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Monday, June 17, 2019

UniQure considering potential sale

UniQure (NASDAQ:QURE) +6.8% pre-market following a Bloomberg weekend report that the company is exploring options including a potential sale or partnerships.
QURE is drawing interest from pharmaceutical companies looking to expand in gene therapy, according to the report, and a deal would bring access to a pipeline of experimental treatments for hemophilia, Huntington’s disease and other disorders.
QURE developed Glybera, the first gene therapy approved for sale in Europe, though the $1M treatment had disappointing sales and the company said it would not renew its marketing authorization in 2017.
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Abbott launches rapid point-of-care diabetes diagnosis test

Abbott’s (NYSE:ABT) Afinion HbA1c Dx assay is now available for use on the Afinion 2 Analyzer, as well as the Afinion AS100 Analyzer.
The Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the FDA in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.
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FDA grants orphan drug designation to Orgenesis’ insulin therapy

Orgenesis (NASDAQ:ORGS) +6.7% pre-market on news that the Food and Drug Administration granted Orphan Drug designation for its Autologous Insulin Producing cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis.
The technology is exclusively licensed by the company’s wholly-owned Israeli subsidiary from Tel Hashomer Medical Research Infrastructure and Services and is based on the work the company’s Chief Scientific Officer, who also is a researcher at THM.
ORGS says its patented transdifferentiation (or cell reprogramming) process involves the conversion of one adult tissue or cell into another type of cell, with its distinct phenotype and function; the company’s therapy utilizes its transdifferentiation process and its Point of Care liver expansion technology to transform liver cells into AIP cells.
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Bio-Techne nabs accelerated review in U.S. for ExoDx EPI test

The FDA has granted Breakthrough Device Designation to Bio-Techne’s (NASDAQ:TECH) ExoDx Prostate IntelliScore (EPI) test.
Breakthrough Device status provides for more intensive guidance on development and accelerated review of the marketing application.
This designation also marks a milestone in the advancement of the company’s patented technology platform.
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Voyager Therapeutics to restructure Sanofi gene therapy deal

Voyager Therapeutics (NASDAQ:VYGR) -3.4% pre-market on news it is restructuring its gene therapy relationship with Sanofi Genzyme (NASDAQ:SNY).
VYGR says it will gain worldwide rights to the VY-HTT01 Huntington’s disease program and ex-U.S. rights to the VY-FXN01 Friedreich’s ataxia program, while VYGR will transfer the ex-U.S. rights to VY-FXN01 to Neurocrine Biosciences (NASDAQ:NBIX).
Sanofi Genzyme will obtain exclusive option rights to select novel AAV capsids owned or controlled by VYGR for exclusive use for up to two non-central nervous system indications.
To focus its resources on the now wholly-owned Huntington’s disease program, VYGR says it will seek a partner to advance its pre-clinical program for SOD1 amyotrophic lateral sclerosis and will not file an IND application for VY-SOD102 in 2019.
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Teva bull drops price target

Catching up the big decline in the stock, Citi’s Liav Abraham slashes her price target on Teva (NYSE:TEVA) to $13 from $23. While still expecting a global settlement over opioid painkillers, the timing is difficult to predict, she says. At current levels, the stock has priced in liabilities of $5B-$20B.
Also cutting her price target in Mizuho’s Irina Koffler – to $11 from $18. She remains at Neutral on the stock.
The Quant Rating pulls no punches, giving Teva a Very Bearish outlook.
Shares are off a couple of pennies in premarket action.
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Biotechs on watch after Pfizer-Array blockbuster

Biotech targets that could see some interest today per Bloomberg after Pfizer ponied up a 62% premium for Array Bio Pharma include Biohaven (NYSE:BHVN), Seattle Genetics (NASDAQ:SGEN), Arena Pharmaceuticals (NASDAQ:ARNA), Sage Therapeutics (NASDAQ:SAGE), Sarepta Therapeutics (NASDAQ:SRPT), Neurocrine Biosciences (NASDAQ:NBIX), BioMarin (NASDAQ:BMRN), Bluebird Bio (NASDAQ:BLUE) and Blueprint Medicines (NASDAQ:BPMC).
The names in the group with premarket bids already in are showing about a 1% gain.
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