Omeros downgraded to Underperform at BofA after FDA decision on narsoplimab

BofA analyst Greg Harrison downgraded Omeros to Underperform from Neutral with a price target of $3, down from $8, after the company announced that the Office of New Drugs of the FDA has denied the company’s formal dispute resolution request appealing the issuance of a complete response letter, or CRL, concerning the biologics license application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. The unfavorable formal dispute resolution decision is a "setback" for the narsoplimab program and he expects continued pressure on shares given that the data collection and resubmission process will extend any potential approval further, Harrison tells investors. He now models 10% odds of success for narsoplimab in TA-TMA, down from 25%, and pushes out a potential launch expectation to 2024 from 2023.