ANAVEX NY TRÅD 2022 - positive resultater for 3-71!!!
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Anavex Husk J P Morgan den 13. januar 14.30 DK-tid!
J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 8:15 am Eastern Time
President and Chief Executive Officer, Christopher U. Missling, PhD, will present at the 40thAnnual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 8:15 am Eastern Time at the Westin St. Francis Hotel in San Francisco, CA.
A live webcast of the presentation, as well as an archived recording, will be available at https://jpmorgan.metameetings.net/events/healthcare22/sessions/40488-anavex-life-sciences-corp/webcast?gpu_only=true&kiosk=true and in the Investors section of the Company's website at www.anavex.com.
Efter at have hørt CCèn fra i går, så lød det til, at Avatar kunne komme, hvornår det skulle være de næste dage.
Samtidig synes Missling at være meget ovenpå og gentog også til sidst, at de forventer at deres platform vil kunne hjælpe i forskellige CNS indikationer over hele verden - dette ville han nok ikke sige/gentage, hvis han troede på dårlige Avatar resultater? -
Anavex ... Enormt spændende dage forude som investor !!!
Coronapandemien er forhåbentlig snart afblæst således, at Anavex kan få lidt fart på med at afvikle de mange studier, der står standby.
Først og fremmest villle det være super, at få FragileX kørt ud over rampen. Tror pts står klar og at man relativt hurtigt kunne få et fase 3 studie gennemført.
Evt. godkendelse i FragileX kunne godt komme H123, hvis de vil det !
Det samme med AD og måske Rett omkring årsskiftet 22/23.
Håber at Avatar-data er så gode, at der direkte kan ansøges på dem uden hensyn til Excellence. Sidstnævnte blev jo i går yderligere udsat til vel H222. Skal vi afvente dette tidspunkt vil aktiekursen svinge på et forholdsvist lavt niveau indtil dette tidspunkt.
Selv om man måske siger farvel til $100 mln i voucherværdi, fordi godkendelse til Rett-børn ikke kommer først, vil en markedsgodkendelse et halvt år tidligere sagtens være godt givet ud.
Håber også at de får ansat lidt flere personer i staben. Synes hjemmeside forbedres, men der er stadig flere steder der ikke opdateres. Bl.a. gårdsdagens konf hos HC Wainright mangler. De har ikke fået 2022 sat op, hvorfor nyheder fra i år sættes under 2021. Sådanne ting virker ikke overbevisende på kommende og nuværende investorer.
De indikationer Anavexs produkter henvender sig til er ENORMT !
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Anavex ... Lidt mere kritik
Anavex har nu i over et år haft de fremragende PDD data liggende. Et er at investorerne ikke har fået det fulde datasæt. Det er der muligvis en forklaring på. Men man er tilsyneladende ikke kommet videre til mere end at kommunikere, at et fase 3 er på vej - det er skammeligt, at det ikke går hurtigere både for patienter og aktionærer !
De har nu også sat sig selv i en lidt vanskelig situation mht partnerskab på den store indikation AD. De har nu to forskellige stoffer kan være aktive i AD - dvs parterskab skal dække begge stoffer, hvilket jo nok også er muligt.
Jeg fornemmer, at man har holdt oplysninger tilbage - nok af hensyn til konkurrenterne - men at posen åbnes nu. Jeg håber så at partnerskab indgås snart på de store indikationer (PDD, PD og senere AD) og at forsøgene accelerer i hastighed herfra. Det er åbentlyst, at Anavex har nok at se til i de små indikationer de selv vil markedsføre.
Gode Avatar-data vil give dem rygstødet hertil
Man bliver ikke en succes i biotech, hvis man ikke kan eksekvere hurtigt. Konkurrenterne har fuld fart på hele tiden.
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Anavex. Rettelse: J P Morgan er kl. 14.15 DK-tid på torsdag!
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Anavex Hmm - ingen nyheder kl. 13.00 ?
Anavex er på JP Morgan kl. 14.15 DK-tid i dag.
Tidligere har de ved andre konferencer nogen gange udgivet nyheden/præsentationen umiddelbar før de gik på en live CC. - Late breaking!
Så håber derfor på noget omkring kl. 14.00!De har jo allerede i mandags opdateret deres Januar 2022 præsentation inkl. 3-71 resultaterne og efterfølgende webcast vedr. 3-71.
Det ville derfor virke fuldstændig vandvittig, hvis Anavex allerede skulle have brændt deres krudt af før denne ultimative mulighed for at sælge sig selv bedst muligt!
Går man på en live CC af denne kaliber, hvis enhver kunne hente den ønskede viden fra en 3 dage gl. præsentation?
Avatar resultaterne kan selvfølgelig først præsenteres, når de er klar - men Missling må simpelthen have et eller andet ekstraordinært med til denne CC - ellers har han godt nok forspildt en kæmpe mulighed!!Nå - vi må se om han performer!
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Anavex ... Jeg havde også regnet med, at de havde gemt Avatar til i dag. Selv om jeg også mener, at de skal offentliggøre data så snart de er vidende om dem.
De mangler også at ligge webcasten fra i mandags på deres hjemmeside. Håber at de ikke er gået i sort
Måske corona i hele firmaet er jo ikke utænkeligt.
Mere og mere tålmodighed behøver vi !
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Tror ikke man kan se med på konferencen uden invitation Budweis.
Ja vores tålmodighed har været testet til det yderste kan man vist roligt sige.
Jeg mister stille og roligt interessen må jeg indrømme, læser kun udvalgte posts på Ihub nu, gider ikke at læse 200 posts når jeg vågner op når der ikke er noget nyt, nogle af dem skændes som små børn hvad jeg finder ret grinagtigt, ha-ha.
Jeg bruger mere tid på Brainchip hvor jeg har tjent en god skilling (over 100% profit indtil nu).
Jeg beholder selvfølgelig mine AVXL indtil der kommer nyheder og tager det derfra.
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Anavex ... Igen en fremragende konference hos JP Morgen.
Først Avatar lige om hjørnet og "we are excited"
Første gang han løfter sløret for dosering i Avatar - slightly higher.
Missling mener nu at Ecellence er parat sidst i H122.
Det hele lyder næsten for for til at man tror på det.
Slides med de enorme antal pts som deres stoffer henvender sig til.
Det skal knald på i 2022, hvis de skal have gang i alle de forsøg de planlægger !
Der lægges en recorded version op hos JP Morgan senere.
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Anavex Udmærket webcast, men ikke meget nyt - endnu!
En meget vigtig sætning!
About AVATAR, Missling: "As I said, it's literally around the corner. I think that's what I can say at this point, and we're very excited."
Anavex bygger mere og mere på pipelinen og alt virker som en meget bundsolid platform til behandling af mange CNS indikationer - uden bivirkninger.
Alt spiller - MOA, omfanget og bredden af indikationer og penge i banken ( 150 mill. $ ).Men Avatar er det eneste, der pt. kan rykke os ud af kursniveauet.
Markedet kigger kun på resultater og disse må simpelthen ikke være helt klar endnu - antydes dog til at være meget positive. -
Ja, ja nu nærmer vi os
Først "Data at year end", dernæst "around year-end" og nu "literally around the corner" - Stor er boksen for kreative reformuleringer af en reel forsinkelse af en lovet deadline.Jeg synes Missling har et kæmpe problem på sin troværdighed når tidsplaner ikke bliver kommunikeret transparent og i overensstemmelse med virkeligheden - Dette ses nu afspejlet i kursen. Vi er langt under hvad en god nyhed på 3-71 i mandags burde have betydet for kursudviklingen.
På trods af dette håber jeg fortsat det bedste, og krydser fingre og alt andet andet for de gode nyheder snart må vende udviklingen til det vi alle drømmer om.
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3-71 ligger langt ude i fremtiden, derfor ikke noget som gav noget på kursen men er dog meget fint da Anavex har noget at bygge på og nogle mener at 3-71 er bedre end 2-73.
Hvorfor er der tavshed om PDD? Det var jo rigtig gode resultater de kom med der? Måske de venter på FDA som er vildt forsinket med alt i oejeblikket:
Anavex pipe line er forøget noget på den sidste præsentation, se side 9:
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Anavex ... Biogen ser efter Aduhelm ud som en total fiasko sammen med FDA.
De er nu gået til Goldman Sachs og de skal sørge for at finde overtagelsesemner eller partnerskaber.
https://finance.yahoo.com/news/biogen-eyes-potential-acquisitions-stat-203444096.htmlNu er det først man bliver bange som Anavex aktionær. Der er en poisonpille på plads til at afværge et fjentligt overtagelseforsøg på Anavex. Men GS kan noget med at tage røven på andre så det er nu Missling skal vise sit værd.
Et partnerskab til anden side ville være rettidigt omhu for at holde ulven for døren.
Avatar kommer forhåbentligt i næste uge og lad Missling så komme med lidt strategi, der rykker lidt hurtigere på tingene end tilfældet nu.
God weekend !
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Anavex. Ja Biogen er gået i fuldstændig selvsving!
Biogen vil bl.a. oversvømme Medicare med indsigelser pga. deres afvisning af dækning til Alzheimer patienter, der ønsker at bruge deres hjerneblødningsgift!
Det er panik i fuld udbrud!- og nu forsøger de desperat at finde et nyt halmstrå, for at redde deres grådige pengemaskine!
Et ekstremt eksempel på et selskab, der kun tænker på indtjening og ikke på reelt at hjælpe patienter.
De er de sidste, der har fortjent at komme i nærheden af Anavex - og det kommer heller ikke til at ske!
Tror og Missling har samme indstilling - ( så hellere Merck eller Pfizer. )
Og når Anavex langt om længe præsenterer resultaterne fra Avatar og dermed vil styrke hele casen og MOA - vil Biogen slet ikke have råd til at købe Anavex.Biogen har mistet al værdighed!
Ser frem til tirsdag - mandag fejre man Martin Luther King i US.
Ved gode Avatar resultater, ville en evt. indledet dækning fra JP Morgan kunne rykke tingene!God weekend
- og nu forsøger de desperat at finde et nyt halmstrå, for at redde deres grådige pengemaskine!
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Anavex Randi Hagerman mfl. udgivelse pr. 14. januar.
Selvom markedet åbenbart ikke har fanget casen i Anavex helt for alvor, så er det udmærket, at nogle forskere kender til bl.a. 2-73.
Ser ud til, at 2-73 har et rigtig godt potentiale i Fragile X - nu mangler vi bare, at Missling snart leverer på Avatar, før der kan trykkes på knappen for start af øvrige indikationer/forsøg.Anavex 2-73
Anavex 2-73 (AV 2-73; Blarcamesine) is a sigma 1 receptor agonist that works between the endoplasmic reticulum and the mitochondrial membrane to normalize calcium dysregulation, oxidative stress, and mitochondrial dysfunction which is seen in many forms of ASD. It has demonstrated significant benefits in the KO mouse model of FXS where multiple behaviors were improved and deficient brain derived neurotropic factor (BDNF) levels were normalized [144]. In addition, Kaufman et al. [145] also reported significant benefits in the Rett syndrome mouse model with a rescue of behavior and BDNF levels and this work lead to patient studies in Rett syndrome that have demonstrated efficacy in a controlled trial (Anavex Life Sciences press release 2021). AV2-73 also has beneficial effects in neurodegenerative disorders because of improvement in proteostasis, autophagy, oxidative stress, prevention of protein aggregates, and improvement in mitochondrial function leading to benefits in Alzheimer' disease and Parkinson's disease dementia [146,147,148]. Significant potential exists for AV2-73 to improve symptoms in Fragile X-associated Tremor Ataxia (FXTAS), a neurodegenerative disease seen in approximately 40% of older carriers of the fragile X premutation, because calcium dysregulation, mitochondrial dysfunction, proteostasis, and aggregations of proteins causing inclusions occur in FXTAS [149]. -
Tom Bishop har stadig en køb rating for AVXL her i 2022:
https://www.moneyshow.com/articles/tptp2022-57945/top-picks-2022-ramaco-resources-metc/
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Anavex Super Seeking Alpha artikel!!
https://seekingalpha.com/article/4479980-anavex-2022-has-major-pivotal-catalysts#comments
Ikke meget nyt, men den kan måske få nye investorer til at interesserer sig lidt for casen.
Når man endnu en gang kigger på Anavex`s pipeline, som alt er baseret på ekstrem grundig forarbejde og kun udelukkende positive resultater, ingen gæld og 150 mill.$ på bogen - så kan man godt undre sig, at MC ikke er højere pt. - fratrækkes likvider, er Anavex og hele dets pipeline sat til en værdi på sølle 900 mill.$!!2022 bliver showdown året!
Anavex: 2022 Has Major, Pivotal Catalysts.
Bottomline
AVXL has proven itself, over and over again, as a stock that rallies on news, however slight. 2022 is a year full of major catalysts for the stock, so the stock looks attractive from that point of view. However, these catalysts, and especially the AD trial, are major binary events. If the company succeeds with that trial, it will be worth billions and billions of dollars. If it fails, well, they do have two other indications with topline data this year, but a failure in AD will impact the stock very badly. No wonder everyone, including even analysts at earnings calls, are walking softly around the Alzheimer's question. It appears to me that the Street does not want to take anything but a fluid position, for fear of being wrong.Kopi til dem, der ikke abonnerer.
Anavex: 2022 Has Major, Pivotal Catalysts
Jan. 17, 2022 10:12 AM ETAnavex Life Sciences Corp. (AVXL)5 Comments5 Likes
Summary
Anavex's long story is coming to a climax this year.
The company will announce topline data from the Alzheimer's trial by 2H 2022.
This will be the most important event in the lifecycle of this company.
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Hot air balloons flying over the Botan Canyon in TURKEY
guvendemir/E+ via Getty ImagesSince my April coverage of Anavex (AVXL), a midstage drug developer for Alzheimer's and other CNS diseases, the stock nearly doubled, then subsided right back to where it was in April. Some of the spike may have been caused by the surprise approval of Biogen's (BIIB) Aduhelm, which occurred in early June. However, AVXL stock has stayed at a decent price on its own merit, not just as a sympathy play.
Anavex's lead candidate is ANAVEX 2-73, or blarcamesine, an agonist of the intracellular sigma-1 chaperone protein. This company has a broad pipeline targeting various CNS indications.
Anavex pipeline
Anavex pipelineAnavex website
ANAVEX 2-73 is targeting Rett syndrome and Parkinson's disease and Parkinson's dementia, as well as Fragile X syndrome. However, the lead indication is Alzheimer's, where the asset is running late-stage trials.
In my previous coverage, I discussed the company's long and arduous path towards success in this indication, a variety of early-stage data, and that the DSMB has approved that a larger phase 2/3 trial continue as planned. In mid-2021, this study exceeded its target enrollment of 450 patients:
The study exceeded enrollment beyond 450 patients at 52 sites across North America, Europe and Australia using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.
In October, the DSMB approved - a second time (?) - that the trial, now with 509 patients, should continue as planned.
Topline data is expected in mid-to-late 2022; this will be the most important catalyst in the lifetime of Anavex.
A research report published in the journal of Expert Opinion on Therapeutic Targets, and available here describes how ANAVEX2-73 may address Alzheimer's Disease or AD through the activation of autophagy. Autophagy is a physiological process that works like a scavenger of damaged cellular components, including those components that have long been held to be responsible for AD. ANAVEX2-73 targets and activates the sigma-1 receptor, which is thought to chaperone a number of these housekeeping processes. AVXL owns and is developing a number of such Sigma-1 receptor agonists like AF710B, T-817 MA, and ANAVEX2-73. The key statement of the report is:
...the activation of σ-1R and autophagy could alter amyloid precursor protein processing to inhibit amyloid-β production by reconstituting cholesterol and gangliosides in the lipid raft to offer neuroprotection against AD.
Other key highlights of the article:
The σ-1R's expression increases with age; however, in Alzheimer's disease (AD) pathology, it decreases.
The decrease in σ-1R expression during AD coincides with an age-related decrease in autophagy.
The σ-1R may compensate for loss of receptors and autophagic machinery during healthy aging.
Activation of the σ-1R can induce cytoprotective autophagic pathways.
Promising σ-1R ligands used as AD drugs have been shown to induce autophagy.
Autophagy plays a key role in the progression of AD pathology.
Like I said, the AD trial is AVXL's biggest catalyst ahead. This trial now has an extension phase due to patient requests, said company management in their earnings call:
So we have an extension study called ATTENTION-AD, which is a two-year study of following up as an open label after the 48-week, which has started, after the first patient finished the 48 weeks. And because these patients have actually, some of them finished this phase two Open Label Extension, they had requested to continue to stay on the study drug.
And so what we did, we initiated and we're successful in expanding now this ATTENTION-AD study Open Label Extension from two years to three years. So patients who are finish the study, the placebo control study, enter into the EXTENSION study finish the two years will now continue to go into the third year. And that is because of request by the patient, the caretakers and the physician. It also, I like to add that the -- I like to add also that the conversion from the placebo-controlled part of the study to the open label is very high it's above 94% currently, which is a good sign.
Earlier in 2021, the company also announced positive data from its Parkinson's disease study. The molecule was able to improve motor and cognitive functions in patients, while, at the same time, improving SIGMAR1 concentration. This correlation between efficacy and biomarker is important, says FierceBiotech, because it scores one over Biogen's aduhelm, which was approved on the basis of only biomarker improvement.
About the pipeline progress, Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said during November earnings:
Anavex concluded an exceptional fiscal year 2021 while continuing its momentum, highlighted by the efficient execution and full enrollment of three Precision Medicine clinical trials, including the Phase 2b/3 ANAVEX
2-73 clinical trial in Alzheimer's disease, the Phase 2/3 ANAVEX2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX3-71.Financials
AVXL has a market cap of $1.04bn and a cash reserve of $152.1mn as of September. This is a considerably better number than what we saw in my April article. This may have been assisted by two fundraisings. In June, AVXL announced a $50mn direct offering. In September, the company filed for what appears to be a $150mn secondary offering. R&D costs for the company were $33mn in 2021, and $9mn was G&A expenses. At that rate, the company has cash for a number of years.The company is very heavily publicly owned, with just about 30% of the company in the hands of funds and institutions. Key holders are BlackRock, State Street and Vanguard. There are very few insider transactions at Anavex; however, the few that are, are buys:
AVXL stock insider transactions
Anavex insider dataOpeninsider
The company is covered by the following analysts:
Anavex <span class='ticker-hover-wrapper'>(NASDAQ:<a href='https://seekingalpha.com/symbol/AVXL' title='Anavex Life Sciences Corp.'>AVXL</a>)</span> stock analyst coverage
AVXL Analyst CoverageAnavex website
Here's a look at the company management and advisory board:
Anavex management
AVXL managementAnavex website
Bottomline
AVXL has proven itself, over and over again, as a stock that rallies on news, however slight. 2022 is a year full of major catalysts for the stock, so the stock looks attractive from that point of view. However, these catalysts, and especially the AD trial, are major binary events. If the company succeeds with that trial, it will be worth billions and billions of dollars. If it fails, well, they do have two other indications with topline data this year, but a failure in AD will impact the stock very badly. No wonder everyone, including even analysts at earnings calls, are walking softly around the Alzheimer's question. It appears to me that the Street does not want to take anything but a fluid position, for fear of being wrong.About the TPT service
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