Omeros

OMER

Market cap $866M

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.

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced 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), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. YARTEMLEA is the first and only approved lectin pathway inhibitor. YARTEMLEA selectively inhibits MASP-2, the ef.

SEATTLE--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced the closing of the asset sale and licensing transaction between Omeros and Novo Nordisk for the candidate drug zaltenibart (formerly OMS906). Zaltenibart is a first-in-class, late-stage clinical humanized monoclonal antibody targeting MASP-3 – the most upstream and key activator of the alternative pathway of the complement system – and has shown multiple potential advantages over other alternative pathway inhibitors in.