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MRK

Merck

$84.50

1.58 (1.91%)

, AZN

AstraZeneca

$45.05

-0.24 (-0.53%)

10:39
09/30/19
09/30
10:39
09/30/19
10:39

AstraZeneca, Merck presents results from Phase 3 PROfound trial of LYNPARZA

AstraZeneca (AZN) and Merck (MRK) presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer who have a mutation in their homologous recombination repair genes and whose disease had progressed on prior treatment with new hormonal agent treatments e.g. abiraterone or enzalutamide. The trial was designed to analyze men with mCRPC harboring HRR-mutated genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes. Results showed a statistically-significant and clinically-meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival in BRCA1/2 or ATM-mutated tumors reducing the risk of disease progression or death by a median of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide. LYNPARZA reduced the risk of disease progression or death by 66% for these men. The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for those receiving abiraterone or enzalutamide. In the key secondary endpoint of time to pain progression, median TTPP was not reached with LYNPARZA and was 9.92 months with abiraterone and enzalutamide in patients with BRCA1/2 or ATM mutations. Results also showed a trend at this interim analysis time point for improvement in overall survival, another key secondary endpoint. LYNPARZA extended OS to a median of 18.5 months versus 15.1 months for abiraterone or enzalutamide in men with BRCA1/2 or ATM-mutated tumors, of which 81% started on abiraterone or enzalutamide and, following confirmed disease progression, then switched to LYNPARZA. At this interim analysis, the OS endpoint did not meet statistical significance. In an exploratory analysis, a similar trend in OS was observed at this interim analysis in the HRRm population with a median of 17.5 months for men treated with LYNPARZA vs. 14.3 months for those receiving abiraterone or enzalutamide. The trial showed a confirmed overall response rate a key secondary endpoint of 33.3% for LYNPARZA vs. 2.3% for abiraterone or enzalutamide in patients with BRCA1/2 or ATM mutations. In an exploratory analysis of patients in the overall HRRm population, confirmed ORR was 21.7 % for LYNPARZA vs. 4.5% for patients receiving abiraterone or enzalutamide. The safety and tolerability profile of LYNPARZA in the PROfound trial was in line with that observed in prior clinical trials. The most common adverse events greater than or equal to20% for LYNPARZA compared to abiraterone or enzalutamide were anemia, nausea, fatigue and asthenia, decreased appetite, and diarrhea. Grade 3 or above AEs were anemia, fatigue and asthenia, vomiting, dyspnea, urinary tract infection, nausea, decreased appetite, diarrhea, and back pain. AEs led to discontinuation of treatment in 16% of patients on LYNPARZA vs. 9% on abiraterone and enzalutamide. AstraZeneca and Merck are also exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, evaluating LYNPARZA as a first-line therapy in mCRPC for patients with or without HRR mutations, in combination with abiraterone acetate.

MRK

Merck

$84.50

1.58 (1.91%)

AZN

AstraZeneca

$45.05

-0.24 (-0.53%)

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    Mar

MRK Merck
$84.50

1.58 (1.91%)

08/15/19
LEER
08/15/19
INITIATION
Target $103
LEER
Outperform
Merck initiated with an Outperform at SVB Leerink
SVB Leerink analyst Daina Graybosch initiated Merck with an Outperform rating and $103 price target.
08/16/19
08/16/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Merck (MRK) initiated with an Outperform at SVB Leerink. 2. DocuSign (DOCU) initiated with a Buy at DA Davidson. 3. iQIYI (IQ) initiated with an Underweight at JPMorgan. 4. Goodyear Tire (GT) initiated with an Outperform at Exane BNP Paribas. 5. BlackBerry (BB) initiated with a Neutral at Macquarie. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
09/18/19
RHCO
09/18/19
NO CHANGE
Target $14
RHCO
Hold
Lannett price target raised to $14 from $10 at SunTrust
SunTrust analyst Gregg Gilbert raised his price target on Lannett (LCI) to $14, adjusting his model to reflect its potentially significant opportunity with the recent launch of posaconazole - a generic version of Merck's (MRK) Noxafil. The analyst notes that he now models sales and EBITDA at the higher end of the company's FY20 targets while also raising his FY20 EPS view by 19c to $1.33. Gilbert still keeps his Hold rating on the stock, citing the uncertainty around Lannett's capital structure and limited pipeline visibility as well as the challenging environment for generics.
09/30/19
GUGG
09/30/19
INITIATION
Target $12
GUGG
Buy
Guggenheim starts Bellus Health at Buy with $12 price target
As previously reported, Guggenheim analyst Dana Flanders initiated Bellus Health (BLU) with a Buy rating and $12 price target. BLU-5937 for refractory chronic cough is the primary value driver in "a potential multi-billion dollar category," said Flanders, who also sees the opportunity for label expansion and the potential for M&A interest in Bellus. Merck (MRK) acquired Afferent, which also has a P2X3 antagonist asset called gefapixant, in 2016 for $500M upfront and up to $1.25B with milestones, noted Flanders.
AZN AstraZeneca
$45.05

-0.24 (-0.53%)

08/13/19
BOFA
08/13/19
DOWNGRADE
Target $7
BOFA
Neutral
Clovis downgraded to Neutral from Buy at BofA/Merrill
BofA/Merrill Tazeen Ahmad downgraded Clovis (CLVS) to Neutral and lowered his price target to $7 from $13 after last week's release of positive topline results for its PARP inhibitor Lynparza to treat prostate cancer by the company's competitor AstraZeneca (AZN). The analyst notes that the Lynparza update alters his expectations in the prostate cancer market to assume a two-player landscape from day one, reducing his expectations for Clovis's Rubraca peak sales to $250M from $406M with peak U.S. BRCA penetration of 15%.
08/14/19
ARGS
08/14/19
NO CHANGE
Target $50
ARGS
Buy
AstraZeneca price target raised to $50 from $46 at Argus
Argus analyst John Eade raised his price target on AstraZeneca to $50 and kept his Buy rating, saying the stock has outperformed over the past quarter thanks to the pipeline developments that are returning the company to growth. The analyst notes that the company's future growth should be driven by its checkpoint inhibitor Imfinzi, and he sees the program tracking toward a billion-dollar blockbuster status from $338M reported in Q2. Eade further notes that AstraZeneca management has made efforts to address the ongoing pricing pressure and generic threats to its former blockbusters Nexium and Crestor by reducing costs and assembling a new drug pipeline.
09/03/19
DZBN
09/03/19
DOWNGRADE
DZBN
Sell
AstraZeneca downgraded to Sell from Hold at DZ Bank
DZ Bank analyst Elmar Kraus downgraded AstraZeneca to Sell from Hold with a price target of 66 pounds.
09/03/19
09/03/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Boston Beer (SAM) downgraded to Underperform from Hold at Jefferies with analyst Kevin Grundy saying his consumer survey and web scrapes point to the potential for greater competitive intensity in the "rapidly growing" spiked seltzer category. He views Boston Beer's valuation as "stretched" given its competitive risk in hard seltzers. 2. Spirit Airlines (SAVE) downgraded to Outperform from Strong Buy at Raymond James with analyst Savanthi Syth now expecting a delay in the inflection of sentiment to early 2020. 3. AstraZeneca (AZN) downgraded to Sell from Hold at DZ Bank. 4. Heico (HEI) downgraded to Sell from Neutral at UBS with analyst Louis Raffetto citing valuation. 5. Hilton (HLT) downgraded to Neutral from Outperform at Macquarie with analyst Chad Beynon saying he believes the stock's current valuation with near-peak EBITDA multiples prices in the positives while the company faces a lack of catalysts. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

AMRN

Amarin

$22.66

1.17 (5.44%)

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NCNA

NuCana

$5.59

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KZR

Kezar Life Sciences

$2.59

(0.00%)

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FSM

Fortuna Silver Mines

$3.01

-0.19 (-5.94%)

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LN

Line Corp.

$46.46

-4.13 (-8.16%)

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CANG

Cango

$5.83

-1.01 (-14.77%)

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BCH

Banco de Chile

$23.88

2.49 (11.64%)

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ITCB

Itau Corpbanca

$7.51

(0.00%)

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FTCH

Farfetch

$9.80

2.31 (30.84%)

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KRP

Kimbell Royalty Partners

$13.99

(0.00%)

09:58
11/15/19
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09:58
Conference/Events
Kimbell Royalty Partners management to meet with TD Securities »

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BANC

Banc of California

$14.75

(0.00%)

, FCBP

First Choice Bank

$22.50

(0.00%)

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Banc of California names Lynn Hopkins as CFO after John Bogler resigns »

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BANC

Banc of California

$14.75

(0.00%)

FCBP

First Choice Bank

$22.50

(0.00%)

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AMAT

Applied Materials

$61.35

4.46 (7.84%)

, PCG

PG&E

$6.92

0.22 (3.28%)

09:55
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Options
Early notable gainers among liquid option names on November 15th »

Notable gainers among…

AMAT

Applied Materials

$61.35

4.46 (7.84%)

PCG

PG&E

$6.92

0.22 (3.28%)

DHR

Danaher

$141.30

5.14 (3.78%)

LRCX

Lam Research

$281.95

7 (2.55%)

OXY

Occidental Petroleum

$39.06

1.3 (3.44%)

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EA

Electronic Arts

$99.12

1.58 (1.62%)

09:51
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09:51
Recommendations
Electronic Arts analyst commentary  »

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FX Action: The dollar »

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GDDY

GoDaddy

$68.00

0.22 (0.32%)

09:48
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Periodicals
GoDaddy's new investors include 'constructive activist,' Dealreporter says »

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BCH

Banco de Chile

$21.39

(0.00%)

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BSAC

Santander Chile

$24.53

2.37 (10.69%)

09:47
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FTCH

Farfetch

$9.97

2.48 (33.11%)

09:47
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09:45
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General news
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General news
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EWW

iShares MSCI Mexico

$44.07

(0.00%)

, RH

RH

$175.19

(0.00%)

09:40
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Unusually active option classes on open November 15th »

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EWW

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RH

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$175.19

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PDD

Pinduoduo

$41.29

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ORCL

Oracle

$56.10

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JCP

J.C. Penney

$1.10

(0.00%)

AMRN

Amarin

$21.49

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CSCO

Cisco

$44.92

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GRUB

GrubHub

$38.52

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QCOM

Qualcomm

$90.48

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BA

Boeing

$367.30

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