Anavex Life Sciences Corporation (AVXL) News

Any regulatory agency not approving Blarcamesine after 9 plus years of proven safety drug trial results in the CNS space are not worth listening too. imo

Happy Fathers Day to All of us Fathers. Rather than one individual I think we have many posters who all have some specialty to contribute to our group. On July 4th 2025 I celebrate my 27th year retired as Roller on a Stainless Steel Bar Mill. I had the job for 20 years. What's a Roller? My job to be sure what comes out the last hole in the mill was sold rather than Scrapped. Tolerance of a few thousandths. 2 high reversing roughing mill into a 12 stands in a row continuous mill. We made rounds, squares, hex, flats and Angle. As to Alz I have a serious hatred for the disease. Three generations of my Maternal Grandmother All Females born of a female have had Alz. None of the Males whether born of a female or male have had Alz. My wife is a long retired Med Tech and Respiratory Therapist. My Mother's last 19 months she spent living with us along with yes I had a 40+ hours per week caretaker. Mothers last 9 months I was retired. Caretaker's job slightly changed. If I was here set and extra plate for lunch. Now we wait to hear from CHMP for clock to start counting again.
John k9uwa

The question is what will insurance or national HealthPlans pay for a product that they know costs pennies to make. Granted many hundreds of millions of dollars may have been spent on its development, but I suspect it will be substantially under $30K a year.

In terms of pill counts, this could be one of the highest counts for a prescription drug, it may be recommended for everyone over a certain age. I suspect that in some third world counties it could be available for slightly more than it costs, but in most of the world they should make a healthy profit.

Where peoples healthcare coverage doesn't pay the entire cost, I suspect the average monthly payment will be $20 or less. It's insurance or other systems that will pay the bulk of the cost, I'd be surprised if it's much over $10K a year. Remember, I'm speaking about what they'll pay, the list price may be substantially higher.

Gary

As a stockholder looking to maximize my ROI, I want Anavex to charge as much as the market will bear. $30,000 a year seems very reasonable for a drug that does everything some believe it can do.

Of course everything depends on regulatory approval, which may or may not happen.

rx and Zadie, several years ago, TGD stated that Anavex had enough pills in its inventory to give one to each person on Manhattan. In that quarter's report, the company had $1 million on its balance sheet for other current assets, in which the inventory was included. At the time, Manhattan had 1.7 million residents. So, it was calculated that the cost per pill to manufacture was no more than 60 cents ... volume production will probably cause it to be significantly less ... but, again, we are talking pennies.

Even if NOT July, one has to wonder why Anavex had neither anticipated and formulated answer(s)
OR
Their answer(s) was not well received.

A slam dunk/WGT assumption would then be suspect.

You may be right, but frankly it's often the person with the disease who doesn't think that there is a problem, it's the caregiver who'll insist it be taken, and will pay for it.

I believe that if sufficient people all over the world are taking the drug it can be very profitable if people are paying well under $50 a month. Once developmental and production costs have been returned, along with a reasonable profit, the price could be dropped substantially, especially if it became available without a prescription. I suspect in time it would be recommended for all over a certain age, and even at pennies a pill it would be very profitable.

I don't know if the company can maintain exclusivity more than 12 years after approval. If by that time no prescription is required, but if the price is really low, generics won't be eager to compete for the business. On the other hand, if they have name brand recognition. like Bayer Aspirin, they may be successful charging somewhat more than generic prices. If it's only available by prescription, then if they don't match the generics price most business will go to the maker of generics. The company can make a ton of money while they have exclusivity, I rather like the idea of keeping generics off the market by making the price to low for them to invest in competing with them.

Gary

You so funny. Lol.

Yes , excatly 👍

More like we certainly don't disagree on everything 😄

So we agree on something. 

It amuses me that some seem unable to reason in the first place.

SAB,

I really don't think any weight can put on someone "willing" to keep holding stock from cashless exercise.
the recent insider option exercise at least indicated that Steffen was willing to keep a lot of stock and do the whole cashless exercise by selling "just enough" to pay the taxes!....Prior to that, Missling did the same back in April.
Even if he wanted to sell, it would be disastrous for the stock price and upset other insiders. It would not be wise and hence keeping the incentive stock is literally an autopilot thing.

Let's see what happens in the next few EMA updates. If longer the chances of a positive outcome are diminished, but as always there are a few outliers that are still positive with a very long clock stop one - just few and far between.

Inv2014

It amuses me a bit that you try to reason with people like him. 

You mean the MAA that you said would NEVER be applied for?

kund
I read your post, but fail to get why you say this from what has recently happened! I'm not a WGT type of person at all....I think Investor's recent post pointing to his estimate as to how things are progressing at CHMP meetings makes a lot of sense.....July or August timeline.

Maybe even June?, I don't know.....however, the recent insider option exercise at least indicated that Steffen was willing to keep a lot of stock and do the whole cashless exercise by selling "just enough" to pay the taxes!....Prior to that, Missling did the same back in April. MIssling is "excited"....sounds like he expects something positive......or.........he is wrong and sitting on a pile of stock. I have not seen any large sale of stock by him yet.

I realize that you do not like Missling, at all....but your efforts to downplay what is now occurring during Clock Stop One at CHMP stands out as very early and does not make sense....even you stated "we'll know very soon"......maybe just wait?

I'm positive, but it's certainly possible that I'm wrong.

Oh yeah, Happy Father's Day

There’s not an egg in sight, yet the WGTs are already counting chickens. Misleading seems ready to pull out the MAA, we’ll know very soon.

I pay more than that for Creon so I can digest food! If it works, people will pay!

Sadie,

My educated estimate is about 10 cents to produce a 50 mg blarcamesine pill.

Good luck and GOD bless,

People won't pay $50./month to get their life back. Get real. They pay $10./day for starbucks.

Hi Powerwalker, thanks no still around just been focussing on other things more during this period but the second half of this year should be a lot more catalyst rich for Anavex.

TC--"Here is post "---thanks for showing entire post--Bingo ! WGT !!!

Here is post referenced by Plex

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176198038

Thx rx. I guess even they charge $250 a month for patients that would be tremendous revenue based on 5 mil patients in whole Europe. May be more. Because these days everyone has a family with this disease.

Someone in this group a while back said it cost 60 cents a pill to produce.
No idea if correct.
However the chemistry appears to be pretty straight forward so possible.
If produced in very high numbers may be even cheaper.

Does anyone know how much it cost to produce one pill of Blarcamesine? Tia

Must see post---from hnbadger --post #490011--published in "The Political Economist" May 15,2025---go to hnbadger profile site to read article--click on "latest posts"---- entering the post # did not work for me--probably the best article I've seen on Anavex !!!!!

Here is a search link to the relevant.
upcoming EMA Events

I think the July or August ones are the most relevant for hopefully good news. If we have to wait beyond August, I would start to get concerned.

bb86-" They are sub par to Blarcamesine"--strong reason why Blar.should be (will be) approved !!!!!

Serious question, but first I would like to wish all you fine men , and whinny Mike a happy Father’s Day. !!
With as much posting everyday about what Missling should or shouldn’t do, some of you seem to know a lot about science and this process, medicines , and daily charts , etc.
Surely a few of you are scientists or stock brokers , and maybe even doctors correct?
If so, who is the scientist ? Who is most qualified on this panel of experts ?
I bet it is George !
Please answer if u will .
I am definitely not. I have a high school degree , and many years in service, and now own an auto glass company in SC.
I would just like to know . I am sure I want get an answer , but all good
Thanks

Hosai, long time, no hear from. Hope all is well with you. Having lost so many over the years, most recently nidan, was concerned about you.

Peace and to all the board's Fathers, Happy Father's Day (USA-style).

Yes there will always be people who do not want to pay even $50/ month. However if they do not get the drug without paying, many of them will find willingness. My guess.

I'd agree that it would be a fair annualized cost; however, most people probably won't pay over $50 a month for it, so insurance needs to cover roughly 95%. That's not to say that if it cost $100 a month people wouldn't pay, but it would be far fewer. At $500 a month, perhaps 10% of those who'd pay $100.

I suspect that insurance will negotiate for less than $20K a year, but it will still be very profitable as so many people will get coverage at whatever price is agreed to, and people will pay a fairly low co-pay.

Gary

Should not be any problem to charge 20k/year of Blarkamesine

During the call, was there any mention of the 3-71 POC trial TLR? At this point they should have a clearer view of expected completion time range.

I was lost after I read this quote. Blarcasamine cant happen soon enough. Soon statements like these will be null and void.

God speed!

Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said refusal would be “deeply disappointing” and send “a damaging signal to the life sciences sector — undermining confidence in the UK as a global leader in dementia research, clinical trials and innovation, with knock-on effects for patients and the wider economy”.
She added: “These treatments are not perfect, and we recognise the challenges they pose around cost, delivery and safety. But scientific progress is incremental, and these drugs represent a vital foundation to build on.”

The right decision.

The UK system is struggling to provide basic health services and spending huge sums on a boutique therapy with minimal effectiveness, high risk and exorbitant cost is not the right thing to do.

This piece reads as a company paid promo.,

Nice post, Hosai. Lecanemab, made by Eisai, and donanemab, made by Eli Lilly are crap drugs in the CNS space. They do not have the safety drug trial results that Blarcamesine has and are not endorsed by the worlds best 58 doctors / scientist in the CNS space after a peer review study like Blarcamesine is. They are sub par to Blarcamesine. Imo

Article - "NHS patients denied breakthrough Alzheimer’s drugs" (The Times - UK).

"Breakthrough drugs for Alzheimer’s will be refused for use on the NHS this week, denying the treatments to about 70,000 patients in England.
Lecanemab, made by Eisai, and donanemab, made by Eli Lilly, are the first drugs proven to slow the underlying cause of dementia, clearing toxic amyloid protein from the brain and delaying cognitive decline.
When the first positive drug trial results were announced in 2022, campaigners greeted it as “the beginning of the end” for Alzheimer’s.
Both treatments were last year given UK drugs licences, making them available privately, but the health watchdog, the National Institute for Health and Care Excellence (Nice), has repeatedly refused to recommend them for use on the NHS.
Nice is understood to be announcing its final decision this week, turning down both drugs on the grounds of cost-effectiveness. “It is the end of the road for these drugs on the NHS,” one insider said.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said refusal would be “deeply disappointing” and send “a damaging signal to the life sciences sector — undermining confidence in the UK as a global leader in dementia research, clinical trials and innovation, with knock-on effects for patients and the wider economy”.
She added: “These treatments are not perfect, and we recognise the challenges they pose around cost, delivery and safety. But scientific progress is incremental, and these drugs represent a vital foundation to build on.”
• UK’s most prescribed drug may reduce dementia risk by 13 per cent
Alzheimer’s affects about 600,000 of the one million people with dementia in the UK. The drugs are licensed for those in the early stages of Alzheimer’s, when they are most effective, which would have made them available to about 70,000 people in England if approved.
The treatments were shown in trials to slow the rate of decline as a result of mild to moderate Alzheimer’s by an average of about four to seven months. Some patients have reported far more dramatic results — with some even claiming it has halted their decline for years. But Nice insists the overall benefits simply do not justify the costs charged.
A year’s course of the drugs, which are administered via a drip, costs about £20,000 to £25,000, although the NHS has been offered a confidential discount on that price. The cost of scans, doctors’ appointments and the regular hospital sessions to receive an infusion means the overall price at least doubles.
In a draft document in March, Nice said: “The evidence presented so far shows neither donanemab nor lecanemab provide enough benefit to justify the substantial resources the NHS would need to commit to implement access to them.” There are also concerns about side-effects; some clinicians warn that the risk of brain bleeds are not justified by the limited benefits.
Privately, patients are charged £60,000 to £80,000 a year, according to Alzheimer’s Research UK.
Despite the cost, there is a small but growing private market for those who can afford the drugs. Eli Lilly alone said it has so far provided donanemab to about 50 private patients.
Nick Brake, 60, from Rutland in the East Midlands, was told he had Alzheimer’s last year, after a four-year battle to receive a diagnosis. He started treatment on lecanemab in February, travelling to the private Cleveland Clinic in London every fortnight to receive his infusion.
“I have no idea if it is working but you have to be positive about it and just hope it’s slowing it down,” said the father of two, who has run a series of businesses, including a café, ski chalets and a charcuterie business. “I feel much better being on it — at least we are doing something positive, rather than just sitting here thinking, ‘Oh God’.”
His wife, Nicky, 58, added: “It has been a massive boost for us. We would try anything. With all your heart, you just want everyone to have the same access.”
Dr Emer Macsweeney, chief executive of Re:Cognition Health, said she has seen a surge of interest since offering the new drugs in recent months in clinics in Bristol and London. She has even treated patients who travelled from Europe, as donanemab is not yet licensed in the EU and lecanemab received authorisation there only in April.
The US, Australia, Japan, Singapore, Taiwan, South Korea, China and several nations in the Middle East and South America have approved one or both drugs.
Macsweeney said patients who cannot afford the drugs can take part in clinical trials, which she runs on behalf of pharmaceutical clients. “The only eligibility to get onto a trial is clinical,” she added. “They are available for everybody, for free, although there is a 50 per cent chance you will be on placebo.”
Emily Pegg, medical director for Eli Lilly in the UK, said Britain would struggle to attract research and tech investment if new drugs continue to be turned down. “For us to stay competitive and become a really exceptional market that is seen as the place to come and launch a medicine, that entire [pharmaceutical] life cycle needs to function seamlessly,” she said.
“But if the patient ultimately can’t get that treatment, then fighting our corner to become one of the first markets to get an approval becomes more challenging.”

https://www.thetimes.com/uk/healthcare/article/breakthrough-alzheimers-drugs-will-not-be-available-on-the-nhs-p8xqwkj29

Your probably correct Leo. Out Chartist's think it is possible to drop a buck maybe. All of us of course hope that doesn't happen but we for sure will fluctuate.
Good Luck
John k9uwa

Anyone have the info when Anavex will be presenting at this year's AAIC ??? Also what will the topic be ???? TIA

No problem, hnbadger1.

The article is worthy of rep's. More the merrier!

WGT!

Sorry xodcode , I didn’t see that you already posted the cell paper.
WGT

About 400 shares traded @ 8.37
before someone decided to paint the weekend @ 7.93 with that late 100 shares.

VWAP (which I follow especially in low volume environments) was 8.06.

How will Monday open relative to THAT SP?
I still feel there is time to await 7.50 ish prior to participating in the next bounce.

George…I expected nothing else in your emoji response. Thanks for confirming that knowledge base.

Michael Tavares on FB- Nice mention in this new paper's conclusion:
"Thus, given the current mixed success of amyloid-targeting strategies, therapies aimed at improving lysosomal and autophagy function could represent complementary or alternative approaches. One promising example is Blarcamesine, a sigma-1 and muscarinic receptor agonist, which enhances waste clearance through autophagy. A recent Phase 2B/3 trial in early AD reported a 36% slowing of clinical progression - outperforming
Lecanemab - alongside reduced brain atrophy and no amyloid-related imaging abnormalities
[128], offering promise for (combined) therapeutic intervention."

https://www.cell.com/trends/neurosciences/pdf/S0166-2236(25)00102-X.pdf

There was an 8-K filing today regarding the ASM vote. Why did he choose to file it after hours on a Friday for something so trivial? Not sure what kind of game Misleading is playing.

Combined? We don't need to combine with anyone. We become SOC.

Likin' this:

Nice mention in this new paper's conclusion: "Thus, given the current mixed success of amyloid-targeting strategies, therapies aimed at improving lysosomal and autophagy function could represent complementary or alternative approaches. One promising example is Blarcamesine, a sigma-1 and muscarinic receptor agonist, which enhances waste clearance through autophagy. A recent Phase 2B/3 trial in early AD reported a 36% slowing of clinical progression – outperforming Lecanemab – alongside reduced brain atrophy and no amyloid-related imaging abnormalities [128], offering promise for (combined) therapeutic intervention."
[https://www.cell.com/.../pdf/S0166-2236(25)00102-X.pdf]

and yes, WGT!

Plex Rec
Thanks from this Lisdexic AVXL Long