EU Regulator Issues Negative Opinion on Omeros' Narsoplimab, Shares Plunge 25%
OMER has more than doubled off its 52-week low of $2.95.
Summary
The European Medicines Agency (EMA) has issued a negative opinion on Omeros' marketing authorization application for narsoplimab, a drug for hematopoietic stem-cell transplant-associated thrombotic microangiopathy (TA-TMA). This is a major setback for the company's efforts to commercialize the drug in Europe, despite its current approval in the U.S. The news immediately sent shares down 25% in premarket trading, significantly impacting the company's growth prospects following its recent return to profitability with YARTEMLEA. Omeros plans to request a re-examination of the opinion.
At the time of this announcement, OMER was trading at $8.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $775.9M. The 52-week trading range was $2.95 to $17.65. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.