Aurinia Pharmaceuticals (AUPH) Misses Q3 EPS by 7c; Initiates Talks with Japan for Voclosporin Phase 1

November 7, 2016 8:27 AM EST
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Aurinia Pharmaceuticals (NASDAQ: AUPH) reported Q3 EPS of ($0.21), $0.07 worse than the analyst estimate of ($0.14).​

Aurinia plans to initiate a single, Phase 3 clinical trial (AURORA) whose design is consistent with that of the ongoing AURA clinical trial. The totality of data from both trials will serve as the basis for a New Drug Application (NDA) submission following completion of the Phase 3 trial, and the Company is focusing its efforts on finalizing the study protocol and regulatory submissions in parallel with site selection, making the necessary investments now to ensure the team has the tools to execute a successful clinical trial.

“We have made exceptional progress over the last few months announcing the first global clinical trial in LN to meet its primary and all secondary endpoints,” said Charles Rowland, CEO of Aurinia Pharmaceuticals. “Additionally, the recent selection of the AURA Phase 2b results for late-breaking presentations by the American College of Rheumatology (ACR) and American Society of Nephrology (ASN) is a testament to the hard work executed by our world-class clinical team. We look forward to advancing voclosporin into Phase 3 for the treatment of LN and pursuing our goal of helping patients living with this devastating disease.”

For earnings history and earnings-related data on Aurinia Pharmaceuticals (AUPH) click here.

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