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Anavex Life Sciences Corp. (AVXL)

NasdaqGS - NasdaqGS Delayed Price. Currency in USD
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17.67-0.23 (-1.28%)
As of 11:43AM EDT. Market open.
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  • S
    Steve
    saw missling carrying two large boxes into the office..must be the data....
  • E
    End2War
    "The M1 muscarinic receptor is clinically significant in the central nervous system, and it influences neurologic functions. Muscarinic agonists play an important role in the treatment of Alzheimer disease(AD). Memory loss in Alzheimer disease patients is associated with a cholinergic deficit due to the reduced activity of choline acetyltransferase, which synthesizes acetylcholine. Another important feature of AD is the accumulation of amyloid plaques and neurofibrillary tangles. Amyloid plaques are aggregates of amyloid-beta derived from cleaving amyloid precursor protein. Muscarinic agonists appear to increase the activity of a protease enzyme that cleaves amyloid precursor protein in such a manner that there is no production of amyloid-beta. Through such mechanisms, muscarinic agonists treat memory deficit and amyloid deposition in AD.[17][18]"

    https://www.statpearls.com/ArticleLibrary/viewarticle/25378
  • P
    Pick
    Let me know what is wrong with the thought below:

    People think that the AD readout is the most important price catalyst for the company, but I believe that the more short-term Rett readouts are the real game-changer. If these are consistent with past results (and the evidence so far indicates that they will be), the readouts will be almost as good as approval. Taking the lowest estimate provided by Dr Missling yesterday of $200k per patient per year and assuming only 50% of patients in the US will take the drug, we are talking of about $1B revenue. With a modest multiple of 5x for a high-growth biotech, we are looking at a valuation of around only $70 pps just for the Rett indication. This ignores the extra indications which concern millions of patients. Again, you can assign any conservative probability and revenue on PDD and AD and you can get a share price of about $100-150 before the AD results. All these under conservative assumptions.
  • g
    georgejjl
    Mitochondria-Targeted Drug Development Summit 22-24 February, 2022

    24 February, 2022 2:30 pm Using Precision Medicine in Clinical Trials to Advancing Therapeutics for both Degenerative & Rare Mitochondrial Diseases

    Christopher Missling
    President & Chief Executive Officer, Anavex Life Sciences Corp

    Synopsis
    Assessing clinical data with biomarker-correlated outcomes of ANAVEX2-73 (blarcamesine) in Alzheimer’s, Parkinson’s, and Rett Syndrome
    Reviewing mechanistic analysis of involvement of mitochondrial function

    https://mitochondria-targets.com/program/day-two/

    Good luck and GOD bless,
    Bullish
  • g
    georgejjl
    Expect ABSOLUTELY GREAT NEWS within the NEXT 4 WEEKS!!!

    1. A Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients With Rett Syndrome
    Actual Study Start Date : May 6, 2019
    Estimated Primary Completion Date : September 2021
    Estimated Study Completion Date : September 2021

    https://clinicaltrials.gov/ct2/show/NCT03941444

    2. A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71
    Actual Study Start Date : July 3, 2020
    Estimated Primary Completion Date : September 2021
    Estimated Study Completion Date : October 2021

    https://clinicaltrials.gov/ct2/show/NCT04442945

    3. Official Title: Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001
    Actual Study Start Date : October 10, 2019
    Estimated Primary Completion Date : October 31, 2021
    Estimated Study Completion Date : October 31, 2021

    https://clinicaltrials.gov/ct2/show/NCT04575259

    Good luck and GOD bless,
    ANAVEX2-73 Study in Patients With Rett Syndrome - Full Text View.
    ANAVEX2-73 Study in Patients With Rett Syndrome - Full Text View.
    clinicaltrials.gov
    Bullish
  • s
    sharon
    Regarding SAVA ~~ when the CP gets thrown out a partnership comes into play resulting in a soaring stock price......the sector will once again catch fire while AVXL will soar as well on its own good news or fundamental story that being the strong data for Rett's which could gain FDA approval in early 2022 then we have the big read out on Alzheimers in mid 2022 with Parkinson's in the wings on its own strong data as well.....Anavex could be the powerhouse in CNS disease while the cheap stock price today wont last and mostly sector related (aduhelm and simufilam)....... go avxl,,
  • R
    Robert
    From earlier this year but does a nice clear explanation of how the Sigma1 agonist works and what we know about the Parkinson’s disease data so far.

    https://scienceofparkinsons.com/2021/06/29/anavex/
  • P
    Pick
    Interview with the Principal Investigator for the Australian leg of the Rett trial (link in comments):

    "Is there something that you are currently working on that you are particularly excited about?

    I am excited to be the Principle investigator for the Anavex clinical trial. Participation in this trial will enable our team to attract further clinical trials to Australia. Also, our Rett clinic team is reviewing our experiences caring for girls with Rett syndrome over the last 20 years in NSW.

    Do you have a message for the Rett Syndrome Community?

    Yes! One day there will be a cure for Rett syndrome!"
  • X
    Xonder
    How can I not be excited?

    $SAVA - Simufilam treatment led to 12 month cognition improving by 3.2 on ADAS-Cog, best ever data for AD. MC= ~2B

    $AVXL - Has clinical data showing its drug 2-73 works for multiple neurodegenerative diseases by activating the endogenous neuroprotective pathway. MC = ~ 1.4B

    Dont lose sight of the big picture! The only reason these stocks are trading at such a low valuation is because amyloid drugs have a high failure rate for AD, but neither of these drugs are amyloid drugs.
    Bullish
  • K
    KO
    Have to believe there will be plenty of BO or partnership offers coming next year. If so, hope they are really really High. Miracle meds don’t come cheap or often. If not, I’m patient enough to wait for a company run sales force. Either way, there will be many thrilled patients and shareholders in ‘22….. me included. Go AVXL
  • H
    Harry
    In the beginning of the year Rett data was indicated to be coming in mid Aug. That moved to 3Q and to mid Oct subsequently. All theses timelines have passed. Did anyone get any info related to this in today's presentation. Would appreciate if anyone could add anything. TIA
  • T
    Todd Luttenegger
    In the conference Missling said $200,000 - $600,000 per patient per year, 11,000 US Rett patients, $2-6B peak sales for Rett alone.
    Bullish
  • J
    Jerome
    Cortexyme imploded in AH after very disappointing results. Glad I avoided that one. The whole theory was always a stretch...AVXL will be the last one standing...
  • P
    Pick
    NEWS OUT:
    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 the Independent Data Safety Monitoring Board (DSMB) for the Company's Phase 2b/3 Alzheimer’s disease study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2b/3 study data.

    As specified in the protocol, the DSMB reviewed the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical study ANAVEX®2-73-AD-004 and its Open Label Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.

    Upon review of the interim safety data, the DSMB made the following recommendation:

    The DSMB recommendation is to continue the 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.

    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.[1]

    PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.[2]

    The placebo-controlled 509-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer's diseaseachieved full enrollment and includes prespecified SIGMAR1 gene expression as endpoints using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.[3] The Company anticipates topline data in the second half of 2022.

    Anavex Life Sciences’ product portfolio includes small drug molecule lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
  • g
    georgejjl
    Catalysts to Drive Value in 2021
    The company has multiple clinical milestones

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

    >. Top-line data Phase 1 ANAVEX®3-71 clinical trial – expected 2H 2021

    >. Initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical trial – expected 2021

    Pipeline expansion opportunities for ANAVEX®2-73

    > Initiation of potentially pivotal Phase 2/3 Fragile X clinical trial – expected 2021

    > Initiation of potentially pivotal Phase 2/3 clinical trial for the treatment of a new, rare disease
    indication – expected 2021

    https://e1cd7807-443e-425e-9433-41548681800c.filesusr.com/ugd/73f698_021c7a1cb7a24d78b02dac05e7262ef7.pdf

    Good luck and GOD bless,
    Bullish
  • g
    georgejjl
    An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.

    https://www.anavex.com/post/anavex-life-sciences-reports-anavex-2-73-featured-as-a-disease-modifying-small-molecule-in-trials

    GOD bless,
    NEW YORK – March 16, 2021 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
    NEW YORK – March 16, 2021 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
    www.anavex.com
    Bullish
  • K
    KO
    Won’t take much to pass SAVA MC, Rett approval would do it. Still hoping the best for both companies as I’m in both. Need a winner or two in the AD space, asap.
  • L
    Lon
    This may be why the stones are in order now.
    Anavex Life Sciences (AVXL)

    In a report released today, from H.C. Wainwright reiterated a Buy rating on Anavex Life Sciences, with a price target of $39.00. The company’s shares closed last Wednesday at $17.67.
    Bullish
  • B
    Barrington
    As you all know, Michael J Fox Has Parkinson's disease. His foundation have given grants to AVXL for their trials in Parkinson's. Recently Michael J Fox has said that " he feels good, he's comfortable in his skin and he can sit down and be calm. "Something he couldn't do years ago". What if it's he's taking the AVXL drug (pill)and that is making him better? Just a thought.
  • s
    sharon
    Just one of the many reason we revisit our 52 wk high above 28 coming soon:

    Anavex Life Sciences (NASDAQ:AVXL) says that after a pre-planned review of preliminary safety data, an Independent Data Safety Monitoring Board (DSMB) has recommended the company to continue Phase 2b/3 Alzheimer’s disease study for ANAVEX2-73 (blarcamesine) without changes.
    The double-blind, randomized, placebo-controlled trial is designed to evaluate ANAVEX2-73 for the treatment of early Alzheimer’s disease.
    The 509-patient has achieved the full enrollment, and topline data from the trial are expected in H2 2022. The patients were randomized into 1:1:1 to two different ANAVEX2-73 doses or placebo.
    In addition to safety, both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL, and CDR-SB, will be considered as the primary and secondary endpoints
    ANAVEX2-73 is an experimental candidate under investigation for Alzheimer’s disease, Parkinson’s disease, and Rett syndrome.

    Latest advancement follows a go-ahead given by the DSMB earlier this year to continue the trial after an interim review of safety data.

    Source: SA
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