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Home  /   Forum   /   Anavex Life Sciences Corp   /   Forum Anavex Life Sciences Corp geopend

Aandeel Anavex Life Sciences Corp OTC:AVXL.Q, US0327973006

Vertraagde koers (usd) Verschil Volume
8,475   +0,235   (+2,85%) Dagrange 8,050 - 8,480 923.556   Gem. (3M) 945,2K

Forum Anavex Life Sciences Corp geopend

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401 Posts
Pagina: «« 1 ... 14 15 16 17 18 ... 21 »» | Laatste | Omlaag ↓
  1. Gabriel de Zwaluw 15 juni 2023 13:39
    Health Canada Special Access Program (SAP) Authorizes ANAVEX®2-73 (blarcamesine) for patients after successful completion of Open-Label Extension (OLE) study

    Granting of requests are also ongoing in United Kingdom and Australia – representing all regions of Rett Syndrome study participation

    NEW YORK, June 15, 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 announced that the first patients with Rett syndrome from the ANAVEX®2-73-RS-003 study (EXCELLENCE) are able to continue treatment with ANAVEX®2-73 (blarcamesine) thanks to Health Canada’s approval of the Special Access Program (SAP), allowing for compassionate use following completion of the 48-week Open-Label Extension study.

    Special Access Program (SAP) applications are granted at a physicians’ request on behalf of patients. Based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that the study drug will continue to benefit patients, Anavex will continue its responsibility to support patients post study by facilitating the supply of ANAVEX®2-73 (blarcamesine) to patients in Canada. Approved compassionate programs are also ongoing in the United Kingdom and Australia, representing all regions of the Rett Syndrome study participation.
  5. Gabriel de Zwaluw 28 juni 2023 09:28
    Anavex Life Sciences and Partex Group Announce Strategic Partnership to Leverage AI for Drug Development and Healthcare Sales Marketing Building a Patient-Centric Digital Ecosystem
    Anavex Life Sciences Corp.
    Tue, June 27, 2023 at 1:30 PM GMT+2·5 min read
    In this article:

    Anavex Life Sciences Corp.
    Anavex and Partex agreed to enter into a strategic partnership to leverage Partex’s proprietary AI (Artificial Intelligence) technology for Anavex’s drug pipeline to enhance the patient experience

    The partnership brings together a unique integrated platform with a “Precision medicine” approach covering CNS indications and a “patient-centric” digital ecosystem

    In addition to this innovative take on CNS indications, Anavex and Partex may also leverage the platform for drug development expansion

    NEW YORK, June 27, 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, and Partex N.V. Group (“Partex”), the first Data-to-Drugs digital pharma platform, today announced a strategic partnership with the overall ambition to reshape the future of the biopharma business model.

    By combining Anavex's innovative small molecule precision medicine drug development platform and Partex's disruptive approach of Artificial Intelligence (AI) enabled drug development and healthcare sales marketing, this collaboration is intended to drive efficiency, effectiveness, and innovation across the value chain with patient-centric focus at every step.

    Under the partnership, Anavex and Partex intend to co-develop a disease-focused Patient App ecosystem. The first feature will be to inform patients and caregivers on preventive and curative options available in clinics and on the market. Further, Partex will implement AI-based ‘Healthcare Sales Marketing’ in preparation for Anavex’s late stage drug pipeline.

    Gunjan Bhardwaj, PhD, CEO of Partex, commented: “We are excited to embark on this impactful journey together with Anavex. We will start by extending our patient ecosystem together. Further, we intend to leverage our Life Sciences Language Processing platform with Generative Artificial Intelligence capabilities, which is expected to significantly improve patient outcomes.”

    "As a biopharmaceutical Company with a proprietary late stage pipeline for CNS indications, Anavex brings expertise in precision medicine drug development to the partnership and we are excited to collaborate with Partex and fully leverage AI to expand beyond our R&D into healthcare sales marketing to bring better treatment options to patients in a patient centric way,” said, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
  6. Gabriel de Zwaluw 28 juni 2023 13:55
    Long-term Clinical Study Demonstrates Disease Modifying Effects of ANAVEX®2-73 (blarcamesine) for Rett Syndrome
    Anavex Life Sciences Corp.
    Wed, June 28, 2023 at 1:30 PM GMT+2·8 min read
    In this article:

    Anavex Life Sciences Corp.
    NEW YORK, June 28, 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 announced that long-term clinical study results from the U.S. ANAVEX®2-73-RS-001 (NCT03758924) study demonstrate disease modifying effect of ANAVEX®2-73 (blarcamesine) for adult patients with Rett syndrome.

    Usually, symptomatic therapies treat the symptoms of the disease but do not address the underlying cause of the disease. Disease-modifying therapies target the underlying cause of the disease.

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    ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) which, data suggest, is pivotal to restoring cellular homeostasis and promoting neuroplasticity.1

    In the U.S. ANAVEX®2-73-RS-001 trial, of all 25 patients who both started and completed the randomized, double-blind, placebo-controlled study, 24 patients voluntarily enrolled in the 12-week open label extension (OLE) study, receiving once daily oral liquid ANAVEX®2-73 (blarcamesine) formulation for further evaluation of long-term safety, tolerability, and effectiveness of ANAVEX®2-73 (blarcamesine) in patients with Rett syndrome. The 12-week extension study was subsequently further extended to 36 weeks.

    The effect of ANAVEX®2-73 (blarcamesine) in the double-blind part of the U.S. ANAVEX®2-73-RS-001 study was maintained in the open label 12-week extension study. Results from pharmacometric modeling of the full clinical data (i.e., from baseline of the double-blind study to the end of the open label extension study) indicates that the data are best characterized by a combined symptomatic and disease modifying drug effect model. Meaning that ANAVEX®2-73 (blarcamesine) exhibited both symptomatic and disease modifying effects in the treatment of Rett syndrome in a clinical setting.

    Patients assigned first to ANAVEX®2-73 (blarcamesine) in the double-blind part of the study and who continued on ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) study had a statistically significant (p = 0.01147) reduction in disease severity when compared with patients assigned first to placebo in the double-blind part of the study and who then received ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) part of the study – a criterion for classification as a disease modifying agent.


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    Continued improvement from the drug, as measured with the Rett Syndrome Behavior Questionnaire (RSBQ) total score,2 was observed from the start of the double-blind study to the end of the open label extension part for patients continuing on ANAVEX®2-73 (blarcamesine). Patients previously on placebo, who switched to ANAVEX®2-73 (blarcamesine) in the OLE part of the study experienced improvement during the OLE part.

    Additionally, disease progression, which is defined as change in Rett syndrome disease severity with time, was also reduced with long-term treatment with ANAVEX®2-73 (blarcamesine).

    Patients assigned first to ANAVEX®2-73 (blarcamesine) in the double-blind part of the study and who continued on ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) study had a statistically significant (p = 0.01752) reduction in disease progression when compared with patients assigned first to placebo in the double-blind part of the study and who then received ANAVEX®2-73 (blarcamesine) during the open label extension (OLE) part of the study – a criterion for classifying a drug as a disease modifying agent.

    Patients assigned to ANAVEX®2-73 (blarcamesine) at the start of the double-blind study experienced more benefit of drug effect than could be explained by symptomatic benefit alone – hence, ANAVEX®2-73 (blarcamesine) exhibited both symptomatic and disease modifying effect.

    The reduction in annual rate of disease progression for those patients, who continued on ANAVEX®2-73 (blarcamesine) was over 3-fold greater, relative to those who switched from placebo to ANAVEX®2-73 (blarcamesine): Ratio of reduction in annual rate of disease progression = 3.17 (Reduced disease progression rate [Double-blind Part/ OLE — ANAVEX®2-73/ ANAVEX®2-73] = -1.383/year; Reduced disease progression rate [Double-blind Part/ OLE — Placebo/ ANAVEX®2-73] = -0.4357/year).

    Anavex plans to submit the data for publication in a peer-reviewed medical journal.

    ANAVEX®2-73 (blarcamesine) has previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

    “We believe these promising long-term clinical results in adult patients with Rett syndrome provides further support of the beneficial effect of ANAVEX®2-73 (blarcamesine) for patients with Rett syndrome,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Rett syndrome is a devastating, non-inherited genetic post-natal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life. We are looking forward to the upcoming read-out of the ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett syndrome clinical trial in pediatric patients with Rett syndrome.”
  11. Gabriel de Zwaluw 8 augustus 2023 17:49
    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.
    Recent Business Highlights:

    On August 7, 2023, the Company announced a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved its cardiovascular safety objectives. The publication is entitled, ‘Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease'.
    On June 28, 2023, the Company announced that long-term clinical study results from the U.S. ANAVEX®2-73-RS-001 clinical trial demonstrate disease-modifying effect of ANAVEX®2-73 (blarcamesine) for adult patients with Rett syndrome.
    On June 27, 2023, the Company announced a strategic partnership with Partex N.V. Group, the first Data-to-Drugs digital pharma platform in which Partex will implement AI-based ‘Healthcare Sales Marketing' in preparation for Anavex's late-stage drug pipeline.
    On June 12, 2023, the Company announced the publication of a relevant new peer-reviewed study in the American Journal on Intellectual and Developmental Disabilities, entitled ‘Rett Syndrome Behaviour Questionnaire in Children and Adults With Rett Syndrome: Psychometric Characterization and Revised Factor Structure.' In the EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 Rett syndrome pediatric clinical trial, the characterized Rett Syndrome Behaviour Questionnaire (RBSQ), together with the Clinical Global Impression Improvement Scale (CGI-I), represent the co-primary efficacy endpoints of the study.
    On June 6, 2023, the Company announced completion of dosing of all participants of the placebo-controlled EXCELLENCE Phase 2/3 clinical trial ANAVEX®2-73-RS-003 in pediatric patients with Rett syndrome.
    On June 1, 2023, the Company announced that it was awarded a new U.S. Patent No. 11,661,405 entitled "CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS" from the United States Patent and Trademark Office (USPTO), expanding Anavex's patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof.
    Financial Highlights:

    Cash and cash equivalents of $154.8 million at June 30, 2023 compared to $149.2 million at fiscal year end September 30, 2022.
    General and administrative expenses for the quarter of $3.2 million compared to $3.2 million for the comparable quarter of fiscal 2022.
    Research and development expenses for the quarter of $10.3 million compared to $9.3 million for the comparable quarter of fiscal 2022.
    Net loss for the quarter of $11.3 million, inclusive of $3.9 million in non-cash items, or $0.14 per share, compared to a net loss of $12.4 million, inclusive of $4.0 million in non-cash items, or $0.16 per share for the comparable quarter of fiscal 2022.
    The financial information for the quarter ended June 30, 2023, should be read in conjunction with the Company's interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
  12. galaking 9 augustus 2023 18:16
    Het gaat lekker vandaag met Anavex op de beurs: 14% in de plus met een omzet die nu al het dubbele is van de gemiddelde dagomzet in de afgelopen 10 dagen. Waarschijnlijk door iig 2 koopaanbevelingen met hoge koersdoelen naar aanleiding van de kwartaalcijfers en de berichten over de voortgang in de pijplijn.
  14. Gabriel de Zwaluw 14 september 2023 13:33
    Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows Neurodegeneration
    share:
    September 14, 2023 - 7:30 am
    Significant Reduction of Amyloid Beta Biomarkers of Alzheimer’s Pathology

    NEW YORK, Sept. 14, 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 announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did demonstrate a statistically significant slowing in cognitive decline associated with Alzheimer’s disease.

    The clinical effect was complemented by two independent biomarkers: A significant reduction in pathological amyloid beta levels in plasma1, as well as a significant slowing in the rate of pathological brain atrophy2 on MRI (Magnetic Resonance Imaging)3 scans.

    The trial was a Multicenter (52 medical research centers/hospitals in 5 countries), randomized, double-blind, placebo-controlled, 48-week phase 2b/3 trial that enrolled 508 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia). Participants were randomized to receive blarcamesine (n = 338) or placebo (n = 170) oral capsules once daily for 48 weeks.

    All prespecified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM). The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation.

    The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.

    In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P = 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing treatment to placebo. In the respective safety population, common treatment-emergent adverse events included dizziness, which was transient and mostly mild to moderate in severity, and occurred in 120 participants (35.8%) during titration and in 76 participants (25.2%) during maintenance with blarcamesine and 10 (6.0%) during titration and 9 (5.6%) during maintenance with placebo.

    “There is hope that new therapies for Alzheimer’s that target the disease beyond amyloid that may slow progression of the disease for many people with the earliest forms of the disease,” said Marwan Noel Sabbagh, MD, Professor of Neurology and Chairman of the Scientific Advisory Board. “The advantage of blarcamesine (ANAVEX®2-73) is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and excellent safety profile.”

    This is among the first drugs to prospectively demonstrate efficacy on biomarkers of neurodegeneration.

    “These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” says Michael Weiner MD, Professor of Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology at the University of California, San Francisco (UCSF) and Principal Investigator of the Alzheimer's Disease Neuroimaging Initiative (ADNI).

    “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide, and Anavex’s clinical development is a testament to our determination to follow the science,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We like to thank all the people involved in the study for their invaluable contributions and we look forward to advancing blarcamesine as a potential new convenient orally available treatment option for Alzheimer’s disease.”
  19. Joho 2.0 25 oktober 2023 17:02
    Dit nieuws van vandaag zorgt dan in eens wel voor een flinke koersstijging (voor nu nog 7%):
    Anavex Life Sciences Reports New Publication in Scientific Journal Demonstrating the Potential of ANAVEX®3-71 to Prevent Cognitive Decline in Alzheimer’s Disease.
    Of wordt deze stijging versterkt door het hoge percentage aandelen short (20% volgens yahoofinance) icm dit nieuws ?
  20. Gabriel de Zwaluw 25 oktober 2023 17:44
    De stijging zal niet lang meer duren, dit type nieuws is gemakkelijk voor de shorts om tegen te werken. Het belangrijkste is vooral dat Missling nogmaals vermeldt heeft dat AD en Rett resultaten de komende 2 maanden zouden openbaar gemaakt worden. Dus nog een beetje afwachten tot we naar de $20,$30,... gaan
401 Posts
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