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Anavex Life Sciences to Present at the 7th Annual Evercore ISI HealthCONx Conference 2024

NEW YORK, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:...

Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA

• First marketing authorization submission for blarcamesine NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE...

Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal

NEW YORK, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:...

Anavex’s Blarcamesine Achieves Pre-specified Efficacy in Phase IIb/III Alzheimer’s Trial: Data Presented at CTAD Conference 2024

Data of Blarcamesine confirm upstream SIGMAR1 activation Presented as Late Breaking Oral Communications at...

ZenaTech, Inc. (NASDAQ: ZENA) Software Company Acquisition

ZenaTech, Inc. (NASDAQ: ZENA) Software Company Acquisition Miami, FL – October 23, 2024 -- InvestorsHub...

Anavex Life Sciences Announces Encouraging Preliminary Biomarker Results from Ongoing Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia

Part A of the placebo-controlled Phase 2 study has been completed ANAVEX®3-71 demonstrates a dose-dependent...

Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference

ANAVEX®2-73 corrects directly to humans’ translatable EEG biomarkers in a model of Fragile X Syndrome (FXS...

Form S-3 - Registration statement under Securities Act of 1933

Hoskuld 25 minutes ago

Amazon Pharmacy is run much more rigorously than the more general Amazon marketplace.

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ignatiusrielly35 34 minutes ago

But will Amazon engage in marketing and engaging with healthcare practitioners? Seems to me that Amazon could handle distribution very well but that's about it. I don't see the logic in using Amazon, personally.

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sab63090 34 minutes ago

Citrati
Thanks for your comments & I certainly agree with the negative divergences both in the RSI and CCI and especially the resistance on the 200 weekly (6 times!!!!)...momentum has stopped being hot, but, so far, the stock has not collapsed rather we are testing the 2 prior lows of a few days ago which is just an observance at this point.

Not sure I would welcome a move down to that $8 plus area...I guess I would be OK with $8.61 to $8.40, but not happy! lol

My objective remains $15 plus if this stock can take out $10.26 to $10.50 on high volume and is able to stay there.

Hope Thanksgiving was nice for you & family.......Cheers!

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sumbuysumsell 44 minutes ago

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sumbuysumsell 44 minutes ago

a bit tongue in cheek but doesn't amazon only sell products made in the peoples republic of china?

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taketobank 49 minutes ago

yes. I also remember him mentioning Amazon as an example of a possibility. Not sure if that is a great idea due to the potential of 'fake' anavex being sold online. jmo

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BIOChecker4 55 minutes ago

A dose of reality that runs counter to the approved WGT narrative always stings, doesn’t it? Anyone who dares to voice an opinion and poke the WGT bubble with facts is immediately labeled a FUDster or basher.

Only listening to the people you agree with could be detrimental to your financial health.

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mike_dotcom 60 minutes ago

Shorts - cover now. FREE ADVICE.

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BakedLangostino 1 hour ago

Amazon can undercut any BP. It has more cash, the best logistics and distribution network in the world, a massive marketing budget and manufacturing and warehouse facilities.

Now imagine if Amazon were to be offered exclusive distribution rights? It could ship to pharmacies for patients who need to pick up in-person, but more importantly, it has the cash to make a serious offer. For Amazon, it gets increased membership which means more people using its platform and it'll make money selling a wildly popular drug.

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Hosai 1 hour ago

Yeah he emphasized how it can be stored and transported at room temperature etc, unlike the MABs which require cold chain logistics.

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williamssc 1 hour ago

The value I see is Amazon pre-sorted pill pac could easily deliver Blar right to the door.

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Citrati 1 hour ago

sab, until the daily negative divergences finish playing out or more news comes this consolidation must occur. The speed of the rise created structural price weakness. Also of importance is the weekly 200period resistance currently at 10.39. History of last 3 years shows that AVXL does not like price outside the upper bb for long. Currently it has been 5 weeks. Finding new support for the next move is needed IMO. The weekly rising 8ema and 150sma at 8.05-8.17ish are in play.
Just a WAG, however daily could test 8.61 to 8.40's on a closing basis and still maintain this up move trajectory. Time will tell.

Weekly says 12 is the top of next strongest resistance after 10.45 based on VbP structure and then the swing high candle identifying 12-15.24 zone.
Best Wishes.

PS: price has been holding up well today so far. Closes are always most important for future analysis.

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Hoskuld 1 hour ago

Manufacturing is a non-issue: this is solid dosage and they don't need to do anything more than pay for that service. Sales and marketing is where a partner could bring real value. Distribution using Amazon is interesting. What value add does Amazon bring?

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Steady_T 1 hour ago

He also said partnering after approval.

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tredenwater2 2 hours ago

BL he did mention Amazon.

“ Amazon is intriguing but I've yet to find any evidence that Dr. Missling specifically mentioned Amazon which leads me to believe it's an internet rumor.”

Just not in the context of a partnership per say. What I recall, more than once was something to the effect of:

“Unlike the mabs, our drug is easily distributable, if Amazon can reach you, you will have access to take our drug.” (Paraphrased)

Is a partnership inferred, probably not but I wouldnt rule it out. Amazon is wanting to get into the space and like other companies is sitting on a huge pile of cash.

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williamssc 2 hours ago

Thanks. My thought is partnering through manufacturing. Yes in fact, I heard myself where Missling said Amazon could be used for distribution. Amazon does have it's own a pill pak pharmacy.

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BakedLangostino 2 hours ago

Partnership is a very broad term though. Will it be a full partnership where Anavex hands over the reigns and collects royalties every month? Or will it just be for manufacturing and/or distribution, with Anavex hiring an inside sales team to market the drug? It wouldn't be too hard to poach the best of the best for a drug that will presumably sell itself if approved.

I don't think Dr. Missling played it this aggressive only to capitulate early on in a bad deal. He's positioned the company to have the means to go at it alone -- yeah it'll mean postponing PDD and all the others, but we don't need a partner if there aren't any good offers.

Amazon is intriguing but I've yet to find any evidence that Dr. Missling specifically mentioned Amazon which leads me to believe it's an internet rumor.

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powerwalker 2 hours ago

george, isn't Anavex presenting at a Noble investors' meeting this week?

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williamssc 2 hours ago

Dr Missling said they would be partnering for Alzheimer's. Still waiting on that shoe to drop.

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BakedLangostino 2 hours ago

$150 is aspirational right now. Let's check back in 3-5 years and see what is aspirational then? It's possible that Anavex is out of business but it's also possible that it becomes a multi-billion dollar company with predictable cash flow streams and a multi-tiered pipeline for expansion.

It wouldn't take much to get 1.75 million people globally each paying (or insurance paying) $5000/year. That puts us at $8.75B gross and figure a 20% royalty payment leaving us with $1.75B net income. Operating costs may be 40% so that puts us around $1B EBITDA. Assume 100mm shares outstanding and a P/E of 15x to get to $157/share.

I think the TAM, if this gets to market, is much larger than my back of the napkin numbers. I've got Mayo and Dado in one corner and Doc and Investor in the other. I don't trust anyone on iHub so I'll go to the professionals for guidance. I've got Martin Shkreli vs Dr. Sabbagh, and Adam Feuerstein vs Dr. Jin.

Hey, you never know. Sometimes the Washington Generals get lucky and win.

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boi568 3 hours ago

Peter actually did go after SAVA before the trial was reported, eventually calling its drug worthless.

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williamssc 3 hours ago

I noticed neither Mayo or Peter wasted their intellect on SAVA..

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Hoskuld 3 hours ago

Obviously $150 per share is aspirational and "surprise" just means that "if the world was a generous place then...". The Market is unpredictable: true that the stock price has not surged through $10 yet - but maybe the MAA acceptance in 2 weeks time will change that (assuming it happens.)

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mike_dotcom 3 hours ago

Same old same old.

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georgejjl 4 hours ago

Anavex, will participate in a fireside chat being held December 4th, 2024 at 3:25pm ET at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL.

An audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com

Good luck and GOD bless,

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powerwalker 5 hours ago

As this is "Giving Tuesday," let us do our best $$ for those causes we believe in and support.

Peace,
powerwalker

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LakeshoreLeo1953 5 hours ago

The Market seemingly can not support even 9.80 which would lead me to take my final bite.
"Surprise" at not $150 seems absurd within current context.
I would be willing to supply 15K @ $15 and save you the ten multiple.
Oh that's right. The Market makes a better offer now and likely for at least the near future.

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LakeshoreLeo1953 5 hours ago

Pot calling the kettle black?

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Lacey1 5 hours ago

I am surprised we are not at 150 share price today with the lack of side effects and reduced brain loss. This will be used prophylacticly across the entire neurological spectrum of indications. And people are still trying to short this.

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Hosai 5 hours ago

Can't definitely say there wouldn't be any other kind of trial but if there ever was hopefully it would be post approval.
The idea that the EMA would not at the very least give conditional approval (the benefits are greater than the risks) would be kind of absurd when they have approved Lecanumab which even in the sub-group approved had a weaker ADAS COG & CDR SB score vs placebo than Blarcamesine and worse risks in terms of safety (outside of the small risk of death from drug Lecanumab has been approved despite it not being clear yet why it seems to shrink the brain).
To say otherwise I would suggest someone has some kind of financial incentive in it taking a lot longer for patients to try Blarcamesine rather than having patients interests at heart.

The variant finding was very low p value - 0.0001 but doesn't necessarily mean much yet due to the sheer number of genes and variants looked at as it could be argued they may have been bound to stumble on one with that level of significance (sigma wt sub-group which showed improvement was obv pre-specified though). However the OLE looking positive (from title) is great news and clearly was seen as significant enough for Dr Sabbagh to do a 15 minutes presentation on it at the AP/PD summit.

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sab63090 6 hours ago

Above my head, so thanks for shaking the tree!

I have to rely on people like Dr. Sabbagh, Dr. Jin, and someone recently who made things happen with the MAA filing (Talavera) to be one step ahead of the negative comments I've read about such as:

"There will be no MAA filing before year end"
"no peer review paper"

Although the price has been stopped quite a few times below that $10 area, it continues to stay right below it without crashing; makes me think that the momentum up is just stalling for now.

Yes, there is a negative divergence currently with RSI/price..the reading can easily shift to very strong over +70 to over +80 on a quick volume/price push up!

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sab63090 7 hours ago

12x

You always seem to be aware of things not openly discussed, so thanks for bringing these things out..I would think (hope) that Dr. Sabbagh and Talavera (the recently praised person who made the MAA filing happen), and Dr. Jin all worked on these things to bring the magic together! I'm still waiting for good OLE data to support our efforts.

I have not been counting on the peer paper which has been promised; it would be nice though.

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Hoskuld 14 hours ago

SunAlan will you please send PowerWalker a PM - I can't reply here but PW can give you my email address and we can correspond that way?

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Hoskuld 14 hours ago

Shorts are working this board, and others, hard. Why? Because the jig is up: the MAA is submitted and nearly accepted; the 3-71 schizophrenia program is nearly done with P2; a PD P3 is about to start. The OLE apparently was very successful. I am not a big fan of post hoc analysis - but there is enough there to be of extreme interest to regulator agencies because the subgroups were the majority of patient in an overall very successful trial - not tiny groupings segregated in desperation to rescue a failed trial. Skrkeli is nothing - many of us called SAVA a failure 2 years ago (and when you lump in the fraud indictments, the dismissal of the CEO and CSO, and the admission that data was selectively released,,,nearly everyone knew SAVA was going to fail, even Shrkeli who sounds like he is pretty clueless.) This is going to be a nice ride. AVXL actually executed last week - part of what we hope is a new pattern.

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catdaddy 15 hours ago

He has an agenda with every post.

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catdaddy 15 hours ago

Be careful playing straight man for the charlatan.

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georgejjl 15 hours ago

Anavex 3-71 and/or blarcamesine are both activators of the M1 muscarinic receptor

M1 muscarinic receptor activation reverses age-related memory

https://www.sciencedirect.com/science/article/pii/S0197458024001830?via%3Dihub

Good luck and GOD bless,

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bb8675309 15 hours ago

Here comes the Disqualification Team. People that take Blarcamesine feel better. It's the safest proven drug with over eight years of drug trial results in the CNS space. Hands down...
Drug regulators need to approve this drug so people with CNS disease can finally get better. We want access to Blarcamesine now..

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12x 15 hours ago

Always great insight Doc! I understand the company may be aiming for a headline like 'Best Blarcamesine cohort can halt AD progression', but I agree these findings are hypothesis-generating and could inadvertently impact the approval chances.

What’s your perspective on the seemingly promising OLE results hinted at by Dr. Sabbagh’s AD/PD 2025 oral presentation title: 'Phase IIB/III Attention-AD trial Over three years of continuous treatment with oral Blarcamesine continues to SIGNIFICANTLY BENEFIT early Alzheimer’s Disease patients'; While it doesn’t address dropout rates or safety, does it suggest that efficacy—at least based on ADAS-Cog13—is sustained over three years? This was one of my main concerns, especially given the delayed separation in efficacy until 48 weeks during the earlier trial phase.

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catdaddy 15 hours ago

Thanks, Doc, but I believe I will go with this:

https://media.stocktwits-cdn.com/api/3/media/558354/default.jpg

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Doc328 17 hours ago

Here's some amateur analysis of the new gene discovery on Stocktwits by Mayomobile and Peter Karol (posting as "Formeridiot88"):

Amateur indeed. Mayo needs to understand the difference between WES (whole exome sequencing) and RNA-Seq (RNA transcriptomics analysis). The abstract that 12x posted was WES not RNA-Seq. WES looks at all the exons in the DNA to determine if genes are WT or gene variants (i.e S1R WT vs Q2P variant or in this case COL24A1 WT vs variant) and RNA-Seq looks at mRNA gene expression. So of the 25000 genes in the human genome a couple hundred showed different responses between WT and variant. We don't see the p value threshold used (usually 5 x 10^-7 to handle multiplicity) or definition of 'trait' (in this case response definition). Of course if COL24a1 did better than mixed WT and variant, then the variant would have done worse, maybe even no response to A273.

Peter takes an optimistic approach to imply neurogenesis due to a differential response to A273 based on COL24A1 WT vs variant. Gene expression of COL24A1 can be found in some neurons but is not necessarily linked to AD (though COL25A1 is!). There actually is not too much known about .

Data like this is hypothesis generating. A different cohort will be needed to confirm the association ---- perhaps the phase 3 study will pre-specify the 40% of AD patients who are S1RWT and COL24A1 WT.

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oldmystic 17 hours ago

Respectfully, please make the company aware of your concerns.

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12x 18 hours ago

These appear to be CHMP-requested post-hoc analyses based on pre-specified APOE types, rather than company-initiated ones conducted pre-submission. My concern is that AVXL needs to tread carefully between hypothesis generation and confirmation, especially at this critical drug approval stage. These genome analyses can quickly turn into hypothesis generation if not managed correctly.

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sab63090 19 hours ago

Tom & Kentucky
I recommended your posts...got nothing right now, so I am playing the "Waiting Game" ha ha......let's break that 10.25 to $10.50 level with a strong close, stick above and go for $15.......wish we had a good OLE result to help out!

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sab63090 19 hours ago

Evercore (Roger Altman) has a very good global M&A business!

I'm not sure they presented there before? If so, it might mean something

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BAR123 20 hours ago

I think that you can count on a confirmatory trial with the EMA. That is not so bad as they have 5 years to get it completed I believe and they will be selling the drug the entire time. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf

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Hosai 20 hours ago

I don't believe the relevant sub group the EMA approved was pre-specified as they were expressed as "additional analysis' -

"During the re-examination, the CHMP re-assessed the data submitted by the company. The company proposed to restrict the use of Leqembi to patients with only 1 or no copy of ApoE4 and provided additional analyses of data from the main study, which excluded data from 274 patients who carried 2 copies of the ApoE4 gene and were therefore at highest risk of ARIA."

https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-approval-marketing-authorisation-leqembi-lecanemab_en.pdf

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12x 20 hours ago

For LEQEMBI (lecanemab), APOE-related safety analyses were predefined, as the potential for ARIA-E (amyloid-related imaging abnormalities with edema) and ARIA-H (hemorrhages) in ApoE4 carriers is a well-documented safety concern in anti-amyloid antibody trials. These analyses aimed to evaluate and mitigate the risk in this subgroup.

Regarding efficacy: APOE subgroup efficacy analyses were also predefined, not post-hoc. The Phase 3 CLARITY AD trial specified subgroup analyses to examine treatment effects across ApoE genotypes (e.g., carriers versus non-carriers) as part of the study's statistical analysis plan (SAP). This is consistent with standard practices in Alzheimer’s trials, where stratification by ApoE genotype is often included due to its known influence on disease progression and response to treatment.

Thus, both safety and efficacy analyses for the APOE subgroup in LEQEMBI's trials were planned in advance and were part of the pre-specified analyses submitted to regulators like the FDA and EMA.

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Kentucky123 20 hours ago

Hourly indicators are oversold.

https://bigcharts.marketwatch.com/advchart/frames/frames.asp?show=&insttype=Stock&symb=avxl&time=18&startdate=1%2F4%2F1999&enddate=10%2F1%2F2024&freq=8&compidx=aaaaa%3A0&comptemptext=&comp=none&ma=1&maval=9&uf=8&lf=2&lf2=4&lf3=32&type=4&style=320&size=3&x=34&y=11&timeFrameToggle=false&compareToToggle=false&indicatorsToggle=false&chartStyleToggle=false&state=11

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Steady_T 21 hours ago

If you are going to compare the remaining population of the ITT with the COL24A1 subtracted to the placebo group, you need to subtract the COL24A1 from the placebo group to get a fair comparison.

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Anavex Life Sciences Corporation (AVXL)

Professional-Grade Tools, for Individual Investors.

AVXL News

Anavex Life Sciences to Present at the 7th Annual Evercore ISI HealthCONx Conference 2024

Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA

Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal

Anavex’s Blarcamesine Achieves Pre-specified Efficacy in Phase IIb/III Alzheimer’s Trial: Data Presented at CTAD Conference 2024

ZenaTech, Inc. (NASDAQ: ZENA) Software Company Acquisition

Anavex Life Sciences Announces Encouraging Preliminary Biomarker Results from Ongoing Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia

ZenaTech, Inc. (NASDAQ: ZENA) First US Trial of IQ Nano Drone for Inventory Management

ZenaTech, Inc. (NASDAQ: ZENA) To Commence Trading Today

Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update

Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024

Form 8-K - Current report

Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference

Form S-3 - Registration statement under Securities Act of 1933

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Professional-Grade Tools, for Individual Investors.

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Anavex Life Sciences to Present at the 7th Annual Evercore ISI HealthCONx Conference 2024

Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA

Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal

Anavex’s Blarcamesine Achieves Pre-specified Efficacy in Phase IIb/III Alzheimer’s Trial: Data Presented at CTAD Conference 2024

ZenaTech, Inc. (NASDAQ: ZENA) Software Company Acquisition

Anavex Life Sciences Announces Encouraging Preliminary Biomarker Results from Ongoing Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia

ZenaTech, Inc. (NASDAQ: ZENA) First US Trial of IQ Nano Drone for Inventory Management

ZenaTech, Inc. (NASDAQ: ZENA) To Commence Trading Today

Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update

Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024

Form 8-K - Current report

Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference

Form S-3 - Registration statement under Securities Act of 1933

AVXL Discussion

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