Anavex
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God weekend
Sjovt at se udviklingen i de mest shortet aktier i denne uge, fing har også været berørt...Shorting er normalt et vigtigt instrument på aktiemarket, og er med til at holde kurserne i et fornuftigt kursleje, men der er ingen tvivl og af nogle hedgefondene de sidste år, har kørt en uærlig og manipulerende hetz mod en del virksomheder.
Så i min verden, er det befriende at se nogle hedgefonde smage deres egen medicin, for normalt er det altid de private der står tilbage som taberne...
Det kan være vi får et mere ærligt sats på kursfald, end det har været tilfælde de sidste par år....
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Anavex Er helt enig TDT!
Må sige det har været noget af det bedste, der er sket på aktiemarkedet i nyere tid.
Shorting i sig selv er måske ikke så slemt og kan i en vis grad lægge en dæmper på en ellers unormal overophedning - men det er manipulationen, som disse hedgefonde med deres store finansielle muskler, super computer med specielle algoritmer udøver!
Her havde en mening investor ikke en kinamands chance for at gøre noget - indtil nu!
Tror dette måske kan være med til at få shorterne til at tænke sig om en ekstra gang og lade selskaberne få en mere retvisende prissætning.Som i Anavex casen, har en unaturlig lav prissætning gjort det dyrere og i sidste ende måske forlænget udviklingen af ny livsvigtig ny medicin.
- marts er Missling med RAM på hos selveste NIH:
Rare Story #2: Industry and Patient Advocacy Collaborations - Making It a
Win-Winhttps://ncats.nih.gov/news/events/rdd
God weekend
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Godt at se Missling kommer de rigtige steder
Markedet taber pusten, men kursudviklingen er stadig tilfredsstillende. Muligt at shorterne både pga casen, men også det aktuelle short kill har medvirket til nogle fornuftige dage kursmæssigt.
Stadig en utroligt spændende case. Drømmer om at data holder og de mange $bn ligger forude
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Anavex. Næste mål for Reddit måske biotek?
Tror dog ikke Anavex har brug for hjælp fra den side.
Som sagt bliver der i fremtiden måske manipuleret lidt mindre og handlet mere på baggrund af resultater og fremtidig potentiale.Den 5. februar er det 30 dage siden, at ledelsen fik tildelt optioner til kurs 5,49 $.
En passende og mener en etisk korrekt periode uden større nyheder, hvor alle har haft mulighed for at købe sig ind i selskabet.
Der kommer min. 3-4 nyheder inden udgangen af Q1.
( Se evt. tidligere indlæg ) -
Anavex. Selvsikker indlæg på Facebook!
- januar 2021.
Oversat:
Neuro-udviklingsforstyrrelser er nedsat vækst og udvikling af hjernen og / eller centralnervesystemet. En snævrere anvendelse af udtrykket henviser til en forstyrrelse i hjernens funktion, der påvirker følelser, kognitive evner, adfærdskontrol og hukommelse, der udfolder sig, når et individ udvikler og vokser.
Hos Anavex er vores team fast besluttet på at bringe lovende terapi til berørte patienter og familier, der har til formål at stoppe sygdomsprogression, vende forringelse og / eller effektivt kurere både sjældne og almindelige CNS-lidelser blandt andre tilstande.
Kan Anavex tillade sig at skrive dette på et stort socialt medie?
At anfører muligheden for potentielt at kurere CNS sygdomme, virker da ekstrem selvsikker og må alt andet end lige bunde i de data vi har set og sandsynligvis også fra data, som indtil videre kun Anavex har kendskab til. ( læs - åbne ekstension forsøg m.m. )
Ovenstående set i lyset af, at Anavex hidtil har været meget forsigtig med at udtale sig omkring egne evner.Anavex har også øget aktiviteten på Twitter med lidt kryptiske opslag.
Lidt mere omkring Reddit og biotek:
Måske en forestående "Perfect storm" - med evt. gode nyheder på vej fra Anavex og nervøse shorts, samt en generel positiv markedsudvikling grundet udbredelsen af vaccine og ny handlekraftig ledelse i US?
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Anavex SAVA med gode data fra åben Alzheimer forsøg.
SAVA har vist fremgang på hos 50 patienter i et åben Alzheimer forsøg over 6 mdr.
Dvs. alle patienter ved de får medicinen.Cassava Sciences’ Simufilam Improves Cognition and Behavior in Alzheimer’s Disease in Interim Analysis of Open-label Study
- Patients’ Cognition Improved 1.6 Points on ADAS-Cog11 -- Patients’ Behavior Improved 1.3 Points on NPI - - Improvements Maintained at 6 Months - - Results Support Advancing Simufilam into Phase 3 Clinical Program - AUSTIN, Texas, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today announced results of an interim analysis from an open-label study of simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Patients’ cognition and behavior scores both improved following six months of simufilam treatment, with no safety issues. In a clinical study funded by the National Institutes of Health and conducted by Cassava Sciences, six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6. In these same patients, simufilam also improved dementia-related behavior, such as anxiety, delusions and agitation, by 1.3 points on the Neuropsychiatric Inventory, a 29% mean improvement from baseline to month 6. Alzheimer’s is a progressive disease. Over time, a patient’s cognition will always worsen. “Experience based on longitudinal studies of ambulatory patients with mild to moderate Alzheimer’s disease suggest that scores on ADAS-cog decline by 6 - 12 points per year”, according to FDA’s Prescription Information sheet for ARICEPT® (donepezil), a drug approved for the treatment of dementia of the Alzheimer’s type1.“We could not be more pleased with these interim results,” said Remi Barbier, President & CEO. “We would have been satisfied to show simufilam stabilizes cognition in patients over 6 months. An improvement in cognition and behavior tells us this drug candidate has potential to provide lasting treatment effects for people living with Alzheimer’s disease. It’s an exciting development.” The safety profile of simufilam in the interim analysis was consistent with prior human studies. There were no drug-related serious adverse events. Adverse events were mild and transient. “Today’s data once again suggests simufilam could be a transformative, novel therapeutic,” added Nadav Friedmann, PhD, MD, Chief Medical Officer. “It appears the drug’s unique mechanism of action has potential to provide a treatment benefit following 6 months of dosing.” About the Interim AnalysisCassava Sciences’ on-going, one-year, open-label, multi-center study is evaluating the long-term safety and tolerability of simufilam 100 mg twice daily in 100 patients with mild-to-moderate Alzheimer’s disease. This study was initiated March 2020 and is now approximately 80% enrolled. Today’s pre-planned interim analysis summarizes clinical data at the midway point of enrollment, i.e., the first 50 patients who have completed at least 6 months of drug treatment. ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) is a standard test for assessing changes in cognition in Alzheimer’s disease trials. NPI (Neuropsychiatric Inventory) is a widely used tool for measuring changes in dementia-related behavior. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly. The interim analysis shows mean baseline scores of 15.5 on ADAS-Cog11, 4.5 on NPI and 22.1 on MMSE. Much of the value of the open-label study is to gain data to support simufilam’s long-term safety profile in patients. Interim efficacy data from an open-label study has limitations compared to efficacy data from a fully completed, large, randomized controlled clinical trial, or from a fully enrolled open-label study. However, prior clinical research in Alzheimer’s disease conducted by other sponsors can serve as a contextual reference for estimates of an expected rate of decline in cognition in placebo patients: In 2019, a randomized controlled trial of aducanumab (Biogen) was conducted in >1,000 patients with early Alzheimer’s disease.2 In this Phase 3 study (EMERGE), patients on placebo showed a mean decline in cognition of approximately 1.4 points on ADAS-Cog13, a 6.3% decline, from baseline to month 6. Mean baseline ADAS-Cog13 score was 22.2. Mean baseline MMSE was 26.4.A randomized controlled study of ARICPET® (donepezil, Eisai) was conducted in >400 patients with mild-to-moderate Alzheimer’s disease.3 In this Phase 3 study, patients on placebo showed a mean decline in cognition of approximately 1.9 points on ADAS-Cog, a 7.3% decline, from baseline to week 24. Mean baseline ADAS-Cog score was 26. MMSE range was 10-26. Next StepsCassava Sciences believes today’s data and prior clinical results support advancing simufilam into a Phase 3 clinical program in Alzheimer’s disease. Initiation of a Phase 3 trial remains on schedule for 2nd half 2021. Cassava Sciences and the U.S. Food and Drug Administration (FDA) recently concluded a successful end-of-phase 2 (EOP2) meeting for the simufilam drug development program. Details of the EOP2 meeting will be announced Q1 2021 after official FDA meeting minutes are finalized. Based on today’s results and inbound demand from Alzheimer’s patients and their caregivers, the enrollment target for the open-label study will be increased by up to 50 additional patients, to a total target of approximately 150 patients. The Company is also in discussions with its scientific and clinical advisors about other potential enhancements to the open-label program. About Alzheimer's Disease Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older developed Alzheimer’s in 2019.4 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, resulting in a growing social and economic burden.5About SimufilamSimufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. Cassava Sciences is also developing an investigational diagnostic, called SavaDx, to detect Alzheimer’s disease with a simple blood test. Simufilam and SavaDx were both developed in-house. Both product candidates are substantially funded by peer-review research grant awards from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party. About Cassava Sciences, Inc.Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com For More Information Contact:Eric Schoen, Chief Financial OfficerCassava Sciences, [email protected](512) 501-2450 Cassava Sciences’ open-label study of simufilam in Alzheimer’s disease is funded by clinical research grant #AG065152 from the National Institutes of Health (NIH/NIA). The content of this press release is solely the responsibility of Cassava Sciences and does not necessarily represent the official views of the NIH/NIA. Cassava Sciences Safe HarborThis news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: our strategy and plans; the treatment of Alzheimer’s disease; the status of current and future clinical studies with simufilam, including the interpretation of an interim analysis of open-label study results; inherent limitations of the ADAS-Cog and NPI testing batteries; planned enrollment and other changes to the open-label program; our intention to initiate a Phase 3 clinical program with simufilam in 2nd half 2021; results of our EOP2 meeting with FDA and the timing of further announcements; verbal commentaries made by our employees; and potential benefits, if any, of the our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019 and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov. This news release may also contain statistical data and drug information based on independent industry publications or other publicly available information. We have not independently verified the accuracy or completeness of the data contained in these publicly available sources of data and information. Accordingly, we make no representations as to the accuracy or completeness of such data or information. You are cautioned not to give undue weight to such data. 1 Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf (2018)2 Source: Biogen, EMERGE Phase III study, slide 24, https://investors.biogen.com/static-files/8e58afa4-ba37-4250-9a78-2ecfb63b1dcb (2020)3 Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf (2018)4, 5 Source: Alzheimer’s Association. Disease Facts and Figures. https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
Yahoo Finance (finance.yahoo.com)
Man vil nu i dialog med FDA om evt. opstart af et fase 3 forsøg slut 2021.
SAVA er som tidligere beskrevet nok det, der i virkemekanismen er tættest på Anavexs 2-73.
Mener dog stadig, at MOA i 2-73 er mere upstream og bedre beskrevet.
SAVA har heller ikke en fedtfjernelsestilgang, som alle BP har praktiseret uden held i flere år.Anavex har tilsvarende resultater i Alzheimer ( 148 uændret efter 148 uger på høj dosis 2-73 ) og ikke mindst, modsat SAVA, placebo kontrollerede forsøg i Parkinson og RETT.
Når SAVA engang kommer så lang til at de skal have indrullet de første patienter i et større fase 3 forsøg, er Anavex næsten klar med data fra deres!
Længe før dette, er 2-73 dog højst sandsynlig blevet markedsgodkendt i RETT.Har som tidligere nævnt også et efterhånden stort frimærke i SAVA, fordi SAVA har bedre forbindelser til Wall Street og NIH - og har den MOA der ligner Anavex mest.
Anavex er midlertidig min. 3 år forud for SAVA og har en langt bredere pipeline.
Tror markedet og investorer på et tidspunkt opdager dette for alvor og vil øge investeringen i Anavex betragteligt!Har selv på den baggrund f.eks. tjent rigtig godt på at finde selskaber i den grønne omstilling, som af en eller anden grund ikke var fulgt med de øvrige sammenlignelige selskaber.
Alt i alt en positiv udvikling for Alzheimer og for Anavex!
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Tasso, takker for din analyse af SAVA og hvem der er bedst (formodentlig) og hvorfor de får den opmærksomhed som AVXL ikke får i samme grad.
Man bliver jo noget bekymret over at SAVA kører op +60% i dag og vi må nøjes med 5%.Anavex er dog også ganske godt kørende når man kigger på Yahoo Finance mobil: 1 år= +141%, 6 måneder= +63%, 1 måned= +28%, 5 dage= +13%, slet ikke dårligt.
Jeg har selvfølgelig også andre aktier end AVXL og nyder ca 500% profit på LXRX over ganske kort tid, så det er mange penge jeg har tjent på den.
Ohh kom så AVXL, næsten kurs 7 nu, ville værre rart at passere den og holde over 7.
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Tak Tasso1
SAVA har gennem noget tid kørt op. Så nogen har vidst noget.
AVXL kører også ganske fint og den korte dd jeg gjorde på SAVAs produkt faldt også ud til 2-73's fordel.
Men det er jo nu ret vigtigt, at det holder i mål....
Hvis det holder får vi sikkert også 10% dage
SAVA har jo lige nu den fordel, at have en større pharma i ryggen. Men skal jo også dele med dem...
Min nok største tvivl er om hvorvidt AVXL's forsøg er store nok til fda.
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Anavex Velbekommen Kyed01
Kan se at SAVA lige pludselig er blevet min 2. største aktie!
Har dog en samlet bred portefølje i grøn omstilling, der er noget større.Vores tid i Anavex skal nok snart komme for alvor.
Som jeg tidligere har skrevet, mener jeg, at Anavex er en krudttønde, der meget snart kan blive antændt på samme måde som SAVA.
Nu har SAVA sat et fint foreløbig målepunkt, som jeg mener Anavex faktisk allerede burde ligge på.
( Anavex og SAVA er ofte blevet nævnt sammen af forskellige analytiker - fra eksempelvis Seeking Alpha )Ville være et godt tidspunkt for Anavex at komme med nogle af de ventede nyheder fra FDA eller andre myndigheder - eller data fra et af de mange forsøg de har kørende.
Tror nyheden fra SAVA kan have givet Anavex et udmærket tiltrængt skub til også at åbne op for "nyhedsposen" - nu når markedet har rettet fokus på en alternativ tilgang til bl.a. Alzheimer, i stedet for fedtfjernelsesprincippet. -
Anavex AVXL and SAVA likely target the same sets of molecules!
All roads lead to Rome: compounds from AVXL and SAVA likely target the same sets of molecules — Biotech Changes Lives
Cassava Sciences (SAVA) presented the phase 2b data on its lead drug, Sumifilam, from its re-analysis. The results look impressive from the view of biomarkers, although the new analysis is not blinded. Initial analysis by an independent company in a blinded fashion showed no effect from treatment.
Biotech Changes Lives (www.biotechtoinvest.com)
Tror markedet kommer frem til dette inden længde!!
Anavex dog som sagt 3 år forud!MC SAVA nu ca. 4X MC Anavex!
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@Tasso1
Der har været en fin trend i Anavex på det seneste. Det må man sige. Jeg var noget misfornøjet, da den røg fra 7,5 til 5 senest. Har dog holdt aktien, da den saglige argumentation herinde er god - specielt fra Tasso1, som lader til at følge aktierne tæt.Jeg har i periode ret travlt, så det er guld (og penge) værd at følge gode tråde her på proinvestor.
Jeg nåede selvfølgelig lige at se, at du har en bred portefølje i grøn omstilling, Tasso1. Har du nogle gode kandidater, som du vil dele med os andre? Jeg plejer selv lige at læse lidt om virksomhederne og se deres regnskab før jeg hopper i med begge ben. Så jeg ved godt, at anbefalinger skal tages med forbehold.
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Et støttende indlæg fra en god skribent på Investorhub
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161424935
Nu vil markedet få øjnene på AVXL
Tak til Tasso1 for vedholdende, at holde os orienteret. Jeg havde forsvoret, at turde tage et bet i CNS sygdommen
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hold da op , er der gået gamestock i den hø hø sælger ikke før kurs 1000,
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God morgen fra Thailand, sikke en dejlig dag at vågne op til, AVXL 1$ op per aktie i værdi og hele mit portfolie gik op med over 10% i går, når det regner på præsten drypper det på degnen.
Over 3 mill i volumen, så over dobbelt af normalen.Vi kan vel godt blive enige om at det burde værre den anden vej (AVXL-SAVA) men ser ud til at vi er på den rette vej og som nævnt af Tasso, FDA nyheder eller nogle data fra Missling ville bestemt værre rart.
Ja mon ikke SAVA snart kører lidt ned igen?
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Anavex Portefølje Boersboe
Hej Boersboe - tak for de pæne ord:)
Du må få oversigten af min og familiens lille investeringsportefølje pt.
Vil kraftig understrege, at dette ikke er en anbefaling og man selv skal undersøge selskaberne grundig, før man evt. tænker på at investere!!!
Nogle positioner er øget og andre reduceret - de fleste er dog holdt neutralt i den sidste måned.Grøn omstilling.
FCEL, IDEX, TESLA, ALTO, GEVO, Vestas
- et par mindre frimærker.
Biotek.
Anavex, SAVA, Genmab, SRNE, LXRX, NYMX, CCXI
- flere mindre frimærker
Andet.
Royal Unibrew
Frimærkerne er dem, der er gået fra observationslisten til et mindre køb.
IGEN - ikke en anbefaling!!!
Lige en ting til eftertanke!
De relative pæne stigninger vi har set i Anavex og SAVA den sidste tid, skal ses ifht. de stigninger som LLY og BIIB oplevede ved deres annoncering af langt svagere data ( læs ubrugelige ) i lignende indikationer/forsøg.
Her så vi stigninger på 15 -20 milliader $.Omregnet til MC i Anavex og SAVA ville det give et helt andet kursniveau - og på data der faktisk også ser ud til, at ville være til gavn for patienterne!
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