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EPZM

Epizyme

$15.75

-0.73 (-4.43%)

10:47
12/02/19
12/02
10:47
12/02/19
10:47

Epizyme announces FDA advisory committee meeting to review NDA for tazemetostat

Epizyme announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration is scheduled to review data supporting the company's New Drug Application, or NDA, requesting accelerated approval for tazemetostat, an oral, first-in-class EZH2 inhibitor, at a meeting on Dec. 18, 2019 at 1:00 p.m. ET. The proposed indication to be discussed at this upcoming ODAC meeting is for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. "ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of a product is made solely by the FDA. Epizyme announced on July 25, 2019 that the FDA had accepted for filing the NDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery with Priority Review and a Prescription Drug User-Fee Act action date of Jan. 23, 2020. Epizyme's NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat," the company stated.

  • 07

    Dec

EPZM Epizyme
$15.75

-0.73 (-4.43%)

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.
06/13/19
HCWC
06/13/19
NO CHANGE
Target $25
HCWC
Buy
Epizyme selloff yesterday an overreaction, says H.C. Wainwright
Yesterday, Epizyme's abstract to be presented at the International Conference on Malignant Lymphoma indicated a slip of the median duration of response in EZH2 wild type patients, H.C. Wainwright analyst Andrew Fein tells investors in a research note. He believes the stock overreacted due to concern "about a possible regulatory hiccup and a potentially narrower label." The analyst, however, continues to believe tazemetostat's data package should support a broad label in follicular lymphoma. He reiterates a Buy rating on Epizyme with a $25 price target.

TODAY'S FREE FLY STORIES

JBSS

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0.47 (0.48%)

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SUPN

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SFIX

Stitch Fix

$25.17

1.04 (4.31%)

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LVGO

Livongo Health

$27.40

-0.6 (-2.14%)

16:44
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Syndicate
Livongo Health files to sell 2.78M shares of common stock for holders »

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EAT

Brinker

$42.69

-0.56 (-1.29%)

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WEN

Wendy's

$21.71

0.14 (0.65%)

16:42
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Wendy's initiated  »

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  • 11

    Dec

CMG

Chipotle

$827.56

5.39 (0.66%)

16:38
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DNKN

Dunkin' Brands

$76.21

-0.41 (-0.54%)

16:38
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MCD

McDonald's

$194.71

-0.75 (-0.38%)

16:37
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16:37
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16:37
Initiation
McDonald's initiated  »

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SBUX

Starbucks

$86.28

-0.04 (-0.05%)

16:36
12/09/19
12/09
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Initiation
Starbucks initiated  »

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ZDGE

Zedge, Inc.

$1.75

0.11 (6.71%)

16:34
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Syndicate
Breaking Syndicate news story on Zedge, Inc. »

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  • 10

    Dec

FSLR

First Solar

$52.39

-0.97 (-1.82%)

16:34
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First Solar CHRO Chris Bueter to retire, Caroline Stockdale to succeed »

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DPZ

Domino's Pizza

$286.59

0.05 (0.02%)

16:34
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Initiation
Domino's Pizza initiated  »

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  • 11

    Dec

  • 13

    Dec

TOL

Toll Brothers

$41.40

0.515 (1.26%)

16:33
12/09/19
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Earnings
Toll Brothers sees Q1 deliveries 1,650-1,850 units »

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  • 10

    Dec

CF

CF Industries

$45.41

0.07 (0.15%)

16:33
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Downgrade
CF Industries rating change  »

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CNS

Cohen & Steers

$66.56

-0.56 (-0.83%)

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Cohen & Steers reports preliminary AUM $71.2B as of November 30 »

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  • 26

    Feb

TOL

Toll Brothers

$41.40

0.515 (1.26%)

16:32
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Earnings
Toll Brothers reports Q4 EPS $1.41, consensus $1.30 »

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  • 10

    Dec

BEN

Franklin Resources

$27.01

0.015 (0.06%)

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TXRH

Texas Roadhouse

$56.45

-0.67 (-1.17%)

16:30
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Initiation
Texas Roadhouse initiated  »

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  • 11

    Dec

ROAD

Construction Partners

$20.57

0.67 (3.37%)

16:30
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Earnings
Construction Partners sees FY20 revenue $830M-$870M, consensus $855.39M »

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  • 10

    Dec

YUM

Yum! Brands

$98.99

0.22 (0.22%)

16:30
12/09/19
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16:30
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16:30
Initiation
Yum! Brands initiated  »

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MDB

MongoDB

$131.01

-0.21 (-0.16%)

16:30
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16:30
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Breaking Hot Stocks news story on MongoDB »

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  • 09

    Dec

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  • 18

    Dec

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Options
Preliminary option volume of 16.9M today »

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