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Grabbed more shares today. Looking forward to our Q3 $65M
All the WEF/Biden admin needs to do is turn the oil back on…
Those who sell now, in my opinion, are plain idiots.
Thanks Jess. I get a kick out of the title saying that these stocks are to be sold NOW, but then it details this guy selling them in the 2nd quarter. We are at the end of the 3rd quarter and almost all the stocks mentioned have been beaten down. Wrong time to sell.
Best post of the day:
“I was wondering where you were Cervelo!! Felt like the news was too positive so you had to manufacture something up in your mind eh?
You forgot to mention the CEO's salary in your message.”
His departure was rather abrupt.
Probably a bad point, I have swing shares stuck at $9.90 range from 3 months ago lol. Writing calls to slowly make it back.
yak that is a good response thank you.
I would hope that being the case that management would/should have thanked him for all his hard work in moving the company forward and his diligent work in the company achieving EU approval and anything else he offered while on the Bod.
I wish the market saw the EU approval as good news, share price would have moved up.
We will just have to remain ecstatic with our continued 27.00 loss after BMY announced their position to present a BO.
Things could be worse I could of jumped on the emotional redbox rollercoaster and lost 100%
10 stocks to sell now.
https://finance.yahoo.com/news/10-stocks-sell-now-according-174147199.html
I was wondering where you were Cervelo!! Felt like the news was too positive so you had to manufacture something up in your mind eh?
You forgot to mention the CEO's salary in your message.
It appears that Walbert was there only to (help) secure EU approval, and, with this accomplished, he is moving on. The fact that the resignation happened the same day as the EU approval, and that it was effective immediately, supports this thesis.
In general, directors' compensation is not tied to specific milestones, though it is possible.
There may also have been a "gentleman's agreement" to the effect of "help us get through EU approval" and then we'll go our separate ways.
since the company wrote that and not Mr. Walbert as he was leaving I would read it correctly as such. Otherwise why not make his own reason for departure.
Mr. Walbert's departure from the Board is due to disagreement with the Company and the Board in matters relating to the operations, policies and practices of the Company.
Then again it is only my opinion which I am not allowed to have here.
On September 19, 2022, Timothy P. Walbert, a member of the board of directors (the Board) of Aurinia, notified the Company of his intent to resign from the Board, effective at the close of business on September 19, 2022. Mr. Walbert's departure from the Board is not due to any disagreement with the Company or the Board on any matter relating to the operations, policies or practices of the Company.
Above is from the recent 8-k
Jess, I think that if that was the case, someone would have latched on to AURINIA by now….
What Director left??
Excellent point Cosa, could not agree more
It’s not too far fetched that Voclosporin may one day become a potential candidate in treating Alzheimer’s disease IF the speculation in the article below holds true that Alzheimer’s disease is caused by overactive immune system within the brain. Why not, it is being considered in ARDS anyway…jmo.
https://www.sciencealert.com/alzheimers-might-not-actually-be-a-brain-disease-expert-says
I will defer to U as the board expert on the EU reimbursement process … so good luck .
In Germany they can probably launch while they negotiate… at least for the first 6 months
Kiwi
Yes, this was all priced in. No reason yet for the market to get excited. Sales are extremely slow here in the States and we (as does the market) know that Europe is a lot tougher than the U.S.
The reimbursement negotiations not only will depressing from the perspective that the EU countries will want to pay very little, but it will take a lot of time. So becoming profitable is not in the cards in the very near future.
What hopefully this means though, is that some prospective buyer gets or remains interested, seeing acceptance of the drug worldwide and we can get made whole here.
Jess etc all, does the departure of the director have any impact for or against the assumption of merger talks in the background? Have any you seen this in past mergers?
thx, Longbear
50% swing opportunity here. The 3rd quarter rev in November will blow estimates out of the water. We know it is because of the EMA approval deal, but most others don't look at why, they only look at the $ compared to last ER report.
Was EU approval in doubt ? The challenge is reimbursement negotiations.
Ask poster RMB ( Rosemouth) … he knows the road map for EU / UK reimbursement decisions
Kiwi
Nope. The issues with KZR are
1) no significant data until ASH early Nov
2) will they need one or two P3 trials for FDA approval
One trial to match Lupkynis P3 trial … ie includes induction therapy
The other to match KZR’s P 2 trial but on a larger scale … ie mainly refractory patients
IMHO. Both ( if there’s 2 ) will mandate steroid tapering
Risk of dilution if they go with 2 P3 trials
Kiwi
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.
Jess, I bought in on 9/15 as my post indicates. You should follow the thread..
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169960791
Geez BR. How could anyone believe you anymore? You’re giving us especially zzaatt plenty of ammunition. You dumped your non-existent shares with a slight gain?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169788470
Its a sell the news event
Weak market response so I dumped my shares just now for a very slight gain……Some day…
This PR was expected since 9/15. Its delay is what caused many (including me) to hope for the merger news at last. I really hope that news is in the making and will be out soon. Until then however given how crazy market is we might see dips... Fingers crossed, holding strong since after ARIA.
This is big news, oddly quiet on the trading side though.
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.
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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