Diskussion und Einschätzungen zu Aurinia Pharmaceuticals (Seite 44)

[holgi-w]

Antwort auf Beitrag Nr.: 54.534.111 von franke96 am 14.03.17 15:54:22

Habe mir gerade noch einmal den Kursverlauf angesehen. Wenn ich die seit Januar zu rund 2,xx € halten würde käme ich wohl auch aus dem Grinsen nicht mehr heraus.
Was hat Dich bzw. @DerKleine_Prinz damals dazu bewogen diesen Wert zu kaufen?

[franke96]

Antwort auf Beitrag Nr.: 54.533.895 von holgi-w am 14.03.17 15:29:33

Doch, wenn ich nicht auch schon seit Januar dabei wäre, würde ich jetzt Zuschlagen
Es fühlt sich auch nicht an wie ein Absturz, wir sind lediglich auf dem Stand von vorgestern

[holgi-w]

(...)
Aurinia Pharmaceuticals stürzen dagegen um 27,6 Prozent ab, nachdem das Biotechnologie-Unternehmen eine Kapitalerhöhung angekündigt hat, ohne zunächst deren genauen Umfang zu nennen.
(...)

Quelle: Dow Jones Newswires 14.03.2017 09:19 ET (13:19 GMT)

Kurs aktuell 7,77 € (Tradegate)
Wäre das nicht ein interessanter Einstiegskurs?

[DerKleine_Prinz]

...da geht die Aktie so dermaßen ab und in Deutschland interessiert es keinen...
Bin seit knapp Mitte Januar dabei (einen großen Teilbetrag des Gewinns aus Ariad Pharmaceuticals reinvestiert)... ...und ich muß sagen, derzeit macht das echt Spaß!

[techinvestor69]

interessant

AURINIA ANNOUNCES APPOINTMENT OF COMPANY FOUNDER, DR. RICHARD M. GLICKMAN, AS ITS NEW CHIEF EXECUTIVE OFFICER

Aurinia Pharmaceuticals Inc.'s board of directors has appointed Dr. Richard M. Glickman, L.LD (honours), the company's founder and chairman of the board, as Aurinia's chairman and chief executive officer. The board accepted the resignation of Charles Rowland as CEO and an executive member of the board, effective immediately.

"My decision to take on the CEO role at this important time for Aurinia is fueled by my absolute conviction in the potential for voclosporin to transform the lupus nephritis treatment landscape," said Dr. Glickman. "I have worked on LN for much of my career and believe that voclosporin will significantly improve the lives of patients suffering from this disease. Building on the success of the Phase 2 AURA study, Aurinia's goal is to advance voclosporin while optimizing the company's strategic vision and maximizing shareholder value. I look forward to engaging with our key stakeholders and working with this world-class team as we unlock the value and potential of this unique program, beginning with the initiation of our planned pivotal Phase 3 trial in the second quarter of 2017."

"On behalf of the board, I am grateful to Charlie for his leadership as CEO over the last year and his many contributions to the strategic and operating imperatives of the company," added Dr. Glickman.

Dr. Glickman brings over 30 years of experience in the creation and operation of healthcare ventures, founding and co-founding numerous companies during his career. As the co-founder, Chairman and CEO of Aspreva Pharmaceuticals, he played an integral role in developing and establishing CellCepttrademark, or MMF, as the current standard of care for the treatment of lupus nephritis (LN). Aspreva Pharmaceuticals was acquired by Swiss pharmaceutical company Galenica for nearly $1B in 2008. He currently serves as founding Chairman of Essa Pharmaceuticals Inc., Chairman of the Board of Engene Corporation and a Director of Cardiome Pharma. He is also a Partner at Lumira Capital, one of Canada's most successful healthcare focused venture capital firms. Dr. Glickman has served on numerous biotechnology and community boards, including member of the federal government's National Biotechnology Advisory Committee, Director of the Canadian Genetic Disease Network, Chairman of Life Sciences B.C. and a member of the British Columbia Innovation Council.

Dr. Glickman is the recipient of numerous awards including the Ernst and Young Entrepreneur of the Year, a recipient of both BC and Canada's Top 40 under 40 award, the BC Lifesciences Leadership Award and the Corporate Leadership Award from the Lupus Foundation of America (LFA).

"Dr. Glickman is a long-time supporter of lupus patients, clinicians and researchers and I know first-hand and greatly admire what his tenacity and passion can accomplish," said Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America. "He is a true visionary and a pioneer in lupus, a field in which development of new medications to treat the disease has been challenging. I'm thrilled to be working with him in this capacity and with the Aurinia team as voclosporin moves towards potentially becoming the first FDA approved treatment for lupus nephritis."

About Lupus Nephritis (LN)

Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Voclosporin

Voclosporin, an investigational drug, is a novel, best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,000 patients across multiple indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States to at least late 2027 under the Hatch-Waxman Act.

About Aurinia

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN). The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.

[DomRuinart]

Geht da noch mehr?

Aurinia Pharmaceuticals' (AUPH) Price Target Raised to $10 at H.C. Wainwright

H.C. Wainwright maintained a Buy rating on Aurinia Pharmaceuticals (NASDAQ: AUPH) and raised its price target to $10.00 (from $7.00). Comments follow the release of AURA-LV trial earlier this week.

Analyst Ed Arce said investors focused only on the number of deaths, and appeared to attribute them largely to voclosporin, in spite of the natural history of the disease.

Arce explained, "On Monday, AUPH shares dropped 55.8% (vs. NBI +0.9%) as investors fretted over the number of deaths in the study. Yet, we are less concerned with the rate of deaths, which we view as well within the range of recent analogues (see table). Rather, our focus is on the imbalance of deaths (and SAEs) across the treatment arms, which we believe is likely due, in large part, to the degree of patients enrolled from sites in Asia, as we discuss in more detail below. On the whole, while results from AURA-LV carried some noisy data and unexplained imbalances, after further analysis, we have grown confident that voclosporin has the potential to be combined with CellCept as the new SOC for the treatment of active LN. This believe results from our more nuanced view that the results of AURA-LV, if confirmed or perhaps even improved upon in a Phase 3 trial, tips the scales of overall risk-benefit, which has long been the ultimate arbiter of approvability for the FDA."

[DomRuinart]

Mein Reden...

Aurinia Pharmaceuticals' Share Price Plummets Despite Voclosporin Meeting Primary Endpoints In Phase 2B Study

Aug.16.16

Steven Goldman

Special situations, long/short equity, Event driven investments, biotech

Summary

•Despite Aurinia announcing a successful Phase 2B study for voclosporin meeting its primary endpoints, AUPH's share priced plunged 55% because 13 patients in the study died.

•The Phase 2B investigators had concluded that the 13 deaths were unrelated to voclosporin.

•Phase 2B results are actually very positive. Aurinia plans to file for Breakthrough Therapy Designation for voclosporin in Q4 with the FDA;

•55% share price today was unjustified. This may be a great opportunity to accumulate AUPH shares.

I was thrilled this morning to read Aurinia Pharmaceuticals (NASDAQ: AUPH) press release that its 265 patient Phase 2b clinical trial assessing its lead product candidate voclosporin met its primary efficacy endpoint treating patients with active lupus nephritis (Pending:LN), after 24 weeks of treatment. (Press release.) The Phase 2b trial continues on to week 48. The company held a conference call at 8 a.m. (EST) Monday morning to present the Phase 2b 24 week findings and answer questions. It was all very positive.

During the conference call, Aurinia was clearly thrilled with the Phase 2B results and confirmed that it would be seeking Breakthrough Therapy Designation with the FDA in Q4. The webcast can be accessed on the company's web site for 45 days. My broker sent me an early morning email advising me that AUPH's share price was up about 20% pre-market.

I was therefore more than a little shocked after the market opened when AUPH's share price plunged by about 55% today, trading more than 11 million shares. At first I couldn't figure out what had happened as it appeared the Phase 2b results were so positive. Later in the morning I read that there were concerns that the 13 patients who died during the study had died because of being treated by voclosporin.

Aurinia had explained both in today's press release and the conference call held this morning that all of the 13 patient deaths, while unfortunate, had been investigated thoroughly and none of the 13 deaths were related to voclosporin.

Quelle: Seeking Alpha

[DomRuinart]

sorry, super Überschrift...(der Klassiker)

[DomRuinart]

Phase II Ziele erreicht, Kurs halbiert...

Selten eine so heftige Reaktion auf einen "Target-Hit" in einer Phase IIB gesehen. Sicher, die Todesfälle lassen alle Alarmglocken läuten, aber wir sprechen von LUPUS (Dr. House lässt grüßen) und da halte ich die Erklärungen von Aurinia für durchaus einleuchtend. Ich denke hier kann man mal was probieren...

Aurinia lupus candidate hits PhII target, but deaths send stock down

Aurinia Pharmaceuticals has published positive new data for its experimental drug voclosporin for active lupus nephritis--but 12 deaths in the study's treatment arm has sent alarm bells ringing.

Canadian biotech Aurinia Pharmaceuticals ($AUPH) posted the topline results from its Phase IIb AURA-LV study this morning in a test that was focused on patients with active lupus nephritis (LN), a form of the disease known as lupus or systemic lupus erythematosus (SLE), which has a number of subpopulations and complications from the broader condition.

Lupus kidney disease (a.k.a. lupus nephritis) is one of the most serious and potentially life-threatening complications of this autoimmune disease, affecting as many as 60% of people with lupus.

The biotech said that its trial hit the primary endpoint by showing statistically significantly greater complete remission of the disease in patients treated with voclosporin twice a day over 24 weeks of treatment.

The trial pitted voclosporin added to current standard-of-care therapy, namely Roche’s ($RHHBY) organ rejection drug CellCept (mycophenolate mofetil), against placebo plus CellCept in achieving complete remission in 265 patients with active LN.

Data showed that 32.6% of patients in the low dose voclosporin arm, 27.3% in the high dose arm and 19.3% in the control arm achieved complete remission (CR), the study’s primary endpoint. Patients treated with voclosporin were also twice as likely to achieve CR compared with placebo. But the market has not responded well to these data, with its shares down around 50% pre-market.

Analysts at Leerink said that the stock was trading down because there were 13 deaths across the study, with 10 in the low dose arm of the drug. The company said however that these deaths were due to the severe underlying nature of the disease, and not its drug.

“While this does naturally raise questions, it is important to be mindful that these lupus nephritis patients were extremely sick and treated at many sites with differing practice patterns in Asia, some of which we believe were in much less developed places,” Leerink said in a note to clients.

“The company noted that there were no clear underlying patterns among the deaths, and that one patient (who achieved complete remission) for example had baseline proteinurea of 29 grams, which was the highest value they have ever seen in their entire career of treating lupus patients.”

It also said on the efficacy side that at first glance, the effectiveness seen in the drug arms “looks lower than what we had expected, but is still respectable.”

The drug works as a calcineurin inhibitor and as an immunosuppressant. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses.

“We are very pleased by these encouraging results and are grateful to those that participated in our clinical trials,” said Neil Solomons, Aurinia’s CMO.

“The AURA study was conducted under rigorous and stringent criteria, enhancing our confidence in voclosporin’s potential ability to provide a substantial improvement over the currently accepted standard of care, especially given that study participants had such active disease and were exposed to such a low corticosteroid load. We continue to work diligently towards our goal of improving long-term outcomes for these patients.”

Aurinia said in a statement that it now plans to meet with the FDA at the end of the year to: “Discuss these data and the drug’s subsequent clinical development and path to registration in LN.”

There are still more data to be presented, however, and the study will continue through 48 weeks, with results set to be released early next year.

A number of companies are looking into lupus treatments, including Biogen’s ($BIIB) anti-BDCA2 antibody that is currently in Phase I and UCB’s dapirolizumab pegol, an anti-CD40 ligand currently in early-stage trials that is expected to move into midstage by year’s end. Biogen also recently snuck in a new lupus treatment, a Bruton’s tyrosine kinase (Btk) inhibitor known as BIIB068, into the clinic earlier this year.

SLE is a difficult-to-treat disease with a number of variations and subpopulations of patients such as LN--but one littered with late-stage failures.

A few years ago, GlaxoSmithKline ($GSK) became the first drugmaker in more than half a century to gain approval for a new treatment for the disease in the form of Benlysta (belimumab).

The drug, a human monoclonal antibody that selectively targets B-lymphocyte stimulator, has however struggled to make much of a sales impact for the company since its FDA approval in 2011.

Benlysta has a license for patients with active, autoantibody‑positive SLE who are receiving standard therapy--but brought home just £230 million ($338 million) in 2015. It has not, however, been approved for severe active lupus nephritis.

Other candidates are also in the mix for lupus, including UCB’s epratuzumab--although this failed two Phase III trials last year after missing its primary endpoints. AstraZeneca ($AZN) also posted positive Phase II data for its SLE candidate anifrolumab last year. Eli Lilly ($LLY) had been testing its drug tabalumab for the condition, but this was axed in 2014 after it too failed several pivotal late-stage studies.

Anthera Pharmaceuticals’ blisibimod, which focuses on anti-BAFF activity in LSE, is still going in mid- to late-stage studies. And in May, a new startup biotech called Thunderbolt was launched as the brainchild of Baxalta, the Mayo Clinic and Velocity Pharmaceutical Development, with a focus on SLE, also via an anti-BAFF mechanism.

Quelle: Questex LLC