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PFE

Pfizer

$35.68

-0.01 (-0.03%)

08:03
05/17/18
05/17
08:03
05/17/18
08:03

Pfizer's LYRICA Oral Solution CV Phase 3 trial meets primary endpoint

Pfizer announced positive top-line results of a Phase 3 study examining the use of LYRICA Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the U.S. Food and Drug Administration. LYRICA is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, four of which have been completed and two of which are actively enrolling. This Phase 3 study was a double-blind, placebo-controlled, randomized, parallel group, multi-center study that included 14 days of double-blind adjunctive treatment. In this study, 175 pediatric patients with partial onset seizures who were not adequately controlled with one to three concomitant antiepileptic drugs were enrolled from 52 centers in 22 countries. Patients were randomized to placebo, or one of two fixed doses of LYRICA divided three times daily: LYRICA 14 mg/kg/day or LYRICA 7 mg/kg/day in a 2:1:2 ratio. The safety profile observed in this study is comparable to the known profile of LYRICA in prior epilepsy studies in pediatric and adult patients. No unexpected or new safety findings were reported in the pediatric patients with partial onset seizures in this study. The most common adverse events with LYRICA 14 mg/kg/day in this study were somnolence, upper respiratory tract infection, and pneumonia. The most common adverse events with LYRICA 7 mg/kg/day in this study were somnolence, upper respiratory tract infection, and pyrexia. The most common adverse events with placebo were upper respiratory tract infection, vomiting, somnolence, and pyrexia. Complete study results are expected to be submitted for publication in a peer-reviewed medical journal. These data along with those of prior studies will be submitted to the FDA for LYRICA pediatric exclusivity determination.

  • 20

    May

  • 05

    Jun

PFE Pfizer
$35.68

-0.01 (-0.03%)

04/16/18
NORL
04/16/18
NO CHANGE
NORL
Outperform
Pfizer appears to be BioLife Solutions customer, says Northland
Northland analyst Suraj Kalia believes Pfizer (PFE) has never publicly announced itself as a customer of BioLife Solutions (BLFS), but a link to a presentation apparently made at the AAPS conference seems to highlight Pfizer' use of BioLife's CryoStor cryopreservation medium in its CAR-T program. Kalie noted this is the first time he has learned of Pfizer being a customer and of the use of BioLife's CryoStor being used in allogeneic CAR-T applications, both of which he finds interesting. Kalia has an Outperform rating on BioLife.
04/19/18
04/19/18
NO CHANGE

BTIG says Allergan may be interested in Shire after insufficient Takeda offers
BTIG analyst Timothy Chiang noted that Shire (SHPG) is trading higher after news that at least one other company other than Takeda (TKPYY) is interested in acquiring Shire, and naming Allergan (AGN) as one of those possible suitors. Chiang also believes that other companies, such as Pfizer (PFE), could entering into the bidding for Shire. BTIG maintained a Buy rating and $195 price target on Shire shares.
05/15/18
LEER
05/15/18
NO CHANGE
Target $121
LEER
Outperform
Sarepta price target raised to $121 from $88 at Leerink
Leerink analyst Joseph Schwartz raised his price target for Sarepta (SRPT) to $121 from $88, while reiterating an Outperform rating on the shares. The analyst notes that Sarepta is one of three companies developing microdystrophin gene therapy for Duchenne muscular dystrophy, in competition with Pfizer (PFE) who acquired Bamboo, and Solid Biosciences (SLDB). With Solid's clinical hold still in place, Sarepta could potentially be first-to-market, and is expected to report the first clinical data for a micro-dystrophin candidate at their R&D day on June 19, he adds.
05/16/18
MSCO
05/16/18
NO CHANGE
Target $200
MSCO
Overweight
Epogen biosimilar should have little impact on Amgen, says Morgan Stanley
After the FDA approved Retacrit, Pfizer's (PFE) biosimilar version of Amgen's (AMGN) Epogen, Morgan Stanley analyst Matthew Harrison said he does not see significant impact to his forecasts due to the news, noting that Amgen has already discounted Epogen net selling price significantly to secure an extended supply agreement with DaVita (DVA). Amgen renegotiated the supply agreement in early 2017 and the vast majority of Epogen volume is from DaVita, added Harrison, who maintains an Overweight rating and $200 price target on Amgen shares.

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BWA

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JLL

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RACE

Ferrari

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5.465 (4.11%)

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SMRT

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-0.09 (-4.37%)

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1.05 (0.94%)

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TSM

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SPX

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1.55 (0.54%)

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SQ

Square

$87.97

1.1 (1.27%)

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MSFT

Microsoft

$113.24

1.05 (0.94%)

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KL

Kirkland Lake Gold

$17.57

-0.64 (-3.51%)

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  • 23

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MSFT

Microsoft

$113.24

1.05 (0.94%)

18:39
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Breaking Hot Stocks news story on Microsoft »

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OMAB

OMA Airports

$56.18

2.13 (3.94%)

18:23
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Downgrade
OMA Airports rating change at Santander »

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CE

Celanese

$113.41

-0.03 (-0.03%)

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WYNN

Wynn Resorts

$132.97

0.56 (0.42%)

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GLD

SPDR Gold Trust

$113.43

-0.18 (-0.16%)

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SPDR Gold Trust holdings fall to 742.23MT from 742.53MT »

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JAZZ

Jazz Pharmaceuticals

$161.89

0.92 (0.57%)

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RIG

Transocean

$11.93

0.335 (2.89%)

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NE

Noble Corp.

$6.15

0.19 (3.19%)

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  • 24

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CCOEY

Capcom

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BBY

Best Buy

$77.70

0.67 (0.87%)

17:24
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Breaking Syndicate news story on Best Buy »

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DO

Diamond Offshore

$17.86

0.55 (3.18%)

17:22
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Initiation
Diamond Offshore initiated at Morgan Stanley »

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TSM

TSMC

$43.57

-0.2 (-0.46%)

17:20
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WHD

Cactus

$35.93

1.24 (3.57%)

17:17
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Initiation
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ZTCOY

ZTE Corp.

$0.00

(0.00%)

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Senators seek punishment if ZTE strays from deal, Reuters says »

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AKCA

Akcea Therapeutics

$26.58

1.73 (6.96%)

17:15
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  • 06

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OIS

Oil States

$30.85

0.55 (1.82%)

17:13
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Initiation
Oil States initiated at Morgan Stanley »

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NOV

National Oilwell

$44.55

0.44 (1.00%)

17:07
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