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EPZM

Epizyme

$13.74

-0.2 (-1.43%)

06:35
06/03/19
06/03
06:35
06/03/19
06:35

Epizyme reports new data from Phase 2 Trial of Tazemetostat at ASCO

Epizyme reported updated data on tazemetostat from the epithelioid sarcoma cohort of its ongoing Phase 2 study in patients with molecularly defined solid tumors. Favorable safety and tolerability have been observed with tazemetostat in this Phase 2 study cohort. The majority of treatment-emergent adverse events were grade 1 or 2, with only 13% of patients experiencing grade 3 or higher treatment-related TEAEs. Reported TEAEs regardless of attribution with an incidence of 10% or greater were fatigue (39%), nausea (35%), cancer pain (32%), decreased appetite (26%), constipation (21%), vomiting (24%), cough and headache (18% each), diarrhea, weight decrease and anemia (16% each), dyspnea (13%) and plural effusion (11.% ). Two percent of patients were dose-reduced due to an adverse event and one patient discontinued treatment due to an adverse event in the Phase 2 cohort. The safety data from the 62 epithelioid sarcoma patients in the study cohort are consistent with the overall safety observed to date in over 800 people in the tazemetostat clinical program. Dr. Shefali Agarwal, chief medical officer of Epizyme said, "We are pleased that the data presented today are consistent with what we have seen throughout our development of tazemetostat for epithelioid sarcoma, demonstrating meaningful clinical activity and good tolerability. Importantly, the totality of these data formed the foundation for our first NDA submission, which we just announced last week. If we are successful, tazemetostat would be the first FDA-approved EZH2 inhibitor."

  • 04

    Jun

EPZM Epizyme
$13.74

-0.2 (-1.43%)

01/07/19
01/07/19
UPGRADE
Target $12

Outperform
Epizyme upgraded to Outperform at Leerink on tazemetostat label visibility
As previously reported, Leerink analyst Andrew Berens upgraded Epizyme to Outperform from Market Perform after the company disclosed agreement with FDA over plans to seek accelerated approval of tazemetostat in both EZH2 mutant and wild-type follicular lymphoma as part of the same filing based on the current data set. The updated regulatory plan, and management confidence, raises his conviction in the potential for tazemetostat to be approved in a broader population. Additionally, Berens increased his probability of success for both mutant and wild-type patients, and now models commercial uptake in both settings in 2020. The analyst also raised his price target on the shares to $12 from $11.
02/25/19
COWN
02/25/19
NO CHANGE
COWN
Epizyme coverage transferred with an Outperform at Cowen
Cowen analyst Yaron Werber assumed coverage on Epizyme with an Outperform and $18 price target. The analyst noted that Tazemetostat is a de-risked asset with approval expected in 2020, and he anticipates $1B in peak sales, making this an "attractive overlooked opportunity."
02/27/19
OPCO
02/27/19
NO CHANGE
Target $18
OPCO
Outperform
Epizyme price target lowered to $18 from $27 at Oppenheimer
Oppenheimer analyst Leland Gershell lowered Epizyme's price target to $18 from $27 after assuming coverage of the name with an Outperform rating. Impressive efficacy in r/r follicular lymphoma demonstrated by lead candidate tazemetostat should enable this drug to become the 3rd line treatment of choice in the about 20% w/EZH2-activating mutations as well as drive its use within the wild-typep opulation, he contends, adding that an NDA submission for all-comers is expected in Q4 of 2019.
05/30/19
SBSH
05/30/19
INITIATION
Target $25
SBSH
Buy
Epizyme assumed with a Buy at Citi
Citi analyst Mohit Bansal assumed coverage Epizyme with a Buy rating and $25 price target. Under a prior analyst, Citi had a Buy rating on the shares with a $28 price target.

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SPX

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AMC

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TCEHY

Tencent

$0.00

(0.00%)

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CLNC

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  • 07

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