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..TIME'S UP.
boi568
NICE WORK hnbadger1...This is exactly the kind of response we might expect when, "RWE-Real World Evidence" begins to get out to the ROW...along w/ " RWD-Real World Data " .
Bless us all...;
"
What is going on w/SP? A mess...any insights? Are we up $ 0.31 @9.53 am or not ?
Agree,,,thx and bless those RSD kids and their families...
Thanks Powerwalker...does not look authentic to me but...we'll see...all the best to every (real) AVXL investor
now this???seems like some kind of scam???
7.57+0.36 (+4.99%)
At close: 04:00PM EST
7.46 -0.11 (-1.45%)
After hours: 05:30PM EST
7.57+0.36 (+4.99%)
At close: 04:00PM EST
7.90 +0.33 (+4.36%)
After hours: 04:56PM EST
comments anyone...? real or noise?
My guess on attracting the very best would be...they are lining up to get in the door. My guess is the best and the brightest already see-understand where AVXL is headed (many CNS treatment theories discussed here with W/W results being leaked to those who GET IT). Recruiting the staff is probably not and issue. AVXL is a nucleation site for those CNS BIO-MED WW best and brightest . Stand by, this is only the beginning.
We have a Brick Wall in both $XBI and $AVXL.....tomorrow should be up, but certainly just my 2 cents!!!YUP...god bless our RSD kids and their families.
I struggle to wrap my mind around the enormity of what is proposed by some on this board in regards to where Anavex might be 5 years down the road.
Steady Lad!
Take a deep breath and pay attention . BP and the WS thieves have outlived any usefulness they may have presented as the, "Full size Cars of the future". The systems they put in place cannot get out of their own way. Leadership Speed, lab skills and adaptability w/ integrated technical-clinical knowledge will prevail...but (I do agree) the corrupt and ineffective establishment has to be nuked first.
Just watch as the key indicators quickly present themselves and prevail. The use of EU to leverage the management + technology process is a brilliant touch.
So, another drug-science professional signs on with Anavex. What could she be thinking?
Employment history info here:
https://www.linkedin.com/in/terrie-burrell-kellmeyer-phd-77657613/
Here’s what her former employer, Acer Therapeutics, told about her qualifications:
Dr. Kellmeyer has worked in all phases of drug development (pre-clinical through Phase 4 and post-approval) in the therapeutic areas of hepatology, metabolic disorders, and rare diseases. Dr. Kellmeyer has made significant contributions to multiple marketing submissions in the United States and European Union, served as a key team member for two FDA Advisory Committee Meetings, has led clinical development programs, and has been responsible for all externally and internally facing corporate scientific communications. Prior to rejoining Acer, Dr. Kellmeyer served as Vice President of Regulatory Affairs at Madrigal Pharmaceuticals and has held positions of increasing responsibility in Clinical Development and Regulatory Affairs at Intercept Pharmaceuticals, Acer Therapeutics, Amylin Pharmaceuticals, and Gen-Probe.
https://www.acertx.com/acer-management/
So, she now decides to attach her career to the fortunes of a small biotech startup that has no drugs approved for sale, and no revenues. Seems pretty hazardous; perhaps career-ending.
But maybe she was invited to see clinical data that Anavex hasn’t yet revealed to the public, and on the basis of what she learned decided to align the rest of her career with Anavex, realizing that the company’s drugs will revolutionize medical science.
[color=red]Anavex Life Sciences Corp, a career maker or breaker? Which do you suppose Dr. Kellmeyer believes?
Agree, strong message. If this is a strong WW signal that the ROW is tired of waiting for the (WS-FDA-NIH-U.S. Govt. and the system-whatever that is-including peer reviewed wonder magic-summation) . The WW medical process is (and has been) broken for decades seemingly waiting for (anyone-w/the stones) to draw a RED LINE AND SAY ENOUGH.
My own sense is that now MAYBE the summation of AVXL CNS research S1R concepts and trials have started to stick . Our little company may just begin to lead the ROW into the light. We still have a long way to travel but we have a strong story and (finally) there is evidence that the right people are listening. And, BTW, the ROW will finally tell WS corrupted system to ..."sit down and Shut the F** UP". We GOT HOPE.
So, now what? An informed senior stock broker tells me that AVXL share price behavior today is , "What Should Happen". Now that AVXL has been cleared for take off. Fly the runway heading to FL XXXX. Contact departure control on ####......GOOD DAY SIR.
So....., WE MADE IT. [/b ]After 10+ years , the AVXL development team has done well, in spite of many difficult and uncertain periods. Now the REAL FUN STARTS...We will emerge from the shadow-confused land of BIOTEC start up as the signal from EU medical process takes command for the next segment .
So, this is what SHOULD HAVE HAPPENED . Now AVXL gets an opportunity to play real hard ball , which (no doubt), will require development of new leadership skills for those in the cockpit and new reasoning and tolerance skills from all the rest of us.
Thanks to all who got us here , blessings to all who will be treated. Carry on.
avxl_going_long...Huh???
He will not be able to use his credibility to achieve the greatest possible benefit. We need someone the street trusts to get the most benefit. Chris missed this opportunity."
boi568
The EMA says AD patients in the EU will double in seven years -- that an older age cohort, already working their way toward poorer health in their seventies, is an enormous bulge in their demographic snake.
That same data will also look good when it is published in a journal.
Excellent work. Thanks.
WS and the BP herd will not want to see AVXL win one w/EU AD support on 11/17/23. If we step back and consider the WW financial scope of what AVXL is doing it is impressive. Instead of bashing our collective-investment-science heads against the 50+ year old BP entrenched WS systems AVXL is going to conduct a brilliant tactic. We are going to expose the fact that the WS financial-political-CNS medical-regulatory system is exposed for what it is , a 50+ year old fraud. I expect a massive over reaction for weeks to come. The EU will be presented as the opponent of all that is good .
The brilliant medi-Regulatory-political-compliance liars and savages will be at each others throats but that will not last long. RWD and RWE will become critical weapons in this demonstration. This is a very gutsy move being initiated by AVXL. The struggle will be a long and complex one B/C the US-FDA-BP system is so politically corrupt that the real problems of it's complete lack of efficacy will be hidden by the massive political-financial stink which is certain to be raised, big time.
Semper fi...WGT.
Pilots and crews report to you ready rooms. Prepare the flight deck to commence air operations.
https://finance.yahoo.com/news/anavex-life-sciences-reports-fiscal-113000867.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAMvii-3oVnF-grGW2XiY34ZezndqLFyYku7KnWTyV5XVX5jmxAh9brZWX27ue1tvCttOSRknx6WfS6wxJBs-2EzTyrJZtxqjj6ApXYkbYV1OdnQorcd3te_vHy9EmNz9ToIKP1gEqhv9HTEtrLp_FEMdjPi7athsUG6dDGqxrQ91
On track to release top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study in Alzheimer’s disease with convenient oral treatment to be released in the second half of 2023
Company to host a webcast today at 8:30 a.m. Eastern Time
NEW YORK, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal quarter ended June 30, 2023.
“We are very excited to be entering an important phase of the Company, with several key data readouts based on innovative science at Anavex with ANAVEX®2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), involved in restoring neural cell homeostasis and promoting neuroplasticity,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We remain focused on execution as we prepare for a pivotal year ahead of us potentially involving a digital ‘Healthcare Sales Marketing’ pharma platform and also making meaningful advances in our other neurodevelopmental and neurodegenerative precision medicine portfolio, including schizophrenia and Parkinson’s disease.”
Key Near Term Pipeline Updates:
Rett syndrome: Top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial. Company expects to announce topline results from this study in the second half of 2023.
Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. Company expects to announce data in the second half of 2023.
Parkinson’s disease: Initiation of ANAVEX®2-73 pivotal clinical trial.
Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused clinical trial.
Fragile X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
Schizophrenia: Initiation of ANAVEX®3-71 Phase 2 clinical trial.
New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
Publications: Several clinical publications involving ANAVEX®2-73, ANAVEX®3-71 and Rett syndrome Burden of Illness study.
BTW, No Other med-pharma company has EVER DONE ANYTHING CLOSE TO THIS...THE SHIP (W/S) IS TURNING INTO THE WIND>>>
I am Expecting the details on Peer reviewed publication to be made available during Monday's conference.
Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.
https://www.anavex.com/post/anavex-life-sciences-to-announce-fiscal-2023-year-end-financial-results-on-monday-november-27-2023?mc_cid=a5824b7d7e&mc_eid=0688b12ec0
Anavex: https://www.bloomberg.com/quote/12X1:GR
Thanks..Foo, .will give it a long try...
The big area to take out is that range between $7.50 and $8.00 or so....once that area has been cleanly broken a quick run towards $9.50 or so should occur....
sab63090
I think we all should be aware of the short interest report coming also on the 27th after the close! Although the short interest report will be late, i.e. 10 days behind, it might indicate (by market action) that some covering of those short positions are being closed out now.
The story increases the odds that Missling will be able to have his promised data results for RETT by year end!
What financial metric from EU financial markets can be used to track (real time would be nice) equivalent SP to WS share price ? Real time link would be best of course but I would like a credible $$ marker for simple SP math. Sadly most WS SP nums are what we use to trace (good-not good-daily successes) price actions. It may be a mess until we figure out the best way to track - evaluate how the day is going in EU market and then to await (after the liars and crooks get done) what the bottom line is to U.S. holders. Hope we do not end up w/yet another layer of slime bags (liars) that we have to pick through on a min x min basis.
BTW, if there is no simple answer that's OK...just wanted to establish some kind of direct-simple-knowledge-table (EU-WS) truth wall interface-truth table if such a thing is possible. TIA.
Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.
I am both optimistic and awwww-struck by the power and scope of this PR.
Just imagine how this simple PR touches the lives of so many...amazing stuff.
https://www.anavex.com/post/anavex-initiates-regulatory-submission-of-oral-blarcamesine-for-alzheimer-s-disease-to-european
A very impressive list of accomplishments and medical-systems claims. No other firm is even close to this. Danke sehr...(Thank you very much)
https://www.anavex.com/post/anavex-life-sciences-to-announce-fiscal-2023-year-end-financial-results-on-monday-november-27-2023?mc_cid=a5824b7d7e&mc_eid=0688b12ec0
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11/24/2023 Day after Thanksgiving Open until 12 PM...could be an eye opener on Friday 11/24
tradeherpete, thx again for posting this excellent, well written , informative paper. IMO, this paper is a direct hit on AD root causes, including links to stresses...all the pieces fit IMO.
GLOBENEWSWIRE 7:00 AM ET 6/14/2021
NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp.(AVXL) (“Anavex” or the “Company”) , a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported that ANAVEX®2-73 (blarcamesine) and ANAVEX®3-71 (AF710B) are featured in a new peer-reviewed publication in the journal of Expert Opinion on Therapeutic Targets, titled “The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's”.1
Scientific Paper Highlights:
Sigma-1 receptor (SIGMAR1)’s expression increases with age, however in Alzheimer’s disease (AD) it decreases
The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
SIGMAR1 is activated by ANAVEX-compounds
ANAVEX®2-73 has been shown to induce autophagy
Activation of the SIGMAR1 can induce cytoprotective autophagic pathways
The authors of the paper point out that studies using positron emission tomography (PET) have shown that in healthy aging, there is no loss of the SIGMAR1; in fact, there is a possible increase in SIGMAR1 expression2 that coincides with the age-related loss of the M1/M4 muscarinic receptors3, D1/D2 dopamine receptors4, and serotonin (5HT2A) receptors5. The increase in SIGMAR1 expression may be a compensatory mechanism for the loss of the other receptors6.
However, PET scans of patients with a recent AD diagnosis show a reduction of SIGMAR1 expression7. SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aß production8.
The publication explains that AD is a multifactorial disease, where several pathways interlink with each other and cause cognitive impairments. The available drugs only tend to target a single pathway and mitigate the symptoms of AD without slowing the disease progression. Combinatorial therapy has been suggested as a treatment strategy; however, the existence of drug-drug interaction is a concern. Hence, there is a need for the development of drug molecules that can target multiple pathways to halt disease progression and improve the memory function.
SIGMAR1 has emerged as one of the prominent targets in treating neurodegeneration. It is involved in the modulation of glutamate levels, maintaining endoplasmic reticulum (ER) function, and calcium regulation, promoting neurogenesis, reducing reactive oxygen species (ROS) formation, suppressing neuroinflammation and ameliorating Aß toxicity9. Recent studies with ANAVEX®2-73 show that SIGMAR1 activation is also involved in autophagy, an intricate phenomenon that clears damaged cellular organelles and misfolded proteins10. SIGMAR1 agonists, including ANAVEX®2-73 and ANAVEX®3-71 have been reported to block toxic Aß, tau and neuroinflammation11.
Autophagy and the cellular machinery involved are essential to homeostasis and cell survival. Autophagy has been shown to be important for axonal health and homeostasis as autophagy inhibition leads to axonal wasting12.
During the early stages of AD, it has been noted that there is an accumulation of Aß and tau protein in the dystrophic or swollen neurites of AD patients’ brains. Furthermore, it is well known that autophagy plays a key role in the management of Aß and tau protein levels, and that some of the key proteins involved in the autophagy mechanism disappear with age, resulting in decreased autophagy in older brains13. At the same time the SIGMAR1 is upregulated, possibly compensating for the reduction in autophagy, and reduction in other receptors, such as muscarinic receptors14, dopamine receptors15, and serotonin receptors16, in an attempt to protect the neuron cells.
Since it has been observed that a number of SIGMAR1 agonists, including ANAVEX®2-73, is able to upregulate SIGMAR1 expression in the brain, it is possible that these drugs could help the cells to compensate for the loss of other receptors and autophagy machinery.
The authors conclude, that in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagy, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the prevention of heart disease today in an effort to prevent the loss of the SIGMAR1 receptor seen during AD.
“This independent paper highlights the understanding of the relevance of utilizing sigma-1 receptor activation as compensatory mechanism to chronic CNS diseases, currently tested in late-stage placebo-controlled ANAVEX®2-73 Phase 2b/3 clinical Alzheimer's disease study, which recently completed enrollment, as well as in Parkinson’s disease dementia (ANAVEX2-73-PDD-001) and ongoing Rett syndrome program (ANAVEX2-73-RS-001/002/003)”, said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.17
Anavex Life Sciences’ product portfolio platform includes small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome and ANAVEX®3-71 for frontotemporal dementia.
Regarding Alzheimer's agitation treatment.
https://www.axsome.com/conditions/alzheimers-disease-agitation
One can only hope that there is plenty of documented (and measurable) evidence of sleep improvement in the data that has been collected and analyzed. I know insomnia has been discussed plenty in this forum, I just wonder the plan to monitize?
Kmadd
Could it be that at some future point we will learn this string have the same CNS root cause?
One can only hope that there is plenty of documented (and measurable) evidence of sleep improvement in the data that has been collected and analyzed. I know insomnia has been discussed plenty in this forum, I just wonder the plan to monitize?
https://www.anavex.com/post/anavex-life-sciences-announces-grant-of-u-s-patent-covering-blarcamesine-anavex-2-73?mc_cid=149800c81c&mc_eid=a2160c00e9
IMO...IT's all about STRESS AND THE CNS HARM RELATED ...My Identical Twin Brother recently passed while being treated from/with AD diagnosis...he and I were on same ship (A/C) carrier and both flew in the same airplanes (USN never allowed us to fly in same plane) ...WE were OFTEN QUOTED as saying..."We SHOULD BE DEAD". (sadly) That is a very common theme in much of US Military vets . He died before his time and(IMO) stress was the real cause, even though his death cert said AD...BLAH, BLAH...tell that to his wife and kids.
At the end of the day...this is about stress treatment (IMO). Each human has to deal w/stress while each one of us has a unique BIO-Cell-DNA -capability structure. IMO, we still have a lot of CNS dots to connect but AVXL and team are on the right path.
About Insomnia and Anxiety
Insomnia - Left untreated, insomnia can affect memory and concentration, and raises health risks in many areas, such as high blood pressure, coronary heart disease, diabetes, cancer, depression. According to the CDC, about 1 out of 3 U.S. adults complain of poor sleep. Growing evidence shows that sleep deprivation can affect the buildup of beta-amyloid in the brain, a pathological link to dementia, Alzheimer’s disease, and Parkinson’s disease.[4]
Anxiety - Symptoms of anxiety characterize several neurological conditions. Anxiety is particularly common in individuals with symptoms of dementia and/or Alzheimer’s disease, especially for those patients who retain self-awareness of their condition. Anxiety can make certain symptoms of dementia worse, by affecting cognitive function such as attention, planning, organizing and decision-making.[5]
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Does Anavex have convincing evidence or data to show that Blarcamesine treats insomnia, anxiety and agitation? Will this provide some collateral benefit for EMA or other regulatory approval?
Safe and effective alternative, especially when compared to…
https://time.com/5584937/sleeping-pills-safe/