vial price for Yarcomlia is approximately $36,000, with a median treatment course of 8 to 10 vials; the U.S. market sees approximately 11,000 allogeneic transplants annually, with TATMA developing in up to 56% of recipients.
Yarcomlia demonstrated a complete response in 61% of patients in the pivotal study and 68% in the expanded access program, along with a favorable safety profile that includes no box warning, REMS, or vaccination requirement.
Omeros is implementing reimbursement strategies, including an application for a new technology add-on payment (NTAP) expected to be effective in October 2026, and reported approximately $172 million in cash and short-term investments as of December 31, 2025.

Jan 7, 2026, 9:30 PM

Transcript

Omeros Announces FDA Approval of YARTEMLEA for TA-TMA

OMER

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Omeros Corporation announced on December 24, 2025, that the U.S. Food and Drug Administration (FDA) has approved YARTEMLEA (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), making it the first and only approved therapy for this condition.
YARTEMLEA is approved for use in adults and children ages two years and older.
The approval was supported by data showing complete response rates of 61% in the pivotal trial and 68% in the Expanded Access Program, with 100-day survival rates of 73% and 74%, respectively.
Omeros plans its U.S. product launch in January 2026.
A marketing authorization application for YARTEMLEA is currently under review by the European Medicines Agency (EMA), with a decision anticipated in mid-2026.

Dec 29, 2025, 11:08 AM

8-K

Omeros Reschedules YARTEMLEA® Approval Conference Call

OMER

Product Launch

New Projects/Investments

Omeros Corporation has announced a revised date for its conference call to discuss the recent FDA approval of YARTEMLEA®, now scheduled for Wednesday, January 7, 2026, at 4:30 p.m. ET.
YARTEMLEA® (narsoplimab-wuug) is the first and only FDA-approved therapy indicated for hematopoietic stem cell transplant-associated thrombotic microangiangiopathy (TA-TMA) in adults and children ages two years and older.
The U.S. market launch of YARTEMLEA is planned for January 2, 2026.
A marketing authorization application for YARTEMLEA is currently under review by the European Medicines Agency (EMA), with a decision expected in mid-2026.

Dec 26, 2025, 11:36 PM

Press Release

Omeros receives FDA approval for YARTEMLEA

OMER

Product Launch

Omeros Corporation (NASDAQ: OMER) announced on December 24, 2025, that the U.S. Food and Drug Administration (FDA) approved YARTEMLEA® (narsoplimab-wuug).
YARTEMLEA is indicated for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation.
This therapy is the first and only approved lectin pathway inhibitor.

Dec 25, 2025, 12:25 AM

Press Release

Omeros Secures FDA Approval for YARTEMLEA

OMER

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Omeros Corporation received FDA approval for YARTEMLEA (narsoplimab-wuug), the first and only approved therapy for hematopoietic stem-cell transplant-associated thrombotic microangiopathy (TA-TMA) in patients aged two and older.
The approval was supported by pivotal trial and expanded-access data, demonstrating complete response rates of approximately 61% in the trial and 68% in the expanded program, with 73–74% 100-day survival.
Omeros plans a U.S. launch in January 2026, with a European Marketing Authorization decision expected mid-2026.
Despite this regulatory milestone, Omeros faces financial headwinds, characterized by an estimated market capitalization of $620.38 million, high stock volatility (beta ~3.95), and recent negative EPS of approximately -2.02.

Dec 24, 2025, 2:12 PM

Morningstar

Omeros' YARTEMLEA Receives FDA Approval

OMER

Product Launch

New Projects/Investments

Omeros Corporation announced the FDA approval of YARTEMLEA® (narsoplimab-wuug) on December 24, 2025, as the first and only approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children ages two years and older.
The approval was supported by data showing complete response rates of 61% in the pivotal trial and 68% in the Expanded Access Program, alongside 100-day survival rates of 73% and 74%, respectively, from TA-TMA diagnosis.
Omeros plans a U.S. product launch in January 2026 and has a marketing authorization application for YARTEMLEA under review by the European Medicines Agency, with a decision anticipated in mid-2026.

Dec 24, 2025, 2:00 PM

Press Release

Omeros Closes Zaltenibart Asset Sale to Novo Nordisk and Announces Share Repurchase Program

OMER

M&A

Debt Issuance

Share Buyback

Omeros Corporation completed the asset sale and licensing transaction of its MASP-3 inhibitor, zaltenibart (OMS906), to Novo Nordisk on November 25, 2025.
The transaction included an upfront cash payment of $240.0 million to Omeros, with potential for up to $2.1 billion in total payments, including milestones and tiered royalties on net sales.
Omeros used approximately $72.6 million of the upfront payment to fully repay its senior secured term loan, terminating the credit agreement and releasing a $25.0 million minimum liquidity covenant.
The company anticipates the remaining proceeds will be sufficient to repay the $17.1 million principal balance on its 2026 Convertible Notes and fund more than 12 months of operations.
On November 29, 2025, Omeros' Board of Directors approved an indefinite term share repurchase program for up to $100.0 million of its common stock.

Dec 1, 2025, 1:30 PM

8-K

Omeros Reports Q3 2025 Financial Results and Provides Update on Novo Nordisk Deal and Yartemlya Approval

OMER

Earnings

M&A

Product Launch

Omeros reported a net loss of $30.9 million, or $0.47 per share, for Q3 2025, with an adjusted net loss of $22.1 million, or $0.34 per share, after excluding non-cash charges. As of September 30, 2025, the company held $36.1 million in cash and investments.
The company entered a definitive agreement with Novo Nordisk for its MASP-3 antibody, Zaltenibart, valued at up to $2.1 billion in upfront and milestone payments plus royalties. Upon closing, expected in Q4 2025, Omeros will receive $240 million in upfront cash and an additional $100 million in achievable near-term milestones.
Proceeds from the Novo Nordisk transaction are intended to fully repay the $67.1 million secured term loan and the remaining $17.1 million principal balance on 2026 convertible notes.
The Biologics License Application (BLA) for narsoplimab (Yartemlya) for transplant-associated thrombotic microangiopathy (TATMA) is under FDA review with a PDUFA date of December 26, 2025, and commercial launch preparations are underway.
Omeros anticipates becoming cash flow positive in 2027.