Showing posts with label EPZM. Show all posts
Showing posts with label EPZM. Show all posts
Monday, September 24, 2018
-=Epizyme (EPZM) : FDA lifts hold on trial enrollments
Shares of Epizyme Inc. (EPZM) shot up 5% 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 through Friday.
Labels:
big pops,
EPZM,
FDA reviews
Friday, August 4, 2017
=Epizyme (EPZM) reported earnings on Fri 4 Aug 2017 (b/o)
CAMBRIDGE, Mass. (AP) _ Epizyme Inc. (EPZM) on Friday reported a loss of $28 million in its second quarter.
On a per-share basis, the Cambridge, Massachusetts-based company said it had a loss of 48 cents.
The results beat Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 56 cents per share.
The biopharmaceutical company posted revenue of $10 million in the period, also surpassing Street forecasts. Three analysts surveyed by Zacks expected $3.7 million.
Epizyme shares have climbed nearly 3 percent since the beginning of the year. The stock has climbed 23 percent in the last 12 months.
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