Aurinia Pharmaceuticals's (AUPH) Outperform Rating Reiterated at FBR Following AURA-LV Phase IIb Data

August 15, 2016 10:58 AM EDT
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Price: $2.81 -1.4%

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    2 Buy, 0 Hold, 0 Sell

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    Up: 21 | Down: 36 | New: 11
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FBR Capital reiterated an Outperform rating on Aurinia Pharmaceuticals (NASDAQ: AUPH). Shares declined after the company announced results from the AURA-LV Phase IIb clinical study with voclosporin in lupus nephritis (LN) patients. Analyst Vernon T. Bernardino sees top line results as a positive.

"We think the consensus view had settled on the potential to file for voclosporin’s approval with the AURA-LV results, as the study design had elements of registration quality, and thus, approval by 2018. We view the top-line as positive, i.e., the trial achieved its primary endpoint (1EP) of demonstrating statistically significantly greater complete remission (CR), as defined by confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg at 24 weeks and confirmed at 26 week (p=0.045)," said the analsyt.

Bernardino added, "However, we had always projected approval in 2020 after a Phase III trial was completed, as AURA-LV was the first large clinical trial conducted with voclosporin outside of Asia, and thus, not completely satisfy the FDA’s requirements for registration. We think a result being overlooked is that tapering steroids use (part of current standard of care) looks possible with voclosporin, which is a clinically meaningful benefit treating physicians have been looking for in the long-term treatment of LN."

For an analyst ratings summary and ratings history on Aurinia Pharmaceuticals click here. For more ratings news on Aurinia Pharmaceuticals click here.

Shares of Aurinia Pharmaceuticals closed at $4.09 yesterday.



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