)
Visual
test
Omeros
Omeros (OMER) investor relations material
Omeros FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA Announcement summary7 Jan, 2026
Introduction and purpose
YARTEMLEA received FDA approval on December 23, 2025, as the first and only therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children aged two and older.
The approval addresses a significant unmet need for a life-threatening complication in stem cell transplant recipients, previously managed only with supportive care.
Details of approval or decision
YARTEMLEA is approved for all TA-TMA patients, both standard and high risk, including adults and children aged two and older, with no box warning, REMS, or vaccination requirement.
Approval was based on a 28-patient pivotal trial and a 221-patient expanded access program.
Dedicated billing and reimbursement codes have been established, and a U.S. product launch is planned for January 2026.
A marketing authorization application is under review by the European Medicines Agency, with a decision expected mid-2026.
Impact on industry and stakeholders
The launch is expected to shift the standard of care for TA-TMA, especially in pediatric patients, with early adoption focused on high-volume transplant centers.
A new ICD-10 code and two CPT codes have been established, supporting reimbursement and limiting off-label therapy use.
Providers and patients will have access to the YARTEMLEAssist™ support program in Q1 2026.
The ex-U.S. opportunity is substantial, with a pending EMA application and partnership evaluations underway.
Detail YARTEMLEAssist program's financial support
How does MASP-2 inhibition preserve host defense?
What factors could delay EMA approval?
How will NTAP timing affect early YARTEMLEA uptake?
Strategy to displace off-label C5 inhibitor use
How to increase TA-TMA diagnosis rates?
Partial view of Summaries dataset, powered by Quartr API
Research faster. Power your platform.
Latest summaries
- TimeTickerHeadlineOpen
- XEL
Ongoing EPS reached $3.80 in 2025; 2026 guidance is $4.04–$4.16 with a $60B capital plan. - EL
Strong Q2 results and raised FY26 outlook, with sales and margins up despite headwinds. - KCR
Record profitability and strong orders in 2025; stable outlook for 2026 amid uncertainties. - 532539
Record Q3 FY26 revenue and profit growth, major expansions, and strong industry outlook. - HAE
Gross margin and net income rose despite lower revenue; guidance for EPS and cash flow increased. - QIGD
Revenue up 18% but net profit down 15% as higher costs and dividends reduced margins and equity. - MYCR
Record annual sales, Q4 order drop, strong Global Technologies, and four acquisitions. - 532548
Revenue up 18.4% YoY, margin gains, and capacity expansions support a positive outlook. - THERMAX
Profit after tax rose 80% and order booking grew 34%, led by Infra and data center wins. - LPG
Net income more than doubled on strong TCE rates, higher revenues, and efficient fleet operations.
Next Omeros earnings date
Q4 202531 Mar, 2026
Omeros
Next Omeros earnings date
Q4 202531 Mar, 2026
The essential earnings season companion
The #1 app for qualitative research. Live earnings calls, AI chat, transcripts, and more. All for free.
Live calls and transcripts
Listen to earnings calls, CMDs, investor conferences, and more – with a podcast-like experience.
Find what you need faster
Search for any keyword across all transcripts simultaneously.
Easily store key findings
Capturing important takeaways is as simple as it gets. Even during your lunch run or commute.
Your watchlist. Your dashboard.
Follow the companies that matter to you. Get a personalized feed with real-time updates.
Be the first to know
Set keyword alerts for any company, product, or competitor. Get notified the moment they're mentioned.
Consensus estimates
Access analyst consensus estimates, valuation multiples, and revenue segments splits.
All IR material in one place
The easiest way to stay updated during earnings season.
Global coverage
All events from public companies. Live and recorded.
Just click and listen
No webcast links. No manual registrations.
excellent app, it gives me free access to company earnings calls and annual reports. I also love the convenience of calls being available offline so I can listen in whilst doing other things and even when internet or WiFi isn't available.
)
Leroy DaleyApp Store
One of the very few apps you could call perfect. If something was to add to it, maybe the share price of the company when you search for it, but it's already excellent.
)
Eferix Drawings Google Play
This is genuinely one of the cleanest and fastest finance apps out there to track the market.
anuj283App Store
excellent app, it gives me free access to company earnings calls and annual reports. I also love the convenience of calls being available offline so I can listen in whilst doing other things and even when internet or WiFi isn't available.
Leroy DaleyApp Store
One of the very few apps you could call perfect. If something was to add to it, maybe the share price of the company when you search for it, but it's already excellent.
Eferix Drawings Google Play
This is genuinely one of the cleanest and fastest finance apps out there to track the market.
anuj283App Store
I can't remember the last time an app had such a positive impact on my investment process.
)
@ankurshah47_ x.com
Love the app! Quartr makes it really easy to keep track of earnings calls. It also includes the reports and slides to make it easier to follow along.
Amina0781App Store
Quartr is amazing, no way around it. It is the best right now for earnings calls, presentations, and the like.
@theshortbearx.com
I can't remember the last time an app had such a positive impact on my investment process.
@ankurshah47_ x.com
Love the app! Quartr makes it really easy to keep track of earnings calls. It also includes the reports and slides to make it easier to follow along.
Amina0781App Store
Quartr is amazing, no way around it. It is the best right now for earnings calls, presentations, and the like.
@theshortbearx.com
)
)
Frequently asked questions
Omeros Corp is a biopharmaceutical company focused on developing and commercializing small-molecule and protein therapeutics. The company's research is centered on treatments for inflammation, immune disorders, and central nervous system conditions. Omeros also explores therapies targeting complement-mediated diseases, aiming to address various unmet medical needs. Its pipeline includes both clinical-stage and preclinical programs, with a focus on advancing innovative therapies that modulate key biological pathways involved in immune and inflammatory responses. The company is headquartered in Seattle, Washington, and its shares are listed on the NASDAQ.
Quartr provides global coverage of all investor relation material from public companies.
Mobile app: Research anytime, anywhere with the #1 app for live earnings calls, transcripts, analyst estimates, and more. All for free.
Desktop (Quartr Pro): The leading platform for qualitative research, used daily by top firms and financial institutions.
Quartr API: Build custom solutions powered by live earnings calls, live transcripts, filings and reports, slide presentations, and more.
Yes, the Quartr mobile app is free on both iOS and Android.
Yes. Quartr provides global, industry-leading live coverage of company events such as regular earnings calls, capital markets days, M&A announcements, and investor conferences. Live with zero delays. Just click and listen.
Yes, capturing important takeaways is as simple as it gets. Even during your lunch run or commute.
Yes. Follow the companies that matter to you. Get a personalized feed with real-time updates, a tailored earnings calendar, and instant alerts when earnings calls go live.
Yes. Set keyword alerts for any company, product, or competitor. Get notified the moment they're mentioned, regardless of who's talking.
Explore our global coverage