Omeros

OMER

Market cap $849M

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced the successful completion of its initial study in nonhuman primates evaluating the efficacy and safety of its OncotoX-AML cancer therapeutic platform. Omeros' OncotoX-AML therapeutic is first targeting acute myeloid leukemia (AML), an aggressive and highly fatal bone marrow and blood cancer. The effectiveness of current AML treatments, such as chemotherapeutics and antibody-drug conjugates, are limited by substantial si.

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced that the first commercial shipments of YARTEMLEA® (narsoplimab-wuug) to its distributors were completed last week, with orders from transplant centers beginning that same day. Both adult and pediatric patients with stem cell transplant-associated thrombotic microangiopathy (TA-TMA) are now receiving YARTEMLEA, including patients who have recently failed prior off-label C5-inhibitor regimens, in both hospital and outpati.

Omeros Corporation (OMER) Discusses FDA Approval and Commercialization Plans for YARTEMLEA in TA-TMA Treatment Transcript

Omeros will price its recently approved drug for a life-threatening transplant complication in adults and children aged two and older at $36,000 per single-dose vial, CEO Gregory Demopulos said on a call with analysts on Wednesday.

OMER wins FDA approval for YARTEMLEA, the first TA-TMA therapy, marking its first commercial product and a shift to revenue generation.

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced a revised date for its conference call to discuss the recent FDA approval of YARTEMLEA® (narsoplimab-wuug), the first and only therapy indicated for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). To ensure broad participation following this significant milestone — and to accommodate shareholders' and investors' holiday schedules — the call will now take place on Wednesday, January 7,.

It won approval for a medicine that treats a potentially fatal complication from stem cell transplants. This is the first drug approved for that indication.

Omeros (OMER) receives FDA approval for Yartemlea (narsoplimab) in TA-TMA, driving shares up nearly 80% to a $1bn+ valuation. Yartemlea is the first and only approved therapy for TA-TMA, showing high complete response rates and strong survival benefits in pivotal trials. I estimate Yartemlea's peak revenue potential at ~$300m, with commercialization pacing dependent on awareness, funding, and OMER's ability to scale.

U.S. stocks traded higher midway through trading, with the Dow Jones index surging more than 200 points on Wednesday.

The U.S. Food and Drug Administration has approved Omeros' drug for a dangerous transplant complication, marking the first treatment to be greenlit for the condition, the company said on Wednesday.