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0 0.00185701021355613 0.00162488393686149 0.0125348189415042 0.011142061281337 0.0027855153203342 -0.00417827298050155 -0.00835654596100294
Stock impact report

Epizyme Has One FDA Approval Down, One More To Go In Coming Months [Seeking Alpha]

Epizyme, Inc. (EPZM) 
Last epizyme, inc. earnings: 2/24 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: epizyme.com
Company Research Source: Seeking Alpha
Summary Epizyme received FDA accelerated approval for TAZVERIK for the treatment of patients with relapsed/refractory epithelioid sarcoma. It is estimated that TAZVERIK, for the treatment of patients with epithelioid sarcoma, could see $100 million in peak sales. An NDA submission for potential accelerated approval of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma had already been submitted back in December of 2019. Follicular lymphoma accounts for 20% to 30% of all non-Hodgkin's lymphoma (NHL) cases, which is why if tazemetostat is approved for this indication it will be a bigger market opportunity. EPZM FDA Accelerated Approval Based On An Unmet Medical Need I believe that the FDA approved tazemetostat because of the unmet medical need that exists with this patient population. Why do I make such a claim? There are two important reasons to highlight. The first reason is because about 45% of those with this type of cancer have metastases. That Show less Read more
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