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RTRX

Retrophin

$21.50

0.23 (1.08%)

16:54
03/01/17
03/01
16:54
03/01/17
16:54

Retrophin says plans Phase 3 trial before sparsentan regulatory filing

Retrophin provided an update on the regulatory pathway for its late-stage product candidate sparsentan: "Following guidance received from the FDA during the company's End of Phase 2 meeting, the company plans to initiate a single Phase 3 clinical trial to enable a New Drug Application filing for sparsentan for the treatment of focal segmental glomerulosclerosis. Notably, the trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. The confirmatory endpoint of the study will subsequently compare changes from baseline in estimated glomerular filtration rate, or eGFR. The company is working with the FDA to finalize the study protocol and expects to initiate the trial in 2H17."

  • 01

    Mar

RTRX Retrophin
$21.50

0.23 (1.08%)

11/11/16
LEER
11/11/16
NO CHANGE
LEER
Outperform
Retrophin agreement for RE-024 bodes well for approval in 2019, says Leerink
Leerink analyst Joseph Schwartz says that the trial design for Retrophin's pending Phase 3 trial of RE-024 and the announced agreement with the FDA under the Special Protocol Assessment process for this trial bode well for potential approval in 2019. The analyst believes the company plans to initiate this trial by the end of 2016, with a drug that has shown "great promise" for the treatment of pantothenate kinase-associated neurodegeneration. He reiterates an Outperform rating on the shares.
11/21/16
LEER
11/21/16
NO CHANGE
LEER
Outperform
Retrophin DUET data reintroduces accelerated approval optionality, says Leerink
Leerink analyst Joseph Schwartz says full DUET Phase 2b results for Retrophin's sparsentan in focal segmental glomerulosclerosis presented at the American Society of Nephrology Kidney Week meeting look "very strong" in terms of the ability of the drug to produce modified partial remissions and even some complete remissions during the 8-week double blind period. The analyst believes the "strong data" provides the company with as good an argument as ever to discuss the potential of accelerated approval with the FDA, although he notes that predicting FDA is "tough." He reiterates an Outperform rating on the shares.
11/21/16
BMOC
11/21/16
NO CHANGE
BMOC
Retrophin price target raised to $46 from $40 at BMO Capital
BMO Capital analyst Do Kim raised the price target on Retrophin after the company provided data on its Sparsentan treatment that the analyst views as positive. Kim now sees a 55% chance that the drug will be approved, up from 45% previously. The analyst continues to believe that the FDA might not accept proteinuria as an endpoint, but sees "growing evidence for proteinuria as a surrogate to kidney survival." Kim keeps an Outperform rating on the stock.
12/15/16
JMPS
12/15/16
NO CHANGE
JMPS
Experts support quick approval of Retrophin sparsentan, says JMP Securities
JMP Securities analyst Liisa Bayko says the firm's survey of experts who participated in the Phase 2 study of Retrophin's sparsentan in focal segmental glomerulosclerosis "showed strong support for accelerated approval" of the drug. Bayko reiterates a $28 price target and an Outperform rating on the shares of Retrophin.

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  • 24

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SRE

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0.76 (0.66%)

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  • 14

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AAP

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FL

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-13.32 (-27.92%)

, AAP

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FL

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AAP

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LB

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URBN

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PFE

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, BMY

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BMY

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CAH

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PDCO

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RMD

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UNH

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GDI

Gardner Denver

$21.97

-0.03 (-0.14%)

, KKR

KKR

$18.14

0.11 (0.61%)

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MSI

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$87.37

0.24 (0.28%)

, T

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CCI

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SBAC

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AMT

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COMM

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LMT

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  • 23

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SBUX

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$52.70

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  • 23

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MRK

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MRK

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INTC

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UA

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UAA

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CPB

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JNJ

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UTX

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BX

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JPM

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AET

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ANTM

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CI

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CTL

CenturyLink

$19.16

-0.22 (-1.14%)

, LVLT

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LVLT

Level 3

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KSU

Kansas City Southern

$105.80

-0.07 (-0.07%)

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Kansas City Southern director Henry Maier buys 3,000 shares »

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  • 06

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RXII

RXi Pharmaceuticals

$0.58

-0.02 (-3.36%)

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  • 26

    Sep

WIN

Windstream

$1.98

0.06 (3.13%)

17:27
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Windstream CEO acquires 25,381 common shares »

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CVM

CEL-SCI

$2.44

-0.22 (-8.27%)

17:27
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Breaking Syndicate news story on CEL-SCI »

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TRN

Trinity Industries

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17:25
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LPTN

Lpath

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PGR

Progressive

$48.63

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TMO

Thermo Fisher

$172.57

-0.32 (-0.19%)

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Thermo Fisher director sells 11,318 shares »

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  • 06

    Sep

SMBC

Southern Missouri Bancorp

$31.18

-0.05 (-0.16%)

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IEP

Icahn Enterprises

$50.00

-0.2 (-0.40%)

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