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Anavex Life Sciences Corp. (Nasdaq: AVXL) is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for neurodegenerative and neurodevelopmental disorders. Headquartered in New York, Anavex focuses on precision medicine to treat diseases with high unmet medical needs, such as Alzheimer's disease, Parkinson's disease, Rett syndrome, and schizophrenia.
Anavex's lead compound, ANAVEX 2-73 (blarcamesine), is an orally available small molecule targeting sigma-1 and muscarinic receptors. It aims to restore cellular homeostasis, showing promise in multiple CNS disorders. Blarcamesine has successfully completed Phase 2a and Phase 2b/3 trials for Alzheimer's disease and various studies in Rett syndrome, including a recent Phase 2/3 EXCELLENCE pediatric trial demonstrating significant improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) scores.
The company also has other promising drug candidates, such as ANAVEX 3-71, targeting sigma-1 and M1 muscarinic receptors. This candidate has exhibited disease-modifying activity in Alzheimer's disease models and is currently in a Phase 2 trial for schizophrenia.
Anavex actively engages in partnerships and collaborations, including support from the Michael J. Fox Foundation for Parkinson's Research. With a robust intellectual property portfolio, Anavex is committed to advancing its pipeline through rigorous clinical trials to bring effective treatments to market.
Recent highlights include presenting at key industry conferences and filing a Marketing Authorisation application with the European Medicines Agency (EMA) for blarcamesine in Alzheimer's disease. Anavex also recently bolstered its executive team with seasoned professionals to drive its R&D and clinical strategies forward.
For more information, visit www.anavex.com or follow the company on Twitter, Facebook, Instagram, and LinkedIn.
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Anavex Life Sciences Corp. (AVXL) has been granted a new U.S. Patent expanding the coverage of ANAVEX®2-73 (blarcamesine) therapy to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to MeCP2 gene mutations. The patent is expected to remain in force until at least January 2037, further reinforcing the company's position in providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases.
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Anavex Life Sciences Corp. (AVXL) announces participation in the 42nd Annual J.P. Morgan Healthcare Conference. President and CEO, Christopher U Missling, PhD, to present on January 11, 2024, at 10:30am PST.
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Anavex Life Sciences Corp. (AVXL) announced topline results from the Phase 2/3 EXCELLENCE clinical study in pediatric Rett Syndrome. The study evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX®2-73 in 92 pediatric patients. The study showed improvement in the Rett Syndrome Behaviour Questionnaire (RSBQ) but did not meet the Clinical Global Impression – Improvement scale (CGI-I). Anavex believes a high placebo response may have masked the therapeutic effect of the drug. A preliminary review of the safety results indicates no new safety signals in the study. Over 91% of patients completing the trial continued into a 48-week open-label extension study (OLE), which is ongoing. The company has established Compassionate Use Programs in Canada, Australia, and the UK for pediatric patients. ANAVEX®2-73 has previously received Fast Track designation, Rare Pediatric Disease designation, and Orphan Drug designation from the FDA for the treatment of Rett syndrome.
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Anavex Life Sciences Corp. (AVXL) announced the first entire clinical gene pathway data from the ANAVEX®2-73-RS-002 AVATAR Rett syndrome trial. The study confirmed that Rett syndrome is a neurodevelopmental disorder with a key metabolic component, addressable with therapeutic intervention. The ANAVEX®2-73 treatment showed significant activation of key developmental and metabolic gene pathways, potentially compensating for dysregulated genes. The study included 33 patients with Rett syndrome and analyzed gene expression changes, single nucleotide polymorphisms/variants, and transcriptomics analysis. The results highlighted significant differences between the active treatment group and placebo, suggesting potential correction of metabolic alterations in patients with Rett syndrome.
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Anavex Life Sciences Corp. (AVXL) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has deemed oral blarcamesine for Alzheimer’s disease eligible for submission of a Union Marketing Authorisation in the EU under the centralised procedure. Anavex aims to submit the Marketing Authorisation Application in 2024. Blarcamesine addresses a broader Alzheimer’s disease population compared to monoclonal antibodies and has shown significant improvement in dementia symptoms and reduction of pathological aggregation of amyloid in early Alzheimer’s disease.
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Anavex Life Sciences Corp. (AVXL) reported financial results for its fiscal year ended September 30, 2023, with key pipeline updates for Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and more. The company also highlighted recent business and financial highlights, including the grant of a new patent, initiation of a Marketing Authorisation application, and appointment of a new Senior Vice President. The company's cash and cash equivalents stood at $151.0 million at September 30, 2023, with a net loss of $10.1 million for the fourth quarter.
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Anavex Life Sciences Corp. (AVXL) will issue financial results for its fiscal year ended September 30, 2023, on November 27, 2023. The company is a clinical-stage biopharmaceutical company developing therapeutics for neurodegenerative and neurodevelopmental disorders. A conference call will be held to review financial results and provide an update on the execution of the Company’s growth strategy.
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Anavex Life Sciences Corp. (AVXL) announced the grant of U.S. Patent No. 11,813,242 entitled 'A2-73 AS A THERAPEUTIC FOR INSOMNIA, ANXIETY, AND AGITATION.' This patent expands the company's existing patent coverage of ANAVEX®2-73 (blarcamesine), ANAVEX®1-41, and ANAVEX®19-144 for treating insomnia, anxiety, and agitation. The patent is expected to remain in force until July 2037, providing extensive coverage for the company's lead compounds. Anavex aims to deliver holistic care for patients with Alzheimer’s dementia or Parkinson’s diseases, who often concurrently suffer from insomnia and/or anxiety.
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Anavex Life Sciences Corp. (Nasdaq: AVXL) met with the European Medicines Agency to discuss blarcamesine (ANAVEX®2-73) Alzheimer’s disease clinical program results. Anavex initiated the process for submitting a Marketing Authorisation application to the EMA for oral blarcamesine. The goal is to allow direct access to the European Union market for the treatment of Alzheimer’s disease. An estimated 7 million people in Europe have Alzheimer’s disease, with costs of care estimated at $439 billion in 2019. Anavex aims to provide convenient oral treatment options for Alzheimer’s patients, addressing the urgent need for simple patient-centered administrations and shared decision-making.
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Anavex Life Sciences Corp. has appointed David Goldberger as Senior Vice President Regulatory Affairs. Goldberger brings over 40 years of experience in pharmacy practice and the pharmaceutical industry, with expertise in regulatory strategies and global interactions for CNS development projects. He will succeed Emmanuel O Fadiran, who is retiring. Goldberger has previously led regulatory efforts for CNS products at Otsuka Pharmaceuticals and Johnson and Johnson. Anavex is a clinical-stage biopharmaceutical company focused on developing therapeutics for neurodegenerative and neurodevelopmental disorders.
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FAQ
What is the current stock price of Anavex Life Sciences (AVXL)?
The current stock price of Anavex Life Sciences (AVXL) is $9.02 as of November 21, 2024.
What is the market cap of Anavex Life Sciences (AVXL)?
The market cap of Anavex Life Sciences (AVXL) is approximately 755.4M.
What is Anavex Life Sciences Corp's primary focus?
Anavex Life Sciences Corp focuses on developing novel therapeutics for neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and schizophrenia.
What is ANAVEX 2-73?
ANAVEX 2-73 (blarcamesine) is Anavex's lead drug candidate. It targets sigma-1 and muscarinic receptors to restore cellular homeostasis and has shown promise in treating various CNS disorders.
What recent results were obtained from Anavex's trials?
Recent trials for ANAVEX 2-73 in Rett syndrome showed significant improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) scores. The company is also progressing in trials for Alzheimer's disease and schizophrenia with ANAVEX 3-71.
What partnerships does Anavex Life Sciences have?
Anavex partners with several organizations, including the Michael J. Fox Foundation for Parkinson's Research, which supports the development of ANAVEX 2-73 for Parkinson's disease.
What are Anavex's recent business highlights?
Recent highlights include presenting at key industry conferences, filing a Marketing Authorisation application with the European Medicines Agency (EMA) for blarcamesine in Alzheimer's disease, and strengthening the executive team.
Where is Anavex Life Sciences headquartered?
Anavex Life Sciences is headquartered in New York, USA.
How can I stay updated on Anavex Life Sciences' developments?
You can stay updated by visiting their website at www.anavex.com and following their social media profiles on Twitter, Facebook, Instagram, and LinkedIn.
What is the significance of ANAVEX 3-71?
ANAVEX 3-71 targets sigma-1 and M1 muscarinic receptors, showing disease-modifying activity in Alzheimer's disease models. It is currently in a Phase 2 trial for schizophrenia.
What makes Anavex Life Sciences' approach unique?
Anavex uses precision medicine to develop therapeutics based on genomic data, aiming to address high unmet medical needs in CNS disorders.
Who are the recent additions to Anavex's executive team?
Recent additions include Dr. Juan Carlos Lopez-Talavera as Senior VP of Research and Development, Dr. Terrie Kellmeyer as Senior VP of Clinical Development, and Dr. Jeffrey Edwards as VP of Clinical Pharmacology and Science.
Anavex Life Sciences
Nasdaq:AVXL
AVXL Rankings
AVXL Stock Data
755.43M
82.21M
3.05%
32.06%
21.59%
Biotechnology
Biological Products, (no Disgnostic Substances)
United States of America
NEW YORK