Epizyme (EPZM) Shares Surge More Than 100% YTD: Here's Why?
Zacks Investment Research | May 27, 2019 09:02PM ET
Epizyme Inc.'s (NASDAQ:EPZM) share price has increased 109.9% year to date compared with the industry ’s growth of 13.2%. It is a development-stage biopharmaceutical company, focused on bringing novel epigenetic therapies for the treatment of cancer and other diseases to market.
Pipeline Progress
Epizyme has made significant progress with its lead candidate, tazemetostat (an EZH2 inhibitor).
The company is on track to submit its first new drug application (NDA) for tazemetostat for epithelioid sarcoma (ES) in the second quarter of 2019, based on the ongoing phase II study. If approved, tazemetostat will be the first commercially available EZH2 inhibitor and the first treatment specifically indicated for epithelioid sarcoma patients.
Epizyme also plans to submit an NDA for accelerated approval of tazemetostat in patients with follicular lymphoma (FL), regardless of their EZH2 mutational status, who have been previously treated with two or more systemic therapies. The NDA submission is planned for the fourth quarter of 2019.
The two defined registration paths for tazemetostat in two indications look promising. If approved, the drug will be able to generate significant value for the patients and physicians, who need new treatment options, and for Epizyme.
The company is planning to initiate multiple clinical trials to expand the benefit of tazemetostat in earlier treatment lines of FL, and explore new combinations and potential indications in both FL and solid tumors.
Further, Epizyme achieved the first milestone from its partnership with Boehringer Ingelheim, which further validates its research expertise and collaboration strategy in epigenetic target discovery and drug development.
On approval of an Investigational New Application (IND) for EZM8266, a novel, first-in-class G9a inhibitor, in patients with sickle cell disease, Epizyme anticipates beginning clinical development in the second half of 2019 with a phase I study on the candidate.
However, with no approved product in its portfolio, the company is yet to generate revenues.
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Zacks Rank and Other Stocks to Consider
Epizyme currently has a Zacks Rank #2 (Buy).
Some top-ranked stocks in the biotech sector are Anika Therapeutics Inc. (NASDAQ:ANIK) , Applied Genetics Technologies Corp. (NASDAQ:AGTC) and Axovant Sciences Ltd. (NASDAQ:AXGT) . All of them carry a Zacks Rank #1 (Strong Buy). You can see Zacks Investment Research
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