Anavex Life Scie Stock Price, News & Analysis

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.