FDA Approval for LUPKYNIS

1/25/21 11:31:10 AM ET

$AUPH

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 213716
Company: AURINIA PHARMACEUTICALS, INC.

Products on NDA 213716

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUPKYNIS	VOCLOSPORIN	7.9MG	CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213716Orig1s000ltr.pdf

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Recent Analyst Ratings for
$AUPH

Date	Price Target	Rating	Analyst
11/4/2022		Outperform → Perform	Oppenheimer
5/5/2022	$34.00 → $25.00	Overweight	Cantor Fitzgerald
3/8/2022	$30.00 → $22.00	Outperform	SVB Leerink
3/1/2022	$31.00 → $27.00	Outperform	RBC Capital
2/23/2022	$34.00 → $31.00	Outperform	RBC Capital
12/10/2021	$33.00 → $31.00	Perform → Outperform	Oppenheimer
11/4/2021	$32.00 → $33.00	Perform	Oppenheimer
11/4/2021	$35.00 → $40.00	Buy	HC Wainwright & Co.

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$AUPH
Financials

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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) today announced financial results for the three months ended March 31, 2025. First Quarter 2025 Financial Results Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024. Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024. License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty
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Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company) today announced that it will release first quarter 2025 financial and operational results before markets open on May 12, 2025. Aurinia's management team will host a conference call and webcast at 8:30 AM ET that day to review these results and provide a general business update. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170 / +1 201-493-6756. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia Pharmaceuticals is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medi
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Aurinia Pharmaceuticals Reports Financial Results for the Three and Twelve Months Ended December 31, 2024 and Provides Update on Recent Corporate Progress
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) today announced financial results for the three and twelve months ended December 31, 2024 and provided an update on recent corporate progress. Fourth Quarter 2024 Financial Results Total Revenue: For the three months ended December 31, 2024, total revenue was $59.9 million, up 33% from $45.1 million in the same period of 2023. – Net Product Sales: For the three months ended December 31, 2024, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $57.6 million, up 36% from $42.3 million in the same period of 2023. – License, Collaboration and Royalty Revenue
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Biotechnology: Pharmaceutical Preparations
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$AUPH
Press Releases

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New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis
LUPKYNIS Data Presented at LUPUS 2025, the 16th International Congress on SLE, May 21-24 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS® (voclosporin), mycophenolate mofetil (MMF), and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. The analysis assessed the achievement of urine protein creatine ratio (UPCR) targets of ≤0.4 g/g, ≤
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$AUPH
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Biotechnology: Pharmaceutical Preparations
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$AUPH
Biotechnology: Pharmaceutical Preparations
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FDA Approval for LUPKYNIS

Products on NDA 213716

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213716

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $AUPH

$AUPH FDA approvals

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FDA Approval for LUPKYNIS

$AUPH Financials

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Aurinia Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025

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$AUPH Insider Trading

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$AUPH Analyst Ratings

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$AUPH Press Releases

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New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis

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