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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 (Nasdaq: AVXL) announced it will release its fiscal 2024 fourth quarter financial results on Monday, December 23, 2024. The company will host a conference call and webcast at 8:30 am ET on the same day, where management will review financial results and provide updates on the company's growth strategy. The event will include a Q&A session and will be accessible via webcast on www.anavex.com or by phone for U.S. participants.
Anavex is a clinical-stage biopharmaceutical company developing treatments for various CNS disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other neurodegenerative and rare diseases.
Anavex Life Sciences (Nasdaq: AVXL) announced it will present new long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial for blarcamesine in early Alzheimer's disease at the J.P. Morgan 2025 Healthcare Conference. The presentation will showcase data from up to 144 weeks of continuous treatment in the OLE phase, following a 48-week double-blind study, totaling approximately 4 years of safety and efficacy data.
The oral once-daily treatment's scalable and easy-to-use features could potentially offer broader access to early Alzheimer's disease patients due to its convenient administration and favorable safety profile, addressing current healthcare ecosystem barriers.
Anavex Life Sciences (Nasdaq: AVXL) announced its participation in the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL. CEO Christopher U. Missling will engage in a fireside chat on December 4th, 2024, at 3:25pm ET. The conference brings together over 600 industry experts and leaders from more than 225 healthcare companies, covering sectors including Biotechnology, Pharma, Healthcare Distribution, Services & Technology, Life Science Tools & Diagnostics, and Healthcare Facilities.
The presentation will be available via audio webcast through Anavex's website, with a replay option available later that day. Anavex focuses on developing therapeutics for various conditions including Alzheimer's, Parkinson's, schizophrenia, and Rett syndrome.
Anavex Life Sciences has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine, an oral treatment for Alzheimer's Disease. The drug demonstrated clinically meaningful improvement over 48 weeks, with ADAS-Cog13 score improvements exceeding 2 points. The treatment shows superior numerical clinical efficacy compared to approved therapies while slowing neurodegeneration in early AD patients. Blarcamesine offers advantages including once-daily oral administration, no routine MRI monitoring requirement, and a favorable safety profile. There are approximately 7 million people with Alzheimer's in Europe, with care costs estimated at $439 billion in 2019.
Anavex Life Sciences announced the acceptance of a peer-reviewed manuscript detailing Phase IIb/III trial results of oral blarcamesine for early Alzheimer's disease treatment. The manuscript, titled 'Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,' will be published in an Alzheimer's-focused medical journal around Q4 2024/Q1 2025. The company is proceeding with regulatory submission to the European Medicines Agency (EMA) in the current quarter of 2024.
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.
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