Anavex Life Sciences Corporation (AVXL) オプション

The patent moat keeps getting larger.

Ummm. That just not how YOU think it should be done.

Not quite the same thing.That’s just not how it’s done.

True - but if A2-73 is approved and is reasonably priced, it is unlikely that EMA country national healthcare systems would not pay.

Keep in mind that healthcare in Europe is generally a very different arrangement compared to the U.S.

The charts we have just seen for the OLE overall continues to decline without a plateau effect seen.

Maybe it exist, but it wasn't shown either in the presentation regarding 74 Compassionate Use patients, which we only mentioned in the PR.
Compassionate Use:

Lastly, there are currently 74 participants receiving blarcamesine within the Compassionate Use Program, who continued treatment with blarcamesine subsequent completion of respective preceding open-label-extension studies from both ANAVEX®2-73-AD-EP-004 in early AD and from ANAVEX®2-73-003 in mild-to-moderate AD. Including the start of the respective preceding studies, some participants are on oral blarcamesine once daily for over 9 years. Importantly, no severe or life-threatening adverse events were attributed to blarcamesine.
There is also no actual control in the data presented, not even ADNI.

It's like protecting the barn after the animals have left.

I think you really have to squint and turn the results on their head to come away with that take bio checker.

Haven’t heard from from Nidan7500 in a few weeks.
Are you still with us?

You are referencing authorization, which is different than reimbursement. Without reimbursement the vast majority of patients would not be able to afford the medicine and reimbursement means that the healthcare system of that country offers it to the patient at a very low cost.

It may not be a miracle drug but please name a better drug for AD? Also, I think they have another PR lined up for Monday.

Yes. I understand that point. But it's my understanding that A2-73 prevents further shrinkage...thereby providing continuous benefit as the patient ages.

The European Union-wide procedure for the authorisation of medicines, where there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines are eligible for the centralised procedure.

This is a patent application, not an issued patent, that we have previously discussed.

Fortunately, Anavex has plenty of money to allow it to stay in business while it secures country-specific approvals in Europe following an EU approval. Or, as is likely, a partner helps out. Jeesh.

Slightly interesting quirk in terms of the completion rates in OLE:

Completion rate in ADAS COG to 96 weeks of those who finished main trial:

Early start - 65.97%
Delayed start - 52.46%

It seems on ADAS COG only just over half of the original placebo group who finished main trial completed the OLE to 96 weeks. Whereas early start group had significantly higher completion to this point. It could theoretically be that "weaker" original placebo group members dropped out of the OLE before 96 weeks.
From 96 weeks to 144/192 it's slightly more balanced between the two groups.
In terms of % from week 0 ADAS COG - 30.87% of early start group completed to week 144 vs 28.66% for delayed start and for ADL 35.57% early start completed to week 144 vs 30.49% from delayed.

Therefore no longer any argument of surivival bias in-fact the opposite, with higher dropout from the original placebo group over the course of OLE.

Also, the original placebo group had slower titration in OLE so there is arguably less of a "reason" for their dropout then there was for original dosed group with its higher dropout in main trial which was argued to be due to the too fast titration.

If you show up too late you can't get the missing brain back. It has already shrunk too much. The function you want to save has already been lost.

Missling was required to issue the PR on Saturday per Reg FD.

more then your dream.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

I would think a 2nd repeat PR will be forthcoming Monday morning. Hasn't this already occurred?

I think the data are just fine without that analysis.

Anavex could have simply added something like in green below.
Additionally, the comprehensive data from the blarcamesine Alzheimer’s disease program represents a solid foundation for the subsequent strategy of our Phase III and IV pipeline development plan.”
If that is what the comment in an Alzheimer's specific PR was about.

The PR's statement that "the comprehensive data from the blarcamesine Alzheimer’s disease program represents a solid foundation for the subsequent strategy of our Phase III and IV development plan" is in contrast to the previous PR in January stating that “these data serve as the foundation for the MAA filing that is currently being reviewed by the EMA.” (Incidentally both quotes come from Talavera.) The MAA is also not mentioned in our AD/PD conf deck.

Our MMA submission has been pretty prominent in the company's communications about 2-73 to date. The MAA review is no doubt still in place, but it raises the question of whether there has been some recent interaction with the CHMP that warranted the above. Could be positive (phase 3 refers to other indications, phase 4 refers to possible AA), or less so (feedback that MAA probably not viable without more clinical testing).

Let's see what Missling says about the MAA or the "subsequent development plan" on Monday.

How much do you and your friends own? 30%? Based on your posts, it seems closer to 50%.

Highly accurate blood test diagnoses Alzheimer’s disease, measures extent of dementia

Could help determine which patients are likely to benefit from new Alzheimer’s drugs

A newly developed blood test for Alzheimer’s disease not only aids in the diagnosis of the neurodegenerative condition but also indicates how far it has progressed, according to a study by researchers at Washington University School of Medicine in St. Louis and Lund University in Sweden.

Several blood tests for Alzheimer’s disease are already clinically available, including two based on technology licensed from WashU. Such tests help doctors diagnose the disease in people with cognitive symptoms, but do not indicate the clinical stage of the disease symptoms – that is, the degree of impairment in thinking or memory due to Alzheimer’s dementia. Current Alzheimer’s therapies are most effective in early stages of the disease, so having a relatively easy and reliable way to gauge how far the disease has progressed could help doctors determine which patients are likely to benefit from drug treatment and to what extent. The new test can also provide insight on whether a person’s symptoms are likely due to Alzheimer’s versus some other cause.

The study is published March 31 in Nature Medicine.

In the study, the researchers found that levels of a protein called MTBR-tau243 in the blood accurately reflect the amount of toxic accumulation of tau aggregates in the brain and correlate with the severity of Alzheimer’s disease. Analyzing blood levels of MTBR-tau243 from a group of people with cognitive decline, the researchers were able to distinguish between people with early- or later-stage Alzheimer’s disease and separate both groups of Alzheimer’s patients from people whose symptoms were caused by something other than Alzheimer’s disease.

“This blood test clearly identifies Alzheimer’s tau tangles, which is our best biomarker measure of Alzheimer’s symptoms and dementia,” said co-senior author Randall J. Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor of Neurology at WashU Medicine. “In clinical practice right now, we don’t have easy or accessible measures of Alzheimer’s tangles and dementia, and so a tangle blood test like this can provide a much better indication if the symptoms are due to Alzheimer’s and may also help doctors decide which treatments are best for their patients.”

Tracking Alzheimer’s disease progression from blood
Alzheimer’s disease involves a build-up of a protein, called amyloid, into plaques in the brain, followed by the development of tangles of tau protein years later. Cognitive symptoms emerge around the time tau tangles become detectable, and symptoms worsen as the tangles spread. The gold standard for staging Alzheimer’s disease is positron emission tomography (PET) brain scans for amyloid plaques and tau tangles. Amyloid scans yield information about the presymptomatic and early symptomatic stages, while tau scans are useful for tracking later stages of the disease. PET brain scans are highly accurate but expensive, time-consuming and frequently unavailable outside of major research centers, so they are not widely used.

Bateman leads a team that is developing blood tests for Alzheimer’s disease as a more accessible alternative to brain scans. They have developed two blood tests that correlate closely with the amount of amyloid plaques in the brain. Both are now used by doctors to aid diagnosis. But until now, there has been no blood test that reports on tau levels in the brain.

In a previous study, Bateman and colleagues — including co-first authors Kanta Horie, PhD, a research associate professor of neurology at WashU Medicine, and Gemma Salvadó, PhD, then a postdoctoral researcher at Lund University, and co-senior author Oskar Hansson, MD, PhD, a professor of neurology at Lund University — showed that cerebrospinal fluid levels of MTBR-tau243 correlate closely with tau tangles in the brain. In the current study, the team extended the analysis to blood. A blood sample is easier to collect than cerebrospinal fluid, which is obtained via spinal tap.

The researchers developed a technique to measure MTBR-tau243 levels in people’s blood and compared it to the amount of tau tangles in their brains as measured by brain scans. They piloted the approach on data from two cohorts: volunteers at WashU Medicine’s Charles F. and Joanne Knight Alzheimer Disease Research Center, which included 108 people, and a subset of 55 people from the Swedish BioFINDER-2 cohort. To assess whether the approach was generalizable, they validated it in an independent dataset consisting of the remaining 739 people in the BioFINDER-2 cohort.

The people in the two cohorts represented all but the most severe end of the spectrum of Alzheimer’s disease, from the presymptomatic stage when brain amyloid levels are elevated but people remain cognitively healthy, through early-stage disease with mild cognitive impairments, to late symptomatic disease when patients exhibit full-blown dementia. For comparison, cognitively healthy people with normal amyloid levels, and people with cognitive symptoms due to conditions other than Alzheimer’s disease, were included.

The researchers’ analysis showed that blood MTBR-tau243 levels reflected the amount of tau tangles in the brain with 92% accuracy. MTBR-tau243 levels in the blood were normal in asymptomatic people regardless of amyloid status, meaning that blood MTBR-tau243 levels do not change between healthy people and people in the presymptomatic stage of Alzheimer’s disease with amyloid plaques.

Among people with cognitive symptoms due to Alzheimer’s disease, MTBR-tau243 levels were significantly elevated for people in the mild cognitive impairment phase of Alzheimer’s disease and much higher — up to 200 times — for those in the dementia phase. Those differences translated into clear separation of people in early- and late-stage Alzheimer’s disease. At the same time, MTBR-tau243 levels were normal in people with cognitive symptoms due to diseases other than Alzheimer’s, meaning that the test effectively distinguished Alzheimer’s dementia from other kinds of dementia.

The technology underlying the blood test for tau aggregates has been licensed by WashU to C2N Diagnostics, a WashU startup that developed the blood tests for amyloid. These amyloid tests incorporate measures of another form of tau called p-tau217.

“I believe we will use blood-based p-tau217 to determine whether an individual has Alzheimer’s disease, but MTBR-tau243 will be a highly valuable complement in both clinical settings and research trials,” said Hansson. “When both of these biomarkers are positive, the likelihood that Alzheimer’s is the underlying cause of a person’s cognitive symptoms increases significantly, compared to when only p-tau217 is abnormal. This distinction is crucial for selecting the most appropriate treatment for each patient.”

Blood tests could inform personalized Alzheimer’s treatment

Two Alzheimer’s therapies have been approved by the Food and Drug Administration (FDA) to slow progression of the disease, and both work by lowering amyloid levels in the brain. Horie said the number and variety of available Alzheimer’s medications may soon be expanding, as several experimental drugs that target tau or other aspects of Alzheimer’s disease are in the pipeline. With blood tests to diagnose and stage the disease, doctors would be able to tailor treatments to the patient’s particular disease state.

“We’re about to enter the era of personalized medicine for Alzheimer’s disease,” Horie said. “For early stages with low tau tangles, anti-amyloid therapies could be more efficacious than in late stages. But after the onset of dementia with high tau tangles, anti-tau therapy or one of the many other experimental approaches may be more effective. Once we have a clinically available blood test for staging, plus treatments that work at different stages of the disease, doctors will be able to optimize their treatment plans for the specific needs of each patient.”

https://medicine.washu.edu/news/highly-accurate-blood-test-diagnoses-alzheimers-disease-measures-extent-of-dementia/

told a few friends to buy more tomorrow.all data set for approval .JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS

I especially liked these points:

Maximizing Visibility

Releasing data while it’s being discussed at a major international meeting ensures real-time engagement from researchers, media, and investors.

Releasing potentially market-moving news over the weekend allows time for stakeholders to digest complex scientific data before markets open Monday.

Implications for Investors

It’s also a time when high volatility is likely first thing Monday morning, depending on how the data is received.

From a weather guesser to space junkie, back to the friendly sky's of aviation. Interesting lifetime...

Question to ChatGPT - you could try it, good for checking things you know!

"is it common for biotech companies to release news over a weekend in relation to scientific conference presentation?"

Yes, it is fairly common for biotech and pharmaceutical companies to release news over a weekend, especially when it coincides with scientific or medical conferences such as:

Alzheimer's Association International Conference (AAIC)

American Academy of Neurology (AAN)

American Society of Clinical Oncology (ASCO)

European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Why Weekend Releases Happen During Conferences
Conference Presentation Timing

Scientific conferences often run Thursday through Monday, with key data presentations on Saturday or Sunday.

Companies time press releases to coincide with live presentations or abstract unveilings, maximizing exposure.

Respect for Embargoes

Journals and conference organizers frequently place embargoes on clinical trial results.

Companies can only release information once the embargo lifts, which might be Saturday at midnight, for example.

Maximizing Visibility

Releasing data while it’s being discussed at a major international meeting ensures real-time engagement from researchers, media, and investors.

Market Neutrality

Releasing potentially market-moving news over the weekend allows time for stakeholders to digest complex scientific data before markets open Monday.

Examples of Notable Weekend Releases
Biogen & Eisai released aducanumab and lecanemab data over weekends tied to major neurology and Alzheimer’s conferences.

Anavex Life Sciences, Cassava Sciences, and others have followed similar timing during AAIC and CTAD (Clinical Trials on Alzheimer’s Disease).

Implications for Investors
Investors following biotech stocks should be alert to conference schedules and expect weekend press releases or data drops.

It’s also a time when high volatility is likely first thing Monday morning, depending on how the data is received.

Conclusion
Yes — it’s a strategic norm in biotech to release clinical trial updates over a weekend when tied to major scientific meetings. It's not suspicious or unusual, but a calculated move to align with the scientific and investor communication cycle.

Would you like a calendar of key upcoming biotech conferences to watch?

Has there been analysis to show that DPZ-naive patients fair differently published in the peer reviewed papers we have seen? If not why would Anavex withhold such clear and useful information? Or maybe I just missed it!

Blarcamesine to treat or prevent brain atrophy...
"[0003] Brain atrophy, or cerebral atrophy refers to loss of brain cells (neurons), connections between brain cells, and/or loss of brain volume, and when accelerated over the normal brain atrophy of aging is associated with many different diseases that can affect the brain. Brain atrophy can manifest in a generalized form across the entire brain or can be more localized to a portion of the brain. Depending on the area and extent of tissue loss and atrophy, various brain functions including executive functions can be impacted. Symptoms of brain atrophy may include seizures, dementia, memory loss and aphasias.

[0004] Diseases and conditions of the brain may involve brain atrophy include among others, Alzheimer’s disease, stroke, traumatic brain injury, Pick’s disease, fronto-temporal dementia, cerebral palsy, Huntington’s disease, leukodystrophies, mitochondrial encephalomyopathies, multiple sclerosis, and infectious diseases....

Blarcamesine to treat or prevent brain atrophy...new patent.
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2025054599&_cid=P22-M882DW-31323-1

I posted something similar yesterday but you expressed it better.  Even if we get EMA approval it basically means very little until you get all the individual reimbursements.  And you outlined (better than me) the reasons that will be very difficult. 

Hmm...how can there be a "point of no return where A2-73 no longer is effective" if the drug stops the brain mass from shrinking?

Brain shrinkage (atrophy) deteriorates brain cells. If you stop the deterioration of brain cells, you are providing a continuous benefit to the patient.

Keep dreaming. That’s just not how it’s done.

I read the same PR you did and came away with a different interpretation. To me it looks like blarcamesine has some utility in a subset of very early stage AD patients only. Plus, Alzheimer’s is very difficult to diagnose, which means a great many patients aren’t diagnosed until they are past the earliest stages of the disease, thereby severely limiting the market. I suspect doctors will be reluctant to prescribe blarcamesine for patients who have not been definitively diagnosed since memory issues and cognition can have multiple causes that may be more amenable to treatment by other means. Likewise, insurance companies will likely not pay to cover the drug unless there has been a confirmed early AD diagnosis. Prophylactic use of blarcamesine is unlikely in my opinion.

I think the EMA is likely to require large Phase 3 trials. The FDA would also want large Phase 3 trials, which is why Missling has not filed a NDA. He’s throwing a Hail Mary pass with the EMA in the hope that blarcamesine can squeak through.

We already knew this info and the EMA has had it for months, too. Odds are unchanged but maybe the stock will get more attention now.

What stupid take - Missling issued the PR on Saturday to give the market as much as  time as possible to evaluate the news which is his responsibility 

From a disclosure perspective Missling did not need to issue the PR yesterday. He could have issued the PR pre-market (say 7:00 am) tomorrow. Even if there were investors at the conference who saw the presentation and wanted to invest, they could not have done so until the market opened tomorrow. Issuing the PR at 7:00 am would have given all investors the opportunity to see the news and would have met legal disclosure requirements.

Issuing the PR on a Saturday morning only served to bury the news. The only possible reason a CEO would issue a PR on a weekend would be to bury the news. Perhaps that is what Missling intended since the data make clear blarcamesine is not the miracle drug many here imagine it to be.

I think we could see the stock open lower tomorrow.

Sure, and if that's the case we'll just go back to Arciept+.

But to be honest, it's likely that the FDA's approval process and timeline will not matter much to those posting here today. If Anavex is approved in Europe and it becomes a popular drug in Europe, many here will have made more than enough to not really care about what happens in America during the short-term.

And given the urgent unmet need in Europe, it's unlikely that the EMA will require another trial -- that's something that would have come up in preliminary discussions with the regulators and would have precluded submitting an MAA.

I think the results of the DPZ-naive participants are known and are what is going to carry the day.

In fact, there might be a black box warning that states: "Do NOT take Blarcamesine with any other CNS drugs!!!"


ANAVEX NOW ... RIGHT NOW ... FOR ALL AGES!!!

Me too!!

Well, well, well, if approval probability was 80% to 90%, given EMA submission acceptance combined with JPAD blarcamesine article release, then those odds just increased greatly with the release of yesterday's highly positive test results.

The other major investment consideration is the estimation of AVXL NPV. Some hear have calculated $80 as a reasonable estimate of NPV.

Utilizing those two main price determinants, one can reasonable conclude that at $8.00, the AVXL price is way, way undervalued. Even in a negative or flat general market, AVXL's underpinnings support a much higher price. Analyst estimates of $40 for AVXL do not appear unreasonable for AVXL price this year,

Oh yes, and by the way,

WGT! WGT! WGT! WGT! WGT! WGT! WGT!
WGT! WGT! WGT! WGT! WGT! WGT! WGT!
WGT! WGT! WGT! WGT! WGT! WGT! WGT!
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I guess I hit the nail on the bald head.

I never questioned your commitment, nor I question investor's.

It is just wild to go after a promising AD company lol

Actually, with an early professional position as a Meteorologist
I am very familiar with analyzing data and coming to an independent conclusion.

That may be a foreign concept to some lemming investors.

BTW....What hair? Shaving requires commitment and practice.

It seems your straws are thinner than Leo's hair.

Yea i know you enjoy the weather man that tells you it will rain on a rainy day lol!

I'm not surprised....

Perhaps more valid than ad hoc guarantees.

Increased holdings of a spec bio in a risk off environment seems less than prudent.
Evaluating making that investment in AVXL occasionally based upon company specific events
is an entirely different animal.
The concept of ever present "dry powder" remains a mystery from some who profess to be
ALL IN and WGT while never selling upon those denigrated trimming(s) on irrational spikes.

Can't have it both ways. Unless you have a constant supply of Square Grouper that must
find its way into the Market, in the context of claims on this site, Dry Powder is a FARCE.
(and I emphasize the comical)

Oh post hoc odds calculations, I see lol

Now that's odd.

The data has spoken for itself...requiring a P3 from the FDA.

Hoping my $AVXL investment will help.