Anavex Life Sciences Corporation (AVXL) Share Price

Very kool, thanks Steady.

MAA on subset. I think this bodes well for Anavex.

Anavex's blarcamesine and/or Anavex 3-71 as treatments for ischemic stroke

******************************

Sigma-1 receptor signaling: A potential therapeutic approach for ischemic stroke

Alex Ngo 1 , Nikolai Fattakhov 1 , Michal Toborek 1 2

1 Department of Biochemistry and Molecular Biology, Miller School of Medicine, University of Miami, Miami, FL, USA.
2 Institute of Physiotherapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.

PMID: 39246093 DOI: 10.1177/0271678X241281547

Strokes constitute over 50% of all neurological diseases, standing as the foremost cause of physical and mental disability. Currently, there are no widely accepted gold standard treatments for ischemic strokes beyond intravenous thrombolysis and mechanical thrombectomy applied during the acute therapeutic window. Therefore, the need for novel treatments targeting crucial signaling mediators involved in ischemic stroke is of utmost importance. The sigma-1 receptor (S1R), a molecular chaperone located at mitochondria-associated endoplasmic reticulum membranes (MAM), has exhibited neuroprotective effects when modulated by synthetic and endogenous agents across various cerebrovascular diseases. In this review, we describe the emerging therapeutic role of S1R agonists and antagonists in regulating blood-brain barrier (BBB) dysfunction, neuroinflammation, and neurocognitive impairment following ischemic stroke.

https://pubmed.ncbi.nlm.nih.gov/39246093/

Good luck and GOD bless,

I knew you’d find a way to declare great news this week. Like I said, your bar for great news is extremely low. Of course, nobody else thinks there was great news today but that’s beside the point, right?

I had a very busy day but finally got to see the presentation. Missling’s hair looked good! However, I’m beginning to wonder if it’s his real hair. After all, he’s a 50-something year old with a full head of hair and no gray. Very unusual. Makes me wonder.

Oh, the presentation and his presentation of it have improved. OK, I’m admitting it.

The big news came through today right as scheduled.

Anavex Life Sciences has a great pipeline of drugs with a great number of milestones scheduled to occur during the next 4 months.

GOD bless,

I’ve been out of the loop all day so could someone bring me up to date re georgejj’s “big news prediction” for today? TIA.

The size of the PD trial will tell us a lot: if powered properly then maybe Anavex has learned from past mistakes and they are serious about competing. If they launch another underpowered trial then we maybe has to conclude that Missling and co are just in the business of raising money.

They type faster? Down goes Big Lots!

I don't think it actually took Prilena only 6 months I think they just announced their EMA application intention to the market later in the process than Anavex did. Their March PR said this - "We are now finalizing our MAA submission for mid-2024 and preparing to make pridopidine commercially available for patients in Europe, if approved.”

https://news.prilenia.com/press-releases/press-release-details/2024/Prilenia-Plans-to-Submit-Marketing-Authorization-Application-MAA-in-the-EU-for-Pridopidine-in-Huntingtons-Disease/default.aspx

Also the EMA guidance itself says minimum 7 months from the notification to them of intention to submit to actually submitting it so I do not believe Priliena's March PR could have been the start of the process with them targetting mid 2024 at that point.

The Prilenia’s Pridopidine for Huntington’s Disease Accepted for European MAA comparison is informative. Both Pridopidine and 2-73 are small molecules and target the Sigmal-1 receptor. It took Prilenia only 6 months (PRed plan to file in April-24 and accepted in Sep-24) while Anavex PRed plan to file in Nov-23 and still no filing yet.

The Pridopidine p3 trial was also only 499 patients. The primary endpoints were not met for the entire population but a subset. Prilenia did set an example for Baby Bio to file CNS drugs through EMA, not the FDA. It does look like the EMA is trying to provide an easier path than the FDA for CNS indications.

Another word salad. At many point he was gasping for the word, does he has stuttering problem?

WHEN!! It comes out.

If the peer reviewed paper comes out Very big IF

If the peer reviewed paper comes out very supportive of 2-73 and its MOA there maybe a Weinstein event for some on the board. Some from joy and some from sorrow.

With our few 1000s of profitable AVXL LTCG shares, I’m still waiting for those peer-reviewed journal results CM mentioned a time or two. My “Weinstein event” referred to an alert, stating Harvey had been hospitalized with a heart attack. Life, and message boards, are stressful for many people, AMRN shareholders included. Thanks for your calm response.

Hosai.....very sound logic and you wonder why the FDA and the US Government are not doing every thing possible from a scientific and economic perspective to conquer Alzheimers! It is a sure death sentence for "everybody" who contracts it and is a tremendous emotional and money drain for the families of the patients. You would think that a cause which kills nearly or more than 1,000,000 of us a year would be one of our country's top priorities. Yet politics and money have slowed our progress. Cancer has coalesced our medical focus, but maybe its Alzheimers attack on the older end of humanity that have dulled our efforts. Those who have a loved one with the disease would want you to listen!!!

Leaving Alzheimers progress as a market decision is really a crime against humanity!

North has been around biotech for a long, long time! I'm glad he decided to post recently...he is normally on Dew's board.

Well yes obv there are differences but I was talking about a one day increase of $13.28 billion so it was based purely on the profit potential of the AD drug for Eli Lilly (though likely still a discounted profit potential due to the relatively poor data). All the other BP aspects such as the safety in it being a massive company would already have been priced into Eli Lilly before this announcement.
Also it's not like AVXL is in a finanically perilious situation compared with the average pre-revenue biotech with decent cash and no debt.

We’ll, Not We
What does WGT mean?
It’s an awkward, pejorative acronym used by various posters to mean for (but not by) AVXL longs, “We Got This.”

In fact, all of us who hold long AVXL positions know that neither we nor Anavex have ‘gotten this.’

But, for us, the acronym still works, when it’s “Well Get This."

The future of Anavex Life Sciences Corp is sound and strong. Will just take longer than we hoped.

In that regard, I’ve punched all of the relevant numbers into my AVXL investment spreadsheet. Over the years, with fully discretionary funds (left over after all financial obligations were paid off) I’ve accumulated a very modest AVXL position, a few thousand shares.

And, of course, the cumulative value of that position hasn’t much appreciated. But I knew going in that startup pharmas take many years (10 or more) to achieve full commercial success.

I can wait; when I compare what my AVXL purchase funds would have produced in a conventional ETF or other “safe” investment, compared to the rewards I’ll receive when Anavex finally has global sales for several CNS diseases. Then, I’ll be WAY ahead — worth the long wait.

There is more than a little difference between a large BP with a MC over $860B and a big revenue stream and Anavex with no revenues and no approved drug.

That $15B increase was about 1.7% increase in their MC. A similar increase for AVXL would be lost in the daily SP swings.

Like comparing apples to hand grenades.

The level of uncertainty between the two is massive.

Yes, Tom the look is bearish & the touch to the 200 day sma was the kiss off!

Don't know how far down from here, but who knows? There is a slight gap below $5.....I give up!!

Kund has been most accurate in describing Missling........

https://medicalxpress.com/news/2024-09-brain-cell-affected-differently-rett.html

It's hard not to be a little conspiracy theorist when you see the stark differences in valuation with some BP.

Eli Lily added $13.2 billion to their market cap ($15.28 billion adjusted for inflation today) on announcement of FDA accelerated approval pathway in June 2021 which was based on their phase 2 data that was pretty much inferior to Anavex 2b/3 data in every way.
For Anavex a $15.28 billion increase would be an increase in sp of $180.20 dollars a share.

Perhaps you might consider separating those that firmly believe in the safety and efficacy of Blarcamesine from those who also hold conspiracy beliefs. While there is overlap between those groups they are not the same.

Is it Venn diagram time? 😉

Hi North
see you still hanging around.
trying to understand why company keeps shifting goals eg PDD results were good 2-3 years ago. They never pursued a new trial or released peer review....later it was claimed that industry was still developing biomarkers to measure disease etc at least that is my recollection. RETT is more recent - nothing announced yet to start new trials.
I do understand they have been concentrating on EMA filing....waiting on progress there.
How do you see things? TIA

WGT is an acronym for We Got This. The WGTers, as I call them, are shareholders who firmly believe Anavex has already proven the safety and efficacy of Blarcamesine beyond any doubt. Further, they believe and promote conspiracy theories that the FDA, big pharma, and certain Wall Street investors who are in cahoots are doing everything they can to ensure that Anavex fails. For the WGTers, there is no room for any doubt and anyone who dares to question or challenge anything Missling says is a FUDster or (God forbid) worse.

Overall the percentage of subjects that choose to continue on 2-73 after the OLE trials is very high. I thought he said that some of the Rett girls have been on 2-73 for 4 years.

That stands for We Got This. A shorthand used by those investors that believe that Anavex has a drug that will be approved and garner a large market.

Investor uses it to poke at people who do not share his sense of skepticism.

I read what was written on the slides today while listening to what was said by CM. What does WGT mean? An abbreviation for some kind of a Weinstein event?

At 16:55 Missling seems to say "which is really nicely demonstrated in the paper" (or maybe he says "a paper"). Does he mean the 2a paper?
Also at 13:37 - "and when the paper comes out this will be accelerating even further".
Sounds a bit more definitive that it's coming?

https://journey.ct.events/view/0adae96a-6102-40ae-90d4-ef4336266886

Too many holes in the data why waste more money just keep milking until 3-71 becomes something in the next 7 years

I'm starting to feel that Misleading is slowly abandoning 2-73. It became evident when the PDD OLE failed to recruit, followed by the utter failure in Rett. Those AD odds ratios now looking good.

AVXL closed even for the day. If you are a day trader it was a good day for trading. Stock peaked at $5.53 and closed at $5.15 for a potential gain of about 7% if you were fast enough to catch the peak.

So if it was a schitti trading day it sounds like a problem behind the keyboard.

Read what the company wrote again. Take a moment.

With all your innuendo and bluster, the fact remains that, "Oral blarcamesine demonstrated superior clinical safety and efficacy compared to mAb Leqembi and mAb Donanemab and slowed neurodegeneration in early Alzheimer’s disease.” From Missling today.

The little surge to 5.50 sells right back down.
Steve, would you consider today's candlestick a "pin bar" (Pinocchio ) ? Resistance steps continue to be around 5.25/5.35 area. The pin bar is considered a bearish sign, for continued downwave. 🤔 🎱

Expect AVXL to close at or near the low of the day on volume of around 700K shares sold.

There is clearly no anticipation of HUGE, GREAT, or ABSOLUTELY GREAT market-moving news in the foreseeable future. (Certainly not this week!)

I knew there would be a WGT explanation - comforting end to another schitti $AVXL trading day, thanks!

Hey Georgejjl, $AVXL really going close on or near the low of day again?

The “or” could be used to introduce an additional alternative trial.

Anavex should present at every investor conference it gets invited to. It’s an opportunity to meet new investors and catch up with investors he hasn’t seen in a while. There are also potential partners at many of these conferences. Also, it’s always possible to pick up some valuable intelligence from those 1X1 meetings, sidebar meetings in the hallways, or at lunch (or cocktails). The problem isn’t attending too many conferences. The problem is the messenger and his lack of credibility with investors. He should bring Dr. Kaufmann to these conferences and let him do the presentations and be a strong second in 1X1 meetings. The problem is that Missling has a big ego that won’t allow him to share the spotlight with anybody else.

Well, if it ain't a wallet or a comb, it must be a schedule for releasing......something

That's the concern. The wording changed in the near-term milestone from "imaging trial and p2b/3 PD trial" in July's company presentation to "imaging trial or p2b/3 PD trial" in today's presentation. Because there is very little chance the company will conduct PD p2b/3 over the imaging trial. Therefore, the company is effectively communicating the p2b/3 PD trial is no longer a near-term target.

So what would the prevailing attitude of this message board be if he didn't present when the competition is presenting? I'll bet he has a comb...

It feeds his ego to attend and to present.

Not complicated.

I’m not sure I want see whatever Missling have in his back pocket 🫣

The imaging trial has been played down before, but the whole PDD / PD affair is taking forever. I don’t see much purpose in an imaging trial, a sufficiently powered P3 PD/PDD trial would be more relevant.

Why does Missling present when there is no worthwhile progress or update of importance; it just does not make sense to me! The market players have sensed that and therefore have hit the stock today...lousy volume, no interest.

I keep thinking he has something in his back pocket, but he forgot to take his wallet........ha ha

The presentation's live video feed shows CM sitting in a conference room with a few people (Jin, Lopez, Hammond?) in the suite coming into the room, indicating an important meeting is about to take place. Perhaps a board meeting if the lady behind CM is indeed Ms. Ma. Not a big deal, all speculation but I am disappointed that CM seems to be punting on the p3 PD trial following the Rett program. The imaging trial could just be a tiny trial to satisfy the MJF contract which they already cashed out the funding to avoid a lawsuit.