Yartemlea shipments to wholesalers are expected in the third week of January.
- The company set a $36,000 per-vial price for Yartemlea and confirmed the start of its U.S. launch.
- Typical Yartemlea treatment courses use 8–10 vials.
- The U.S. rollout is underway, with initial deliveries expected later this month.
Omeros Corp shares rose about 5% in after-hours trading on Wednesday after the company outlined pricing and near-term rollout details for Yartemlea, its newly approved treatment for a rare transplant complication, giving investors clearer visibility into the drug’s early commercial opportunity.
Omeros Puts A Price On Yartemlea
On a special call, Omeros said it has set an initial price of about $36,000 per single-dose vial for Yartemlea, the first and only FDA-approved therapy for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
TA-TMA is a complication after stem cell transplants where damaged small blood vessels cause clotting that can lead to organ failure.
The company said that across the trial and the expanded access program, the median utilization was 8–10 vials per treatment course, which would put the total cost at roughly $288,000 to $360,000 per patient.
US Launch Begins
Omeros said it began the U.S. commercial rollout in early January, with its fully hired and trained commercial team now engaging transplant centers nationwide. The company said it is prioritizing high-volume transplant centers, where early utilization is expected to concentrate.
The company said that the drug’s product packaging with the FDA-approved label is underway, with transfer to wholesalers targeted for the third week of January and initial deliveries to transplant centers expected shortly thereafter, supported by a next-day delivery model.
Omeros added that recent manufacturing campaigns, existing inventory, and a five-year shelf life are expected to provide sufficient supply into late 2029.
FDA Greenlights Yartemlea
Yartemlea received FDA approval in late December, becoming the first and only therapy indicated for TA-TMA in adults and children aged two years and older. Approval was based on a single-arm pivotal study of 28 patients, supported by data from an expanded access program involving 221 patients.
In those studies, patients treated with Yartemlea achieved complete response rates of 61% in the pivotal trial and 68% in evaluable expanded-access patients, with 100-day survival rates of 73% and 74%, respectively. All patients met international criteria for high-risk TA-TMA, a population with historically poor outcomes.
Peer-reviewed publications cited by the company showed treatment with Yartemlea was associated with a three to fourfold lower risk of mortality compared to an external control cohort, with one-year survival of about 50% even in previously refractory high-risk patients, compared with earlier survival rates below 20%.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment for Omeros was ‘bullish’ amid ‘high’ message volume.
One user said the move creates an attractive entry point, adding that they remain confident after the special call and expect further upside, citing potential European partnership news, possible analyst upgrades, and an improving bottom-line outlook.
Another user called the latest development a “stellar” conference call.
Omeros’ stock has risen 30% over the past 12 months.
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