Omeros sells YARTEMLEA in the U.S. for thrombotic microangiopathy after stem cell transplants and develops other complement and addiction drugs; YARTEMLEA is not approved in Europe.
YARTEMLEA is the only approved treatment for transplant-associated thrombotic microangiopathy, cleared by FDA in December 2025. Second-quarter net sales were $28.5 million, almost triple the first quarter, and Omeros generated cash. Europe's CHMP rejected the application in June and again after re-examination in October, so sales are U.S. only for now. Omeros spent $60.2 million retiring $30.5 million of convertible notes; $40.3 million remain. It held $132.0 million at June 30.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: U.S. sales keep growing
Do YARTEMLEA sales keep growing in the third quarter with a permanent billing code?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
YARTEMLEA sales are climbing in the U.S. after Europe's regulators said no
YARTEMLEA's early launch funds a rebuild, but the EU rejection and $40M in remaining converts test how far the cash goes
First approved TA-TMA therapy faces EU rejection just months after U.S. launch — commercial ramp determines whether the orphan franchise justifies the valuation
FDA approves YARTEMLEA for TA-TMA
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Blood cancers, Kidney diseases, Psychiatric disorders, Blood disorders, Infectious diseases, Lung and respiratory diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
14 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.