OMEROS (OMER) Company Report

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.

1 day ago

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.

4 days ago

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.

5 days ago

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.

6 days ago

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.

6 days ago

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.

Nov 13, 2025, 9:30 PM

Transcript

Omeros Corporation Reports Q3 2025 Financial Results and Announces Strategic Partnership

OMER

Earnings

M&A

New Projects/Investments

Omeros Corporation reported a net loss of $30.9 million, or $0.47 per share, and a non-GAAP adjusted net loss of $22.1 million, or $0.34 per share, for the third quarter ended September 30, 2025.
As of September 30, 2025, the company held $36.1 million in cash and short-term investments, with a cash burn of $22.0 million during Q3 2025, exclusive of financing proceeds.
Omeros entered an Asset Purchase and License Agreement with Novo Nordisk for zaltenibart (OMS906), which includes an upfront cash payment of $240 million expected upon closing in Q4 2025, and potential milestone payments up to $2.1 billion plus royalties.
This transaction is anticipated to provide sufficient capital for debt repayments and more than 12 months of post-closing operations.
The FDA's target action date (PDUFA) for the Biologics License Application (BLA) for narsoplimab in TA-TMA has been extended to December 26, 2025.

Nov 13, 2025, 9:09 PM

8-K

Novo Nordisk Acquires Omeros' Zaltenibart Drug Rights

OMER

M&A

New Projects/Investments

Novo Nordisk has entered an agreement to acquire global rights to zaltenibart from Omeros Corporation for an upfront and near-term payment of $340 million, with potential milestones and royalties that could total up to $2.1 billion.
Zaltenibart, a clinical-stage antibody for rare blood and kidney diseases including paroxysmal nocturnal hemoglobinuria (PNH), has shown promising Phase 2 trial results and is positioned as a potential standard of care.
Novo Nordisk plans to initiate a global Phase 3 program for PNH and explore additional indications, with the transaction expected to close in the fourth quarter of 2025.

Oct 15, 2025, 1:45 PM

Bloomberg

Omeros announces asset purchase and license agreement with Novo Nordisk for zaltenibart

OMER

M&A

New Projects/Investments

Omeros Corporation has entered into an asset purchase and license agreement with Novo Nordisk for its clinical-stage MASP-3 inhibitor, zaltenibart (OMS906), which targets rare blood and kidney disorders.
Under the terms, Omeros is eligible to receive an upfront cash payment of $240.0 million and up to a total of $2.1 billion including potential development, approval, and sales-based milestones, plus tiered royalties on net sales.
Novo Nordisk gains exclusive global rights to develop and commercialize zaltenibart, while Omeros retains rights to certain preclinical MASP-3 programs.
The transaction is anticipated to close in the fourth quarter of 2025, with $67.1 million of the upfront payment allocated to repay outstanding debt.