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BMY

Bristol-Myers

$59.87

0.06 (0.10%)

17:32
09/06/17
09/06
17:32
09/06/17
17:32

Bristol-Myers: FDA places partial clinical hold on three Opdivo-based studies

The U.S. Food and Drug Administration has placed a partial clinical hold on CheckMate-602, CheckMate-039 and CA204142, three clinical trials investigating Opdivo, nivolumab,-based combinations in patients with relapsed or refractory multiple myeloma.This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma. The FDA determined data currently available from non-Opdivo studies indicate the risks of PD-1/PD-L1 treatment plus pomalidomide or lenalidomide and possibly PD-1/PD-L1 treatments alone or with other combinations outweigh potential benefit for patients with multiple myeloma. As part of the terms of the partial clinical hold, patients currently enrolled in CheckMate-602, CheckMate-039 and CA204142 who are experiencing clinical benefit can continue treatment. No new patients will enroll in the studies at this time. Bristol-Myers Squibb remains steadfast in our commitment to improve outcomes for patients with multiple myeloma, and will work closely with the FDA to address concerns. Other studies of Opdivo outside of multiple myeloma will continue as planned. Empliciti, elotuzumab, is approved in the US in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received one to three prior therapies. Reference Link

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BMY Bristol-Myers
$59.87

0.06 (0.10%)

08/16/17
PIPR
08/16/17
NO CHANGE
Target $29
PIPR
Overweight
After Bristol data, Piper continues to expect approval for Exelixis
Bristol-Myers Squibb (BMY) reported "mixed" top-line Phase III CheckMate-214 data on 1,070 front-line metastatic renal cell carcinoma patients, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. He continues to expect a front-line renal cell carcinoma supplemental new drug application for Exelixis' (EXEL) Cabometyx in Q3 with approval next year. Tenthoff anticipates Cabometyx use in front-line RCC expanding the current market opportunity before ultimately showing IO combination benefit. The analyst reiterates an Overweight rating on Exelixis shares with a $29 price target.
08/16/17
FBCO
08/16/17
NO CHANGE
Target $58
FBCO
Neutral
Reaction to Bristol-Myers CM-214 data 'overly pessimistic,' says Credit Suisse
Credit Suisse analyst Vamil Divan notes that Bristol-Myers (BMY) reported topline data for the Phase 3 CheckMate-214 study of Opdivo + Yervoy in 1st line renal cell carcinoma. For the first two co-primary endpoints in the trial, the results were mixed, with the combination showing an improved objective response rate as compared to Pfizer's (PFE) Sutent but narrowly missing statistical significance on improved progression-free survival, he adds. With the revenue opportunity being pushed out and potentially down due to added competition, the analyst feels modest weakness in Bristol-Myers shares is reasonable, although the actual decline seen seems "a little excessive." Divan reiterates a Neutral rating and $58 price target on Bristol-Myers shares.
08/16/17
LEER
08/16/17
NO CHANGE
Target $34
LEER
Outperform
Leerink sees competitor setback in RCC opportunity for Exelixis
Leerink analyst Michael Schmidt notes that Bristol-Myers (BMY) reported top-line results from the Phase III CheckMate-214 trial investigating Opdivo in combination with Yervoy versus Sutent in intermediate and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma, or RCC. While directionally positive, the trial missed the co-primary endpoint of improving progression-free survival with statistical significance, he notes, adding that this raises the regulatory bar for Bristol-Myers' IO combination at least until positive overall survival data are available likely in mid-2019, which he thinks will be positively received by Exelixis (EXEL) investors. Following the news, Schmidt believes Exelixis continues to look well positioned in RCC, He reiterates an Outperform rating and $34 price target on the latter's shares.
08/31/17
MSCO
08/31/17
NO CHANGE
MSCO
Overweight
Incyte melanoma data exceeded expectations, says Morgan Stanley
Morgan Stanley analyst Andrew Berens said the data on the use of an epacadostat/PD- 1 combo in melanoma treatment presented in an ESMO abstract exceeds expectations and "leaves little doubt" about the combination's efficacy. The analyst, who added that Incyte's (INCY) PFS data exceeds that of a combination of Bristol-Myers' (BMY) Opdivo with Yervoy, keeps an Overweight rating on Incyte and said the data bodes well for the company's Phase 3 program.

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AXTA

Axalta Coating

$33.87

0.33 (0.98%)

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CRM

Salesforce

$108.80

1.44 (1.34%)

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OSUR

OraSure

$16.55

2.59 (18.55%)

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GME

GameStop

$16.73

0.29 (1.76%)

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NUAN

Nuance

$14.67

0.15 (1.03%)

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  • 28

    Nov

AAPL

Apple

$173.14

3.16 (1.86%)

, BAC

Bank of America

$26.73

-0.01 (-0.04%)

07:35
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Unusual call flow in option market yesterday »

Notable call activity was…

AAPL

Apple

$173.14

3.16 (1.86%)

BAC

Bank of America

$26.73

-0.01 (-0.04%)

MU

Micron

$49.40

1.76 (3.69%)

T

AT&T

$34.33

-0.31 (-0.89%)

ORCL

Oracle

$48.63

-0.39 (-0.80%)

AKS

AK Steel

$4.85

0.22 (4.75%)

PG

Procter & Gamble

$88.72

0.45 (0.51%)

TRIP

TripAdvisor

$32.81

2.33 (7.64%)

PEP

PepsiCo

$116.05

1.14 (0.99%)

PAGP

Plains GP Holdings

$20.48

-0.41 (-1.96%)

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EKSO

Ekso Bionics

$4.13

1.21 (41.44%)

07:33
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Technical Analysis
Technical View: Ekso Bionics trades sharply higher, edging 52-week high »

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NTNX

Nutanix

$30.20

0.5 (1.68%)

07:32
11/22/17
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Initiation
Nutanix initiated  »

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HPE

HP Enterprise

$14.12

0.03 (0.21%)

07:32
11/22/17
11/22
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GE

General Electric

$17.83

-0.15 (-0.83%)

, DKS

Dick's Sporting

$28.58

-0.52 (-1.79%)

07:30
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Options
Unusual put flow in option market yesterday »

Notable put activity was…

GE

General Electric

$17.83

-0.15 (-0.83%)

DKS

Dick's Sporting

$28.58

-0.52 (-1.79%)

ROST

Ross Stores

$72.67

-0.07 (-0.10%)

ILG

ILG

$28.11

-0.5 (-1.75%)

03/08/13
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DLTR

Dollar Tree

$99.46

2.35 (2.42%)

07:29
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07:28
11/22/17
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07:28
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Futures above fair value ahead of holiday »

Stock futures are…

SHOO

Steven Madden

$39.80

-0.6 (-1.49%)

07:28
11/22/17
11/22
07:28
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07:28
Conference/Events
Steven Madden management to meet with Buckingham »

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  • 28

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BURL

Burlington Stores

$104.94

-1.61 (-1.51%)

07:25
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RLH

Red Lion Hotels

$8.55

0.1 (1.18%)

07:24
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Red Lion Hotels management to meet with Craig Hallum »

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TIVO

TiVo

$17.65

0.15 (0.86%)

, CMCSA

Comcast

$36.42

0.59 (1.65%)

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TIVO

TiVo

$17.65

0.15 (0.86%)

CMCSA

Comcast

$36.42

0.59 (1.65%)

CMCSK

Comcast

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ADBE

Adobe

$184.15

1.81 (0.99%)

07:22
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PSTI

Pluristem

$1.51

0.05 (3.42%)

07:20
11/22/17
11/22
07:20
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07:20
Conference/Events
Pluristem management to meet with Seaport Global »

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HRL

Hormel Foods

$34.52

1.12 (3.35%)

07:20
11/22/17
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07:20
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General news
FX Update: The dollar has traded softer »

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BAX

Baxter

$64.25

0.37 (0.58%)

07:19
11/22/17
11/22
07:19
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GME

GameStop

$16.73

0.29 (1.76%)

07:19
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PRTA

Prothena

$45.97

1.37 (3.07%)

07:19
11/22/17
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07:19
Conference/Events
Prothena management to meet with Oppenheimer »

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CRM

Salesforce

$108.80

1.43 (1.33%)

07:18
11/22/17
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07:18
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Salesforce analyst commentary  »

Salesforce price target…

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