Anavex Life Sciences Corporation (AVXL) Quote

The Chiakin Oscillator 5 day view took sharp upturn in the last few days. Maybe we won't lose on $AVXL today - my TA is as good as it gets you know!

Yawn...😴

The algos chug along until news, and whining in the mean time is a waste of energy.

ot- I gave you rgti for fun...now eq for fun...

Stocks go up and stocks go down. It happens to all of them. No worrier's my boy.

What a dream -

Blarcamesine
3:10 AM

$AVXL At the JPM partnership conference .. the moment happened! Missling said today we are on the list of drugs under EMA review! It was published this am Missling said! That was it! At that moment the value of Blarcamesine became worth billions of dollars in partnership with about a 90% chance of approval and Missling could then make a partnership deal! I assume he hired Maxim group to compile offers in order to avoid investor interference so news would not leak out. Now Maxim will meet with Missling in Florida, far from the Anavex HQ and I assume we can be somewhere around $50 on or before earnings on February 12. .. on the JPMORGAN conference day with Blarcamesine showing up on the list it became worthy of a significant large pharmaceutical partnership. On a major partnership this will soar .. should be $50
Bullish

Another week of nothing except a declining stock price.

If I thought the drug was helping my brain I wouldn't even tell my doc about most side effects lest she discontinue the meds.

Excellent point.

When I posted this I was thinking more of lifestyle issues.
I've read personal accounts where people felt socially isolated because dinner and/or drinks with friends had no appeal for obvious reasons.

My mother, who died from dementia , was vain about her weight and probably would have starved herself all the while thinking how clever she was.

Annovis just started enrolling its potentially pivotal AD phase 3. 750 patients, 18 months. Good to see it's a relatively small trial. Hopefully that was from direct regulatory feedback.

ihidfromtheX

yes, me too!

williamssc:

Yes, I believe that I read somewhere about some people having "eye problems" like vision loss. We have so many overweight people in the US that something should be done....RFK, Jr. is at least a good physical example rather than some overweight physicians providing guidance.

Abe:

Just the luck with people moving like in a turtle race!

Although Novo is already approved for one indication, it would still be necessary to complete the big trial of over 3000 people for Alzheimer's. I guess it at least puts an urgency into Missling's "go slow" plans.

I would hope that he files an NDA to the FDA soon after or before April 25th

Thank you for sharing. The commonly estimated MC of $20 billion for AVXL doesn't acount for those countries that AI listed I think. I noticed that China and India are not included on the list while I see often Chinese scientists on the AD related articles. The populations of the two biggest country would be more that 1/3 of the world population.

Very succinct and very accurate!

That highlights one of the huge differences between 2-73 and most drugs.

2-73 restores homeostasis in the body, most drugs disturb homeostasis.

or Misleading doing private placement, his cash on hand never goes down. Capital raise at this price will depressed the share price for long long time. Looks like he didn't get any partners after his JPM fumble.

Hi rx7171, let's look at the at the deal regarding 20% partnership. As I read about, the industry acceptable terms 15-30 %. Just for the argument's sake, our partner for the 80% provides Blarca Manufacturing, Marketing, Sales and Distibution. And the net profit might be in the range of 20% of revenues. For AVXL, 20%.of sales go strait to the bottom line. The partner (BP) has resources to ramp up sales, by established sales force, provide TV ADS and other
other media channels. AVXl could concentrate on other clinical trials growing its future business. Another advantage to partner might be positive influence
on regulatory agencies and the market too.
At this time so many unknowns:
- we don't know the partnership terms, assuming 80-20%
- blarca annual price, assuming $6000
- ramp up of sales speed, assuming that
one year from the day of approval, 2 million will be receiving blarca. of course, it will start slow, but the market will value sales using 2 million, IMHO.
so, let's assume that the market could use the following revenue/stock pricing model:
$ 6000 * 2,000.000 (patients) = 12 billions of revenues. AVXL gets 2.4 billion. Operating expense (new trials, increased payroll, etc..) 300 million.
First profitable year - no taxes. 2.1 billion divide over 90 million shares = EPS 23 apply PE of 15,20,25,30,etc
I do not think anybody would campaign about the price at this time and HUGE future potential.
That is why the stock price depressed, under short covering and accumulation right now. Approval by EMA and volcano erupts!

Pretty much that's the side effects of all of my meds...

Anavex Life Sciences Investor Forum
Alex Pechey •
This may further show the importance of an
EMA approval, here is an Al generated list of the countries that have a sped up recognition pathway where they can approve a submission more quickly if already approved by EMA and without the sponsor having to submit a new full-blown application etc, plus asked it to give the number of days after EMA approval this approval could happen. It gave this list which was not exhaustive but you get the idea.

United Kingdom - 60 days - Medicines and Healthcare products Regulatory Agency
(MHRA) - International Recognition Procedure (IRP)
Singapore - 60 days - Health Sciences Authority (HSA) - Abridged Evaluation Route
Switzerland - 3 months - Swissmedic -
Recognition Procedure
Israel - 3 months - Ministry of Health (MOH) - Recognition Procedure
Australia - 6 months - Therapeutic Goods Administration (TGA) - Provisional Approval Pathway or Reliance Pathway
New Zealand - 6 months - Medsafe - Recognition Pathway
Canada - 6 months - Health Canada - Reliance
Pathway (e.g., Project Orbis) Pechey • 15m • l
This may further show the importance of an
EMA approval, here is an Al generated list of the countries that have a sped up recognition pathway where they can approve a submission more quickly if already approved by EMA and without the sponsor having to submit a new full-blown application etc, plus asked it to give the number of days after EMA approval this approval could happen. It gave this list which was not exhaustive but you get the idea.
United Kingdom - 60 days - Medicines and Healthcare products Regulatory Agency
(MHRA) - International Recognition Procedure (IRP)
Singapore - 60 days - Health Sciences Authority (HSA) - Abridged Evaluation Route
Switzerland - 3 months - Swissmedic -
Recognition Procedure
Israel - 3 months - Ministry of Health (MOH) - Recognition Procedure
Australia - 6 months - Therapeutic Goods Administration (TGA) - Provisional Approval Pathway or Reliance Pathway
New Zealand - 6 months - Medsafe - Recognition Pathway
Canada - 6 months - Health Canada - Reliance
Pathway (e.g., Project Orbis)
Saudi Arabia - 6 months - Saudi Food and Drug Authority (SFDA) - Reliance Pathway
South Korea - 6 months - Ministry of Food and Drug Safety (MFDS) - Reliance Pathway Brazil - 6 months - Agência Nacional de Vigilância Sanitária (ANVISA) - Priority Review
Pathway
Taiwan - 6 months - Taiwan Food and Drug Administration (TFDA) - Reliance Pathway
Malaysia - 6 months - National Pharmaceutical
Regulatory Agency (NPRA) - Abridged
Registration Pathway
Mexico - 6 months - Federal Commission for the Protection against Sanitary Risks
(COFEPRIS) - Reliance Pathway
South Africa - 6 months - South African Health Products Regulatory Authority (SAHPRA) - Recognition Procedure
Turkey - 6 months - Turkish Medicines and Medical Devices Agency (TITCK) - Recognition
Procedure
Argentina - 6 months - Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) - Reliance Pathway

Slower early titration fixed that

Dose adjustment/timing completely solved the Blarcamesine dizziness issue but Kund doesn't bother to mention that. Put him on ignore like I recently did and safe yourself some aggravation.

Slower early titration fixed that, also fixed your post. Help yourself to the brain bleed though.

If I remember correctly doctors who have had years of experience with these drugs noticed staggeringly high discontinuation rates

The AD trial protocol provides for a minimum eight week dose escalating titration period for semaglutide so that alone is one challenge.

But may not be as high as avxl2-73. What a pos, runs tiny trial with 30% participant drop out. Mab even after brain bleeding has lower drop out.

Elderly folks are generally not well enough to tolerate these common effects.

To achieve proper balance/perspective when evaluating adverse side effects, you might want to review the percentage of semaglutide patients in which these side effects were found to exist. Common side effects means "shared" side effects. It is the percentage of patients affected and the severity that matters.

This may further show the importance of an EMA approval, here is an AI generated list of the countries that have a sped up recognition pathway where they can approve a submission more quickly if already approved by EMA and without the sponsor having to submit a full-blown application etc, plus asked it to give the number of days after EMA approval this approval could happen. It gave this list which was not exhaustive but you get the idea.

United Kingdom - 60 days - Medicines and Healthcare products Regulatory Agency (MHRA) - International Recognition Procedure (IRP)
Singapore - 60 days - Health Sciences Authority (HSA) - Abridged Evaluation Route
Switzerland - 3 months - Swissmedic - Recognition Procedure
Israel - 3 months - Ministry of Health (MOH) - Recognition Procedure
Australia - 6 months - Therapeutic Goods Administration (TGA) - Provisional Approval Pathway or Reliance Pathway
New Zealand - 6 months - Medsafe - Recognition Pathway
Canada - 6 months - Health Canada - Reliance Pathway (e.g., Project Orbis)
Saudi Arabia - 6 months - Saudi Food and Drug Authority (SFDA) - Reliance Pathway
South Korea - 6 months - Ministry of Food and Drug Safety (MFDS) - Reliance Pathway
Brazil - 6 months - Agência Nacional de Vigilância Sanitária (ANVISA) - Priority Review Pathway
Taiwan - 6 months - Taiwan Food and Drug Administration (TFDA) - Reliance Pathway
Malaysia - 6 months - National Pharmaceutical Regulatory Agency (NPRA) - Abridged Registration Pathway
Mexico - 6 months - Federal Commission for the Protection against Sanitary Risks (COFEPRIS) - Reliance Pathway
South Africa - 6 months - South African Health Products Regulatory Authority (SAHPRA) - Recognition Procedure
Turkey - 6 months - Turkish Medicines and Medical Devices Agency (TITCK) - Recognition Procedure
Argentina - 6 months - Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) - Reliance Pathway

If I remember correctly doctors who have had years of experience with these drugs noticed staggeringly high discontinuation rates
If it's just the cost that's one thing but if the drug needs to be taken long term for AD...

Elderly folks are generally not well enough to tolerate these common effects. I'm now in the elderly category and I know I couldn't

More common side effects
anxiety
bloating
blurred vision
chills
cold sweats
confusion
constipation
cool, pale skin
cough
darkened urine
depression
diarrhea
difficulty swallowing
dizziness
fast heartbeat
fever
headache
increased hunger
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
nausea
nervousness
nightmare
pain in the stomach, side, or abdomen, possibly radiating to the back
seizures
skin rash
slurred speech
tightness in the chest
trouble breathing
unusual tiredness or weakness
vomiting
yellow eyes or skin

If Blarcamesing had even a handful of these effects bashers would be screaming them from the roof tops.

Would those international trial sites pass muster with the FDA? And why would any major company choose trial sites in Russia?

Loaded with side effects [semaglutide].

Numerous but not life threatening--definitely not as clean a safety profile as Blarcamesine.

Agree a combo of semaglutide and blacamesine is not unlikely assuming Anavex gains approval.

Agree a combo of semaglutide and blacamesine is not unlikely assuming Anavex gains approval.

I don't think another trial would be necessary - not an either or thing. Neurologists throw everything at AD that they can. GLP-1 have worse side effects than 2-73 and both together won't be in hailing distance of the cost of either of the mAbs.

I am really curious to see what happens. Not a fan of some of the test sites (Russia and eastern Europe generally, for example, where corruption in trials has been even recently.) But a huge number of sites in reputable centers in the West.

Loaded with side effects

We already know Blarcamesine improves brain function long term.

Yes. GLP-1 drugs have a unique way of penetrating the blood-brain barrier (BBB). And yes, I believe a combo with A2-73 would be beneficial...but that would require another phase 3 trial to prove it.

It is noteworthy that no Phase I or II trials were conducted (the safety of semaglutide having already been extensively studied in indications outside of AD). It is also interesting that patients in the two NOVO AD Phase III trials have the option to continue on or initiate new AD medications (including MABs) during the trial without a randomization stratification factor being established (could be problematic with the trial statistics). The 52 week extension trials will continue into 2026.

Huge trial. Could be a really big deal. Won't necessarily be competition though - could work together and probably would.

So might become even better to be a long-term Novo Nordisk holder...

Thanks for bringing that post over from Stocktwits, hnbadger. It is interesting to see Maxim Group getting interested enough to put Missling in front of its institutional clients. Maxim did cover AVXL somewhat actively pre-COVID. The analyst, I believe was Jason McCarthy, who is now a senior director of institutional research there. Based on this upcoming event, my guess would be that McCarthy is going to reengage and officially cover the stock again with a Buy recommendation in the near future. Would be happier if some higher tier firms took up coverage -- and expect that may happen in the coming months -- but I knew a couple of very solid analysts there some years back, and they did some good business in small cap stocks.

Results mean everything. If the EVOKE trial results are positive in reducing the risk of Alzheimer’s disease (AD)-related symptoms and dementia, I think it will dominate the media for weeks...perhaps months. It will certainly get the attention of the EMA and FDA. And remember, semaglutide is already approved for weight loss and other diseases...so people will be clamoring for it.

It means that competition for the ALZ space isn’t sitting on their thumbs. We have already wasted so much time getting this drug to the regulatory process. This may come back to bite us in the arse.

Looks like a 2 year study , so the last patient will be in September and read out could be as early as November

Does that mean that $AVXL might never be a $8 stock again?

Probably later than sooner—if ever.

IMO, this is our biggest competitor.

EVOKE and EVOKE+: design of two large-scale, double-blind, placebo-controlled, phase 3 studies evaluating the neuroprotective effects of semaglutide in early Alzheimer’s disease
Alireza Atri, Howard H. Feldman, Charlotte Thim Hansen, Julie Broe Honore, Peter Johannsen, Filip Krag Knop, Pernille Poulsen, Lars Lau Raket, Mary Sano, Hilkka Soininen, Jeffrey Cummings

First published: 20 December 2022

Abstract
Background
Preclinical, clinical, and real-world evidence suggest benefits in Alzheimer’s disease (AD)-related symptoms and reduced risk of dementia in type 2 diabetes following treatment with glucagon-like peptide 1 receptor agonists (GLP-1RA; Figure 1). The phase 3 evoke and evoke+ trials (NCT04777396 and NCT04777409, respectively) will assess the efficacy and safety of the oral GLP-1RA semaglutide versus placebo in participants with early AD. Here, we present the design of these trials.

Method
evoke and evoke+ are two randomized, double-blind, placebo-controlled trials (Figure 2) recruiting across 38 countries, with 2 further countries pending (Figure 3). In each trial, a planned 1,840 amyloid-positive participants (aged 55 to 85 years) with mild cognitive impairment (MCI) due to AD (Clinical Dementia Rating [CDR] global = 0.5) or mild AD dementia (CDR global = 1.0) will be randomized (1:1) to oral semaglutide 14 mg once-daily (escalated via 3- and 7-mg doses over 8 weeks) or placebo for 156 weeks. Participants may use approved AD treatments if on a stable dose =3 months before screening. Other key inclusion criteria are: Mini-Mental State Examination score =22 and Repeatable Battery for the Assessment of Neuropsychological Status delayed memory index score =85. The key difference between the trials is the inclusion of =20% of participants with significant small vessel co-pathology in evoke+. The primary endpoint is change in the CDR – Sum of Boxes score from baseline to week 104. Confirmatory secondary endpoints are change in Alzheimer’s Disease Cooperative Study-Activities of Daily Living-MCI score, and time to progression to dementia among participants with MCI at baseline. Exploratory endpoints include effects on neurodegeneration and neuroinflammation assessed by changes in plasma and cerebrospinal fluid biomarkers. After week 104, participants will continue their original randomized, double-blind, placebo-controlled treatment for a 52-week extension phase followed by a 5-week follow-up, allowing assessment of the long-term effects of semaglutide. A full list of endpoints is provided in Figure 4.

Result
The evoke and evoke+ read-outs are expected in 2025. [If the read-outs are positive, I believe this could influence the EMA in terms of n size and duration]

Conclusion
evoke and evoke+ will be the first large-scale phase 3 trials (N total = 3,680) to investigate the hypothesized neuroprotective disease-modifying effect of semaglutide in early AD.

To view all of the graphs, you should click on the link below.
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.062415

Investors in that stock probably thought there was a > 83% chance of approval.

Sooner or Later, Schizo Will Be Big For Anavex
I expect that next Wednesday 12 February 2025 that we will hear updates regarding ... Anavex 3-71 for the treatment of schizophrenia. I, too, am eager to learn the latest on a clinical trial of Anavex 3-71 for schizophrenia.

Most likely, as indicated by all preliminary info on the topic, Anavex 3-71 will prove to be both safe and efficacious to treat or prevent schizophrenia. Over 3 million Americans have the disease; a market Anavex could capture, alone, making the company profitable in a short period.

A clinical trial of Anavex 3-71 for schizophrenia should not be difficult or expensive to conduct. Ample numbers of diagnosed, suffering patients at any and all trial sites. Then, it won't take lengthy periods (years) to assess and quantify clinical results; they should be evident in weeks.

Let's see if Anavex 3-71 (with a new name, then) becomes the SOC, standard of care drug for schizo. Already, at lunch time, Anavex execs may be tossing back and forth new, proposed names for the company's schizophrenia drug, to see how they sound.

Perhaps some Anavex sleuthing will help enlighten you. All gaps I. Anavex fill. And all the company does is stretch the truth...which is why they fill. See you at $5.85

Sorry...you have a comprehension problem when it comes to charts. It has to go up before it comes down. It went up...it is now working it's way down. The good doctor had a much bigger show of nothing burgers this time to keep the drop from happening so quickly.

That isn't a problem...it isn't something that I am just claiming until it happens...it means there has to be an up wave to X (in this case $14)...and when the retrace is complete...that will be at $5.85. I am sorry if some people have trouble understanding that.