ANAVEX NY TRÅD JULI - PRÆVENTIV BEHANDLING AF ALZHEIMER!!!
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Promising Results of Preclinical Study of ANAVEX®2-73
Anavex Life Sciences announced today that preclinical data of the ANAVEX®2-73 (blarcamesine) study in Fragile X syndrome were published in the journal, Scientific Reports.
FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome (www.fraxa.org)
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Anavex er faktisk en del længere fremme end hvad flere tror.
Jeg mener, at PDD data var utroligt stærke og undrer også mig som boersboe, at kursen ikke steg mere end vi har set.
Men da PDD data kom solgte ANXL også selv et ganske betydeligt antal aktier og kvalte hermed stigningerne.
Jeg tror på, at de der akkumulerer og shorterne har fælles interesse i at holde kursen nede. Det vil de lykkes med indtil det er åbentlyst for alle at ANXL vil blive en succes.
Det sidste anser jeg for meget sandsynligt. Ikke pga museforsøg, men mest af alt pga de forsøg vi allerede har set data på. Vi har set god effekt og bivirkninger, der er overordentlig overkommelige - en meget vigtig parameter.
Senere har vi set videnskablige resultater fra andre kilder, der bekræfter at SIGMA1 receptoren kan være vejen til succes i CNS sygdomme. Ikke blot i AD, PDD etc, men også meget overraskende Rett, Fragile X, autisme etc.
De meget omfangsrige dataindsamlinger på alle pts i behandling ser ud til at øge sandsynligheden for succes. Nogle pts vil kunne få rigtig god effekt, mens andre ikke får megen effekt af behandlingen. Netop det forhold er forudsætningen for, at godkendelser af Blarcamesine er meget sandsynlig i de grupper der er effekt i - selv om en evt første analyse af samtlige pts ikke viser signifikans.
Misslings tiltagende selvsikre udsagn om, at ANXL er i en transformativ fase i 2021 styrker også min tro på selskabet.
Jeg er nok mere risikovillig end de fleste, men jeg tror meget på casen - ikke nødvendigvis tro på succes i alt, men mindre kan også gøre det - specielt med den værdiansættelse vi ser nu.
Jeg sælger ikke en eneste aktie før AD forsøget har readout.
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Anavex 100 % enig i dine betragtninger Solsen!
Vi skal have en godtaget markedsansøgning og efterfølgende markedsgodkendelse i RETT fra FDA, så får vi en seriøs afspejling i kursen og senere når 2-73 kommer på markedet, måske også muligheden for hurtig at udvide salget til andre relaterede indikationer.
Dvs. at patienter med Fragil X, autisme mm. burde kunne få adgang til 2-73, før der ligger en særskilt godkendelse i disse indikationer.
Uanset må denne sidste Peer Review have positiv indflydelse på de beslutninger og hvilke retningslinjer FDA giver Anavex i det videre forløb.
Presset fra FRAXA kan måske også skubbe lidt til processen med FDA.
FRAXA varetager jo primært interesser for børn og unge patienter - dette burde i sig selv give en højere prioritering hos FDA - især når der ikke er nogen alternativ behandling.Tak for linket Budweis!
Promising Results of Preclinical Study of ANAVEX®2-73
Anavex Life Sciences announced today that preclinical data of the ANAVEX®2-73 (blarcamesine) study in Fragile X syndrome were published in the journal, Scientific Reports.
FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome (www.fraxa.org)
"We look forward to initiating a double-blind, placebo-controlled Phase 2/3 ANAVEX
2-73 study in Fragile X syndrome""The next phase for Anavex will be Phase 2 double-blind, placebo-controlled study. There are good indications that the results from the next phase will also be promising for both Fragile X syndrome and Autism."
FRAXA ser også mulighed for en effekt af 2-73 i autisme generelt og de vil forsætte samarbejdet med Anavex.
MM - Missling brugte også ordet "clear", udover "intrigued" i beskrivelsen af resultaterne - måske blev dette opfattet uklart af markedet:)
Vi må se - måske får vi en forsinket reaktion, som ved CRTX.
Vi havde jo en relativ lille omsætning af Anavex aktier - tror SAVA hev os med ned i faldet i dag. -
Anavex-tråd: Biogen's New Alzheimer's Drug Beyond Reach for Many Patients
Doctors say insurers' reluctance to pay for the controversial medication, Aduhelm, results in patients being put on waiting lists https://www.wsj.com/articles/biogens-new-alzheimers-drug-beyond-reach-for-many-patients-11630077741?mod=e2tw -
Meget fin artikel om Anavex igen i Seeking Alpha.
Skribenten har aktier i Anavex og regner med ca 75% chance for godkendelser i RETT og PDD.
Pga af lav patient antal i fase 2a i Alz toer skribenten ikke at give ods på hvad chancerne er der, men er rimelig positiv. -
Det er en mega god artikel. Dejligt med noget for og imod i samme skriv. Tak for den Kyed
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Anavex. Udskrift Seeking Alpha
Super positiv kyed01 - tak.
Ser ikke umiddelbar ud til, at det er Lane S., der har forfattet artiklen - han er ellers også meget positiv på Anavex.
Forfatteren glemmer dog at nævne det planlagte Fragile X fase 3 forsøg på baggrund af bl.a. den sidste Peer Review.
Han nævner heller ikke den meget vigtige nyhed, at Anavex planlægger et forebyggende demens forsøg med 2-73.Ellers kunne man næsten få lyst til at købe Anavex aktier mandag - hvis man da ikke lige i forvejen var fyldt helt til skorsten med dem i forvejen.
Måske mangler SAVA folkene et sted, hvor de har muligheden for at tjene lidt af det tabte hjem igen.
( Har selv solgt det meste ud i SAVA )Anavex Life Sciences: Still Room To Run
Aug. 29, 2021 8:11 AM ETAnavex Life Sciences Corp. (AVXL)33 Comments13 Likes
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Small Pharma Analyst
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Growth, Long/Short Equity, Biotech, HealthcareContributor Since 2010
A veteran of the pharma industry. Specializing in the analysis of small pharma companies with a focus on the pipeline and opportunities for licensing or major deals with large pharma. Financial analysis including burn rate, venture capital funding, and cash flow.
SummaryLead candidate ANAVEX2-73 has shown impressive results in placebo-controlled Phase 2 studies in Parkinson's disease and Rett syndrome.
Ongoing studies in Rett syndrome could lead to a filing in 2022 if results are positive.
Encouraging results have been generated in a small study in Alzheimer's disease but are difficult to evaluate since it was not a placebo-controlled study.
Phase 2b/3 study in Alzheimer's disease is fully enrolled with top line data expected mid-2022.
Despite a 4-fold share price increase over the past year, we see continued upside based on Rett and PD, plus anticipation of a positive AD study readout next year.
Volunteer and old people
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Anavex Life Sciences (AVXL) is developing ANAVEX 2-73 as a potential treatment for Alzheimer's Disease (AD), Rett Syndrome, and Parkinson's Disease Dementia (PDD).The positive news on these studies has driven an increase in the share price by 4-fold in the past year to a market cap of $1.5 billion. Given the current investor appetite for any company that is showing a hint of success in AD, we think the share price still has room to run over the next 6-9 months in anticipation of Phase 2B/3 AD results. In addition, two additional Rett studies should read out in 2021, providing the basis for a potential filing in 2022.Brief History and Background of ANAVEX 2-73
ANAVEX 2-73, also named blarcamesine and hereafter abbreviated as A2-73, was described by Professor Alexandre Vamvakides and his group in a 1997 patent application and two publications in 2002. In 2007 the patent rights to ANAVEX 2-73 and other compounds were acquired by Anavex. Since then, the company has been advancing the compound through clinical development at a very slow pace, perhaps due to lack of financial resources.
According to their most recent 10-K, ANAVEX 2-73 binds the sigma-1 receptor (S1R) in the high nanomolar range and the muscarinic receptor in the low micromolar range. This means the compound has quite weak binding to S1R. In their August earnings conference call, CEO Missling stated: "ANAVEX 2-73 is the only available small molecule activator of the Sigma 1 receptor." This is a puzzling statement. While there are no FDA-approved drugs that are S1R agonists, it is now well known that several approved drugs are S1R agonists. The best comparison for AD treatment is Aricept (donepezil). Aricept was approved as an acetylcholinesterase inhibitor in 2004, but has subsequently been shown to be a potent agonist of S1R with low nanomolar binding (14.6 nM). (Lower numbers correlate with increased binding). This means Aricept is at least 50-fold more potent than A2-73 as an SIR agonist.
AVXL has touted data from a PET study that showed A2-73 achieved 70% SIR receptor binding in rat brains at high doses, as shown in the figure below, copied from the AVXL investor presentation.
Anavex - Anavex2-73
In a poster presentation, Anavex authors conclude that the mice equivalent human plasma exposures correspond to human doses of 10-50 mg, the doses that are being studied in clinical studies.
Aricept has also been shown to have SIGMAR1 receptor occupancy in rodent brains, achieving 93% receptor occupancy at 10 mg/kg, substantially higher than the 70% level determined with A2-73 at the same dose. Based on PET studies in human brains, doses of 5 mg and 10 mg Aricept bound to SIR with occupancies of approximately 60% and 75%, respectively. While we don't have a head to head comparison, I think it is safe to conclude that 50 mg A2-73 will not provide higher occupancy than 10 mg Aricept in humans. Since Aricept is marginal at best in treating AD, it seems likely that A2-73 will not be effective for any disease for which SIR binding is the primary mode of action.
A2-73, however, is active on several other brain receptors that may also be involved in neurological diseases. It is an antagonist of muscarinic M1-M4 receptors (with micromolar affinity), Na+ channel site 2, and NMDA receptor (NMDAR). While AVXL is branding A2-73 as a "selective SIGMA1R receptor agonist," the data are more consistent with a poly-pharmacological effect by binding with several receptors, perhaps some that are yet unknown, to achieve efficacy in a range of diseases that include AD, Parkinson's, and Rett Syndrome.
We also note that A2-73 is metabolized in humans to its des-methyl analog, A19-144. Based on data provided in a patent, the potency of A19-144 is similar to A2-73 with low micromolar binding to S1R.
While some of the pre-clinical data raise concerns about A2-73, the clinical data are proving these concerns unfounded. AVXL now have proof-of-concept data in three indications, Alzheimer's Disease, Parkinson's Disease, and Rett Syndrome. We cover each disease indication below in the following order: Rett Syndrome, PDD, and AD.
Rett Syndrome
Rett Syndrome is a severe neurological disease primarily affecting girls. Most cases are caused by a mutation in the MECP2 gene which is needed for nerve development in the brain. The FDA has granted A2-73 fast track and orphan drug designation for this indication.
A placebo-controlled Phase 2 study conducted in the US was completed in December 2020 with 25 adult female patients with Rett syndrome over a 7-week treatment period. Fifteen patients received 5 mg of A2-73 as an oral liquid formulation while 10 received placebo. As shown in the slide below, robust and statistically significant responses were seen in 3 relevant measures. This is impressive data considering the very small size of the study and the quite low dose of only 5 mg.
Anavex - Rett Syndrome
Two additional studies are underway. The second study in Rett began in June 2019 and is similar to the first except that a higher dose is being studied (dose not disclosed). The study involves 33 female adult participants for 7 weeks. The company announced that this study exceeded enrollment targets with top line data available this year.
The third clinical trial is studying A2-73 in 69 pediatric patients, aged 5 to 18, over a 12-week treatment period. The company has confirmed they expect completion of this study this year.
CEO Missling noted on the August conference call that they are in discussions with the FDA regarding whether these studies can be considered pivotal for registration. Given the robust results in the small Phase 2 study, the probability of success in the current two studies is high, perhaps 75%. The main risk is if A2-73 acts differently in adult vs pediatric patients. The average lifetime of a Rett patient is only 24 years, so those who survive longer may have a somewhat different disease than younger patients.
The market opportunity for this indication alone could approach $1 billion annually. The company notes there are about 11,000 Rett patients in the US. Since Rett will be the first indication that gets approved for A2-73, AVXL will be able to price it similarly to drugs for other rare diseases - in the $500,000 range per year. As an example, Orladeyo, approved in Dec 2020 for hereditary angioedema, is a drug that is dosed orally and priced at $495K per year. Assuming net pricing after insurance negotiations is $300K per year and half of the patients in the US take the drug, then 5500 patients x $300,000 = $1.65 billion annual revenue. The company would also likely partner this drug for Europe and Asia where the incidence of Rett is similar to that in the US. A2-73 for Rett is a liquid formulation while PDD and AD are tablets, so there is a possibility of different pricing if A2-73 ultimately gains approval for AD or PDD.
The primary competition for Rett is trofinetide. Acadia (ACAD) has completed a Phase 3 study with results expected by year end. As noted on the AVXL corporate presentation, trofinetide is less efficacious than A2-73 and causes GI problems in a high percentage of patients. Since the mechanism of action of the two drugs is different, it is likely that both could be used concomitantly in patients. In any event, having a competitor should not greatly limit the potential revenue of A2-73 for Rett.
As a final note, the FDA has awarded AVXL a rare disease pediatric review voucher which affords the sponsor a priority review. This review could be up to 6-months accelerated vs a standard review. These vouchers are generally sold to a large pharma company. A voucher has been sold as much as $350 million although most of the recent ones have sold in the $100 million range. This would be a nice bonus for AVXL if A2-73 is approved to treat Rett.
Parkinson's Disease Dementia
In October 2020, AVXL completed a blinded placebo-controlled Phase 2 trial with A2-73 to study its effect on the cognitive and motor impairment of Parkinson's disease. The study enrolled 132 patients for 14 weeks, randomized 1:1:1 to A2-73 doses of 30mg and 50mg, or placebo. The results showed dose-dependent and statistically significant improvements in the primary cognitive efficacy endpoints, CDR system Continuity of Attention (COA) (p = 0.029) and CDR system Power of Attention (PoA) (p = 0.015), and secondary Parkinson's efficacy endpoints Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), MDS-UPDRS Part III (p = 0.024) and MDS-UPDRS Total (p = 0.038). The company has not yet published the data nor presented at a conference so we don't have much information other than the top line data. However, it is impressive that in a small study they were able to generate statistically significant improvement in all primary and secondary endpoints. The company has released two slides on this study in the corporate presentation. The first is improvement in memory, which showed statistically significant dose-dependent (p = 0.003) improvement of CDR system Episodic Memory. Not only is this significant for PDD treatment, but this measure has also been shown to be highly correlated (70%) with the Alzheimer's Disease Assessment Scale-Cognitive score (ADAS-Cog), which we will discuss in the next section.
Anavex - Significant improvements in Episodic Memory with Increased Dose
The second slide shows the improvement in MDS-UPDRS score. This is a global composite score of Parkinson's disease symptom severity and may be considered the most important in the evaluation of overall improvement in these patients. This was one of the secondary endpoints that was perhaps unexpected since the drug is primarily targeting cognition, not the other aspects of PD.
Anavex - Anavex2-73
Based on the Phase 2 study, we believe the probability of success in PDD, and perhaps PD in general, is high, perhaps 75%. The company noted that the patients in this study continued to take other PD medications during the trial, including dopaminergic therapy, levodopa and other anti-PD medications. That A2-73 is showing an effect after 14 weeks of treatment on top of standard of care is remarkable. The timeline and next steps for the company in PDD have not yet been disclosed. In their latest 10-K, the company notes that Shake It Up Australia Foundation for Parkinson's Research has agreed to fund up to 50% of the costs of an Australian clinical study to develop A2-73. The proposed clinical trial would be for at least 48-weeks. If they could initiate a study in 2022 we could perhaps see data by 2024.
Alzheimer's Disease (AD)
Before discussing the Phase 2A data in AD, we start with the Phase 1 study in healthy volunteers since two important findings were determined in this study: (1) at a dose of 60 mg, 3 of 4 subjects experienced headaches and dizziness, limiting the top dose in future studies to 50 mg; and (2) the des-methyl metabolite A19-144 had a 5-fold higher concentration in plasma than the parent compound. The half life of the parent compound was 8.5 hours while that of the metabolite was 29 hours. This suggests that the metabolite may be producing most of the pharmacological effect.
The Phase 2A study in AD was an open-label study in 32 mild to moderate AD patients studying doses of 30 mg and 50 mg A2-73 for 57 weeks. The doses in the primary part of the study, from week 5 to 52, were 10mg, 20mg, 30mg, and 50mg. Patients were provided the opportunity to continue treatment in the extension study for up to 5 years. Currently, 21 patients have progressed to the 3 year timepoint.
Below is a figure that is based on data provided in the journal article that discussed the 2A study. The low, medium, and high dose graphs are based on data in supplemental Figure 1c from the article. We are only showing the 57 week data since the Phase 2B/3 study of 48 weeks will provide the data for potential approval. The gray line is the expected decline in ADCS-ADL score based on historical data of untreated AD patients (decline of 6.7 points in a year). The blue line slightly above this is the score (-5.24) for the 21 participants that completed the study which shows overall almost no treatment effect relative to historical controls. The orange line is for 8 patients who responded well with no decline during the year of treatment - this group had high plasma levels of A2-73 (mean > 4 ng/mL). Most of this group also had MMSE scores >20 (mild disease) and the wild type SIR. The purple line represents the group with middle concentration levels of A2-73. The bottom black line represents the group with low A2-73 plasma levels. This bottom group also included some patients with an SIR variant. The dose effect gives confidence that the effect is real but could be due to the other variables between the two groups. We don't want to over-interpret since this is such a small study without placebo control.
As also seen in the Phase 1 study the metabolite is 5-fold higher than the parent compound in all dose groups. The results are the same whether plotting concentration of parent, metabolite, or sum of both.
Anavex - Phase 2A ADCS-ADL Score
In July 2018, a 48-week Phase 2B/3 trial in Australia began enrolling patients with mild cognitive impairment or early dementia, plus PET or CSF confirmation of AD pathology. Enrollment was completed in June 2021 with 509 participants randomized 1:1:1 to 30 mg or 50 mg A2-73 or placebo for a duration of 48 weeks. Criterion for enrollment was an MMSE score between 20-28, which means that only mild AD patients were studied. Top line results are expected in mid-2022. The primary efficacy outcomes are change in ADAS-Cog and ADCS-ADL. The data from the Phase 2A study suggest the 30mg and 50 mg doses should provide adequate drug levels to achieve efficacy. The improvement in memory effects seen in the placebo-controlled PDD study provides additional confidence in a positive AD outcome.
Bottom Line
A $1.5 billion valuation is high for a company with no approved drugs. The share price is already anticipating a lot of success. Nonetheless, more upside is likely over the next 6-9 months as a build-up of expectations of Phase 2B/3 readout in AD in mid-2022. As a comparison, Phase 3 results for Cortexyme's (CRTX) drug for AD by treating gingivitis are expected in November and the share price has run to >$100, giving the company a market cap of $3 billion.
Pursuing Rett Syndrome is an excellent strategy since this indication is not linked to cognition and may succeed even if PDD and AD do not. The data from the placebo-controlled trials in Rett are exceptional - could not ask for much more out of this small proof-of-concept study. With two additional Rett studies underway we could see a filing in 1H2022 with potential approval by late 2022 or early 2023. Success in Rett will provide a cushion for the share price should AD not be successful.
The Phase 2 study in Parkinson's delivered more than expected. A2-73 showed benefit not only with memory but also with overall motor and non-motor effects of PD. The opportunity in PD is large given the estimated 1 million patients in the US.
Investing in biotech is risky. My general approach is to buy shares then use option collars, which involves buying puts and selling calls. This limits the upside but provides protection to the downside. There are many ways to do this. One example for AVXL that is cost neutral is to sell January 2022 call options at a strike price of $30 for $2.3 and buy January 2022 put options at a strike price of $14 for about the same price. This limits the upside to 58% (30/19) but also protects the downside loss to 25% (14/19).
This article was written by
Small Pharma Analyst profile picture.
Small Pharma Analyst
1.41K FollowersFollow
A veteran of the pharma industry. Specializing in the analysis of small pharma companies with a focus on th... more
Growth, Long/Short Equity, Biotech, HealthcareContributor Since 2010
A veteran of the pharma industry. Specializing in the analysis of small pharma companies with a focus on the pipeline and opportunities for licensing or major deals with large pharma. Financial analysis including burn rate, venture capital funding, and cash flow.
Disclosure: I/we have a beneficial long position in the shares of AVXL either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. -
Anavex. Nyt tildelt patent af 2-73 i Alzheimer!
Tak for link Budweis!
Nu må de snart være dækket ind på alle mulige måder.
Rart at få dette på plads.
Har tidligere argumenteret for, at Anavex gik stille med dørene, så andre ikke kunne løbe med guldet.ACIU har positive resultater i deres AD fase 2 forsøg - giver lidt tiltrængt positiv fokus på Alzheimer igen.
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Anavex. Ingen PR fra Anavex?
Dette ligner et overordnet dækkende patent for Alzheimer generelt.
Igen misser Anavex ligesom ved sidste Peer Reveiw, at informere med en PR., der kunne give lidt positiv afsmitning på kursen.
Det mindste man kunne gøre for os trofaste aktionærer.
Igen skal man finde det frem via. andre dygtige skribenter!Enste undskyldning må være, at Anavex har travlt med endnu vigtigere ting!
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Anavex. Har sendt en mail til Anavex og spurgt efter en PR for det nye patent!
Deres IR kører ofte lidt bagefter på den front - ofte får man først nyheder andre steder fra end fra Anavex selv.
Men bortset fra det, så synes Anavex at køre alt stille og roligt i stilling til at gøre selskabet kommerciel senest i 2022.
Fra ST med alle mulige forbehold!
En har angiveligt snakket med IR:Anavex har ikke brug for en partner pt.
Man forventer ingen forsinkelse i forsøgene.
Afventer udmelding fra FDA vedr. RETT og Parkinson.
MJFF vil betale 50 % af kommende Parkinson fase 3 forsøg!!!
Nøglen er udmelding fra FDA på RETT og potentiel markedsgodkendelse hurtigst muligt.Vi må se, men tingene begynder måske at tage fart nu!
Der mangler mange nyheder bare de næste få mdr. - patenter i Alzheimer var en af de uforudsete." Sorry. .I sure asked about BTD with parkinson's to IR. He said he cannot talk about parkinson's. We just have to wait and see what the FDA says. I asked about partnership possibilities. .he said we will not partner now. They don't need to. The key is getting Rett approved. He said Michael J Fox foundation will pay for half of the PH3 parkinson's trial. Of course we have to see what the fda decides.."
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Ser lige på tv2. Ny rapport fra WHO. I 2030 78 millioner med demens, i 2050 139 millioner.
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Anavex. Fragile X News Today.
Fin lidt mere detaljeret gennemgang af det positive prækliniske forsøg i Fragile X.
Alt ser rigtig lovende ud - nu skal det bare omsættes i et klinisk fase 2/3 forsøg, som vi også har set muligt i RETT og Parkinson.Ja MM - mange mennesker vil stå uden behandlingsmulighed inden for demens, hvis der ikke snart sker et gennembrud på området.
Der vil komme et gennembrud på et eller andet tidspunkt - Anavex er efter min mening det bedste bud pt. -
hej jeg ved ikke om i har set denne her (link),
men jeg syntes at det gør lidt mere forståelige
hvad det er anavex arbejder med, sagt med andre ord ,det er skåret ud i pap
The Anavex results
# # # # This week some encouraging clinical trial results were announced by a biotech firm called Anavex Life Sciences. The company had been testing their lead experimental therapy - a Sigma-1 receptor agonist called ANAVEX2-73 (also known as blarcamesine) - in 132 people with Parkinson's disease dementia over a 14 week period. The…
The Science of Parkinson's (scienceofparkinsons.com)
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Anavex Ja super beskrivelse af casen Poppelk.
Havde den med under 96300 den 24/8 længere oppe, sammen med et par øvrige links.
Tænkt som en relativ hurtig introduktion af casen for nye investorer.
Forklaret på et plan, så de fleste kan være med, uden at undlade de tekniske betegnelser.Lidt træls med en US fridag pga. Labor Day, men omvendt har Anavex fået lidt mere tid til at skrue en evt. PR. samme til i morgen tirsdag, som gennem tiden gennem har været Anavexs mest foretrukne dag for PR.
Vi mangler det der svarer til ca. 1 nyhed pr ugen resten af 2021 - og det er bare det vi er stillet i udsigt!
Øverst på min ønskeseddel er:
BTD eller AA tildeling fra FDA i RETT og/eller Parkinson.
BTD ( Breakthrough Therapy Designation )
AA ( Accelerated Approval )
https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program
Eli Lilly fik f.eks den 24. juni 2021 BTD (lidt uforståeligt efter min mening) i deres Donanemab (fedtfjernelse) - svarende til Biogens ADU.
Dette gav dem alene på dagen en MC stigning svarende til ca. 20 milliarder $ og endnu mere efterfølgende!
Dette svarer til, at MC for Anavex skulle stige ca. 13 gange på dagen , ved en tilsvarende udmelding - lidt mindre dog, da PD og især RETT er mindre end Alzheimer.
Kan Lilly få tildelt en BTD på baggrund af deres (tynde) resultater, så burde Anavex uden tvivl også kunne få en den.
Men dette viser bare, hvor langt nede kursen er ifht. det potentiale der er i casen.
Kigger man på kursudviklingen af Anavex, så ser det i min optik ud til, at kursen er blevet fint konsolideret den sidste måned og nu er klar til et udbrud - og forhåbentlig kraftig opad!En ekstrem spændende tid venter os!!!
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Anavex. Kommende konferencer med Anavex.
TTTav66 fra IHUB er fantastisk til at opstøve informationer som disse.
Der kommer nok også flere konferencer inden året er omme.
A few upcoming conference presentations folks might be interested in tracking. Of course the merits of these appearances may be hotly debated, but some may find them interesting to be aware of...
November 9-10 - Outsourcing in Clinical Trials New England
3:45 pm: Is the pharma industry still too conservative with wearable tech?
This session will give you 5 key takeaways for how and why you should incorporate wearables into your study.
• Discussing what wearable technologies are available and accepted by regulatory authorities
• Exploring home monitoring technologies to collect patient data in a timelier manner
• Overcoming challenges when shifting to wearables whilst ensuring patient safety
• Considering the infrastructure required for wearables when running a large multi-region trial
• How are wearables being more widely used to help with reimbursement?Panelists - Christopher Missling and Daniel Klamer
11:00 am: Clinical Trials for Rare Diseases: Challenges and Opportunities
• Explore challenges in clinical trial execution in rare diseases
• Discuss strategies to overcome these challenges
• Share lessons learned from initiating and completing clinical trials in Rett SyndromePresenters - Christopher Missling and Daniel Klamer
18th Annual Outsourcing in Clinical Trials New England 2026
Your one-stop shop for events around the globe
Arena International (www.arena-international.com)
Nov 18: Microbiome Connect: Gut therapeutics USA
10.00 am: Unravelling The Gut-Brain Axis: The State Of The Gut-Brain Axis Field
• Bolster your understanding of a rapidly growing area of gut-organ axis research so you can make informed decisions pertaining to your investment and entry to the space.
• Create effective clinical trials pertaining to neurological conditions, which encompass multi-disciplinary approaches, by leveraging the lessons learned over many years of research by the expert panel.Panelist - Christopher Missling
https://www.kisacoresearch.com/events/microbiome-connect-gut-therapeutics-usa
Dec 15: Neurodevelopmental Drug Development Summit
11:20 am: Utilizing Precision Genetic Medicine to Treat Rare Neurodevelopmental Diseases: Focusing on Rett Syndrome
Synopsis
• Requirement of clear understanding of target engagement
• Importance of predictive biomarker of response correlating with efficacy
• Relevance of appropriate efficacy endpointsPresenter - Christopher Missling
12:50 pm: Live Q&A Session with Your Expert Speakers
Panelist - Christopher Missling
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Anavex. I grunden meget logisk når kroppen jo renser ud om natten, ikke mindst hjernen. Søvn er bare mega vigtig, husker at 2-73 også kunne forbedre søvnen. Nu laver Missling nok et museforsøg, hvor de små staklers bure skal stå ved en motorvej.... Nå, spøg til side, her artiklen. https://amtsavisen.dk/artikel/nyt-banebrydende-studie-du-bliver-dement-af-trafikstøj
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Anavex. Webcast mandag den 13. Sep. - H.C. Wainwright
Desværre som on demand og tilgængelig mandag, så vi får nok først indholdet frem senere.
Uanset vil vi skulle have en pr. senest mandag, såfremt Anavex har nye vigtige oplysninger.H.C. Wainwright har været en af de analytiker, der har fulgt Anavex længst og måske også en af dem, som har stillet de bedste spørgsmål ved CC' er.
Ram Selvaraju fra HCW har et kursmål på 39 $ pt på Anavex - nu må vi se om Missling kan rykke ved dette estimat. -
Anavex/Biogen Her er lidt mere om Biogen. Jeg tror sgu aldrig Aduhelm vinder et marked, det skib er vist sejlet: https://finance.yahoo.com/news/biogen-loses-7-billion-value-164246287.html
Jeg har købt lidt flere til pensionen her i 19 området, selvom det er godt tosset.Nu er klokken snart 1300, kom så Missling, du skylder.
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