FDA Lifts Clinical Hold on Epizyme’s Lead Candidate’s Study
Epizyme, Inc. (EPZM announced that the FDA has lifted the partial clinical hold on its lead cancer candidate tazemetostat’s study. In April, the FDA had paused U.S.-based enrollment of new patients in a phase I pediatric study of tazemetostat, after one patient who had advanced poorly differentiated chordoma developed secondary T-cell lymphoma (T-LBL). This patient then discontinued tazemetostat and started the treatment for T-cell lymphoma.
Epizyme is in the process of reopening enrollment in all of its company-sponsored studies in the United States, including the follicular lymphoma (FL) EZH2 activating mutation cohort of its phase II non-Hodgkin lymphoma study.
Shares of the company have lost 18.3% year to date compared with the industry’s decline of 2.7%.
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing phase II programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors, both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL), mesothelioma, and combination studies in DLBCL and NSCLC.
The company along with its team did a comprehensive assessment of the risk of secondary malignancies, including T-cell lymphoblastic lymphoma (T-LBL) potentially associated with tazemetostat. The company provided a thorough assessment of efficacy and safety data across all of its studies in hematological malignancies and solid tumors, in both adults and children. It convened a panel of external scientific and medical experts, who reviewed and validated the findings.
The company through constructive dialogues with the FDA resolved the clinical hold. Epizyme is now focused on its priorities, which include preparing for its first new drug application (NDA) submission for tazemetostat in epithelioid sarcoma and defining its registration path in FL. Epizyme will now engage with regulators in France and Germany to resolve the partial clinical holds, and resume enrollment in those countries.
Epizyme, Inc. Price
Zacks Rank & Stocks to Consider
Epizyme is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. ANIK, Ligand Pharmaceuticals Incorporated LGND and Regeneron Pharmaceuticals Inc. REGN. While Anika and Ligand sport a Zacks Rank #1 (Strong Buy), Regeneron carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have increased from 57 cents to 95 cents for 2018 and from $1.02 to $1.49 for 2019 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 20.84%.
Ligand’s earnings per share estimates have moved up from $5.64 to $6.33 for 2018 and from $5.59 to $5.74 for 2019 in the last 30 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 59.54%. Share price of the company has increased 96% year to date.
Regeneron’s earnings per share estimates have increased from $18.99 to $20.38 for 2018 and from $21.15 to $21.74 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 8.18%. The stock has rallied 3.8% so far this year.
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