Epizyme's NDA Filing Acceptance Moves It Forward Toward New Territory [Seeking Alpha]
Epizyme, Inc. (EPZM)
Last epizyme, inc. earnings: 2/24 06:30 am
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Source: Seeking Alpha
Epizyme's NDA Filing Acceptance Moves It Forward Toward New Territory Summary The FDA accepted Epizyme's NDA for tazemetostat to treat patients with metastatic or locally advanced epithelioid sarcoma, with a PDUFA date set for January 23, 2020. An NDA for tazemetostat to treat follicular lymphoma is expected to be filed Q4 of 2019; this would set up potential approval for this indication possibly towards end of 2020. A Phase 3 confirmatory study for tazemetostat to treat epithelioid sarcoma is expected to begin in the 2nd half of 2019. Epizyme has $331 million in cash as of June 30, 2019 and this amount is expected to fund its operations into Q1 of 2021. EPZM announced that the FDA had accepted its NDA for tazemetostat On Track For Priority Review The FDA accepted the review of the NDA for tazemetostat for patients with epithelioid sarcoma. Best part of all is that the NDA was accepted with Priority Review. Priority Review from the FDA means that a drug application is reviewed at 6 mo
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