Whalatane
1 week ago
Well he got this deal done
Aurinia and Otsuka entered a collaboration and licensing agreement in December 2020 for the development and commercialization of oral voclosporin in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.
As part of the agreement, Aurinia is eligible to receive a payment of $10 million U.S. dollars upon approval in Japan along with low double-digit royalties on net sales once launched.
Lupkynis just approved in Japan IIRC.
Lupy is an expensive drug with significant prior approval hurdles to overcome .
Suggest you watch the Oct 2 presentation by VERA where they are expected to announce if they will proceed with their BAFF/APRIL candidate into P 3 .
If they proceed with their P 3 , I suggest you celebrate if Tang is able to get you $12 a share on a buy out ...as I'm certain he will be celebrating
Kiwi
Whalatane
1 week ago
Pete's works for Tang now . Tang is on the BOD and
On September 6, 2024, TANG CAPITAL MANAGEMENT LLC (Trades, Portfolio) made a notable addition to its investment portfolio by acquiring 4,450,000 shares of Aurinia Pharmaceuticals Inc (NASDAQ:AUPH), a biopharmaceutical company based in Canada.Sep 12, 2024
Tang is going to do a deal ...probably within a year ...and probably at less then the all time high in PPS .
Pete is just there to facilitate the deal ,Tang will force ( persuade ) on the BOD
JMO
Kiwi
anbdpm
1 week ago
Otsuka Receives Approval in Japan for Lupkynis® as a Treatment for Lupus Nephritis
RSS
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Lupkynis® (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus, an autoimmune disease.
Lupkynis is a novel, oral immunosuppressive agent developed for the treatment of LN. It suppresses the immune system by inhibiting calcineurin, an enzyme that is crucial for the proliferation and activation of T cells, an important element of the immune system.
In the U.S., Aurinia Pharmaceuticals Inc. (Aurinia) received FDA marketing approval in January 2021 for Lupkynis as a treatment for active LN in adults. In September 2022 Otsuka received European Commission (EC) approval for Lupkynis as the treatment for active LN in EU member countries. Otsuka has subsequently received reimbursement in several EU countries as well as in the UK.
In December 2020, Otsuka and Aurinia announced that they entered into a collaboration and license agreement for the development and commercialization of oral voclosporin for the treatment of LN in Japan, the European Union (EU), and the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
Otsuka Pharmaceutical has been committed to research and development that contributes to patients and their families in order to meet unmet medical needs worldwide, focusing on cardiovascular, renal and autoimmune diseases as one of which are among our priority areas.
About lupus nephritis
Lupus nephritis (LN) is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE). The kidneys are vital organs, and LN is an irreversible and progressive condition that puts them at risk for long-term complications. If left untreated, this kidney inflammation impairs kidney function and can lead to permanent kidney damage and even kidney failure, known as end-stage renal disease (ESRD). LN is one of the most serious complications of SLE.
In Japan, the number of SLE patients is estimated to be between 60,000 and 100,000, with women accounting for 90% of cases. It is particularly prevalent among women aged 20 to 40.1 Asians have a higher incidence of renal involvement compared to Caucasians, with 21% to 65% of Asian patients (living in Asia) with SLE having developed LN by the time of diagnosis, and 40% to 82% developing it over time.2 The development of LN in SLE patients often occurs at a relatively young age and is believed to increase the risk of end-stage renal failure, leading to a deterioration in life expectancy. The challenge is to achieve rapid remission of glomerulonephritis with reduction in proteinuria, while avoiding long-term use of high doses of steroid medication.
About the clinical trials AURORA 1 and AURORA 23, 4
The MHLW approval is based on data from clinical trials, including AURORA 1 and AURORA 2.
The AURORA 1 international phase 3 trial was conducted with the primary endpoint of renal response at 52 weeks. A total of 357 patients with active LN from age 18 to 75 were enrolled in the trial, of whom 179 patients and 178 patients were randomly assigned to the voclosporin and placebo groups, respectively.
Both the voclosporin group and the placebo group were co-administered with mycophenolic mofetil and oral steroids during the trial, with a regimen to reduce the dose of steroids. The proportion of patients achieving renal response at 52 weeks was significantly higher in the voclosporin group at 40.8% compared to 22.5% in the placebo group (p
Whalatane
2 weeks ago
Z. as U know ...Lupkynis targets T cells . AUPH has begun their own BAFF / APRIL program for treating LN ...just several years behind VERA
Inhibiting both BAFF and APRIL is thought to be ( based on the past several yrs of research ) , a more effective way of inhibiting B cell production which is a key factor in developing Lupus Nephritis
Inhibiting B cells and T cells are both important therapeutic approaches in lupus nephritis (LN), but they target different aspects of the disease pathogenesis:
Inhibiting B Cells
B cells play a central role in LN pathogenesis through several mechanisms:
Production of autoantibodies, especially anti-dsDNA antibodies that can deposit in the kidneys and cause damage.
Acting as antigen-presenting cells to activate autoreactive T cells.
Secretion of pro-inflammatory cytokines.
Key approaches to inhibiting B cells include:
B cell depletion therapies like rituximab (anti-CD20 antibody).
Inhibition of B cell survival factors like belimumab (anti-BAFF antibody).
Targeting B cell signaling pathways.
Benefits of B cell inhibition:
Reduces autoantibody production and immune complex formation.
Decreases B cell-mediated T cell activation.
Can lead to long-lasting remission in some patients.
Inhibiting T Cells
T cells, especially CD4+ T helper cells, contribute to LN pathogenesis by:
Providing help to autoreactive B cells.
Producing pro-inflammatory cytokines like IL-17.
Infiltrating the kidneys and causing local inflammation.
Approaches to inhibiting T cells include:
Calcineurin inhibitors like tacrolimus.
Costimulation blockade (e.g., abatacept).
Targeting specific T cell subsets like Th17 cells.
Benefits of T cell inhibition:
Reduces T cell-dependent B cell activation and antibody production.
Decreases inflammatory cytokine production.
Can be effective in cases resistant to B cell-targeted therapies.
Comparison
B cell inhibition tends to have a more direct effect on autoantibody production, while T cell inhibition affects broader immune activation.
B cell-targeted therapies like rituximab and belimumab have shown efficacy in clinical trials for LN, while T cell-targeted approaches are still being investigated.
Some newer approaches aim to target both B and T cells simultaneously, recognizing the complex interplay between these cell types in LN pathogenesis.
In conclusion, both B cell and T cell inhibition strategies have shown promise in treating LN. The choice between them often depends on the specific disease characteristics and patient factors. Combination approaches targeting both cell types may offer synergistic benefits in some cases.
How do B cells contribute more significantly to lupus nephritis compared to T cells
B cells appear to contribute more significantly to lupus nephritis compared to T cells in several key ways:
Production of pathogenic autoantibodies: B cells are the precursors to plasma cells, which produce autoantibodies that are central to lupus nephritis pathogenesis. Anti-dsDNA antibodies in particular can deposit in the kidneys and cause direct tissue damage.
Formation of immune complexes: The autoantibodies produced by B cells form immune complexes that deposit in the kidneys, triggering inflammation and tissue injury.
Cytokine production: B cells produce pro-inflammatory cytokines that contribute to the inflammatory environment in lupus nephritis.
Antigen presentation: B cells can act as antigen-presenting cells to activate autoreactive T cells, perpetuating the autoimmune response.
Infiltration of kidneys: Studies have shown increased infiltration of B cells and plasma cells in the kidneys of lupus nephritis patients and mouse models.
Correlation with disease activity: The number of circulating plasma cells correlates with lupus disease activity and anti-dsDNA antibody levels.
While T cells also play important roles in lupus nephritis, their contributions appear to be more supportive:
Providing help to B cells for autoantibody production.
Producing inflammatory cytokines.
Infiltrating the kidneys to cause local inflammation.
However, the direct tissue damage and formation of immune complexes mediated by B cell-produced autoantibodies seem to be more central to the pathogenesis of lupus nephritis. This is supported by the efficacy of B cell-targeted therapies like rituximab in treating lupus nephritis.
In summary, while both B and T cells contribute to lupus nephritis, the ability of B cells to produce pathogenic autoantibodies and form immune complexes that directly damage the kidneys appears to make their role more significant in the disease process.
Role in pathogenesis:
BAFF and APRIL levels are elevated in patients with systemic lupus erythematosus (SLE) and LN.
They contribute to B cell hyperactivity and autoantibody production, which are central to LN pathogenesis.
Overexpression of BAFF in mice can induce lupus-like symptoms, including glomerulonephritis.
Therapeutic targets:
Inhibiting BAFF and/or APRIL has become a promising treatment strategy for LN.
Several drugs targeting these cytokines have been developed and tested in clinical trials.
Specific treatments:
Belimumab: A BAFF inhibitor approved for treating SLE, including patients with LN.
Atacicept: A dual BAFF/APRIL inhibitor that has shown potential in clinical trials for SLE and LN.
Telitacicept: Another dual BAFF/APRIL inhibitor being investigated for various autoimmune diseases, including LN.
Advantages of targeting BAFF/APRIL:
More specific than traditional immunosuppressants, potentially offering better efficacy and safety profiles.
Addresses the underlying B cell-driven pathogenesis of LN.
Biomarkers:
Serum levels of BAFF and APRIL may serve as biomarkers for disease activity and treatment response in LN.
Ongoing research:
Studies are exploring the optimal use of BAFF/APRIL inhibitors, including combination therapies and identifying patient subgroups most likely to benefit.
In summary, BAFF and APRIL inhibition represents a targeted approach to treating LN by addressing the B cell-mediated aspects of the disease. While some treatments like belimumab are already approved, research continues to optimize the use of these therapies and develop new agents targeting this pathway.
So we should know Oct 2nd if VERA is willing to spend the millions required to advance their LN BAFF / APRIL into a P 3 trial .........so no worries till then
Kiwi
Whalatane
3 weeks ago
Tang and AUPH
Based on the search results, here are the key details about Tang Capital Management's purchases of Aurinia Pharmaceuticals (AUPH) stock:
Recent Acquisition
Tang Capital Management made a significant acquisition of AUPH shares in September 2024:
Acquired approximately 7,229,500 shares
This represents about 5.1% ownership of AUPH
The shares were acquired for approximately $44.5 million
Previous Holdings
Prior to this large acquisition, Tang Capital had smaller positions in AUPH:
As of December 31, 2023: 550,000 shares worth $4.9 million
As of September 30, 2023: 750,000 shares worth $5.8 million
Impact
This recent purchase represents a major increase in Tang Capital's stake in Aurinia Pharmaceuticals:
It's described as a "significant acquisition" that "significantly bolsters" Tang Capital's position in AUPH
The 7.2 million share purchase is over 10 times larger than their previous position
Filing Details
Tang Capital filed a Schedule 13D form to disclose this large acquisition
The 13D was filed on September 12, 2024
This type of filing indicates Tang Capital may intend to actively influence the company's business strategy
This substantial increase in ownership suggests Tang Capital sees significant potential in Aurinia Pharmaceuticals and may seek to play a more active role in the company's direction going forward.
Kiwi
Whalatane
3 weeks ago
The Board has appointed Kevin Tang, President of Tang Capital Management, LLC, a life sciences-focused investment company that he founded in 2002, as a Director. Mr. Tang has more than 20 years of experience investing in, governing and leading companies in the biopharmaceutical industry.
As noted earlier ...Tang's investment in AUPH appears to be very recent . For him to actually want to spend time on this BOD indicates a semi activist role . He's calling the shots and the current Ceo is just the administrator and keeping him in place makes it easier to facilitate a sale ...which is what Tang wants
No position
Good luck
Kiwi
nsomniyak
3 weeks ago
There is a pretty active discussion of AUPH on StockTwits.
I am inclined to agree with some of the posters there who think we will soon see Tang lead a "private equity take under" at a relatively low price. THis seems to have been his MO in the past.
If that happens I will be disappointed to get a far lower price than we had hoped for over the last several years, but I will also feel relief to get some closure and move on.
The fact that they released OUTSIDE directors suggests they are not overly concerned about corporate governance issues over the long term, which further suggests a resolution in the (relative) short term.
Why PG stays on the board I don't know. If there are negotiations in flight, I can see the board saying "we need to keep PG as CEO and point person in those negotiations", but he doesn't need to be on the board for that. Now that I think of it, I imagine PG told the rest of the board "if you accept my resignation I will walk away and you will need to start over on making a deal" (out of vanity and to keep "was voted off the BoD off of his resume) and the board caved.
Certainly, the fact that PG was retained suggests a deal in the near term is the most likely end game, though probably not at the premium we would have liked.
Whalatane
1 month ago
RMB. Theres a new video out on Healio / Nephrology that prescribers in the field are probably aware of .
I can't seem to link it but maybe you can
Explains the decision tree and how they ended up using Lupkynis with good results
In this video, Craig Gordon, MD, nephrologist at Tufts Medical Center and associate professor of medicine at Tufts University School of Medicine, introduces a case of lupus nephritis:
Editor’s note: The following is an automatically generated transcript of the above video.
"I want to introduce myself. My name is Dr. Craig Gordon. I'm an associate professor of medicine at Tufts University School of Medicine and I work in the Tufts Medical Center Center for Glomerular Diseases. And today, we're going to be discussing the case of a young woman with lupus nephritis and to consider questions that all of us are grappling with since the fairly recent publications of randomized control trials of belimumab (Benlysta, GlaxoSmithKline), as well as voclosporin (Lupkynis, Aurinia), as well as the recently published 2024 update to the KDIGO guidelines on lupus nephritis.
I think a lot of treating clinicians are trying to come to grips with which patients would benefit from the addition of either belimumab or voclosporin to standard induction therapy for lupus. And so, I'm going to use a case to help us start the process of thinking about this when faced with seeing a patient with lupus nephritis and to highlight your attention to some very helpful guidance that's been provided by the KDIGO guidelines on lupus nephritis published earlier this year."
And then he finish's with
"Pleased to report that almost six months into this course, she's had a very nice response. Her proteinuria has improved from a peak of around 12.6 grams to recently, a few weeks ago, down to 1.9 grams, with a concomitant improvement in her serum albumin to 3.8 grams per deciliter. Her eGFR has been stable, the most recent value of 89 MLs per minute. Her complement values have returned to normal and double-stranded DNA have normalized as well. So she continues at the present time on full-dose mycophenolate and voclosporin (Lupkynis, Aurinia). We've nearly completely tapered her off prednisone and expect to do so in the next few weeks.
This is great for prescribers ...experts in the field reporting experience with the drug .
Patients definitely want to get off the steroids ( prednisone )
Kiwi
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