Epizyme Inc.'s 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.
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.
Epizyme, Inc. Price
Epizyme, Inc. price | Epizyme, Inc. Quote
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. ANIK, Applied Genetics Technologies Corp. AGTC and Axovant Sciences Ltd. AXGT. All of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.22 to $1.28 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.
Axovant Sciences’ loss per share estimates have narrowed from $9.76 to $9.42 for 2019 and from $7.97 to $7.00 for 2020 in the past 60 days.
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