| Tuesday | ||||
"We are pleased with… "We are pleased with the progress of our clinical Precision Medicine SIGMAR1 platform pipeline and remain on track for the readout of the placebo-controlled ANAVEX2-73 Phase 2b/3 Alzheimer's disease clinical trial, a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "Subsequent data readouts, including the placebo-controlled Phase 2/3 Rett syndrome EXCELLENCE study, which completion is projected by year end as well as initiation of biomarker-driven Precision Medicine clinical studies are expected through the rest of the year as planned." | ||||
| Over a week ago | ||||
Anavex Life Sciences… Anavex Life Sciences announced long-lasting effect of clinical drug candidate ANAVEX 3-71 in preventing cognitive decline in a transgenic rat model of Alzheimer's disease at the Alzheimer's Association International Conference, AAIC, taking place in San Diego, CA and virtually on July 31 - August 4, 2022. ANAVEX 3-71 or control was administered orally once daily in pre-plaque McGill-R-Thy1-APP transgenic rats and wild-type rats divided into four groups, for seven months. Subsequently, after one month of drug interruption, behavioral tests were performed: Novel Object Recognition, Morris Water Maze, and Social Preference. Biomarker analysis revealed that ANAVEX 3-71 prevents McGill-APP transgenic rats from increasing cortical and hippocampal extracellular Abeta deposition. ANAVEX 3-71 also significantly reduces microglia and astrocytes recruitment towards Abeta-burdened neurons in the hippocampus. In the Novel Object Recognition behavioral test, Tg control rats explored the novel object significantly less than wt control rats. The impairment in Tg rats was completely reversed with ANAVEX 3-71. In the Morris Water Maze behavioral test, the rats showed significant differences in learning. In the Social Preference behavioral test, Tg control rats showed less interaction time with a "stranger rat" than wt control rats. This deficit in Tg rats was entirely reversed with ANAVEX 3-71. This new data strengthens the importance and applicability of Anavex's Precision Medicine SIGMAR1 platform and is consistent with previously reported therapeutic significant and dose-dependent preclinical prevention of Abeta induced biomarker-correlated cognitive impairments with ANAVEX 2-73. Both clinical drug candidates ANAVEX 2-73 and ANAVEX 3-71 activate the sigma-1 receptor. Data suggests that activation of SIGMAR1 results in the restoration of homeostatic function within the body and is pivotal to restoring neural cell balance and the promotion of neuroplasticity.2 Recent independent findings strengthen the understanding of the beneficial effects of SIGMAR1 activation as a compensatory mechanism to chronic CNS diseases. "These results strengthen our SIGMAR1 product platform and validate Anavex's approach to CNS target selection and drug discovery," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "This data increases Anavex' confidence in the potential of our Precision Medicine technology to address serious neurodegenerative diseases." | ||||
Latest data shows the… Latest data shows the largest indicative borrow rate increases among liquid option names include: Canoo (GOEV) 109.01% +15.18, Alphabet (GOOG) 2.34% +2.06, Confluent (CFLT) 2.09% +1.58, Virgin Orbit (VORB) 138.98% +0.84, Lightwave Logic (LWLG) 63.45% +0.48, Anavex (AVXL) 1.18% +0.29, iShares Russell 2000 Value Index Fund (IWN) 1.03% +0.25, Hims and Hers Health (HIMS) 0.69% +0.24, Evofem Biosciences (EVFM) 152.17% +0.22, and Heliogen (HLGN) 13.76% +0.19. | ||||
| Over a month ago | ||||
Berenberg analyst… Berenberg analyst Caroline Palomeque initiated coverage of Anavex with a Buy rating and $40 price target. Palomeque believes the market is underestimating the clinical potential of a CNS drug candidate, telling investors in a research note that encouraging clinical data show that ANAVEX 2-73 may be effective in several therapeutic areas within the CNS space. ANAVEX 2-73 has a mechanism of action that is applicable to several CNS diseases such as Rett Syndrome, Alzheimer's disease, and Parkinson's Disease Dementia, and its platform drug approach removes the binary risk often seen in the biotech space, the analyst contends. | ||||
Anavex Life Sciences… Anavex Life Sciences announces Anavex's very first Educational Video News Release, which can be accessed via Anavex's newsroom. | ||||
Anavex Life Sciences… Anavex Life Sciences announced the peer-reviewed publication in American Journal of Medical Genetics identifying a blood biomarker for assessing treatment effect of ANAVEX 2-73 in Fragile X Syndrome, which will be also included in the planned clinical trial of ANAVEX 2-73 in Fragile X Syndrome.Fragile X Syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 At present, there is no approved treatment for Fragile X Syndrome. The findings demonstrate that treatment effect of ANAVEX 2-73 resulting in reversal of hyperactivity, restoration of associative learning and reduction of anxiety in a mouse model of Fragile X Syndrome are also associated with improvements in key blood signaling biomarkers, which are measurable in patients with Fragile X Syndrome as well. Previously reported improvements in cognitive and behavioral paradigms in a mouse model of Fragile X Syndrome, after ANAVEX 2-73 administration, are associated with parallel improvements in peripheral lymphocyte signaling abnormalities Fragile X Syndrome is characterized by multiple cell signaling abnormalities, including increased activation of the PI3K/Akt/mTOR and MAPK/ERK pathways. These have been demonstrated in brain samples from mouse models as well as in lymphocytes from patients. | ||||
| Over a quarter ago | ||||
"We are pleased with… "We are pleased with the continued advancement regarding our lead product candidate ANAVEX 2-73 in Alzheimer's disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs and overall business operations," said Christopher U Missling, PhD, President and CEO of Anavex. "We are also looking forward to next month's R&D Day's event, where we will present our broad SIGMAR1 platform portfolio, which allows us to expand further within the neurodegenerative and rare disease space. We remain on track to deliver data readouts, as well as presentations at medical meetings and initiating biomarker-driven precision medicine clinical studies through the rest of the year as planned." | ||||
Anavex Life Sciences… Anavex Life Sciences announced presentations of Psychometric Evaluation of the Rett Syndrome Behaviour Questionnaire, RSBQ, and Burden of Illness, BOI, study in Rett syndrome by the respective working groups, at the IRSF Rett Syndrome Scientific Meeting, taking place in Nashville, TN, April 26-27, 2022. The presentation is titled "A Psychometric Evaluation of the Rett Syndrome Behaviour Questionnaire, RSBQ, in children and adults." The analyses presented support research and clinical use of the components of the RSBQ with better psychometric properties, in pediatric and adult populations. The data highlight the need for additional evaluations and potential improvements of the RSBQ, considering its more widespread use. The second presentation is titled "Burden of illness in Rett syndrome: initial evaluation of a disorder-specific caregiver survey." Previous studies have shown decreased patient and caregiver quality of life; however, applied instruments have not adequately quantified disease burden on affected individuals and their families in Rett syndrome. Consequently, a global collaboration of stakeholders in the USA, Europe, and Australia conducted the Burden of Illness project utilizing a caregiver questionnaire involving interviews with parents of 756 children and adults with Rett syndrome. The presented data demonstrate that core impairments in Rett syndrome have high burden impact on affected individuals and caregivers. Moreover, problems considered relatively mild in severity, can place a disproportionate burden on affected individuals and their caregivers. | ||||
Biotechnology Analyst… Biotechnology Analyst Zhong holds a virtual meeting with management on March 17 hosted by BTIG. | ||||
Anavex Life Sciences… Anavex Life Sciences announced the presentation of Phase 2 clinical biomarker data from the ANAVEX 2-73-PDD-001 Parkinson's Disease Dementia, PDD, study at AD/PD 2022 International Conference on Alzheimer's & Parkinson's Diseases and related neurological disorders, taking place in Barcelona, Spain, and virtually on March 15-20, 2022. The poster presentation titled, "ANAVEX2-73 - Analysis of Movement and Cognitiv Pharmacodynamic-Biomarker Outcome Measures of Placebo-Controlled Phase 2 Trial in 132 Parkinson's Disease Dementia Patients" is being presented by the Principal Investigator of the trial, Dr. Jaime Kulisevsky. MDS-UPDRS1 Total score improved significantly by -14.51 for patients treated with ANAVEX 2-73 high oral once-daily dose compared to placebo. The improvement is clinically relevant corresponding to a relative improvement of 18.9% over 14 weeks. Balanced and global improvements were observed within all MDS-UPDRS sub-scores Part I-IV. SIGMAR1 mRNA expression significantly increased in ANAVEX(R)2-73-treated patients vs placebo over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system. Christopher Missling, PhD, President & Chief Executive Officer of Anavex, remarked, "ANAVEX2-73 demonstrated dose-dependent efficacy for both motor impairment and cognition, which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX2-73 in Parkinson's disease and Parkinson's disease dementia as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer's disease. We would like to thank all the patients and participating families as well the investigators and clinical site coordinators for their dedication to this study." | ||||
