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Epizyme's (EPZM) Tazverik Aids Growth, Overdependence a Woe
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Epizyme, Inc. has only one marketed drug in its portfolio, namely Tazverik (tazemetostat), which is approved for the treatment of certain patients with epithelioid sarcoma (ES) and follicular lymphoma (FL).
A methyltransferase inhibitor, Tazverik was approved by the FDA in January 2020 to treat adults and pediatric patients aged 16 years and above with metastatic or locally advanced ES not eligible for complete resection. In June 2020, the FDA approved the label expansion for Tazverik to treat two distinct FL indications in adult patients. Both indications are approved by the FDA under accelerated approval.
As part of the accelerated approval for ES & FL, the company is evaluating Tazverik in separate ES & FL confirmatory studies. The ES confirmatory study is evaluating Tazverik in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES. Additionally, the FL confirmatory study is evaluating Tazverik in combination with R2, which is the combination of Bristol Myers’ (BMY - Free Report) Revlimid and Roche’s (RHHBY - Free Report) Rituxan, compared with R2 plus placebo for treating relapsed/refractory FL patients.
Apart from ES & FL, Tazverik is also being developed for the treatment of metastatic prostate cancer. Tazverik, in combination with standard of care treatments — Pfizer’s (PFE - Free Report) Xtandi (enzalutamide) or Zytiga (abiraterone) — is being evaluated in the phase Ib safety run-in portion of the EZH-1101 study for treating men with metastatic prostate cancer. A potential label expansion should boost Tazverik’s sales in the days ahead.
Epizyme also received clearances from the FDA in first-half 2021 for its investigational new drug (IND) application to evaluate Tazverik’s safety and efficacy across multiple solid tumors in the EZH-1301 basket study. The company expects to begin clinical studies in second-half 2021.
The company also received an IND clearance from the FDA for its novel SETD2 inhibitor EZM-0414 as a potential treatment of multiple myeloma and other B-cell malignancies such as large-cell Lymphoma, both as a monotherapy and in combination with the existing and emerging therapies including Tazverik.
While Tazverik shows promise, the company remains primarily reliant on a single drug for growth. A lack of candidates in mid-stage and late-stage clinical studies does not bode well for the stock. An unfavorable outcome from any of the development programs could adversely impact the company’s prospects and the stock performance.
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Epizyme's (EPZM) Tazverik Aids Growth, Overdependence a Woe
Epizyme, Inc. has only one marketed drug in its portfolio, namely Tazverik (tazemetostat), which is approved for the treatment of certain patients with epithelioid sarcoma (ES) and follicular lymphoma (FL).
A methyltransferase inhibitor, Tazverik was approved by the FDA in January 2020 to treat adults and pediatric patients aged 16 years and above with metastatic or locally advanced ES not eligible for complete resection. In June 2020, the FDA approved the label expansion for Tazverik to treat two distinct FL indications in adult patients. Both indications are approved by the FDA under accelerated approval.
As part of the accelerated approval for ES & FL, the company is evaluating Tazverik in separate ES & FL confirmatory studies. The ES confirmatory study is evaluating Tazverik in combination with doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES. Additionally, the FL confirmatory study is evaluating Tazverik in combination with R2, which is the combination of Bristol Myers’ (BMY - Free Report) Revlimid and Roche’s (RHHBY - Free Report) Rituxan, compared with R2 plus placebo for treating relapsed/refractory FL patients.
Apart from ES & FL, Tazverik is also being developed for the treatment of metastatic prostate cancer. Tazverik, in combination with standard of care treatments — Pfizer’s (PFE - Free Report) Xtandi (enzalutamide) or Zytiga (abiraterone) — is being evaluated in the phase Ib safety run-in portion of the EZH-1101 study for treating men with metastatic prostate cancer. A potential label expansion should boost Tazverik’s sales in the days ahead.
Epizyme also received clearances from the FDA in first-half 2021 for its investigational new drug (IND) application to evaluate Tazverik’s safety and efficacy across multiple solid tumors in the EZH-1301 basket study. The company expects to begin clinical studies in second-half 2021.
The company also received an IND clearance from the FDA for its novel SETD2 inhibitor EZM-0414 as a potential treatment of multiple myeloma and other B-cell malignancies such as large-cell Lymphoma, both as a monotherapy and in combination with the existing and emerging therapies including Tazverik.
While Tazverik shows promise, the company remains primarily reliant on a single drug for growth. A lack of candidates in mid-stage and late-stage clinical studies does not bode well for the stock. An unfavorable outcome from any of the development programs could adversely impact the company’s prospects and the stock performance.