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PFE

Pfizer

$42.86

0.57 (1.35%)

08:07
01/14/19
01/14
08:07
01/14/19
08:07

Pfizer announces FDA acceptance of NDAs filings for tafamidis

Pfizer announced today that the FDA accepted for filing the company's New Drug Applications, or NDAs, for tafamidis for the treatment of transthyretin amyloid cardiomyopathy, or ATTR-CM. Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition. The tafamidis meglumine form has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The target Prescription Drug User Fee Act action date for a decision by the FDA is in July 2019. The tafamidis free acid form will be under Standard Review. This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration. The target PDUFA action date for a decision by the FDA is in November 2019.

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    May

PFE Pfizer
$42.86

0.57 (1.35%)

12/28/18
BTIG
12/28/18
NO CHANGE
Target $190
BTIG
Buy
Sarepta's recent weakness represents 'buying opportunity', says BTIG
BTIG analyst Timothy Chiang kept his Buy rating and $190 price target on Sarepta (SRPT), noting that while the stock was among the best performing biotech names this year, its recent weakness represents a "potential buying opportunity". The analyst believes that the company's AAVrh74 micro-dystrophin gene therapy for the treatment of Duchenne Muscular Dystrophy program leads those of Pfizer (PFE) and Solid Biosciences (SLDB) and expects Sarepta to reach about $2B in peak U.S. sales by 2024.
12/31/18
CANT
12/31/18
NO CHANGE
Target $53
CANT
Overweight
Doctors impressed by tanezumab data, says Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen says that investors she's spoken with are expecting the data for Pfizer (PFE) and Eli Lilly's (LLY) tanezumab in the first half of 2019 to be similar to or worse than what was seen in the first Phase 3 data set reported on October 23. However, physicians are impressed by the data and do not believe the rapidly progressive osteoarthritis imbalance would impact their desire to prescribe tanezumab if it is approved, Chen tells investors in a research note. The analyst believes the safety for tanezumab will be better than expected and that the drug could replace opioids for the treatment of pain. If that is right, peak sales potential of tanezumab could be billions of dollars, and drive upside to modest expectations for the drug, says the analyst. She keeps an Overweight rating on Pfizer with a $53 price target.
01/03/19
01/03/19
INITIATION

Pfizer initiates Phase 2b/3 clinical trial for PF-06651600
Pfizer announced the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies. Based on the totality of the data and the emerging clinical profile, PF-06651600 was granted Breakthrough Therapy designation from FDA for the treatment of alopecia areata in September 2018. PF-06651600 will also continue to be evaluated for rheumatoid arthritis, Crohn's disease and ulcerative colitis.
01/14/19
ADAM
01/14/19
NO CHANGE
Target $95
ADAM
Buy
Exact Sciences price target raised to $95 from $87 at Canaccord
Canaccord analyst Mark Massaro raised his price target on Exact Sciences (EXAS) to $95 from $87, citing the company's expanded partnership with Pfizer (PFE). He said management is quite confident in the alliance and as a result, Massaro sees an upside bias to 2019 estimates. Massaro reiterated his Buy rating on Exact Sciences shares.

TODAY'S FREE FLY STORIES

RTN

Raytheon

$161.77

2.4 (1.51%)

12:32
01/17/19
01/17
12:32
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12:32
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Raytheon awarded $434M contract modification for SPY-6 AIM-9X tactical missiles »

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GOOG

Alphabet

$1,079.92

-0.3 (-0.03%)

, FOSL

Fossil

$17.50

0.09 (0.52%)

12:31
01/17/19
01/17
12:31
01/17/19
12:31
Hot Stocks
Fossil to sell select smartwatch technology to Google for $40M »

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GOOG

Alphabet

$1,079.92

-0.3 (-0.03%)

FOSL

Fossil

$17.50

0.09 (0.52%)

GOOGL

Alphabet Class A

$1,089.70

0.87 (0.08%)

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JPM

JPMorgan

$102.54

0.06 (0.06%)

12:30
01/17/19
01/17
12:30
01/17/19
12:30
Options
Call butterfly in JP Morgan is similar to one in Wells Fargo »

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PHG

Philips

$35.40

(0.00%)

12:29
01/17/19
01/17
12:29
01/17/19
12:29
Periodicals
Philips to shutter U.K. factory as Brexit concerns intensify, Bloomberg says »

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LMFA

LM Funding

$2.19

0.765 (53.87%)

12:27
01/17/19
01/17
12:27
01/17/19
12:27
Hot Stocks
LM Funding spikes 53% after completing IIU acquisition, sees accretion in 2019 »

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NWSA

News Corp.

$12.42

0.03 (0.24%)

12:25
01/17/19
01/17
12:25
01/17/19
12:25
Upgrade
News Corp. rating change  »

News Corp. upgraded to…

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FDC

First Data

$22.17

0.9 (4.23%)

12:25
01/17/19
01/17
12:25
01/17/19
12:25
Options
First Data call volume above normal and directionally bullish »

Bullish option flow…

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  • 03

    Mar

BLK

BlackRock

$410.20

-2.65 (-0.64%)

12:25
01/17/19
01/17
12:25
01/17/19
12:25
Periodicals
BlackRock CEO calls on business leaders to tackle social issues, FT says »

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MS

Morgan Stanley

$42.66

-1.82 (-4.09%)

, AAPL

Apple

$154.13

-0.75 (-0.48%)

12:22
01/17/19
01/17
12:22
01/17/19
12:22
On The Fly
Fly Intel: Wall Street's top stories at midday »

Stocks opened in negative…

MS

Morgan Stanley

$42.66

-1.82 (-4.09%)

AAPL

Apple

$154.13

-0.75 (-0.48%)

JNJ

Johnson & Johnson

$128.65

0.65 (0.51%)

SHLD

Sears

$0.00

(0.00%)

SBNY

Signature Bank

$120.40

7.98 (7.10%)

MTB

M&T Bank

$161.77

7.32 (4.74%)

SIG

Signet Jewelers

$25.63

-7.745 (-23.21%)

WDC

Western Digital

$35.97

-1.83 (-4.84%)

03/08/13
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LPCN

Lipocine

$2.24

0.65 (40.88%)

12:17
01/17/19
01/17
12:17
01/17/19
12:17
Recommendations
Lipocine analyst commentary  »

Ladenburg reiterates Buy…

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

12:17
01/17/19
01/17
12:17
01/17/19
12:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

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LMB

Limbach Holding

$5.00

(0.00%)

12:16
01/17/19
01/17
12:16
01/17/19
12:16
Hot Stocks
Limbach awarded contracts totaling $81.4M for hospital construction »

Limbach Holdings provided…

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$NYE

NYSE Market Internals

$0.00

(0.00%)

12:16
01/17/19
01/17
12:16
01/17/19
12:16
Technical Analysis
NYSE market internals summary »

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LPCN

Lipocine

$2.27

0.68 (42.77%)

12:12
01/17/19
01/17
12:12
01/17/19
12:12
Periodicals
Lipocine NASH data contain plenty of 'red flags,' STAT's Feuerstein writes »

This morning's…

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CVE

Cenovus Energy

$7.79

-0.19 (-2.38%)

12:10
01/17/19
01/17
12:10
01/17/19
12:10
Options
Second day of call buying in Cenovus Energy continues as shares slump »

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SQ

Square

$68.79

2.9 (4.40%)

12:04
01/17/19
01/17
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12:04
Hot Stocks
Square launches free debit card for business, with sellers access to funds »

Square announced the…

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ALBO

Albireo Pharma

$24.54

0.08 (0.33%)

12:03
01/17/19
01/17
12:03
01/17/19
12:03
Hot Stocks
Albireo Pharma treatment of biliary atresia granted FDA orphan status »

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GPOR

Gulfport Energy

$8.67

-0.23 (-2.58%)

12:02
01/17/19
01/17
12:02
01/17/19
12:02
Hot Stocks
Gulfport Energy confirms receipt of Firefly letter »

Gulfport Energy…

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UNFI

United Natural Foods

$13.09

-2.32 (-15.06%)

12:00
01/17/19
01/17
12:00
01/17/19
12:00
Hot Stocks
United Natural Foods falls -15.1% »

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ESTE

Earthstone Energy

$5.28

-1.49 (-22.01%)

12:00
01/17/19
01/17
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01/17/19
12:00
Hot Stocks
Earthstone Energy falls -21.9% »

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SIG

Signet Jewelers

$25.49

-7.885 (-23.63%)

12:00
01/17/19
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12:00
Hot Stocks
Signet Jewelers falls -23.6% »

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SKX

Skechers

$27.64

2.27 (8.95%)

12:00
01/17/19
01/17
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12:00
Hot Stocks
Skechers rises 9.2% »

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CSV

Carriage Services

$18.60

1.61 (9.48%)

12:00
01/17/19
01/17
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01/17/19
12:00
Hot Stocks
Carriage Services rises 9.6% »

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SNH

Senior Housing

$12.82

-0.07 (-0.54%)

12:00
01/17/19
01/17
12:00
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12:00
Options
Put buyers in Senior Housing Properties »

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SHLD

Sears

$0.00

(0.00%)

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Sears confirms ESL selected as winning bidder in bankruptcy auction »

Sears Holdings announced…

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