The company said it plans to request a meeting with the FDA "as soon as possible to address the deficiencies raised." Shares plunged 40% by Monday afternoon, with the volume of trading topping 12.2 million compared with the stock's daily average of more than 517,000.
Omeros (OMER) said the FDA has sought additional information to support the approval of narsoplimab, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy. It said the FDA "expressed difficulty in estimating the treatment effect of narsoplimab."
Shares of Omeros dived 28% as trading volume surged to 4 million versus the stock's daily average of about 804,000.
MannKind (MNKD) said the FDA declined to approve the new drug application for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, noting "only one deficiency" related to an open inspection issue.
"We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics' efforts in securing approval of Tyvaso DPI in the coming months," MannKind Chief Executive Michael Castagna said.
Shares slumped 19%, with intraday trading volume at more than five times at 13.4 million shares.
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