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Aurinia's truncated late-stage development plan for voclosporin propels shares 6% premarket

Published 04/07/2017, 09:03 AM
Updated 04/07/2017, 09:03 AM
© Reuters.  Aurinia's truncated late-stage development plan for voclosporin propels shares 6% premarket
  • Aurinia Pharmaceuticals (NASDAQ:AUPH) is up 6% premarket on robust volume in response to its announcement that it plans to conduct only one Phase 3 clinical trial (instead of the usual two identical studies) to support marketing applications in the U.S., EU and Japan seeking approval of voclosporin to treat lupus nephritis.
  • Based on discussions with regulators, the company believes that data from the Phase 3 study, called AURORA, and the recently completed Phase 2b study, AURA-LV, should be sufficient to support the filings in all three jurisdictions.
  • AURORA is a 52-week double-blind study that will compare voclosporin to mycophenolate mofetil (Roche's CellCept) and placebo.
  • Previously: Aurinia's voclosporin meets 48-week endpoints in mid-stage LN study; shares up 43% after hours (March 1)


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