ANAVEX NY TRÅD!! FEBRUAR 2022 POSITIV AVATAR FASE 3!
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Alle holder vejret med den geopolitisk uro. Det ene dårlige signal afløser det andet. Vi er midt i en orkan på aktiemarked. Hvis man ikke har solgt, skal det her morads bare rides af. Jeg har ikke solgt en eneste aktie i mit depot og styrtbløder. Jeg har dog tiden med mig og nægter at sælge med tab. Det er den perfekte storm efter 10 år med aktie fest.
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Anavex. Februar præsentation inkl. Avatar topline data.
Inkl. forklaring vedr. endpoints for Avatar.
Signifikant effekt i alt de har afprøvet 2-73 i.
Resultater fra tre fase 3 forsøg i 2022.
Bred og fremskreden pipeline i nogen af de største indikationer indenfor CNS.
Ingen bivirkninger - overstråler alle potentielle konkurrenter.
Store investorer øger deres andel.
Ingen gæld - 150 mill. $ på bogen.
MC = kun 750 mill. $!
Fratrukket likvider, er hele deres pipeline prissat til kun sølle 600 mill. $!!! - 3-71 alene er næste det værd!Prissætningen var ikke rationelt før - og nu slet ikke efter Putins vandvittige ønske om at skrue tiden 30 eller 100 år tilbage med ønsket om et nyt stort Rusland, der ( igen ) underkuer andre nationers suverænitet!
Manden er bindegal og opfyldt af indædt had til den vestlige verden - og det værste er, at selv herboende russer integretet i det danske samfund, stadig ser manden som et forbillede og stadig tror mere på russiske end vestlige medier!! ( noget svigerfamilie - troede ikke mine egne øre )
Hvordan kan den alm. indbygger i Rusland så se sandheden?Det er ikke andet for end at håbe på, at Putin "nøjes" med udbryderregionerne og dette er nok til han kan stoppe der, uden at tabe ansigt overfor det russiske folk og stadig virke som en stærk leder - tvivler desværre dog!
Vedr. Anavex ( og andre aktier ) så er det ikke andet for, end at ride stormen af - virker 2-73 som de fleste af os herinde tror, så får Anavex sin markedsgodkendelse uanset geopolitisk uro og vil gøre en investering ekstrem god i sidste ende.
Lige nu har jeg dog mest ondt af de stakkels mennesker i Ukraine!
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Anavex. FDA/NDA procedure og tidslinje.
Anavex samler nu alle data for RETT forsøgene og afleverer disse til FDA.
Dette kan måske tage et par mdr. før de så evt. laver en NDA ansøgning for 2-73 i RETT for piger over 18 år.Her et udmærket link med oversigt over processen.
https://www.fda.gov/media/97229/download
Selv med den hurtigste vej gennem systemet, snakker vi stadig 5-8 mdr. for en evt. godkendelse efter indsendelse af NDA - dvs. tidligst slut 2022/ start 2023.
Anavex har jo bl.a. Fast Track, der burde fremskynde processen.
Der er dog flere milepæle i form af flere møder med FDA undervejs og resultaterne af disse, som kan indikerer hvor positiv/negativ FDA ser på ansøgningen.
FDA kan bl.a. tildele BTD eller AA mm., som både vil fremme processen, men også vise, at FDA højst sandsynlig vil tildele en godkendelse i sidste ende.Vi kan ikke andet end at afvente - hele casen lever i bedste velgående og om kursen er 10 eller 30 $ er fuldstændig sekundært - især da Anavex har de finansielle muskler, der skal til, for at gennemfører hele processen de næste 5 år, uden at skulle udvande selskabet ved lån eller større salg af aktier.
Mange tanker til Ukraine!
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Anavex. Webcast den 16. marts. - Needham Virtual Neuroscience.\n\nhttps://ih.advfn.com/stock-market/NASDAQ/anavex-life-sciences-AVXL/stock-news/87501899/anavex-life-sciences-to-participate-in-the-annual\n\nEndnu et forsøg på at udbrede kendskabet til Anavex og især 2-73 - hidtil har dette dog ikke haft den umiddelbare store effekt - selv øgede kursmål preller helt af på prissætningen.\n\nWebcast den 16. marts kl. 14.00 DK-tid\nhttps://wsw.com/webcast/needham118/avxl/2274180\n\n\nFredag den 11. marts afholdes et åbent møde mellem FDA og RETT org. - Anavex er en af hovedsponsorene!\nhttps://rettpfdd.org/\n\nDer kan være delte meninger om sådanne arrangementer, en godkendelse af et produkt skulle helst være baseret på gennemarbejdede forsøg og ikke på måske enkelte forældres oplevelser af behandlingen med f.eks. 2-73 - men det ene udlukker jo ikke det andet. Så måske kan der komme lidt positiv fokus på 2-73 effekt i RETT, fulgt op af vellykkede forsøg.\nRETT US og Avatar var jo meget vellykket - uden det er afspejlet i nuværende kurs.\n\nDet eneste markedet åbenbart lader sig imponerer af er, når vi forhåbentlig får gode resultater i AD fase 2/3 sidst på året.\nOLE Parkinson på 48 uger med ca.132 patienter ventes dog afslutte i april - data herfra måske i juli.\nData fra Excellence burde også komme før AD - og udover dette evt. opstart af de forskellige annoncerede fase 2/3 - 3 i forskellige indikationer.\n\nTingene kommer når de kommer!\n\nEn hilsen fra de norske pister!
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Anavex. Iflg. dygtige TTTav66 fra IHUB får vi nyt fra PDD i næste uge - samt mere vedr. 3-71.\n\nPDD news next week. Anavex will have a poster presentation at AD/PD 2022, March 15-20: \nQuote:\nANAVEX
2-73-ANALYSIS OF MOVEMENT (MDS-UPDRS) AND COGNITIVE (CDR SYSTEM) PHARMACODYNAMIC-BIOMARKER OUTCOME MEASURES PLACEBO-CONTROLLED PHASE 2 TRIAL IN 132 PARKINSON'S DISEASE DEMENTIA PATIENTS \n\nJ. Kulisevsky1 , T. Fadiran2 , E. Hammond2 , C. Missling2 , C. Williams3 , F. Parmentier3 , M. Kindermans3 , M. Afshar3 \n1Universitat Autònoma de Barcelona, Sant Pau Hospital, Barcelona, Spain, 2Anavex Life Sciences, Clinical, New York, United States of America, 3Ariana Pharma, Clinical Analysis, Paris, France \n\nAims: ANAVEX2-73 (blarcamesine), a novel, oral, investigational SIGMAR1 was assessed for movement and cognition in patients with Parkinson's disease dementia (PDD) measuring motor and nonmotor complications (MDS-UPDRS) and cognition (CDR system) and pharmacodynamic-biomarker analysis including mRNA SIGMAR1. \n\nMethods: ANAVEX2-73-PDD-001 14-week study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study. 132 patients with PDD were randomized equally to target doses of 30mg, 50mg ANAVEX2-73 or placebo. MDS-UPDRS, which is a validated global test for PD was assessed to evaluate various aspects of motor and non-motor complications, while cognition was evaluated with Cognitive Drug Research computerized assessment (CDR) system, which is an automated test battery validated for use in AD, PDD and other dementias. \n\nResults: MDS-UPDRS Total score improved significantly by -14.51 (p=0.034) for patients treated with ANAVEX2-73 high oral dose once-daily 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: All MDS-UPDRS sub-scores Part I-IV improved with vast majority of individual items between >71% and >92%. SIGMAR1 mRNA expression significantly increased in ANAVEX2-73-treated patients vs placebo (p=0.035) and significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system. \n\nConclusions: ANAVEX2-73 was generally safe, well tolerated and demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition (CDR system), which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX2-73 in PD and PDD as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer's disease. \n\nhttps://adpd.kenes.com/wp-content/uploads/sites/148/2022/03/ADPD22_-_LIST_OF_GALLERY_ABSTRACTS_FOR_WEB_January-5th.pdf\n\n\nAlso of relevance to Anavex and the MOAs of its drug candidates, both the inventor of Anavex 3-71(AF710B), Dr. Abraham Fisher, and the scientist responsible for much of its pre-clinical development, Dr. Ilya Bezprozvanny, will be giving symposium lectures at the conference. Dr. Abraham's talk will focus on activation of the M1 muscarinic receptor and Dr. Bezprozvanny's is on understanding the signaling functions of the Sigma-1 receptor: \nQuote:\nM1 MUSCARINIC STIMULATION OF POST-SYNAPTIC RECEPTORS FOR THE POTENTIAL TREATMENT AND PREVENTION OF COGNITIVE DECLINE \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/30\nQuote:\nSIGMA-1 RECEPTOR - A ROLE IN NEURONAL SIGNALING AND NEURODEGENERATION \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/51\n\nPDD news next week. Anavex will have a poster presentation at AD/PD 2022, March 15-20: \nQuote:\nANAVEX2-73-ANALYSIS OF MOVEMENT (MDS-UPDRS) AND COGNITIVE (CDR SYSTEM) PHARMACODYNAMIC-BIOMARKER OUTCOME MEASURES PLACEBO-CONTROLLED PHASE 2 TRIAL IN 132 PARKINSON'S DISEASE DEMENTIA PATIENTS \n\nJ. Kulisevsky1 , T. Fadiran2 , E. Hammond2 , C. Missling2 , C. Williams3 , F. Parmentier3 , M. Kindermans3 , M. Afshar3 \n1Universitat Autònoma de Barcelona, Sant Pau Hospital, Barcelona, Spain, 2Anavex Life Sciences, Clinical, New York, United States of America, 3Ariana Pharma, Clinical Analysis, Paris, France \n\nAims: ANAVEX2-73 (blarcamesine), a novel, oral, investigational SIGMAR1 was assessed for movement and cognition in patients with Parkinson's disease dementia (PDD) measuring motor and nonmotor complications (MDS-UPDRS) and cognition (CDR system) and pharmacodynamic-biomarker analysis including mRNA SIGMAR1. \n\nMethods: ANAVEX2-73-PDD-001 14-week study was an international, double-blind, multicenter, placebo-controlled Phase 2 clinical study. 132 patients with PDD were randomized equally to target doses of 30mg, 50mg ANAVEX2-73 or placebo. MDS-UPDRS, which is a validated global test for PD was assessed to evaluate various aspects of motor and non-motor complications, while cognition was evaluated with Cognitive Drug Research computerized assessment (CDR) system, which is an automated test battery validated for use in AD, PDD and other dementias. \n\nResults: MDS-UPDRS Total score improved significantly by -14.51 (p=0.034) for patients treated with ANAVEX2-73 high oral dose once-daily 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: All MDS-UPDRS sub-scores Part I-IV improved with vast majority of individual items between >71% and >92%. SIGMAR1 mRNA expression significantly increased in ANAVEX2-73-treated patients vs placebo (p=0.035) and significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system. \n\nConclusions: ANAVEX2-73 was generally safe, well tolerated and demonstrated dose-dependent efficacy for both motor impairment (MDS-UPDRS) and cognition (CDR system), which correlated with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively. These results support continued development of ANAVEX2-73 in PD and PDD as well as currently ongoing Precision Medicine biomarker-driven late-stage clinical studies in Rett syndrome and Alzheimer's disease. \n\nhttps://adpd.kenes.com/wp-content/uploads/sites/148/2022/03/ADPD22_-_LIST_OF_GALLERY_ABSTRACTS_FOR_WEB_January-5th.pdf\n\n\nAlso of relevance to Anavex and the MOAs of its drug candidates, both the inventor of Anavex 3-71(AF710B), Dr. Abraham Fisher, and the scientist responsible for much of its pre-clinical development, Dr. Ilya Bezprozvanny, will be giving symposium lectures at the conference. Dr. Abraham's talk will focus on activation of the M1 muscarinic receptor and Dr. Bezprozvanny's is on understanding the signaling functions of the Sigma-1 receptor: \nQuote:\nM1 MUSCARINIC STIMULATION OF POST-SYNAPTIC RECEPTORS FOR THE POTENTIAL TREATMENT AND PREVENTION OF COGNITIVE DECLINE \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/30\nQuote:\nSIGMA-1 RECEPTOR - A ROLE IN NEURONAL SIGNALING AND NEURODEGENERATION \nhttps://cslide.ctimeetingtech.com/adpd22/attendee/confcal/show/session/51 -
Anavex - poster med fase 2 PDD data.
Gode data men vi skal videre med fase 3 snarest !
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Du kom mig i forkøbet der Solsen.
Meget fine data må man sige!
Dr. Jaime Kulisevsky, MD, PhD, Principal Investigator of the trial, commented, "PDD is a debilitating disorder with significant co-morbidities and there has not been a mechanistically novel medication approved for PDD in over 20 years. Hence, new therapies are urgently needed to alleviate this suffering and disability. I am impressed with the robust improvement of the MDS-UPDRS across all sub-score parts I-IV coupled with the biomarker correlated outcome measures and I support the implementation of the ANAVEX
2-73 Phase 3 studies in Parkinson's disease and Parkinson's disease dementia, respectively." -
Anavex Overbevisende data i Parkinson!!
Præsentation af yderligere analyserede resultater fra PD fase 2 forsøget på:
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.Anavex Life Sciences Announces Presentation of Phase 2 Clinical Biomarker Data from ANAVEX®2-73-PDD-001 Parkinson’s Disease Dementia Study at AD/PD™ 2022 International Conference
All MDS-UPDRS Part I, II, III, IV sub-scores improved, including substantial majority of individual items between 71% and 92% SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system NEW YORK, March 15, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
Yahoo Finance (finance.yahoo.com)
All MDS-UPDRS Part I, II, III, IV sub-scores improved, including substantial majority of individual items between 71% and 92%
SIGMAR1 mRNA expression significantly increased in ANAVEX
2-73-treated patients vs placebo (p=0.035) over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.Dr. Jaime Kulisevsky, MD, PhD, Principal Investigator of the trial, commented, "PDD is a debilitating disorder with significant co-morbidities and there has not been a mechanistically novel medication approved for PDD in over 20 years. Hence, new therapies are urgently needed to alleviate this suffering and disability. I am impressed with the robust improvement of the MDS-UPDRS across all sub-score parts I-IV coupled with the biomarker correlated outcome measures and I support the implementation of the ANAVEX
2-73 Phase 3 studies in Parkinson's disease and Parkinson's disease dementia, respectively."Stor dosisafhængig effekt og med meget lille usikkerhed p=0,035!
Patienter forbedrede endda deres motorik!!
At de også blev mindre demente med den højeste dosis på 50 mg, vidste vi jo i forvejen, men ikke at de også forbedrede deres motorik - og igen uden bivirkninger!
Nu må markedet da se at vågne op!!! -
Anavex Oversigt præsentation Parkinson
https://stocktwits.com/symbol/AVXL
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Anavex ... Eisai dropper samarbejdet med biogen på Aduhelm.
Anavex Life Sciences Corp (AVXL): From the Benzinga wire today: Biogen,...
powerwalker: From the Benzinga wire today: Biogen, Eisai Amend Their Alzheimer's Drug Marketing Pact 8:01 am, March 15, 2022 Portfolios: First Watchlist...
InvestorsHub (investorshub.advfn.com)
Det ville være en interessant partner til Anavex. Der er også nogle personrelationer, der kunne være adgang for et samarbejde.
Mener også de er med i "konsortiet"
Læser at Anavex arbejder på at give adgang til Blarcamesine for patienter flere steder - interessant hvad der kan ligge i det.
Data burde være gode nok til en godkendelse, men det plejer ikke at være nemt selv om det ville være oplagt.
10% på kursen er latterlig henset til potentialet endnu en gang er synliggjort.
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Fantastisk post fra Veliger som mest poster på Stock Twist:
Veliger
Tuesday, March 15, 2022 8:15:06 PM
Re: Bourbon_on_my_cornflakes post# 354211
Post# of 354315
I'm impatient too. In the past I've shared my analysis of what the fair value and full potential may be here...and full potential is in the hundreds per share. I want to realize it now. I also know I'd be a lot more patient today if the whole bio sector had been flat the past 3-4 months instead of down by nearly 50%, and Anavex was still in the 20's. Unfortunately, that has not panned out.I've been a holder since 2015, and I'm employed in this sector. I can tell you that at an average burn rate of $2.3M a month, while advancing multiple, late stage trials with > $10B/annual revenue potential....there's not much better in terms of time/dollar value out there. There are CEOs that take home more than the Anavex annual burn per year. Yes,, it could be faster if we partnered for peanuts or had diluted the stock to something > 100M outstanding shares. I'm not going to play Monday morning cornerback on these decision, other than to point out that Chris has in the neighborhood of 6M options, and I trust his goal is to maximize the potential here. That said, when he makes statements about shareholder value he's talking about several years...not days, weeks or months. Like you, I still want to see us move faster, buy I accept where we are and that last patient enrolled in the Alzheimer's study is just finishing up week 40 of 48 this week.
I expect we have another 6 months of waiting before the real deal....a RETT NDA filed, 48-week PDD OLE data (building off the good news today), and Alzheimer's into Sept/Oct. I honestly think the NDA being filed (our first of many) will create a very large adjustment in fair value, as it implies Pre-NDA dialogue has led to the path to file and brings legitimacy (whether FDA, UK, Canada, TGA...) which I feel is lacking today. That NDA filing could be this Summer. Obviously an approval means so much more...and that first approval anywhere will force the market to drastically recalculate the fair value, which today is off by at least 4x. GLTA.
Anavex Life Sciences Corp (AVXL): I’m impatient too. In the past I’ve shar...
Veliger: I’m impatient too. In the past I’ve shared my analysis of what the fair value and full potential may be here…and full potential is in the hundreds per...
InvestorsHub (investorshub.advfn.com)
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H.C. Wainwright Thinks Anavex Life Sciences' Stock is Going to Recover:
0 star analyst H.C. Wainwright's Ram Selvaraju reiterated a Buy rating on Anavex Life Sciences (AVXL - Research Report) today and set a price target of $42.00. The company's shares closed last Tuesday at $10.65, close to its 52-week low of $9.28.
Ja ja hellere ha en 0 stjernet positiv analyst end ingen.
Interessant at han også har et kursmaal på over 40 ligesom Veliger i min forrige post, men okay Veliger mener nu og ikke om et år.
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Anavex ... jeg kunne ikke loade mine egne notater fra Needham. Men her et par gode referater.
Anavex Life Sciences Corp (AVXL): My notes on Misslings CC this morning:...
RedShoulder: My notes on Misslings CC this morning: Rett Excellent in 2nd half of year. He was grilled pretty good on the change in end points for Rett. M...
InvestorsHub (investorshub.advfn.com)
Anavex Life Sciences Corp (AVXL): Peter, thanks again for you outstanding...
RedShoulder: Peter, thanks again for you outstanding analysis: Conclusions The improvents in all four parts of the UPDRS are consistent across all measures a...
InvestorsHub (investorshub.advfn.com)
Sidstnævnte med en analyse fra Peter Karol.
Jeg kan nævne Eisai som en mulig partner allerede nu fra Asien til AD, idet der sikkert skal nye forsøg til i asiater, idet adiater kan respondere anderledes en europæer og amerikanere.
God webcast med gode spørgsmål.
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Anavex ... en tråd mere, idet Missling nævnte at der var flere sygdomme Blarcamesine var aktiv i:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168223924 -
Anavex Parkinson News Today!
PDD Patients Given Anavex 2-73 at High Dose Show Range of Benefits
Fik nu lejlighed til at høre Missling på Needham - har været lidt arbejdsramt.
Fine referarter længere oppe i tråden!
Anavex køre med fuld damp på alle cylinder!
Det er bare så vildt, hvilket potentiale hele platformen præsenterer.
Alle data har hidtil været meget overbevisende og uden sidestykke til nuværende mulig behandlingsform.
Anavex ved lige nøjagtig, hvad de har og hvor de skal hen.
Tingene tager tid, med RETT godkendelse er meget realistisk indenfor en kortere tidshorisont - afspejles af, at Anavex er ved at opbygge en salgsorganisation.
Partnerskaber sandsynligvis i Japan, kan komme hvornår det skal være - Takeda (konsortium) eller Eisia med tidligere Anavex konsulent Harald Hampel, som udviklingsleder af nye CNS forsøg for netop Eisai.
Dette i sig selv ville skubbe Anavex op i en anden liga og give en blåstempling af casen.Der er nu mange potentielle nyheder løbende resten af 2022 - med kronen på værket i form af Alzheimer fase 2/3 data, som Missling ikke var forsinket og ville komme i slutningen af 2022.
Holder eller øger og læner mig tilbage og lader tingene komme når de kommer.
Torpedoerne er skudt af - nu venter vi bare på, hvornår og ikke hvis de når målet! -
Anavex ... Endelig ser det ud til at kursen retter sig efter en urimelig nedkøling efter de gode Avatar resultater.
Det er USA biotech og man skal ikke nødvendigvis forstå kursudviklingen. Big money styrer langt hen ad vejen.
Vi kan håbe, at kursen glider forbi 13-13,5 for så er der åbnet op for yderligere 4-6 point, tror jeg.
Jeg har nævnt eksemplet CLDX før. Uden varsel eller nyheder fløj kursen op fra $2 til $50.
Mon vi kommer op i en rimelig værdisætning nu - eller må vi afvente approval og salgsindtægter ?
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Ja det var en fin uge for os Anavex investorer, vores papir penge blev ca 20% forøget hvilket er psykologisk godt.
Det var også voldsomt volumen på, over 3 mill i fredags, hvilket også er meget fint, der er interesse i firmaet.
Hvis man kigger på XBI index kan man se at vi har fuldt det meget nøje men dog med doblet stigning men kurven ligner AVXL kurven meget for 5 dage. Bio Tech er generelt banket helt ned i kul kælderen, måske bunden var nået og folk investerer penge i Bio Tech igen?
Kursen på AVXL burde værre min 40 med den pipe-line og de kan ikke blive ved med at ignorere Anavex, jeg er optimistisk at det store volumen er de tunge drenge som køber ind, de er jo ikke dumme (men grådige).
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Anavex Hvad er der sket med søgefunktionen??
Kan ikke finde egen aktivitet mm. -
Anavex Positiv Seeking Alpha artikel.
Blarcamesine is one of the very best drug candidates for the treatment of Alzheimer's disease.
The current timeline is for Anavex to release phase 3 clinical trial results for Alzheimer's disease during the latter part of this year, but this timeline could be pushed out into the early part of next year. Most investors in the company are probably used to these delays from previous Anavex trials (which also include Rett syndrome and Parkinson's Disease Dementia). More important is if the results remain positive, will the FDA approve a drug based on a phase 3 clinical trial with no U.S. sites? I suppose that it depends on how good the results are, but if the results match those from the open label trials, it is difficult to conceive that the FDA would not at least grant accelerated approval to blarcamesine. Anavex remains one of the very best investments in the Alzheimer's field.
The following article attempts to explain some of the mechanisms of action that may account for these varied results and why Anavex's blarcamesine may potentially provide a successful treatment for Alzheimer's disease.
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