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QURE

uniQure

$33.14

-1.07 (-3.13%)

07:18
02/08/19
02/08
07:18
02/08/19
07:18

uniQure announces updated data on Phase 2b AMT-061 trial

uniQure announced updated clinical data in patients treated in the company's ongoing Phase 2b study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant, for the treatment of patients with severe and moderately severe hemophilia B. These data were presented in an oral session at the annual congress of the European Association for Haemophilia and Allied Disorders, or EAHAD, and show that therapeutic levels of Factor IX, or FIX, activity continue to be sustained in all three patients up to sixteen weeks after a single administration of AMT-061. The Phase IIb study of AMT-061 is an open-label, single-dose, single-arm, multi-center trial being conducted in the United States. Three patients with severe hemophilia were enrolled in the study and received a single intravenous infusion of 2x1013 vc/kg. Prior to the administration of AMT-061, all three patients showed low levels of pre-existing antibodies to AAV5 but were not excluded from the trial on that basis. Updated data presented at EAHAD show that all three patients have demonstrated increasing and sustained FIX levels after the one-time administration of AMT-061. Mean FIX activity for the three patients at twelve weeks increased to 38% of normal, exceeding threshold FIX levels generally considered sufficient to eliminate or significantly reduce the risk of bleeding events. The first patient achieved FIX activity of 48% of normal at sixteen weeks after administration. FIX activity in the second patient was 25% of normal at fourteen weeks after administration, and the third patient achieved FIX activity of 51% of normal at twelve weeks after administration. The second and third patients had previously screen-failed and were excluded from another gene therapy study due to pre-existing neutralizing antibodies to a different AAV vector. Reported FIX activity was measured using an activated partial thromboplastin time, or aPTT, assay performed at a central laboratory. No patient in the study has experienced a material loss of FIX activity, reported any bleeding events or required any infusions of FIX replacement therapy. As previously reported, one patient experienced slight elevations in aspartate aminotransferase, or AST, which quickly resolved without any additional treatment or loss of FIX activity. No patient has experienced any material elevation in alanine aminotransferase, or ALT, after the administration of AMT-061.

QURE uniQure
$33.14

-1.07 (-3.13%)

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.
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.
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.
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.

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