Epizyme Wins FDA Approval and Maybe More for Lymphoma Study

Print Email

Epizyme Inc. (NASDAQ: EPZM) shares jumped on Friday after the company announced a set of pipeline updates, as well as a key update from the U.S. Food and Drug Administration (FDA).

The company has identified a path to submission for accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL), both with and without EZH2 activating mutations.

Also, Epizyme recently conducted a productive meeting with the FDA to discuss the FL registration strategy based on the current patient population in its ongoing Phase 2 clinical trial. Following the discussion, Epizyme has defined a registration strategy for tazemetostat in both EZH2 mutant and wild-type FL patient populations, where patients’ disease has progressed following two or more lines of therapy.

Based on this, the company anticipates submitting a New Drug Application (NDA) for this indication in the fourth quarter of 2019. In addition, the company provided an update on its clinical and preclinical pipeline and anticipated milestones for 2019.

Shefali Agarwal, M.D., chief medical officer of Epizyme, commented:

Follicular lymphoma is an incurable cancer today, and in the third line and later settings, there are limited effective treatment options. Defining a clear path to a regulatory submission for tazemetostat for this patient population marks a huge step forward for patients and an opportunity to change the course of FL treatment. This FL NDA submission would mark the second for tazemetostat in one year, following our first submission for epithelioid sarcoma, which is on track for the second quarter of 2019. If successful, tazemetostat is poised to be the first commercially available EZH2 inhibitor. We look forward to advancing our submission preparations and further engaging with FDA, as we work expeditiously to bring tazemetostat to the patients who need it.

Shares of Epizyme were last seen up about 10% at $6.60, with a consensus analyst price target of $19.56. The stock has a 52-week trading range of $5.14 to $21.40.

I'm interested in the Newsletter