auph fda approval

Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. Aurinia Pharmaceuticals (NASDAQ: AUPH) Receive FDA Approval For LUPKYNIS. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. Aurinia Pharmaceuticals Inc Agreement for Dedicated LUPKYNIS Manufacturing Capacity. ET. The conference call and webcast is scheduled for February 24, 2021 at 4:30pm ET. Aurinia Pharmaceuticals to Present at Three Upcoming March Investor Conferences, https://www.businesswire.com/news/home/20210302005227/en/, Aurinia Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Operational Highlights, https://www.businesswire.com/news/home/20210224006021/en/, Aurinia Pharmaceuticals to Present at the SVB Leerink 10th Annual Global Healthcare Conference, https://www.businesswire.com/news/home/20210218005041/en/, Aurinia Pharmaceuticals to Release Fourth Quarter and Year End 2020 Financial Results on February 24, 2021, https://www.businesswire.com/news/home/20210217005243/en/, FDA Approves Aurinia Pharmaceuticals' LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis, https://www.businesswire.com/news/home/20210122005501/en/, View All CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. Share Price Thoughts. Amounts, unless specified otherwise, are expressed in U.S. dollars. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. Such risks, uncertainties and other factors include, among others, the following: difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. "The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.". If a deal somehow arises after the FDA approval to help with commercialization, then there would be BIG $$$ made. Such risks, uncertainties and other factors include, among others, the following difficulties we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; the results from our clinical studies and from third party studies and reports may not be accurate; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Aurinia will host a conference call and webcast to discuss the fourth quarter and year ended December 31, 2020 financial results today, Wednesday, February 24, 2020 at 4:30 p.m. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “ Aurinia Pharmaceuticals Receives FDA Approval for LUPKYNIS”. "Over the past year, Aurinia matured into a fully-integrated biopharmaceutical company with capabilities spanning R&D, clinical, regulatory, CMC, and commercial. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. ET. Aurinia will receive tiered royalties on future sales ranging from 10 to 20 percent on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active LN. Are you selling or holding for a potential buyout? Severe renal impairment: Reduce LUPKYNIS dose. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally. News, H.C. Wainwright Global Life Sciences Conference fireside chat available on Tuesday, March 9, 2021 at 7:00 a.m. This suggests that it stock is undervalued to its peers and could gain traction from the potential FDA approval and positive data from its clinical studies. It was $21 last year after phase 3 results. ET; and. I am considering taking my profits this week and moving into others positions. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally. The CEO said he is open to selling the company. Patients in the study taking LUPKYNIS also achieved a 50 percent reduction in UPCR twice as fast as SoC, and a higher portion of LUPKYNIS-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. Financial Results for the Year Ended December 31, 2020. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; the accuracy of reported data from third party studies and reports; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties. LUPKYNIS is the first FDA-approved oral therapy for LN. R&D expenses decreased to $13.2 million for the three months ended December 31, 2020 compared to $13.3 million for the three months ended December 31, 2019. January 22, 2021 - 8:24 pm. To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com. Development to be suspended. Use of LUPKYNIS is not recommended in this situation. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Clinical Trial Overview of LUPKYNIS (voclosporin). “The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.” What’s the play here? All forward-looking information contained in this presentation is qualified by this cautionary statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005227/en/, - LUPKYNISTM is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -, - Cash, cash equivalents, and investments of $423 million at December 31, 2020 –, - Conference call to be hosted today at 4:30 p.m. Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. FDA Approved: Yes (First approved January 22, 2021) Brand name: Lupkynis Generic name: voclosporin Dosage form: Capsules Company: Aurinia Pharmaceuticals Inc. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. Multimedia components are available with this press release (link here). If approved, voclosporin is expected to generate between $770 million and $1 billion as a treatment for lupus nephritis. MT - price target is 61 feb extension level. If we are lucky it will be $30. ", "As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS," said Kathleen A. Arntsen President and CEO of Lupus and Allied Diseases Association. An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. Even so, Aurinia's market cap is only $1.7 billion at present. To assist LUPKYNIS patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance™, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient's LUPKYNIS treatment journey. "We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much-needed oral treatment option to address the challenges faced by people living with LN. I think this thing is definitely undervalued. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). "The LUPKYNIS approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia's assumptions relating to the capital required to fund operations into 2023; the assumption that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; that Aurinia's third party service providers will comply with their contractual obligations. It marks the first FDA-approved oral therapy for LN, which causes irreversible kidney damage and raises the risk of kidney failure, cardiac issues, and death. Also, many of the factors are beyond Aurinia's control. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, View source version on businesswire.com: https://www.businesswire.com/news/home/20210122005501/en/, Website design & development Fully agree with you. Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes. ... AUPH - FDA Approved! A…. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada). Spike from FDA approval. Severe hepatic impairment: Avoid LUPKYNIS use. Research and development (R&D) expenses decreased to $50.3 million for the year ended December 31, 2020 compared to $52.9 million for the year ended December 31, 2019. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. The primary driver for the increase of $31.5 million in 2020 was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits, share based compensation expense and professional fees incurred during the quarter. The approval of LUPKYNIS is based on data from Aurinia's pioneering late-stage global clinical studies in LN – the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study. AUPH received much-anticipated FDA approval for its drug with the commercial name Lupkynis for the treatment of lupus nephritis, which is an "unpenetrated therapeutic area." LUPKYNIS is the first FDA-approved oral therapy for LN. LUPKYNIS is the first FDA-approved … 1. Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd. On December 17, 2020, Aurinia announced it had entered into a collaboration and licensing agreement with Otsuka Pharmaceutical Co., Ltd., for the development and commercialization of oral LUPKYNIS for the treatment of LN in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. The site may not work properly if you don't, If you do not update your browser, we suggest you visit, Press J to jump to the feed. If the FDA turns down approval for VOC, they better be ready to deal with the Lupus community. The approval … "There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. After just 30 days, we are pleased by the uptake of LUPKYNIS by the healthcare community and believe we are on track to meet our internal expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005243/en/, - LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -, - LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials, - LUPKYNIS is now commercially available in the U.S. -, - Multimedia components are available with this press release (link here) -, - Conference call to be hosted Monday, January 25, 2021, 8:30 a.m. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals. The stock price should be $25-$28 realistically tomorrow morning. The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act … FDA product label is essentially in line with our expectations, including the approval for active LN and potential extended exclusivity. Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. Don't hesitate to tell us about a ticker we should know about, but read the sidebar rules before you post. We use cookies on our websites for a number of purposes, including analytics and performance, functionality and advertising. LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Aurinia's cash and equivalents totaled $421 million as of September 30, 2020, which is expected to be sufficient to fund operations through 2022. These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil (MMF), and low dose steroids. The FDA has approved Aurinia Pharmaceuticals Inc.'s LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.LUPKYNIS, generically known as voclosporin, becomes the second FDA-approved therapy for lupus nephritis, with the first being GlaxoSmithKline plc's (GSK) BENLYSTA, which was approved as recently as last month. Aurinia Pharmaceuticals (NASDAQ:AUPH) is marching toward a January decision date with the FDA for its lupus nephritis drug candidate voclosporin. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of LUPKYNIS, while expanding existing capacity and providing supply security to meet future commercial demand. Feel like I shoulda sold at open. ", "Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. Check out our wiki and Discord! LOL. It will blow a hole thru the roof next week. Aurinia (AUPH) gets approval from the FDA for Lupkynis as a treatment for active lupus nephritis, a disease that causes irreversible kidney damage. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Aurinia Pharmaceuticals Inc. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia's belief that it is on track to meet its internal expectations for the prescribing of LUPKYNIS; Aurinia will receive certain payments (including royalties and milestones) from its agreement with Otsuka; that operational qualification of the monoplant facility is expected in 2023; Aurinia's belief that it has sufficient financial resources to fund its current plans until 2023. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Condensed Consolidated Balance Sheets ET. Everyone still holding? Looks like you're using new Reddit on an old browser. According to this post people are waiting until even $30. "During 2020, we made calculated investments following the positive AURORA clinical trial results by building out a world-class commercial team, signing a major ex-US partnership with Otsuka, and ensuring we can meet future market demand for LUPKYNIS by securing our supply chain by expanding our manufacturing agreement with Lonza. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. ", "Launching LUPKYNIS within hours of our approval allows us to focus on getting LN patients who need intervention onto therapy as soon as possible," said Max Colao, Chief Commercial Officer at Aurinia. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition," said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. All patients were dosed with concurrent MMF at a target dose 2 g/day. For the year ended December 31, 2020, Aurinia recorded a consolidated net loss of $102.7 million or $0.87 per common share. Net cash used in operating activities was $69.9 million for the year ended December 31, 2020 compared to $63.6 million for the year ended December 31, 2019. The study results were achieved using a protocol-defined steroid taper. Accordingly, you should not place undue reliance on forward-looking statements or information. Revenues were $50 million and $0.03 million for the three months ended December 31, 2020 and 2019, respectively. Wait for buyout? (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). A replay of the webcast will be available on Aurinia's website. Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. Lupkynis FDA Approval History. Voclosporin approval by the FDA is almost assured thanks to the very good phase III trial data presented last December 2019. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. Upon completion of the monoplant, Aurinia will have the right to maintain exclusive use of the monoplant by paying a quarterly fixed facility fee. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). I'm sorta ready to move on which is why I'm leaning towards selling. The conference call and webcast is scheduled for February 24, 2021 at 4:30pm ET. The primary driver for the increase of $73.6 million was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits, share based compensation expense and professional fees incurred during the year. As of December 31, 2020, Aurinia had cash, cash equivalents and investments of $423 million compared to $306 million at December 31, 2019. Someone DID sell 660k shares today alone. In the Phase 3 study, at one year, LUPKYNIS plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Pricing was not disclosed. I present to you Lupkynis. Phase 2/3 trial did not meet primary endpoint - November 2, 2020.

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