Shares of Epizyme Inc. EPZM have soared 246.2% year to date compared with the industry’s growth of 10.3%.
The company’s lead pipeline candidate is tazemetostat, a first-in-class EZH2 inhibitor, which is currently being evaluated for the treatment of solid tumors and hematological malignancies as a monotherapy, and to treat relapsed and front-line diseases as a combination therapy.
In December, the Oncologic Drugs Advisory Committee (ODAC) of the FDA unanimously voted (11-0) in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) that is not eligible for curative surgery. ES is a rare and serious soft tissue sarcoma (STS), with a high rate of local recurrence and distant metastasis.
The committee’s positive vote gives a positive signal to the candidate. The new drug application (NDA) for tazemetostat is currently under Priority Review with the FDA, with an action date of Jan 23, 2020. The NDA was supported by data from the ongoing phase II study in patients with molecularly defined solid tumors. The company is confident that the comprehensive clinical data package for ES, which it has submitted, will support tazemetostat’s approval.
If approved, tazemetostat will be the first treatment for patients with ES. This is expected to significantly benefit the company. It will also be the first commercial product for Epizyme, which will enable it to realize sales. This should boost the company’s growth prospects.
Tazemetostat is being evaluated in multiple indications.
Notably, the company also submitted an NDA to the FDA in December for accelerated approval of the drug for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy. The submission is based primarily on updated phase II efficacy and safety data on tazemetostat in this patient population.
To support the full approval of tazemetostat for FL, Epizyme is conducting a single, global, randomized, adaptive study. The company is evaluating the chemo-free combination of Roche’s RHHBY Rituxan and Revlimid with tazemetostat compared to the combo with placebo in patients with relapsed or refractory FL. The study is expected to enroll 500 FL patients, stratified based on their EZH2 mutation status.
Moreover, the company is exploring tazemetostat to increase the clinical activity of immuno-oncology therapies by combining with an anti-PD 1 or PDL-1 agent. Under its collaboration with Roche, Epizyme is evaluating tazemetostat in a combination with anti-PD-L1 cancer immunotherapy, Tecentriq, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) to determine the recommended phase II dose and advance into the expansion portion of the study.
In addition, the European Commission granted orphan drug designation to tazemetostat for the treatment of patients with FL, DLBCL and malignant mesothelioma.
The potential approval of tazmetostat will significantly boost Epizyme’s growth prospects.
Epizyme also aims at completing IND-enabling studies on EZM8266, its G9a inhibitor designed to treat patients with sickle cell disease (SCD). It is on track to begin the clinical development of the candidate soon, with a dose-finding and safety study.
Epizyme’s proprietary product platform is used to create small molecule inhibitors of a class of enzymes known as histone methyltransferases (HMTs). However, the company faces competition from the likes of Glaxo, Novartis NVS, Pfizer PFE and Constellation, which are developing new epigenetic treatments for cancer-targeting HMTs.
Epizyme currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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