Epizyme Inc.'s 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.
Epizyme currently has a Zacks Rank #2 (Buy).
Some top-ranked stocks in the biotech sector are Anika Therapeutics Inc. (ANIK - Free Report) , Applied Genetics Technologies Corp. and Axovant Sciences Ltd. . 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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It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
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Epizyme Inc.'s 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.
Epizyme currently has a Zacks Rank #2 (Buy).
Some top-ranked stocks in the biotech sector are Anika Therapeutics Inc. (ANIK - Free Report) , Applied Genetics Technologies Corp. and Axovant Sciences Ltd. . 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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