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MRK

Merck

$61.19

-1 (-1.61%)

07:05
12/01/16
12/01
07:05
12/01/16
07:05

Merck says FDA grants priority review to sBLA for Keytruda in relapsed cHL

Merck announced that the U.S. FDA has accepted for review the supplemental Biologics License Application for KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for patients who have relapsed after three or more prior lines of therapy. The FDA granted Priority Review with a PDUFA, or target action, date of March 15, 2017. The sBLA will be reviewed under the FDA's Accelerated Approval program. In April 2016, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this indication. The application is seeking approval for KEYTRUDA at a fixed dose of 200 mg administered intravenously every three weeks and is based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which studied patients with refractory cHL or who had relapsed after three or more prior lines of therapy. This is the first application for regulatory approval of KEYTRUDA in a hematologic malignancy. The KEYTRUDA clinical development program includes more than 30 tumor types in more than 360 clinical trials, including nearly 200 trials that combine KEYTRUDA with other cancer treatments. For hematologic malignancies specifically, Merck is conducting broad immuno-oncology research assessing the role of monotherapy and combination regimens with KEYTRUDA. The program includes nearly 40 ongoing studies - several of which are registration-enabling trials - across more than 20 hematologic subtypes, including leukemia, lymphomas and myeloma.

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MRK Merck
$61.19

-1 (-1.61%)

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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MS

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Morgan Stanley transportation analysts hold an analyst/industry conference call »

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SHLD

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, ROKU

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SHLD

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General news
U.S. initial jobless claims plunged 41k to 220k in the week ended January 13 »

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MS

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IBM

IBM

$168.65

4.8 (2.93%)

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MARA

Marathon Patent Group

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MS

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PTC

PTC

$66.70

1.41 (2.16%)

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OAKS

Five Oaks

$3.04

-0.04 (-1.30%)

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HOMB

Home Bancshares

$24.69

0.07 (0.28%)

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GS

Goldman Sachs

$253.43

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GOOG

Alphabet

$1,131.98

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Alphabet Class A

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AMZN

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$1,295.00

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, HD

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$199.82

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AZRX

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CLBS

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UBS

UBS

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MGA

Magna

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NBRV

Nabriva Therapeutics

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