Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I would say it is realism, and not pessimism. The EU and the UK are under a lot of economy stresses and it is getting more difficult to get good reimbursements. And, we know our drug is very expensive (or at least is priced expensively) so when the authorities do a QALY we may have to accept a much lower than anticipated reimbursement. Look at the stock price. Not many market participants are euphoric over these developments.
Geez, why are you always so pessimistic in your investment. There will always be hurdles on the road to success.
Well, maybe, but first comes the hard part of getting NICE to recommend reimbursement, and at what price.
Aurinia Announces the Great Britain Marketing Authorization of LUPKYNIS® (voclosporin) for the Treatment of Lupus Nephritis.
Hopefully this will bump up sales by 2024
https://ir.auriniapharma.com/press-releases/detail/270/aurinia-announces-the-great-britain-marketing-authorization
That is the way to conduct BO negotiations.
HZNP getting acquired - good old Tim Walbert
Gg
Another insider purchase…10,000 shares @ $4.66
No BP will touch this pig
Clarity request:
Are you speaking about Greenleaf or Lupkynis?
Peter is AKA PiG
Lupkynis is clearly very valuable.
PiG- not so much
The Chief Business Officer is down $20k from his purchase on 11/7 30,000 shares at $5.16. He's probably in PG's office "Do Something!" lol
“No BP will touch this pig”…well, well well, yet here you are owning so many shares like PG.
rose
remember when the board gave pete his well deserved raise for dragging the company down to junk bond value in return pete gave them all free shares.
It's easy to give away the store when you you take no responsibility to stock the shelves.
No BP will touch this pig
Sold to BP not partnered with.
They really need to partner with BP. Then they can reduce or get rid of their sales team and reduce overhead. It would be cash positive more quickly. Let the long arms of BP sales team do the leg work.
Quantum Mechanics…
But he is doing better for himself. Is the BOD only subservient to him or do they care about the company and the drug? They can’t possibly be happy with the way this has been managed.
I owned a digital prepress company. built it from nothing, grew it, ran it for 30 years.
Believe me I could run auph in my sleep better than peter does for a million dollars less in salary than he sucks out.
greggors this is exploding ... poof our money is gone.
This thing is gonna explode! don’t know when
Market cap is so low it is trading near cash on hand. crazy...
Quantum entanglement? Sorry if it affects you too. Moose was even nicer.
LOL! Reminds me of somebody in politics.
Hot dog cart?
Institutional holdings increasing. 58M shares now.
https://fintel.io/so/us/auph
still dropping and fools keep buying.
and peter is still getting 1.3million a year plus benefits all for watching the share price drop 30.00.
Dang where can I get a paycheck like that?
Back when I was a ceo I had to work or I didn't get paid, I guess that is the difference between someone who cares and someone who could care less.
Hey Zzatt. How many scientists do they have. If it works for other biotechs, it MUST work here too right?
“ Are you going to refuse a patient population, with marginalized people over represented, access to the best medication available today, for relief from the devastation of a terrible disease?”
You haven’t had much experience with insurance companies I guess. Why don’t you tell us how cheaply a patient can get V for.
These 5 buck shares really bring the average down quickly.
Well the present reality at the Nephrology dept where my wife works … and sees the occasional LN patient.
Yes we are considering Lupkynis for severe LN … for short periods ( 3-6 mths )
Our challenges
Cost of the drug
Tier rating of the drug plus likely high patient copay
Insurers wanting us to try Benlysta first
And now U know
Good luck
Kiwi
I saw that - it is a good sign.
A little update on that Lupkynis script … the first if it happens at my wife’s hospital ( one of the largest in Nth Ca ) .
Insurers may want patient to fail Benlysta first
Severe LN with declining kidney function on the generics … Tac etc
Nephrologist wants to try Lupkynis.
Thinks insurers will require Benlysta tried first …. Less expensive and works for many
To your pt
Yes of course AUPH could cut the $ amount they charge
This is a repeat of the AMGN saga over Repatha ( which I’m on )
For the first 2 yrs AMGN wanted over $12,000 a yr
Insurers ( including mine ) refused to pay
After 2 yrs of low sales … AMGN cut the price to $4,500 …. at which time insurers ( including mine ) agreed to cover for their patients.
Now a lot more patients are now on Repatha and AMGN isn’t hurting either … chk their PPS chart
Kiwi
Michael Martin bought 30K shares
Most bullish thing for this stock in a long time. Remember, he sold at 30+, maybe he thinks he can do it again, lol
Thanks for that update Kiwi. As I understand it, the company’s margin on the drug is quite high, so why haven’t they used that leeway to offer deals to insurers to get them on board?
Well little update for U
Wife talked to a Nephrologist she works with …who had been at Kidney Wk ( last week ) .
He was impressed with Voclosporin use for severe LN … poster presentation at the conference.
May actually prescribe it and see if the insurer will cover it and if the patient will be willing to pay the copay
Kiwi
U really don't get this do U .
Look at the script numbers .
Drug has a limited market for a short period, way over priced and extremely difficult to get insurers to pay for... and often requires a huge copay from the patient
Good luck
Kiwi
BR, it’s getting closer to your target.
I hope it is not for the fine investors on this board.
On the bright side, you could have invested in Carvana- CVNA…. Was $350 in July of last year, today it is $7.38. I just shook my head when I saw the business model. Dispensing cars from carousel…
BR, it’s getting closer to your target.
You guys should also post on Twitter with some of your positive banter so people see it.. Not many see it this far back in the weeds.. Ceviche should stay here..
…with a predicted upside of 137%
this sounds like a stock for Alex Denner, wonder if he is lurking!
H.C. Wainwright analyst Ed Arce reiterated a Buy rating on Aurinia Pharmaceuticals (AUPH – Research Report) today and set a price target of $14.00. The company’s shares closed last Friday at $5.15.
https://www.tipranks.com/news/blurbs/h-c-wainwright-sticks-to-its-buy-rating-for-aurinia-pharmaceuticals-auph-2?utm_source=stck.pro&utm_medium=referral
I have always thought that Voclosporin was a great drug especially when the sp was down because of the deaths mistakenly attributed to it. Now we're in a situation where the sp is down because of management's incredibly inept performance which caused Sun to sue us in retaliation for the unnecessary dry eye suit and the almost complete neglect in hiring a competent sales force. I'm confident the suit will settle and the sp will be back to low double digits at that point as buyout speculation will immediately resume. As far as a buyout I'm guessing around 20 which is a real kick in the balls after where it was but a good lesson for the next one. I'm sure not one in ten retailers sold in the 30's so misery loves company I suppose. New investors will do well here as will those of us still ahead on this one.
I agree benny, I said that all along.
so ask yourself what do you get with a quality drug 400 million in the bank?
Combined with the worst management team of all time?
you get 5.00 a share down from 34.00 a share.
but while shareholders are all underwater peter is still raking in his 1.3million payload plus bennies. and if he gets a vacation package like those that just jumped the sinking ship you can add another 200thousand to his overpaid benefit package.
I see more share dilution within the next 6 months. that is what peter has done best over the years.
Now be careful benny450 you will now be labeled a gadfly by the high and mighty.
You are correct about the "ONLY" part.
As far as buying in, until we hear something positive regarding the patent issue, it could be a fool's errand if that turns sour.
4. Papp is incompatible with AURA-LV
Papp’s renal criteria are not even compatible with the intended purposes of AURA-LV. EX2003, ¶¶¶165-171. Because AURA-LV’s intended patients would be excluded with Papp’s renal criteria, “n effect, [AURA-LV] teaches away from the... proposed modification.” In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) (inoperable modification teaches away). Sun did not even address this critical consideration.
Consistent with other psoriasis trials, Papp excludes subjects with eGFR<60. EX1006, 1; EX2065, 55:2-56:13, 99:9-23; see supra, §II.D (trend of more restrictive criteria for psoriasis studies). Excluding subjects with eGFR<60, however, is incompatible with the treatment of LN generally, where “most patients with lupus nephritis will have abnormal kidney function” and around 50% will have CKD. EX2065, 10:22-11:15, 105:6-106:9. As Sun’s declarant admits, “if you include only people with normal kidney function in a lupus nephritis trial, you will not have any subjects to include because most patients will have some degree of kidney impairment.” EX2065, 105:6-106:9; see supra, §II.A (treating LN patients with baseline eGFR as low as 15). Papp’s renal criteria are specifically incompatible with
47
Case No. IPR2022-00617 Patent No. 10,286,036
AURA-LV, where the intended population has baseline eGFR as low as 45. EX1005, 8. Papp is thus excluding from treatment any patients with impairment of renal function, including starting eGFR of 45-60, within the population AURA-LV sought to treat, and would render AURA-LV no longer suitable for its intended purpose. EX2003, ¶¶166-167.
Further, Papp teaches terminating treatment if eGFR drops by 30%, regardless of the absolute starting or ending values. EX1006, 1. This means that patients with starting eGFRs of 120 and 110, for example, would be discontinued from voclosporin treatment if their eGFR dropped below 84 or 77, respectively. EX2003, ¶168; EX2065, 198:22-199:13. This directly contradicts AURA-LV, where a final eGFR>60 could be consistent with achieving the “complete remission” even if it had dropped to that level by 30% or more. EX1005, 5; EX2003, ¶169. By excluding these intended patients, Papp would preclude successful treatment according to AURA-LV and render AURA-LV no longer suitable for its intended purpose.
Relatedly, institution was premised on finding that “[1] voclosporin treatment may be performed while eGFR values remain above 60 ml/min and [2] should be terminated at a minimum when eGFR values are reduced below 45 ml/min....” ID, 19. This finding is inconsistent with up to 20% reduced eGFR being part of “complete remission” according to AURA-LV and “a good approximation, basically, to a stable kidney function.” EX2065, 168:18-170:20; EX1005, 5, 8.
48
Case No. IPR2022-00617 Patent No. 10,286,036
Limiting treatment when eGFR remains above 60 or discontinuing treatment when values are reduced to below 45 thus would be inconsistent with and render AURA- LV no longer suitable for its intended purpose. EX2003, ¶¶170-171. Discontinuing treatment at eGFR less than 45 is also incompatible with the treatment of LN generally, where baseline eGFR criteria of as low as 15 were common and continued treatment following up to 50% eGFR reductions did not result in modifying treatment. Supra, §II.A; EX2032, 2; EX2065, 82:2-83:14, 93:11-94:3; EX2003, ¶¶170-171.
C. The Petition Does Not Establish a Reasonable Expectation of Success
As the Board found, independent claim 1, from which all claims depend, entails administering a daily dosage of voclosporin that is effective to treat a PKD under the claimed conditions. ID, 8-9; supra, §III.D. Sun’s Grounds 1-2 fail to establish a reasonable expectation of success for this claimed method.
1. Sun does not assert any reasonable expectation of success
Sun fails to assert, much less establish, that a POSA would have had a reasonable expectation of success in achieving the claimed pharmacodynamic dosing regimen. See Pet., 1-62 (not mentioning reasonable expectation of success). This precludes obviousness. Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1360-61 (Fed. Cir. 2017) (party arguing obviousness “must show the artisan ‘would have had a reasonable expectation of success’” (citation omitted)).
Candidate & Indication | Development Stage | ||||
---|---|---|---|---|---|
Preclinical | Phase 1 | Phase 2 | Phase 3 | Market | |
VOCLOSPORINLupus Nephritis (LN) | Preclinical Phase complete | Phase 1 Phase complete | Phase 2 Phase in progress | Phase 3 Phase not started | Market Phase not started |
Aurinia is committed to working in areas of high unmet medical need and is poised to deliver the first approved therapy in the U.S. and Europe for the treatment of lupus nephritis, or LN.
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across 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 lupus nephritis (LN) when added to standard of care mycophenolate mofetil (MMF). It has been granted “fast track status” by the U.S. Food & Drug Administration (FDA).
Voclosporin has the potential to become a best in class medication and the first approved treatment for LN in the U.S. and Europe, effectively altering the current treatment paradigm for the disease.
Our clinical data suggests that adding voclosporin to the current SoC of MMF for the treatment of lupus nephritis (LN) will yield superior results to using the standard of care alone.
Additionally, voclosporin may prove to be an ideal therapy for lupus nephritis due to advantages such as:
In clinical trials, Voclosporin has been shown to be especially effective in the presence of low dose steroids with rapid reduction of LN inflammatory markers and overall improved renal stability.
The list of potential product benefits includes:
LN Critical Need | Voclosporin (based on AURA Results) | |
---|---|---|
Control of Active Disease | ||
Rapid Disease Control | ||
Lower Steroid Burden | ||
Impact on Extra-renal disease | ||
Convenient Treatment Regimen |
In previous studies, over 2000 patients have been treated with Voclosporin with no abnormal or unexpected SAE’s
Efficacy of calcineurin inhibition has already been established. Voclosporin has a well-characterized safety profile (over 2,000 patient exposures across multiple years) across indications.
No new safety signals were observed with the use of Voclosporin in LN patients; Voclosporin was well-tolerated and renal function remained stable in clinical studies. The overall safety profile is consistent with other immunosuppressive drugs.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |