Janney: Buy The Dip In Uniqure

Uniqure NV QURE shares slid 22 percent in two weeks with no fundamental changes, prompting a Janney analyst to recommend buying the dip. 

The Analyst

Janney analyst Yun Zhong reiterated a Buy rating on the shares of Uniqure and increased the fair value estimate from $25 to $30.

The Thesis

Uniqure's AMT-061 could become the first FDA-approved gene therapy for hemophilia B, Zhong said in a Tuesday note. The deduction is based on the consistent FIX activity levels observed in a Phase 1/2 study; a strong AAV5 safety profile; and what Padua has demonstrated in SPK-9001's clinical study, the analyst said.

Dose confirmation and pivotal Phase 3 studies will begin simultaneously, according to Janney. Among the hemophilia B treatment candidates, AMT-061 maintains the lead position, Zhong said. 

The company's Huntington disease treatment candidate AMT-130 is likely to enter clinical trials by the end of this year or in the first quarter of 2019, the analyst said. The recent data from Ionis Pharmaceuticals Inc IONS's HTTx program is strong evidence supporting the targeting of mRNA of huntington protein for the treatment of HD, Zhong said. 

Janney is adding Uniqure's HD treatment candidate into its valuation of Uniqure, the analyst said.  

Uniqure has a strong balance sheet, with total cash of $159.4 million, he said. 

Janney sees the following as upcoming milestones for Uniqure: 

  • Initiation of dose confirmation study for AMT-061 in the early third quarter of 2018. 
  • Initiation of patient enrollment in a pivotal Phase 3 study for AMT-061 in the early third quarter of 2018. 
  • Top-line data from a dose confirmation study of AMT-061 by the end of 2018. 
  • Initiation of patient treatment in a Phase 3 study of AMT-061 in early 2019. 
  • Completion of the GLP safety and toxicology study of AMT-130 in mid-2018. 
  • IND submission for AMT-130 in HD in the second half of 2018. 
  • Initiation of a Phase 1/2 study of AMT-130 in HD at the end of 2018 or in the first quarter of 2019. 
  • Completion of a preclinical study of AMT-126 in congestive heart failure in the second half of 2018. 

The Price Action

Notwithstanding the recent weakness, Uniqure shares are up about 235 percent over the last year.

Related Links:

The Week Ahead In Biotech: Earnings, PDUFA Dates And More

7 Biotech Stocks With Clinical Trial Outcomes In March

Posted In: Huntington's DiseaseJanneyYun ZhongAnalyst ColorBiotechPrice TargetReiterationAnalyst RatingsGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.