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ORTX

Orchard Therapeutics

$11.34

0.12 (1.07%)

07:03
12/02/19
12/02
07:03
12/02/19
07:03

Orchard Therapeutics announces filing, validation of MAA by EMA for OTL-200

Orchard Therapeutics announced that the European Medicines Agency has validated the company's Marketing Authorization Application for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy in Milan, Italy, for the treatment of metachromatic leukodystrophy. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Orchard previously announced in November 2019 that the EMA had granted accelerated assessment for OTL-200. Accelerated assessment potentially provides a reduced review timeline from 210 to 150 days once the MAA is filed and validated, not counting clock stops when applicants are requested to provide additional information.

  • 07

    Dec

ORTX Orchard Therapeutics
$11.34

0.12 (1.07%)

09/05/19
LEHM
09/05/19
INITIATION
Target $21
LEHM
Overweight
Orchard Therapeutics initiated with an Overweight at Barclays
Barclays analyst Gena Wang started Orchard Therapeutics with an Overweight rating and $21 price target. The company's lentiviral gene therapy platform strategically targets genetic diseases that have validated approaches with hematopoietic stem cell transplant, Wang tells investors in a research note. She believes Orchard's three lead assets are "fairly de-risked" with high likelihood of regulatory approvals in 2020 and 2021. Multiple near- and mid-term catalysts make for a favorable risk/reward on the shares, says the analyst.
09/17/19
GUGG
09/17/19
INITIATION
Target $31
GUGG
Buy
Orchard Therapeutics initiated with a Buy at Guggenheim
Guggenheim initiated Orchard Therapeutics with a Buy and $31 price target.
09/17/19
09/17/19
INITIATION
Target $31

Buy
Guggenheim bullish on Orchard Therapeutics, initiates with a Buy
As previously reported, Guggenheim analyst Whitney Ijem started coverage of Orchard Therapeutics with a Buy rating and $31 price target. The analyst likes the company's ex vivo, lentiviral gene therapy platform which is differentiated and de-risked by the sheer amount of positive clinical data that it has generated. Further, he believes its three lead assets could be approved and launched in the next 12-24 months, which will be followed by an earlier stage pipeline that leverages the same platform.
09/17/19
09/17/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Match Group (MTCH) initiated with a Buy at Citi. 2. Restaurant Brands (QSR) initiated with a Buy at Argus. 3. Orchard Therapeutics (ORTX) initiated with a Buy at Guggenheim. 4. Axonics (AXNX) initiated with an Outperform at SVB Leerink. 5. Cellular Biomedicine (CBMG) initiated with a Buy at BTIG. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

CLDR

Cloudera

$10.02

0.16 (1.62%)

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  • 09

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ORGS

Orgenesis

$2.58

-0.19 (-6.86%)

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ALXN

Alexion

$107.42

-8.07 (-6.99%)

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HAPP

Happiness Biotech

$4.91

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ARAY

Accuray

$2.86

0.09 (3.26%)

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Conference/Events
Accuray management to meet with Lake Street »

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  • 09

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EW

Edwards Lifesciences

$242.87

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COO

Cooper Companies

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1 (0.32%)

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  • 12

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ALNA

Allena Pharmaceuticals

$1.95

-0.36 (-15.58%)

08:56
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  • 11

    Dec

DHR

Danaher

$147.07

-0.25 (-0.17%)

, NIO

NIO Inc.

$2.27

-0.15 (-6.20%)

08:55
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Notable open interest changes for December 6th »

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DHR

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CLH

Clean Harbors

$83.13

0.44 (0.53%)

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  • 16

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PD

PagerDuty

$24.99

-0.66 (-2.57%)

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RCKT

Rocket Pharmaceuticals

$19.76

0.54 (2.81%)

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  • 07

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XENE

Xenon Pharmaceuticals

$13.89

-0.31 (-2.18%)

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08:49
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DE

Deere

$164.60

-0.61 (-0.37%)

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YEXT

Yext

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0.065 (0.39%)

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TARO

Taro Pharmaceutical

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ZM

Zoom Video

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  • 16

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HEXO

Hexo

$2.06

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  • 07

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CPST

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GEMP

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FNMA

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$0.00

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, FMCC

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