Anavex Life Scie Stock Price, News & Analysis

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.

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.