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Omeros faces CHMP negative opinion for narsoplimab filing
The EMA committee’s negative view followed an oral explanation, and Omeros said it will seek reconsideration and an Ad Hoc Expert Panel assessment.
Omeros Corp. said the Committee for Medicinal Products for Human Use, under the European Medicines Agency, adopted a negative opinion on its marketing authorization application for narsoplimab, an antibody aimed at MASP-2 for hematopoietic stem cell transplant-related thrombotic microangiopathy, after an oral explanation meeting on the filing, according to Yahoo Finance. The company plans to request reconsideration of the CHMP opinion and pursue an assessment by an Ad Hoc Expert Panel made up of external clinical and scientific specialists assembled by the EMA, it added. Yahoo Finance also reported that H.C. Wainwright analyst Brandon Folkes cut Omeros’ price target from $40 to $33 while keeping a Buy rating. Folkes said the adjustment reflected higher expected forward R and D spending and the removal of the EU opportunity from the valuation model, characterizing the CHMP outcome as a short-term headwind rather than a major long-term hurdle, and pointing to the U.S. launch as the key value driver.