Epizyme Beats Out the Market With FDA Approval

By Chris Lange Updated Apr 27, 8:51PM EDT · Published Aug 24, 3:58PM EDT

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Epizyme Inc. (NASDAQ: EPZM) survived the market carnage of what was Monday morning’s trading session. In fact this biopharma came out of the fray better off than when it went in. This is in part due to the U.S. Food and Drug Administration’s (FDA) acceptance of an investigational new drug application (IND).

The company announced that the FDA has accepted the company’s IND application for tazemetostat for the treatment of adults and pediatric patients with INI1-negative tumors or synovial sarcoma.

In the second half of 2015, Epizyme plans to initiate a phase 2 study in adults and a phase 1 study in children to evaluate tazemetostat in patients with relapsed or refractory INI1-negative tumors or synovial sarcoma.

For some background, Epizyme is a clinical stage biopharmaceutical company creating novel epigenetic therapeutics for cancer patients. Epizyme has built a proprietary product platform that the Company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases (HMTs).

Peter Ho, M.D., Ph.D., chief development officer, said:

Patients with INI1-negative tumors have a life-threatening disease and few treatment options. Our development approach reflects Epizyme’s strategy for aggressively advancing tazemetostat for indications with high unmet need. These clinical studies and our IND enable the expansion of our clinical development program, as we aim to establish tazemetostat’s benefit globally in multiple therapeutic areas where it has shown promise in early research.

Robert Gould, Ph.D., president and CEO of Epizyme, stated:

We believe the treatment of INI1-negative tumors offers an opportunity for us to establish a strong clinical profile for tazemetostat in multiple patient populations and reinforces Epizyme’s leadership position in the field of targeted epigenetic therapeutics. These new registration-supporting studies in INI1-negative tumors and synovial sarcoma will complement our ongoing 5-arm phase 2 study of tazemetostat in non-Hodgkin lymphoma, which is actively enrolling patients.

So far the company has underperformed the markets in 2015; shares are down over 15% year to date and down 51% in the past 52-weeks.

Shares of Epizyme were up 11.3% at $17.73 on Monday afternoon. The stock has a consensus analyst price target of $32.50 and a 52-week trading range of $13.67 to $37.24.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.