Epizyme, Inc. (EPZM - Free Report) announced that it has identified a path to submission for accelerated approval of its lead candidate, tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL), both with and without EZH2 activating mutations, where patients’ disease has progressed following two or more lines of therapy.
The company held a meeting with the FDA to discuss the same based on the current patient population in its ongoing phase II study. The company expects to submit a new drug application (NDA) for the stated indication in the fourth quarter of 2019. The NDA submission for FL will be the company’s second NDA, following its first submission for epithelioid sarcoma (ES). Epizyme will further advance the phase II study, with updated data to be reported at a medical meeting in mid-2019.
As part of an accelerated approval strategy, Epizyme plans to conduct a confirmatory program to support full approval of tazemetostat in FL, while also supporting its potential expansion into the second-line treatment of FL.
Epizyme is also advancing preparations for its first NDA submission for tazemetostat, using the accelerated approval pathway, for the treatment of patients with ES. This NDA is expected to be submitted in the second quarter of 2019.
Share price of Epizyme decreased 39.2% in the past year compared with the industry’s decline of 20.6%.
The company also plans to explore the potential of tazemetostat in earlier lines of FL as combination therapy. The company is evaluating the opportunity to conduct a combination study that would compare the chemo-free combination of Roche’s (RHHBY - Free Report) Rituxan and Celgene’s (CELG - Free Report) Revlimid with tazemetostat versus the combination with placebo in patients with relapsed or refractory FL. Epizyme plans to provide an update on its combination study plans once they have been finalized.
The company also plans to initiate a combination study in castration-resistant prostate cancer in mid-2019. The company also plans to begin studies in small-cell lung cancer, triple-negative breast cancer and ovarian cancer in the second half of 2019.
As part of a collaboration agreement, Roche initiated assessment of tazemetostat in combination with Tecentriq for the treatment of non-small cell lung cancer (NSCLC) in an arm of its MORPHEUS NSCLC Trial. Before patients had been enrolled in the study, recruitment was halted due to the partial hold placed on tazemetostat studies. Due to the hold and strategic reprioritizations, the companies have jointly opted not to move forward with the NSCLC combination study.
Throughout 2018, Epizyme conducted IND-enabling studies on its next development candidate, EZM8266 for the treatment of sickle cell disease. The company remains on track to begin clinical development of EZM8266 in the second half of 2019 with a dose-finding and safety study.
Epizyme entered into a strategic deal with Boehringer Ingelheim, focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer.
Epizyme has extended its expected capital runway into the second quarter of 2020, based on current operating plans, enhanced operating efficiencies, partner revenues and proceeds from the company’s underwritten public offering completed in October 2018.
The two defined registration paths for tazemetostat in two indications along with plans to expand into other combinations and indications, the candidate looks promising. If approved it has the potential to generate significant value for the patients and physicians who need new treatment options, and for Epizyme.
Zacks Rank & Stock to Consider
Epizyme currently carries a Zacks Rank #2 (Buy).
A top-ranked stock worth considering is Myriad Genetics, Inc. (MYGN - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Myriad’s earnings per share estimates have increased from $1.77 to $1.78 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 25.62%.
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