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Thursday’s Biotech Insights: Aurinia Pharmaceuticals Inc (AUPH), Puma Biotechnology Inc (PBYI)


Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) shares skyrocketed over 65% this morning, after the drug maker announced top-line results from its AURA-LV Phase IIb study with voclosporin (VCS) in patients with lupus nephritis (LN) that showed at 48 weeks, the study met its complete remission (CR) and partial remission (PR) endpoints.

FBR analyst Vernon T. Bernardino commented, “We are impressed with the results, as CRs and PRs at 48 weeks exceeded CRs and PRs at 24 weeks, with one exception. As a reminder, each study arm included standard of care mycophenolate mofetil (MMF) as background therapy and a forced steroid taper. There were no unexpected safety signals or deaths observed in VCS-treated patients. Thus, in addition to strong efficacy, VCS appears to allow safe steroid sparing. We think the results are robust and bode well for a successful Phase III trial, which could make VCS the first approved therapy for LN.”

As of this writing, the 4 analysts polled by TipRanks (in the past 6 months) rate Aurinia stock a Buy. With a return potential of 39%, the stock’s consensus target price stands at $8.50.

Puma Biotechnology Inc (NASDAQ:PBYI) shares lost one-quarter of their value today, after competitor Roche announced positive top-line results from the highly anticipated APHINITY trial, which explores usefulness of Perjeta in adjuvant breast cancer. Recall, Puma has US/EU regulatory applications under review for neratinib in the extended adjuvant setting based on positive Phase 3 ExteNET data.

J.P Morgan Cory Kasimov commented, “Today’s PR is expectedly light on details, so we’ll have to wait for ASCO to get the full picture. In our view, the future of neratinib in this indication largely rests on the nuances of the data, namely: 1) the magnitude of benefit, 2) the subgroups that drive this benefit (HR+ and/or HR-), and 3) details of the safety profile. The ultimate impact on Puma remains to be seen, but this outcome has obviously taken the near-term best-case scenario off the table. Our prevailing expectation was that on positive APHINITY results, PBYI shares could initially lose roughly 1/3 of their value. That said, investor feedback we’ve been getting has suggested that this potential dip could provide an opportunity ahead of the ASCO details as well as a number of pending neratinib data points in 1H17.”

Out of the 8 analysts polled by TipRanks (in the past 12 months), 6 rate Puma Biotechnology stock a Buy, while 2 rate the stock a Hold. With a return  potential of 180%, the stock’s consensus target price stands at $79.

 

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