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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) reported its fiscal 2025 Q1 financial results, highlighting significant developments in its Alzheimer's disease treatment program. The company's oral treatment blarcamesine demonstrated a 36.3% slowdown in clinical progression at 48 weeks, and 49.8% in patients with SIGMAR1 wild-type gene.
Financial results show cash and equivalents of $120.8 million as of December 31, 2024, providing an estimated 4-year runway. Q1 net loss increased to $12.1 million ($0.14 per share) compared to $8.6 million ($0.11 per share) in the previous year. R&D expenses rose to $10.4 million from $8.7 million, while G&A expenses increased to $3.1 million from $2.7 million.
The company secured a new composition of matter U.S. Patent for ANAVEX®2-73, valid until July 2039, covering crystalline forms and various delivery methods.
Anavex Life Sciences (Nasdaq: AVXL) has scheduled its fiscal 2025 first quarter financial results announcement for Wednesday, February 12, 2025. 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 question-and-answer session following management's presentation. Investors can access the live webcast through the company's website at www.anavex.com, or join the conference call by dialing 1 929 205 6099 (U.S. participants) using Meeting ID# 828 2995 9982 and passcode 308966. A replay will be available on the company's website for up to 30 days.
Anavex Life Sciences (Nasdaq: AVXL) has been granted a new U.S. Patent (No. 12,180,174) for crystalline forms of ANAVEX®2-73 (blarcamesine) dihydrogen phosphate salt. The patent covers crystalline forms, freebase, transdermal patches, and enteric coated oral dosage forms for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer's and Parkinson's disease.
The patent will remain in force until at least July 2039 and expands the company's existing intellectual property portfolio, which includes several U.S. Patents (Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908). The dihydrogen phosphate crystals enable convenient once-daily oral dosing and transdermal patch delivery options, potentially improving patient compliance.
Anavex Life Sciences announced the peer-reviewed publication of Phase IIb/III trial results for oral blarcamesine (ANAVEX®2-73) in The Journal of Prevention of Alzheimer's Disease. The study demonstrated that once-daily oral blarcamesine significantly slowed clinical progression by 36.3% at 48 weeks in early Alzheimer's Disease patients, and by 49.8% in the SIGMAR1 wild-type gene group on the ADAS-Cog13 cognitive endpoint.
The drug showed a favorable safety profile with no associated neuroimaging adverse events. Blarcamesine works through SIGMAR1 activation, inducing autophagy and restoring cellular homeostasis. The treatment could represent a novel approach for early Alzheimer's disease, potentially serving as a complementary or alternative option to injectable anti-beta amyloid drugs. The data is currently under review by the EMA as part of an MAA filing.
Anavex Life Sciences (NASDAQ: AVXL) announced positive results from its ATTENTION-AD trial, showing that over three years of continuous treatment with oral blarcamesine significantly reduced clinical decline in early Alzheimer's disease patients.
The trial demonstrated that patients who started treatment earlier showed greater stability of cognitive function compared to those who started later. The delayed-start analysis revealed significant differences in ADAS-Cog13 scores at Week 144 (LS mean difference -2.70, P = 0.0348) and Week 192 (LS mean difference -3.83, P = 0.0165).
The drug exhibited a favorable safety profile with mostly mild to moderate adverse events. The most common side effect, dizziness, was reduced from 25.2% to 9.6% after adjusting the titration period. Currently, 74 participants are receiving blarcamesine through the Compassionate Use Program, with some patients on treatment for over 9 years with no severe adverse events.
Anavex Life Sciences (Nasdaq: AVXL), a clinical-stage biopharmaceutical company, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The presentation will take place on Thursday, January 16th, 2025, at the Westin St. Francis in San Francisco, CA, from 9:00 AM to 9:40 AM Pacific Time.
The company, which focuses on developing innovative treatments for neurological conditions including Alzheimer's disease, Parkinson's disease, schizophrenia, and Rett syndrome, will be represented by Christopher U Missling, PhD, President & Chief Executive Officer. The presentation will be accessible via audio webcast through the Investors section of Anavex's website, with a replay available later that day.
Anavex Life Sciences (NASDAQ: AVXL) reported its fiscal 2024 Q4 results, highlighting key developments in its Alzheimer's disease treatment program. The company's cash position stood at $132.2 million as of September 30, 2024, projecting a 4-year runway. Q4 financial results showed a net loss of $11.6 million ($0.14 per share), compared to $10.1 million ($0.12 per share) in Q4 2023.
Notable achievements include the EMA's acceptance of the Marketing Authorization Application (MAA) for blarcamesine in Alzheimer's disease treatment, and promising preliminary EEG biomarker results from the Phase 2 study of ANAVEX®3-71 for schizophrenia. Research and development expenses increased to $11.6 million from $10.1 million year-over-year.
Anavex Life Sciences (NASDAQ: AVXL) announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for blarcamesine, an oral treatment for Alzheimer's disease. The application is supported by data from the Phase IIb/III ANAVEX®2-73-AD-004 trial and its 144-week open-label extension study.
The once-daily oral medication demonstrated meaningful clinical improvement over 48 weeks, with the primary endpoint ADAS-Cog13 score exceeding 2 points. Blarcamesine works through SIGMAR1 activation, inducing autophagy to restore cellular homeostasis. The drug showed a favorable safety profile without requiring routine MRI monitoring, potentially offering an alternative or complement to injectable anti-beta amyloid antibody treatments.
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.
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