Uniqure NV QURE shares slid 22 percent in two weeks with no fundamental changes, prompting a Janney analyst to recommend buying the dip.
Janney analyst Yun Zhong reiterated a Buy rating on the shares of Uniqure and increased the fair value estimate from $25 to $30.
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.
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