Epizyme's stock soars after FDA lifts hold on trial enrollments [MarketWatch]
Epizyme, Inc. (EPZM)
Last epizyme, inc. earnings: 2/24 06:30 am
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Source: MarketWatch
Epizyme's stock soars after FDA lifts hold on trial enrollments Shares of Epizyme Inc. EPZM, +1.95% shot up 25% in premarket trade Monday, after the company said the Food and Drug Administration lifted its hold on the enrolling of new patients in trials of its treatment for non-Hodgkin lymphoma. The FDA's hold had followed a report of a case of T-cell lymphoblastic lymphoma (T-LBL) in its tazemetostat pediatric study. Epizyme said its response to the FDA included a comprehensive assessment of the risk of secondary malignancies. "The Epizyme team has worked diligently to provide a comprehensive response back to the FDA, and through constructive dialogue, we successfully resolved the partial clinical hold," said Chief Executive Robert Bazemore. "This allows us to turn our full attention to our key priorities: preparing for our first NDA submission for tazemetostat in epithelioid sarcoma and defining our registration path in FL." The stock had tumbled 31% over the past three months th
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