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The article just says EU marketing authorization decision will be issued in approximately 2 months. EU already did that on 9/15. BMS also received on 9/15 marketing authorization for Opdualag similar to AUPH and they issued their PR last week itself.
Not sure why AUPH or Otsuka is not issuing a PR when other companies are doing so unless there is something going on in the background that prevents them from doing so.
Probably be announced on Friday 23 at the close…
Thanks. So according to the article decision in 2 months which would make it Sept. 22.
On the 15th when the alert came up w.r.t marketing authorization, there was no document available. It was noted that it will be available in 48 hrs. Now it is available for downloading. Although it seems not everyone is given access.
That being said, BMY also had a similar EC marketing authorization for which they issued a PR the other day.
My confusion is: if the news for EC is already a public knowledge, shouldn’t that force the company to issue a PR even if there is merger discussions happening?
I thought somebody here said the 22nd.
I thought the EU decision was today for Lupy?
Parties could also agree for a buyout pending on some material events to happen, like EMA approval or settlement from patent litigation. I don’t know, just grasping for possible scenarios on why they are so silent…jmo.
theorized BR. That’s his gut feeling. If a company is bought out, how long can you hold it before announcing it?
But, Jess said they were bought out..
They have a thousand ways of doing it, a wink, a verbal agreement, a handshake, etc. They are not stupid enough to have sold it and not follow all the guidelines of the SEC. They have a cadre of high paid business lawyers that advise them every step they take. You can’t prevent people from speculating what’s going on on any company that is not providing IR news, not holding conferences, not participating in promoting their one and only drug. It could also be true but withholding it based on how long they could hold it time wise. As I said before their silence is so deafening…jmo.
More likely, there could have been some preliminary discussions that ended in "ok, let's table this for a while and talk some more once Lupkynis gets EMA approval.
Big Pharma is generally willing to wait if that resolves uncertainty.
thanks longbear, why no PR from aurinia? maybe tomorrow
“One poster in ST has theorized that the company has been bought already and that it’s just waiting for the official EMA approval.”
Sorry Jess, you legally can’t do that. Or, you can do that, and risk jail time..”
———————————-
Jess, I guess I will clarify it for you as you didn’t follow my post..
If a company (AUPH) has been bought as you stated, that is a SIGNIFICANT corporate event that must be made public.
Do what? Speculate? What are you? A judge?
Longbear. Thanks for that link. I bought a block based on that link. Funny how the price moves on just buying in 1,000 share lots. Not like the good old days where you could buy and sell and it wouldn’t move.
“One poster in ST has theorized that the company has been bought already and that it’s just waiting for the official EMA approval.”
Sorry Jess, you legally can’t do that. Or, you can do that, and risk jail time..
The link I shared earlier indicates EMA gave approval today.
COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Lupkynis - voclosporin", a medicinal product for human use
https://ec.europa.eu/transparency/documents-register/detail?ref=C(2022)6734&lang=en
Unless i am reading this incorrectly.
the EMA decision is due out next week around the 22nd of september
approved by EMA?
https://ec.europa.eu/transparency/documents-register/detail?ref=C(2022)6734&lang=en
Not seeing any PR though...
One poster in ST has theorized that the company has been bought already and that it’s just waiting for the official EMA approval. The reasons he gave is the same reasons you just posted.If this holds true, the shorts will not be happy at all. I hope you guys are right…jmo.
The company doesn't seem to be participating in the normal fanfare for its industry this year: Biotech conferences? Insider buying? Stock options granted at considerably higher prices than the current trading price? Hmmmmm
Auphy the only thing green on my board!
showing strong on a very very bad tape! EMA decision must be coming soon.
You have a NICE graph Jess!
They don’t have the manpower and resources to do a full frontal assault on that issue. Big pharma can do it but they don’t want to let it go with a mediocre BO figure and I can understand that. They have a best in class product for an unmet medical need. The inflation/recession, Ukraine war and this pandemic kind of put the brakes on the momentum but I think they will overcome it if it’s not BO.
Cheap shares going fast now. Almost up 15 percent from capitulation.
Definitely, and Aurinia need to be shoving this in front of the faces of nephrologists and insurance companies.
I have absolutely no interest in your
investment activies, never had in fact.
Since in your kindness you indirectly
introduced me to this company in mid
July 2022 i shorted this stock @$11.89
and closed my position today @6.36
and made a nice $$$ bundle.
Thank you my friend.
I wish you good fortune in your investments!
YEAH! and I won the lottery and I'm buying a private island with a lovely view of Amalfi!
You do not know enough about this company to have made an intelligent investment decision. I expect to make more on the way up than you could have on the way down.
BTW, you seem to have taken an interest in my PURPORTED investment activity. Why? Are you taking your cue from "999"? That's a losing proposition.
Zzaatt made the year..
Closed my short position @6.36.
Thank you Zzaatt for bringing up
this company to my attention!
Thank you sir, made a bundle!
$$$$
So a little inside info
Wife ( Nephrology PA … Yale grad ) says they are increasingly concerned with the cognitive decline associated with long term steroid use .
In this case Presidone often used with LN patients.
More attention given to which LN drugs allow the fastest tapering of steriods ( AUPH … and which may allow steriods to be dropped altogether ( KZR )
Biggest problem AUPH ( Lupkynis ) faces is that it’s usually Tier 5 with a huge patient copay and the script is only for 6 mths
Kiwi
I can hear the sound of silence and it’s really deafening.
Lol, finally you admitted it BR. It took 5+ years but we both made good profit wise so all is swell and well.
Cervelo, to set the record straight, I feared the 2’s with Ariad. I didn’t fair very well with that call, fortunately. Luckily, a handsome profit there as we were absolutely saved by Takeda.
AUPH just needs to find its legs now..
Voclosporin set for EMA approval for lupus nephritis…
https://www.medwirenews.com/rheumatology/ema-approval/23324368
I got tired responding to his antics every time sp drops for even a penny.
These spineless cry babies need to grow a set or stfu and leave.
Stop crying and sell if you cant take it. The rest of us will wait for the suit to settle and the inevitable buyout to happen. You should buy cd's instead of your pathetic moaning.
after getting slammed over and over. you have to admit I was right about peter and his inability to run this company. unless of course you were hoping he would run it into the ground. Maybe BR was right when he said he feared the two's.
from the 34's down to the 6's.
calling people gadflies for stating the obvious. this was supposed to be an investment
6.70-0.52 (-7.25%)
As of 11:34AM EDT.
A new 52w/l
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.
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