Omeros Corporation Aktie News

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.

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 s...

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 O...

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 ...

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 complem...