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QURE

uniQure

$31.29

-0.02 (-0.06%)

07:04
01/22/19
01/22
07:04
01/22/19
07:04

uniQure announces FDA clearance of AMT-130 NDA in Huntington's disease

uniQure N.V. announced the U.S. Food and Drug Administration has completed its review of the company's Investigational New Drug application for AMT-130, and the IND is now effective allowing uniQure to begin its planned Phase I/II study. AMT-130 comprises a recombinant AAV5 vector carrying a DNA cassette encoding a microRNA that non-selectively lowers or knocks-down human huntingtin protein in Huntington's disease patients. "The FDA's clearance of our IND for AMT-130 is a significant milestone for Huntington's disease patients and an important event in the field of gene therapy," said Matt Kapusta, CEO at uniQure. "We expect that AMT-130 will be the first one-time administered AAV gene therapy to enter clinical testing for the treatment of Huntington's disease, a devastating neurodegenerative disorder for which there is no approved disease-modifying treatment.

QURE uniQure
$31.29

-0.02 (-0.06%)

11/16/18
FBCO
11/16/18
UPGRADE
Target $44
FBCO
Neutral
Spark Therapeutics upgraded to Neutral from Underperform at Credit Suisse
Credit Suisse analyst Martin Auster upgraded Spark Therapeutics (ONCE) to Neutral from Underperform but lowered his price target to $44 from $48. In a research note to investors, Auster says that with uniQure's (QURE) update validating AMT-061, its second generation hemophilia B gene therapy construct incorporating the Padua variant, and Freeline's initial data disclosed in ASH abstracts, he sees a more competitive landscape in hemophilia B gene therapy, and lowered his market share assumptions for SPK-9001 to reflect this new dynamic.However, Auster says Spark has been under significant pressure since providing an update on its hemophilia A, and believes most of the value for that program has already been discounted in the share price. Though there is limited visibility in the near-term, he sees optionality going forward within the Pompe program and/or a possible reemergence of the hem A platform ~mid-2019 from either an improved profile for SPK-8011 with prophy steroids or encouraging early data from Spark's second compound SPK-8016.
11/26/18
HCWC
11/26/18
NO CHANGE
Target $60
HCWC
Buy
uniQure price target raised to $60 from $48 at H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay raised his price target for uniQure to $60 saying the company's pipeline augmentation that should be rewarded over the next 12 months. The recent R&D day disclosures of three new, "differentiated" gene therapy programs targeting Hemophilia A, Fabry, and SCA3 are likely to "further upend the HemB centric conversation during 2019 and beyond," Chattopadhyay tells investors in a research note. He keeps a Buy rating on shares of uniQure.
12/17/18
GUGG
12/17/18
INITIATION
Target $35
GUGG
Buy
uniQure initiated with a Buy at Guggenheim
Guggenheim analyst Whitney Ijem started uniQure with a Buy rating and $35 price target. The analyst is "impressed" with the company's recent execution on AMT-061 and thinks initial data bodes well from a factor perspective. She expects additional updates in 2019 will show increases in mean factor level that approach/reach normal levels.
12/31/18
RILY
12/31/18
INITIATION
Target $72
RILY
Buy
uniQure resumed with a Buy at B. Riley FBR
B. Riley FBR analyst George Zavoico resumed coverage of uniQure and kept his firm's Buy rating and $72 price target on the shares.

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FOE

Ferro

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FFIN

First Financial

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CUTR

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