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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.
Anavex Life Sciences presented new data from their Phase IIb/III study of blarcamesine (ANAVEX®2-73) for early Alzheimer's disease at the CTAD Conference 2024. The oral, once-daily treatment demonstrated significant clinical efficacy through SIGMAR1 activation, slowing clinical progression by 36.3% in the primary endpoint ADAS-Cog13 over 48 weeks. In patients with SIGMAR1 wild type genes, progression slowed by 49.8%. The drug showed superior numerical clinical efficacy compared to approved therapies, with a good safety profile not requiring routine MRI monitoring. The company is proceeding with regulatory submission to EMA in Q4 2024.
Anavex Life Sciences Corp. (Nasdaq: AVXL) has announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of its ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. The study demonstrated a dose-dependent pharmacodynamic effect on two key EEG biomarkers in patients with schizophrenia:
1. Improvements in 40 Hz Auditory Steady-State Response (ASSR) Inter Trial Coherence (ITC)
2. Increased Resting State Alpha Power
These effects were most pronounced in the higher dose group, providing evidence of CNS target engagement and potential therapeutic effects. ANAVEX®3-71, a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, was well-tolerated with no serious adverse events reported. The ongoing Part B of the study will provide more comprehensive data, with results expected in the first half of 2025.
Anavex Life Sciences Corp. (Nasdaq: AVXL), a clinical-stage biopharmaceutical company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024 in New York City. Christopher U. Missling, PhD, President and CEO of Anavex, will present on Monday, September 9, 2024, at 11:30 a.m. ET at the Lotte New York Palace.
The presentation will be available via audio webcast on the company's website. Additionally, Dr. Missling will participate in a panel discussion on 'Non-Amyloid-Targeted Approaches in Treatment of Alzheimer's Disease' on September 10, 2024 at 2:00 p.m. ET. Anavex focuses on developing therapeutics for various CNS diseases, including Alzheimer's, Parkinson's, and Rett syndrome.
Anavex Life Sciences reported fiscal 2024 Q3 results and provided a business update. Key highlights include:
1. Advancement of blarcamesine (ANAVEX®2-73) for Alzheimer's disease, with full regulatory submission expected in Q4 2024.
2. Progress in ANAVEX®3-71 Phase 2 trial for schizophrenia.
3. Planned initiation of ANAVEX®2-73 Phase 2b/3 trial for Parkinson's disease in H2 2024.
4. Cash position of $138.8 million as of June 30, 2024, providing an estimated 4-year runway.
5. Net loss of $12.2 million ($0.14 per share) for the quarter.
Anavex Life Sciences Corp. (Nasdaq: AVXL), a clinical-stage biopharmaceutical company, has announced that it will release its fiscal 2024 third quarter financial results on Tuesday, August 6, 2024. The company, which focuses on developing therapeutics for various neurological conditions, will host a conference call and webcast at 8:30 am ET on the same day. During this call, management will review the financial results and provide an update on the company's growth strategy. Investors and interested parties can access the webcast through Anavex's website or join the conference call by dialing 1 929 205 6099 (U.S. participants) using the Meeting ID# 821 9280 7728 and passcode 121725. A replay of the call will be available on the company's website for up to 30 days.
Anavex Life Sciences (Nasdaq: AVXL) reported positive preclinical results for ANAVEX®2-73 (blarcamesine) in a Fragile X syndrome (FXS) model at the 19th NFXF International Fragile X Conference. The study showed significant dose-dependent improvements in translatable EEG biomarkers, particularly in the auditory steady state response (ASSR) test. ANAVEX®2-73 enhanced neural synchrony in the frontal and auditory cortices, demonstrating potential to address behavioral, sensory, and cognitive abnormalities in FXS patients.
FXS, affecting an estimated 62,500 people in the US and 1,088,500 worldwide, is the most common inherited intellectual disability and single gene cause of autism spectrum disorder. Based on these results and previous studies, Anavex plans to initiate a clinical trial to evaluate ANAVEX®2-73's safety and efficacy in FXS patients.
Anavex Life Sciences presented results from their Phase IIb/III trial of blarcamesine (ANAVEX®2-73) for early Alzheimer's disease at the 2024 Alzheimer's Association Conference. The oral, once-daily treatment significantly slowed clinical decline by 38.5% (50 mg) and 34.6% (30 mg) compared to placebo over 48 weeks. Key findings include:
1. Significant improvement in the primary cognitive endpoint (ADAS-Cog13)
2. Positive trends in functional measures (ADCS-ADL)
3. Significant results in the key secondary composite endpoint (CDR-SB)
4. Reduced brain atrophy in key regions
5. Good safety profile with no neuroimaging adverse events
Anavex plans to submit for EMA approval in Q4 2024. The company believes blarcamesine's oral administration and safety profile could provide broader access to early Alzheimer's patients.
Anavex Life Sciences (Nasdaq: AVXL), a clinical-stage biopharmaceutical firm focusing on neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, will be presenting at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference. The presentation will be given by CEO Christopher U. Missling, PhD, and will be available via audio webcast starting June 27, 2024, at 7:00 a.m. ET. Interested parties can access the webcast through the Investors section of Anavex’s official website.
Anavex Life Sciences has announced the expansion of its leadership team with the appointment of three new senior executives: Juan Carlos Lopez-Talavera, MD, PhD as Senior VP, Head of Research and Development; Terrie Kellmeyer, PhD as Senior VP of Clinical Development; and Jeffrey Edwards, PhD as VP of Clinical Pharmacology and Science. Each brings extensive experience in drug development, regulatory affairs, and clinical trials. This move aims to enhance operational efficiency and drive value creation, aligning with Anavex's strategy to bring innovative therapeutics to market for neurodegenerative and neuropsychiatric disorders.
Anavex Life Sciences (AVXL), a clinical-stage biopharmaceutical firm focusing on treatments for neurodegenerative, neurodevelopmental, and neuropsychiatric conditions, announced its participation in the H.C. Wainwright 2nd BioConnect Investor Conference. The event will occur on May 20, 2024, at 10:00am ET at NASDAQ World Headquarters in New York City.
Christopher U. Missling, PhD, Anavex's President and CEO, will engage in a fireside chat. A live audio webcast will be available on the company's website, with an archived version accessible later.
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