Aurinia Pharmaceuticals Initiates Rolling Submission of a New Drug Application to the U.S. Food and Drug Administration for Voclosporin in the Treatment of Lupus Nephritis
Aurinia Pharmaceuticals Inc - Common Shares (AUPH)
Last aurinia pharmaceuticals inc - common shares earnings: 3/5 04:02 pm
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Source: Business Wire
- Company remains on track to complete submission by the end of the second quarter 2020 - VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis (“LN”). The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules by the end of the second quarter of 2020.“Following a positive pre-NDA meeting with the FDA in February, we are pleased to initiate our rolling NDA submission to the Agency, a critical step toward makin
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AUPH
Earnings
- 2/15/24 - Miss
AUPH
Sec Filings
- 4/29/24 - Form 10-K/A
- 3/20/24 - Form SC
- 3/7/24 - Form 4
- AUPH's page on the SEC website