Shares of Epizyme, Inc. EPZM rose about 10.5% after the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted unanimously (11-0) in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) 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 stock has skyrocketed 280.6% so far this year compared with the industry’s growth of 7.2%.
Tazemetostat, a first-in-class EZH2 inhibitor, is being evaluated for both solid tumors and hematological malignancies as a monotherapy and combination therapy to treat relapsed and front-line disease.
The positive vote by the committee gives a positive signal for 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 it has submitted a comprehensive clinical data package for ES to support tazemetostat’s approval.
If approved, tazemetostat will be the first treatment for patients with ES. This willsignificantly benefit the company.
Tazemetostat is Epizyme's lead drug being evaluated in multiple indications. We note that the company has also submitted an NDA to the FDA 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 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 approximately 500 FL patients, stratified based on their EZH2 mutation status.
Epizyme, Inc. Price
Epizyme, Inc. price | Epizyme, Inc. Quote
Zacks Rank & Other Key Picks
Epizyme currently carries a Zacks Rank #2 (Buy).
A few top-ranked stocks in the biotech sector are Anika Therapeutics Inc. ANIK and Innoviva Inc. INVA, both sporting 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 increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.
Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 and from $1.07 to $1.34 for 2020 in the past 60 days.
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