Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) with the stream of -2.17% in the last hour of trading session. FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS (voclosporin) for Adult Patients with Active Lupus Nephritis
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).
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. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.
“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 are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. “The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS.”
“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic,” said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “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.”
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.
“People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant,” said Stevan W. Gibson, President and CEO, Lupus Foundation of America. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.”
“Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. Once patients progress to LN, they face inevitable life-altering effects,” said Kenneth M. Farber, President and CEO, Lupus Research Alliance. “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.”
“New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases,” commented National Kidney Foundation’s Chief Medical Officer Joseph Vassalotti, M.D. “Interventions that are effective to manage and potentially prevent irreversible kidney damage are exciting for people living with lupus nephritis and their clinicians in nephrology and rheumatology.”
Aurinia Pharmaceuticals Inc. (AUPH) shares fell -2.17% to close at $14.86. About 7,997,313 million shares traded hands on 2.23M trades for the day, compared with an average daily volume of 2.23M shares out of a total float of 111.12M. After opening the trading day at $15.22, shares of Aurinia Pharmaceuticals Inc. stayed within a range of $14.61 to $15.89.
With today’s loss, Aurinia Pharmaceuticals Inc. now has a market cap of $1.88B. Shares of Aurinia Pharmaceuticals Inc. have been trading within a range of $9.83 and $20.48 over the last year, and it had a 50-day SMA of $6.02% and a 200-day SMA of $-0.58%.
Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company, develops and commercializes therapies to treat various diseases in the United States and China. It is involved in developing voclosporin, an investigational drug for the treatment of lupus nephritis, dry eye syndrome, and focal segmental glomerulosclerosis. The company is headquartered in Victoria, Canada.
The PEG ratio is used to determine a stock’s value while taking the company’s earnings growth into account, and is considered to provide a more complete picture than the P/E ratio. Last traded has a PEG ratio of 0 where as its P/E ratio was 0. The overall volume in the last trading session was 7,997,313 shares.
Aurinia Pharmaceuticals Inc. has P/S value of 16035.08 while its P/B esteem remains at 4.71. Likewise, the company has Return on Assets of 0, Return on Equity of 0 and Return on Investment of 0. The company demonstrates Gross Margin and Operating Margin of 0 and 0 respectively.
AUPH’s price to sales ratio for trailing twelve months was 16035.08 and price to book ratio for most recent quarter was 4.71, whereas price to cash per share for the most recent quarter was 0. The Company’s price to free cash flow for trailing twelve months was recorded as 0.
Historical Performances to Consider:
The Stock’s performances for Monthly, weekly, half-yearly, quarterly & year-to-date are mentioned below:-
On a Monthly basis the stock was 10.07%. On a weekly basis, the stock remained 2.77%. The half-yearly performance for the stock has 6.52%, while the quarterly performance was -1.07%. Looking further out we can see that the stock has moved 7.45% over the year to date. Other technical indicators are worth considering in assessing the prospects for EQT. RSI for instance was stand at 56.84.