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Anavex Life Sciences Corp. (AVXL)

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11.80-0.32 (-2.64%)
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  • S
    Steve
    Ha...this is nothing but short activity...very low volume...same as last several days. When the data begins to flow..which is "any day, any week" this stock will spike up very nicely. Wish I had more $$ to add...be patient we will be rewarded.
    Today's presentation was excellent...very confident and projected good things coming very shortly (this quarter for many data reads). Also, some how many confused this conference as an announcement of some sort..it was an investors conference and rarely do you see and major releases at the same time. Look for price moving announcement over the upcoming days and few weeks.
  • g
    georgejjl
    Broad and Significant Effects with ANAVEX®2-73 (blarcamesine) in PDD Patients

    • ANAVEX®2-73 (blarcamesine): a novel, oral, investigational sigma-1 receptor (Sig-1R / SIGMAR1) agonist with multimodal activity
    • Data confirm SIGMAR1 as gene “signature” biomarker of response to ANAVEX®2-73 (blarcamesine) confirming SIGMAR1
    activation as mechanism of action
    • Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008) and CDR system Episodic Memory (p = 0.047), representing complex cognitive tasks with impact on quality of life such as making a choice between similar objects and remembering daily personal experiences, which are mostly impaired in both PD and AD1
    • Statistically significant dose-dependent (p = 0.003) improvement of CDR system Episodic Memory, which has been shown to be highly correlated (70%) with the Alzheimer’s Disease Assessment Scale–Cognitive score (ADAS-Cog; r = 0.7)2
    • ANAVEX®2-73 (blarcamesine) does not impair sleep and has a positive effect on REM sleep behavior disorder
    • ANAVEX®2-73 (blarcamesine) was generally safe, well tolerated, and improved safety profile compared to dementia drugs associated with typical adverse effects
    • These results support continued development in PDD / PD as well as currently ongoing Phase 2 and Phase 2/3 clinical studies with ANAVEX®2-73 (blarcamesine) in Rett syndrome3 and Alzheimer’s disease4
    • Data will be submitted to the U.S. Food and Drug Administration to seek regulatory guidance

    Good luck and GOD bless,
  • J
    John Dsouza
    News: The DSMB recommendation is to continue the Rett Syndrome studies without modification. DSMBs are committees commonly used in clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials.

    Based on the previously reported results of the first placebo-controlled U.S. Phase 2 (ANAVEX®2-73-RS-001)3 study in adult patients with Rett syndrome, Anavex is planning to meet with the FDA to discuss the approval pathway. There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome and may be considered for accelerated approval.
    Bullish
  • g
    georgejjl
    Like Anavex 2-73 fluloxamine is a sigma 1 receptor agonist

    Ivermectin or Fluvoxamine for Outpatient Treatment of COVID-19

    https://www.medscape.com/viewarticle/949061

    Good luck and GOD bless,
    Bullish
  • S
    Steve
    Fact: Rett results are due at any moment. The target release date was q1/q2. We are here. Based on past data reads etc..very high likelyhood of success. When this hits, you can look for AVXL to be in the 20 to 30 range. We are days or a few weeks away from this pivot point.
  • E
    End2War
    No one can say exactly when news will be presented, as that is why they call it "news." LOL But I was impressed by Dr. Missling's discussion of the corporate deck yesterday, which I now understand better than I did by just trying to read the slides. I don't think AVXL does a good job explaining what their drug hypothesis is because they don't exactly know why they are getting the results they claim. But, I think they have a good understanding of the results they are getting and those results are clinically positive. The market can little appreciate what AVXL is doing as it is lost in a large group of competing AD stocks and past failures. For those that buy and hold, their is huge potential, IMO.
  • D
    Daniel
    Question for longs
    Why not use standard test adas-cog instead of using MMSE test correspondence?
  • g
    georgejjl
    Anavex is in hurry to complete recruitment for the Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD).

    Remember virtually all of the trial subjects have elected to take Anavex 2-73 each and every day in the OLE (OPEN LABEL EXTENSION) study. Doctors, family, patients, friends can now tell those that are now getting better (previously on placebo) and those who were responding before and now are continuing to get better and better.

    Quote:
    “We’ve certainly seen individual patients, who both seem to be getting side effects from the drugs and who have shown significant improvements,” Professor Macfarlane told AAA.

    “The findings we’ve got can only be anecdotal because it’s a double-blind trial, which means at the moment, we don’t know who’s taking the actual drug and who’s taking the placebo,” said Professor Macfarlane, head of clinical services at HammondCare.

    Stephen Macfarlane
    Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.

    “The fact that they’re getting side effects and they were expected side effects based on what we know about the drug, does suggest that the people who are showing the improvements are on the active drug,” Professor Macfarlane said.

    “For individual patients who have received benefits, the impact for them has been potentially life changing, such as resuming activities they previously had given away, more interest in life, more engagement and better able to converse,” he said.

    For example, trial particpant Rosie Craven had lost confidence and enjoyment in many areas of life before she joined phase three of the study.

    “Rosie had enjoyed watching movies and reading but as Alzheimer’s advanced, she gave up reading and found it hard to engage with movies, and often falling asleep. Now after being on the trial, Rosie is reading again and loves watching movies and discussing them afterwards.

    “She was losing the capacity to write, had been anxious about leaving home for a walk, and stopped using her phone to communicate with friends and family. Now she is once again confidently going for walks, using her phone and writing greetings on cards,” she said.

    Good luck and GOD bless,
    Bullish
  • g
    georgejjl
    Proposed Anavex 2-73 pricing

    $3652.50 per year for Anavex 2-73 pills times 5 million patients per year to start would be over $18 billion per year.

    At a conservative profit margin of about 80% that would equate to over $14.5 billion per year.

    GOD bless,
    Bullish
  • g
    georgejjl
    You might want to buy more AVXL stock before the close of trading on Wednesday 14 April 2021

    Quote:
    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) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 8:45 a.m. EDT.

    A live audio webcast will be available on https://wsw.com/webcast/needham107/avxl/2271566 or in the Investors section of the Company’s website at www.anavex.com. An audio archive of the session will also be available on the website.

    Quote:
    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 announced that its President and Chief Executive Officer, Christopher U. Missling, PhD, will join a panel discussion titled, “Establishing Mutually Beneficial Collaborations,” at the World EPA Congress 2021 event on Thursday, April 15th at 8:55 a.m. EDT (14:55 CET).

    World EPA - Evidence, Pricing and Access - Congress 2021 is the world’s leading healthcare evidence, pricing and access congress and the host of the world’s very first Community-based stakeholder collaboration zone. The virtual congress will be held, April 13th - April 15th, 2021.

    Good luck and GOD bless,
    Bullish
  • g
    georgejjl
    Catalysts to Drive Value

    > Complete data ANAVEX®2-73 U.S. Rett syndrome Phase 2 study – expected Q1/Q2 2021

    > Complete data ANAVEX®2-73 Parkinson’s disease dementia (PDD) Phase 2 study – expected Q1/Q2 2021

    > Top-line data AVATAR: Potentially pivotal Phase 2/3 adult RTT clinical trial – expected 1H 2021

    > Top-line data Phase 1 ANAVEX®3-71 clinical trial – expected 1H 2021

    > Completion of Recruitment for the Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD) imminent

    Good luck and GOD bless,
    Bullish
  • L
    Long-John
    I wonder if the share price is particularly depressed due to lack of trust in the CEO. I listened to his presentation this morning and he was far from convincing and offered nothing new, a simple repeat of previous presentations.
  • g
    georgejjl
    Do you know what orders of magnitude means

    10X is one order of magnitude increase

    100X is two orders of magnitude increase

    1,000X is 3 orders of magnitude increase

    10,000X is 4 orders of magnitude increase

    orders of magnitude is plural meaning more than 1

    Anavex 3-71 (formerly known as AF710B) is orders of magnitude more potent than donepezil (Aricept)and other agonists acting either on the M1 or the s-1 receptors, respectively,” Fisher said.

    Quote:
    First, s-1 receptors. They are strangers to published AD drug development, though pharmaceutical industry research on compounds active in the CNS comes across them frequently. First identified in the 1970s, these receptors were studied pharmacologically until Austrian researchers cloned the gene (Hanner et al., 1996). In the years after, scientists learned that many endogenous peptides, for example, pregnanolone and neuropeptide Y, interact with these receptors, and subsequent knockout and other biological studies showed they act as chaperones associated with the endoplasmic reticulum (Hayashi and Su, 2007). Unusually for chaperones, a slew of endogenous ligands that act as agonists or antagonists operate the s-1 receptor, Tangui Maurice at INSERM in Montpellier, France, told the audience in Zuers.

    The s-1 receptor’s role in neurodegenerative diseases is poorly understood. One mutation appears to cause juvenile ALS (Al-Saif et al., 2011), but beyond that, data on its genetic contribution remain sparse (see AlzGene listing).

    The receptor is ubiquitous. Besides neurons, astrocytes, oligodendrocytes, and Schwann cells, the liver, spleen, heart, kidney, intestine, and other organs express it. It is a transmembrane protein that lives in the ER, particularly at touch points with mitochondria. There, it modulates calcium and influences the composition of lipid rafts. The receptor becomes active in response to ligand binding and in conditions of ER stress. It protects mitochondria by influencing production of radical oxygen species and expression of the anti-apoptotic gene BCL2. It also sits in the plasma membrane, where it interacts with receptors ranging from TrkB, the muscarinic acetylcholine receptor, to sodium and potassium channels. “The s-1 receptor is an important activity-dependent signaling modulator of multiple intracellular pathways in the cell,” Maurice told the audience in Zuers.

    How can the s-1 receptor influence myriad functions in cells? It does so by way of cooperating with other receptors. At least in some cases, it forms heteromers with them, said Abraham Fisher, Israel Institute for Biological Research, Ness-Ziona (e.g., see Navarro et al., 2010). This constellation is how the s-1 receptor may work as a target for certain drugs. For example, haloperidol treats schizophrenia by acting on the dopamine D2 and s-1 receptors; fluoxetine treats depression through a combined effect on the serotonin and s-1 receptors, and donepezil treats AD through an effect on a cholinesterase and the s-1 receptor.

    In Zuers, both Fisher and Maurice presented their respective efforts at finding small molecules that tickle this receptor in a way that might treat AD better than current drugs do. Fisher introduced AF710B, a bicyclic heterocyclic spiro-compound that he said selectively activates both the muscarinic M1 receptor and the s-1 receptor. In detailing its effects on a list of phenotypic parameters—it increases sAPPa secretion, decreases tau hyperphosphorylation and GSK-3ß activity, decreases Bax, and increases BCL2 expression in mitochondria—Fisher emphasized that the former two effects come through the M1 receptor and the latter two through the s-1 receptor. Unlike previous compounds Fisher developed, which were mainly M1-selective orthosteric agonists, AF710B is an allosteric M1 receptor agonist. Its heteromer-specific effects differentiate it from other M1 agonists and modulators. Fisher claimed that the new compound is exquisitely potent, acting as a cognitive enhancer in rats at 1 to 30 micrograms (not milligrams) per kilogram body weight. According to Fisher, the compound is orally available with a safety margin of more than 50,000 times the minimally active dose. “Those are orders of magnitude more potent than donepezil and other agonists acting either on the M1 or the s-1 receptors, respectively,” Fisher said.

    Fisher proposed that the compound has a unique mechanism of action, whereby it sensitizes the M1 receptor through heterodimerization with the s-1 receptor in the membrane of the ER, adding, however, that heteromerization of these receptors has not been formally proven. “We are looking to license it for drug development,” Fisher said.

    Good luck and GOD bless,
    Bullish
  • g
    georgejjl
    You might want to buy more AVXL stock before the close of trading on Wednesday 14 April 2021

    Quote:
    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) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 8:45 a.m. EDT.

    A live audio webcast will be available on https://wsw.com/webcast/needham107/avxl/2271566 or in the Investors section of the Company’s website at www.anavex.com. An audio archive of the session will also be available on the website.

    Quote:
    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 announced that its President and Chief Executive Officer, Christopher U. Missling, PhD, will join a panel discussion titled, “Establishing Mutually Beneficial Collaborations,” at the World EPA Congress 2021 event on Thursday, April 15th at 8:55 a.m. EDT (14:55 CET).

    World EPA - Evidence, Pricing and Access - Congress 2021 is the world’s leading healthcare evidence, pricing and access congress and the host of the world’s very first Community-based stakeholder collaboration zone. The virtual congress will be held, April 13th - April 15th, 2021.

    Good luck and GOD bless,
  • g
    georgejjl
    There is no doubt Anavex 2-73 can and will be used to prevent seizures such as epileptic seizures

    United States Patent 10,813,907
    Missling , et al. October 27, 2020
    A19-144, A2-73 and certain anticholinesterase inhibitor compositions and method for anti-seizure therapy

    Abstract
    This invention concerns a dosage form comprising a therapeutically effective amount of A19-144 or A2-73 and a therapeutically effective amount of at least one AED. This invention further encompasses a method of treating a subject in need of such treatment comprising administering a therapeutically effective amount of A19-144 or A2-73 in conjunction with an therapeutically effective amount of an AED.

    Inventors: Missling; Christopher U. (New York, NY), Durrant; Cameron (Califon, NJ)
    Applicant:
    Name City State Country Type

    ANAVEX LIFE SCIENCES CORP.
    New York
    NY
    US
    Assignee: ANAVEX LIFE SCINCES CORP. (New York, NY)

    Good luck and GOD bless,
    Bullish
  • E
    End2War
    What is the significance of the Data Monitoring Committee giving A2-73 the green light to continue the AD trial? "Safety and Integrity"

    For those that want to review this subject see:

    "Abstract

    "Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local IRB and independent monitoring committees all contribute with complementary but overlapping responsibilities. Consistency among these groups is essential for the smooth conduct of a clinical trial, but may be challenging in resource-limited settings (RLS). Capacity building and training for RLS may improve clinical trials oversight and ultimately medical management. In this paper, we review the components necessary for optimal clinical trial oversight and the issues that arise in the RLS, with some suggested strategies for improvement."

    https://finance.yahoo.com/quote/AVXL/community?p=AVXL
    Find the latest Anavex Life Sciences Corp. (AVXL) stock discussion in Yahoo Finance's forum. Share your opinion and gain insight from other stock traders and investors.
    Find the latest Anavex Life Sciences Corp. (AVXL) stock discussion in Yahoo Finance's forum. Share your opinion and gain insight from other stock traders and investors.
    finance.yahoo.com
  • E
    End2War
    AVXL is down today on what can only be viewed as good news about the data monitoring committee giving more trials clearance. I don't see any change in the rationale to own AVXL other than you can buy it cheaper, LOL.
  • E
    End2War
    I am interested in a possible link between SAVA's hypothetical MOA in AD and AVXL's possible similar MOA. A chapter from a 2017 book on Sigma-1 receptors touches on it in this abstract of the chapter, "The present chapter will review the role of σ1 receptor in learning and memory and neuroprotection, against Alzheimer’s type dementia. σ1 Receptor agonists have been tested in a variety of pharmacological and pathological models of learning impairments in rodents these last past 20 years. Their anti-amnesic effects have been explained by the wide-range modulatory role of σ1 receptors on Ca2+ mobilizations, neurotransmitter responses, and particularly glutamate and acetylcholine systems, and neurotrophic factors. Recent observations from genetic and pharmacological studies have shown that σ1 receptor can also be targeted in neurodegenerative diseases, and particularly Alzheimer’s disease . Several compounds, acting partly through the σ1 receptor, have showed effective neuroprotection in transgenic mouse models of Alzheimer’s disease . We will review the data and discuss the possible mechanisms of action, particularly focusing on oxidative stress and mitochondrial integrity, trophic factors and a novel hypothesis suggesting a functional interaction between the σ1 receptor and α7 nicotinic acetylcholine receptor. Finally, we will discuss the pharmacological peculiarities of non-selective σ1 receptor ligands, now developed as neuroprotectants in Alzheimer’s disease , and positive modulators, recently described and that showed efficacy against learning and memory deficits."

    "Role of σ1 Receptors in Learning and Memory and Alzheimer’s Disease-Type Dementia", in the book titled, "Sigma Receptors: Their Role in Disease and as Therapeutic Targets."
  • s
    sharon
    biotech the XBI and the IBB are being sold and even more intense are small to mid cap biotechnology companies......the upcoming readout on parkinsons which is expected to be market friendly as the recent DSMB review points to as John Dsouza discusses earlier..........so we have a big sell off with biotech and the markets which means for AVXL a big buying opportunity.......patience and rewards are key here!! go avxl ~~
  • g
    georgejjl
    Pre-earnings Bullish Momentum Pattern and Trigger in Anavex Life Sciences Corp

    https://www.cmlviz.com/stocks/AVXL/news/2021/04/16/pre-earnings-bullish-momentum-pattern-and-trigger-in-anavex-life-sciences-corp

    Good luck and GOD bless,
    Bullish