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MRK

Merck

$62.21

0.57 (0.92%)

07:01
11/28/16
11/28
07:01
11/28/16
07:01

Merck's sBLA for Keytruda granted priority review by FDA

Merck announced that the U.S. FDA accepted for review the supplemental Biologics License Application for KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high cancer. The FDA granted Priority Review with a PDUFA, or target action date, of March 8, 2017; the sBLA will be reviewed under the FDA's Accelerated Approval program based on tumor response rate and durability of response. The FDA recently granted Breakthrough Therapy Designation to KEYTRUDA for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer. The application, which is seeking approval for KEYTRUDA at a fixed dose of 200 mg every three weeks, is based on data from five uncontrolled, open-label, multi-cohort, multi-site phase I/II trials investigating the activity of KEYTRUDA in MSI-H cancer.

  • 29

    Nov

  • 03

    Dec

MRK Merck
$62.21

0.57 (0.92%)

10/13/16
10/13/16
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Merck (MRK) upgraded to Buy from Neutral at BofA/Merrill with analyst Colin Bristow citing its opportunity in first line lung cancer. 2. Viacom (VIA, VIAB) upgraded to Market Perform from Underperform at Wells Fargo and to Buy from Underperform at BofA/Merrill. 3. TD Ameritrade (AMTD) and Charles Schwab (SCHW) were upgraded to Buy from Neutral at BofA/Merrill. 4. Talend (TLND) upgraded to Buy from Neutral at Goldman with analyst Jesse Hulsing saying the company will benefit from analytic workloads moving to the cloud. 5. CSC (CSC) upgraded to Buy from Neutral at Citi. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/19/16
LEER
10/19/16
NO CHANGE
LEER
Roche Tecentriq approval increases competition, says Leerink
Leerink analyst Seamus Fernandez says that the FDA approval of Roche's (RHHBY) Tecentriq in second-line non-small cell lung cancer patients regardless of PD-L1 expression comes as no surprise given its previously reported overall survival advantage. Nonetheless, the analyst believes it creates new competition for Bristol-Myers' (BMY) Opdivo and Merck's (MRK) Keytruda in this setting.
10/24/16
RHCO
10/24/16
NO CHANGE
RHCO
Merck Keytruda to have several positive catalysts, says SunTrust
SunTrust analyst John Boris says that several trials of Merck's Keytruda will be stopped early "across multiple tumor types," providing a positive catalyst. Boris says that Keytruda should be approved for 1LNSCLC on or before December 24 and KN-21 chemo combo compendium listing in 1H17. He keeps a $73 price target and Buy rating on Merck.
10/25/16
RHCO
10/25/16
NO CHANGE
RHCO
Merck shares should be bought after early FDA approval, says SunTrust
After Merck announced that the FDA had approved the company's Keytruda treatment for the first-line metastatic non-small cell lung cancer with tumor proportion scores of 50% or higher, SunTrust analyst John Boris says that such patients represent about 30% "of the prevalent first-line population." He adds that the approval was earlier than expected and gives Keytruda an approximately 15 month lead over competing drugs in NSCLC. The analyst thinks that the early approval will enable the company's 2021 revenue to beat expectations by a significant amount, and he recommends buying the stock on the news.

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CLDR

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AOS

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FB

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AAWW

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UTHR

United Therapeutics

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CYTR

CytRx

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EEX

Emerald Expositions Events

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GOOG

Alphabet

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SRPT

Sarepta

$34.72

-0.14 (-0.40%)

19:26
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SRPT

Sarepta

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-0.14 (-0.40%)

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SRPT

Sarepta

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SRPT

Sarepta

$34.72

-0.14 (-0.40%)

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  • 27

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BSAC

Santander Chile

$23.59

-0.36 (-1.50%)

19:02
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  • 28

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BA

Boeing

$183.22

1.51 (0.83%)

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Bombardier

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BA

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Bombardier

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SWN

Southwestern Energy

$7.67

-0.16 (-2.04%)

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CRMD

CorMedix

$1.04

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FET

Forum Energy

$18.10

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18:39
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WDC

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FET

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SJR

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MTRX

Matrix Service

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GIMO

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