Skip to main content

Wednesday, May 31st 2017 - late breaking clinical news

After hours brought news of two late breaking clinical results

Aurinia Pharmaceuticals Inc.  has been selected to present late breaking oral presentations at two upcoming medical conferences. These include: 1)  The 54th European Renal Association-European Dialysis and Transplant Association’s (ERA-EDTA) Congress;  and 2)  the Annual European Congress of Rheumatology (EULAR) 2017, on June 3th-6th, 2017, Madrid, Spain and June 14-17, Madrid, Spain, respectively.
As noted on the Aurinia web site: "The selection of the 48-week data from our successful AURA-LV Phase 2 study for two late-breaking oral presentations during these key medical meetings underscores the high impact of the results to the broader physician community, said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “We look forward to sharing our findings and highlighting the importance of developing a potential therapy for active lupus nephritis."

Presentation 1:  Steroid-Sparing Efficacy of Voclosporin in Active Lupus Nephritis: Stable Kidney Function and BP Without Electrolyte Complications at 48 Weeks
Presentation 2: 48 Week Complete Remission of Active Lupus Nephritis With Voclosporin


Comments

  1. Those presentations serve to remind us why we stay invested and excited about the prospects for this company in the future. The institutional investors who shorted this so heavily after the dilution are doing a classic job of wresting shares away from the nervous retailers who are susceptible to the water torture tactics which have taken this stock down to its current level. However, many of us recognize what is happening and can ride it out knowing that there is nothing except good news surrounding the product Voclosporin. It will be a great day when we awaken to the announcement of a buyout 5 or 6 times its current value. Hang in there longs, better days are ahead.

    ReplyDelete
    Replies
    1. Completely agree. And today's price movement proves for me that this take down over that last week or so is just BS. Happy to say I didn't sell a share, and hope that my fellow longs were not tricked.

      Delete
  2. It's starting to feel like we will be getting more news and data about Vocs potential outside of LN. We know we have a blockbuster LN drug on our hands, and it's hard to even contemplate the drugs potential for all the other diseases and conditions we're starting to realize would benefit from Voclosporin...and there are many!

    ReplyDelete
    Replies
    1. Its good to have a site that welcomes good information and a fair discussion of ideas. I am long AUPH. Dr. Glickman has a plan to keep the stock price up as much as possible. he will release current number of patients enrolled and I believe he will start phase 2 of Voclosporin as a better drug for eyes than cyclosporine. They have the funds to enroll patients quickly plus there are other potential diseases where voclosporin would be effective. I personally don't believe there will be a buyout as Auph has the personnel with the knowledge to get the highest value for the drug by selling it themselves in the United States and probably Europe. there may be deals for Japan, China and other parts of the world. I think every DR. is aware of this company and its drug. I believe it will immediately grab huge market share and may be approved as soon as the 52 week data is released. I am long all the way. Just my 2 cents Mark

      Delete
    2. Great post! It does seem that Glickman wants to take it to market themselves. Is he just a good poker player??? Everyone has a price however, we just don't know what his is. Rights to China have already been sold off, but I do agree with a lot of your thinking.

      Currently Restasis (Cyclosporine) eye drops are pulling in $1.6 billion per year in the U.S. alone and growing at $150-$200 million per year. I'm eager for them to really push to enter this market as well given that Voc is a less toxic and more effective Cyclosporine.

      Delete
    3. $1.6b, and that's without the doggies!!

      Delete

Post a Comment

Popular posts from this blog

June 6, 2017. Buy Out at 63?

Take a spin on our BO pricing model! The Trading Cyclist Our model is generating a range of $35-63 BO PPS , per the low/high case scenarios below - where only the Voc  price  is different (25 k vs 50k). My hunch is that this is both conservative and in the ballpark.  It's conservative b/c: 1) patient population is consistent with Aurinia's projection; 2) assumes only 35% of population on treatment; 3) assumes 75% discount for European market; 4) pricing is at 50% of range projected by Aurinia; 5) uses target P/S ratio of 3, which is below Biotech industry average of 5.0.  Outcome   Patient Pool  (Same for both Scenarios)  Pricing :  Price/Sales ratio   Here's the  Link to the model Low end BO PPS w/30% discount:  $35  ($50 no discount)  High End BO PPS w/30% discount  $63  ($90 no discount)  Prev: 26.5 per 100,000 (Based on epidemiological study)  Total Patient pool (US, Europe, Japan): 252,333  % of patients on treatment: 50%  To

June 8, 2017: The case for early approval of Voclosporin

Voclosporin will likely be approved well before the P3 trial runs it course. Here's how it's going to work.  First, there's a legal and regulatory path for this approval .  While I quote the relevant passage below, here's the link to the  FDA Regulations , as well as  a   list of drugs   t hat received accelerated approval.  Sec. 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoin t that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant stud

iHub has been hijacked by trolls

Yup. iHub can't get rid of "Biotech Researcher," aka BR.  It's both a win for BR (the troll), and a huge loss for iHub. Their platform loses value and credibility when they refuse to take action on perma-trolls that derail the discussion and distract investors from their efforts to just honestly share information and opinions on the equities they own. So shame on iHub for not taking action to resolve this. I'm going to cease and desist on posting there until the troll (BR) problem has been resolved, and credible, valuable posters have been reinstated. I've already cancelled my premium membership some time ago. I suggest you do the same. With kind regards to all Trading Cyclist (aka TC)