Aurinia Pharmaceuticals's (AUPH) Outperform Rating Reiterated at FBR Following AURA-LV Phase IIb Data
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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."
Shares of Aurinia Pharmaceuticals closed at $4.09 yesterday.
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