ANAVEX NY TRÅD SEPTEMBER 2021!
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Anavex Glemte lige udmelding fra FDA vedr. RETT og PDD!!!
- En måske interessant årsrapport - i slutningen af december!
DVS. 8 potentielle nyheder + det løse på 8-9 uger!
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God morgen fra Thailand, dejligt at vågne op til over 20 på kursen, lad os håbe at den bliver over det niveau.
SeekingAlpha artikel som er positiv på Anavex mht AD og et firma som jeg ikke kender Cyclo Therapeutics (CYTH).Ja nu burde vi snart få nogle nyheder, måske i dag tirsdag?
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Anavex Præsentation af de endelige PDD data??
Anavex har jo stadig den samlede datapakke inkl. de nye RNA/DNA parameter fra samtlige patienter i Parkinson Demens forsøget liggende til vurdering hos FDA!
Sidste år præsenterede Anavex helt undtagelsesvis de foreløbige PDD data fra forsøget på den store CTAD Alzheimer konference, idet der jo er ca. 80 % sammenfald mellem målepunkterne i AD og PDD.
Hvis de får en udmelding fra FDA inden da, har Anavex mulighed for at gentage dette med den nu færdige datapakke på dette års CTAD eller evt. i Singapore lidt senere på en anden stor Parkinson konference:
9.-12. nov. 2021:
https://www.ctad-alzheimer.com/18.-19. nov. 2021:
https://waset.org/advances-in-parkinsons-disease-conference-in-november-2021-in-singaporeSker dette og data er positive, så bliver det godt nok dyrt at skulle betale skatten af mine aktiesparekontoer her til januar!!
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Anavex 5 stjernet fastholder kurs 50 $!
Den 3. november 2021:
JonesTrading analyst Soumit Roy maintained a Buy rating on Anavex Life Sciences (NASDAQ:AVXL) on Wednesday, setting a price target of $50, which is approximately 133.86% above the present share price of $21.38.
JonesTrading analyst Soumit Roy is currently ranked with 5 stars on a 0-5 stars ranking scale
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Læs om Nobel pris vinder Dr Barrie Pittock som begyndte AD behandling i 2018 med 2-73 and han ser ud til a ha det fint i dag.
'No point flogging the same dead horse': Australian scientists trial radical Alzheimer's drug
Nobel Prize-winning scientist Barrie Pittock is living with Alzheimer's and is involved in a trial that questions everything we know about the disease. Australian researchers believe the plaque on his brain may be a symptom of the condition, not the cause.
(www.abc.net.au)
Meet Nobel Prize Winner, Dr Barrie Pittock | Mayflower
We would like you to meet Dr Pittock, a climatologist, environmental scientist, and advocate for Australian Indigenous rights, living at Mayflower Brighton.
(www.mayflower.org.au)
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Anavex Kyed01 - Dr Barrie Pittock?
Er der nogen dato på denne sidste artikel?
Kan godt huske artiklen, hvor Dr Barrie Pittock startede i Anavex`s Alzheimer forsøg tilbage i 2018.
Men han fortæller ikke meget om, hvordan han oplevede behandlingen med 2-73.
Vi ved jo heller ikke om han faktisk fik 2-73 eller bare placebo - han burde dog have modtaget 2-73 lige siden, hvis han er forsat i ekstension forsøget.Men ja - han virker til at fungere fint!
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Artiklen er ifølge en fra Ihub fra sidste uge.
Jeg ved ikke hvordan de vælger hvem der for 2-73 og hvem der får placebo? Han er jo Nobel pris vinder så??
Jeg tror ikke at man har lov til at snakke om en medicin når den stadig er i forsøgs stadiet ellers ville vi jo høre om det hele tiden?
Manden er 83 år gammel, har haft AD siden 2014 og er stadig meget aktiv for hans alder så hvis han ikke har fået noget medicin der virker snakker vi jo om et mirakel.
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SAVA er oppe med over 65% efter at de ikke fandt noget galt med deres data!
Jeg tror nu at langsom og stødt er bedre end de der helt vilde udsving (uden nogle data).
Naa mens jeg skrev dette er det nu dalet til 50% (handels stop).
Anavex er jo gået op ca 26% de sidste 5 handelsdage, rimeligt stille og roligt nok i forventning om (gode) nyheder ret snart.
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Nu fik vi forklaringen på SAVAs kursspring i går. Altid nogen der ved mere end andre.
Mht Berrie Pittock så kan han god have fået placebo i forsøget, men alle er efter forsøgets afslutning tilbudt deltagelse i OLE forsøget. Så nu er han klar over at han får 2-73.
Anavex ser vældig stærk ud nu. Lad os se de data.
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Fra Juni 2021 https://youtu.be/8orzf4UXNLA
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Anavex Ny Seeking Alpha AVXL, SAVA og CRTX.
Altid godt med lidt omtale.
Fremhæver SAVA, men giver også Anavex en reel chance for at blive en vigtig spiller i Alzheimer.
Han mangler dog helt basal viden om Anavex casen og hvor fremskreden de er på andre områder også.
Reelt er de ca. 3 år foran SAVA, der nok først i starten af 2022 påbegynder indrulning til 2 AD fase 3 forsøg.
Han nævner dog, at Anavex`s resultater fra deres AD fase 2/3 i 2.h 2022 bliver meget vigtig.
Han nævner slet ikke de gode resultater Anavex opnåede i PDD og RETT og sidestiller Anavex med CRTX, som efter min mening har en dårligere basseret videnskab og er endnu længere efter Anavex - især efter, at de ikke nåede, hverken primære eller sekundære endpoints i deres sidste forsøg sidste uge.
Han nævner, at vi måske bliver klogere efter dette års CTAD konference, men så vidt jeg kan se, har Anavex ikke meldt deres deltagelse her - endnu!9.-12. nov. 2021:
https://www.ctad-alzheimer.com/Alzheimer's - Cassava, Cortexyme Or Anavex: Who Will Come On Top?
Nov. 05, 2021 5:53 AM ETAnavex Life Sciences Corp. (AVXL), CRTX,SAVA3 Comments1 Like
Summary
Cassava Sciences' Simufilam is now seen as the best hope to treat all patients in Alzheimer's disease after disappointment in Cortexyme's data.
Cortexyme failed to prevent disease progression in 50% of patients on what was hopefully an upstream mechanism of action vs. Simufilam.
The CTAD Conference in November will shed much light on the most recent clinical data of Anavex, Cassava Sciences and Cortexyme.
The future of Alzheimer's treatments will probably consist of a combination of treatments to maximize results as in oncology.
On November 4, 2021, Cassava Sciences announced no wrongdoing was found by the American Journal of Neuroscience on its data.
Investors in the biotech sector are closely watching Anavex Life Sciences (AVXL), Cassava Sciences (SAVA) and Cortexyme (CRTX) as the most likely candidates to bring new treatment options to Alzheimer's patients in desperate need of innovation to the current standard of care. It's highly likely all 3 companies will enter the market at some point but what drug candidate becomes the standard of care in the space will make a world of difference on the performance of each of these investments. I am of the belief that Cassava Sciences will come out on top as it will be used to treat 100% of the patient population perhaps in combination with another drug candidate. Furthermore, the market has already given it a premium valuation over its peers based on their data. Even after a 50% haircut Cassava Sciences remains on top based on market cap. I will explore on this article why recent events make Cassava Sciences even more compelling while making the case that Cortexyme still has a chance at entering the space. Finally, I will lightly touch on why Anavex 2-72 could be a combo treatment used with Simufilam.Chart
Data by YCharts
Since my last article was published many new developments have occurred that are making Cassava Sciences (SAVA) primed for a breakout above $100. I believe the risk-reward here is unlike anything I have seen recently in clinical-stage biotechs and the battle between bulls and bears will be epic with bulls regaining control this week of the narrative after a 40% intraday rally on November 2, 2021, and another 51% rally as of the writing of this article on November 4, 2021, after the company published that the Journal of Neuroscience found no evidence of data manipulation. According to ORTEX data, shorts had doubled their short positions to approximately 40% of the free float at an average price of $52 to $68 which is putting them at a very uncomfortable position. I believe bulls have been finally vindicated after suffering much emotional pain and suffering. I quote from my last article:But what short-sellers have done at Cassava Sciences is just totally and completely distasteful while the families of 6.2 million Americans are waiting for any kind of treatment that offers hope for their loved ones. I am all for justice but the Citizen Petition was nothing short of a dump and cover short selling scam which I hope is eventually prosecuted by the SEC!
We still need to see justice done against the manipulators but at least seeing their profits evaporate is a good first step.
Chart
Data by YCharts
Switching gears, Anavex Life Sciences has pushed out of recent resistance to make new 3-month highs as enthusiasm grows after Cortexyme plunge. It's likely Anavex and Cassava will emerge as the contenders for the class pending additional data.Chart
Data by YCharts
Cortexyme Failure Pushes Sava and Anavex to the Front
On October 26, 2021, Pfizer-backed Cortexyme reported Alzheimer's data that failed to meet its primary endpoints. I won't dig into all the specifics of the GAIN Trial (except for the most important ones) but part of what Cortexyme wanted to prove was that P. Gingivalis infection was directly related to Alzheimer's disease. By eradicating P. Gingivalis the hope was to slow cognitive decline. However, not all patients responded to treatment and only about half of the patients saw a 57% cognitive decline response. Though it was not a complete failure, COR388 is highly toxic to the liver and can't be given to all patients as a treatment for Alzheimer's disease. Furthermore, P. Gingivalis is not the cause of Alzheimer's disease but rather it's present in some patients and when COR388 is given to those patients their cognitive decline slows. Why is this significant? Because if P. Gingivalis (which is a mouth infection that usually shows greater concentration on the elderly population) would have shown to be the cause of Alzheimer's disease then its eradication would have been the cure for all patients. A simple test for P. Gingivalis on patients could detect the presence of the infection early on, then treatment with COR388 would proceed and prevent patients from developing Alzheimer's disease. Under such a scenario, Cassava Sciences' Simufilam would be left with a reduced patient population to repair misfolded proteins in the brain. COR388 would have become the standard of care upstream in the disease.However, the 57% slowing of cognitive decline in 50% of the patients that responded is huge and the market is perhaps overpunishing Cortexyme on such an astonishing achievement. The usual 30/30 rule for the FDA would almost guarantee that COR388 will eventually gain approval. (30% of patients getting a response of at least a 30% disease progression alteration) If I were to speculate about why Cortexyme was down 70% was because liver enzyme levels were three times the upper limit normal indicating very high levels of toxicity. However, even with a black box warning, it's very likely that COR388 would become a blockbuster if Anavex and Cassava Sciences candidates weren't racing to enter the market. The 50% of the population of 643 participants in the GAIN Trial that experienced a 57% slowing of cognitive decline is huge by any measure.
Why then is Cortexyme being punished? My answer is Cassava Sciences. Because COR388 can't be used on all patients and isn't the cause of Alzheimer's disease the market will now place Simufilam as the most likely candidate to treat the general Alzheimer population. The zero toxicity of Simufilam will allow close to 100% of the patients to take it in the hopes of reversing cognition decline. Furthermore, it's shown that all Alzheimer's disease patients suffer from misfolded Filamin A proteins and Simufilam helps those proteins go back to their original shape.
P. Gingivalis is a step better than Amyloid Beta but a step lesser than Anavex 2-73
For years, all Alzheimer's research has been based on Amyloid Beta buildup on Alzheimer's patients. Researchers thought that clearing the Amyloid Beta buildup would help the brain work better. However, more recent data has seemed to come to the conclusion that when Filamin A is misfolded the natural response of the brain is to entrap such proteins with Amyloid Beta. It's in simple terms the body's natural immune response. In low levels, Amyloid Beta doesn't interfere with brain function. However, excessive buildup eventually causes brain fibers to suffer damage and connections to be lost. COR388 could be Similar to Anavex 2-73 mode of action in that excessive P. Gingivalis could be causing the body to produce excessive inflammatory mediator peroxynitrite in the brain which when generated in excess may damage cells by oxidizing and nitrating cellular components. Anavex 2-73 mode of action is to inhibit the formation of peroxynitrite, removing it, and partially reversing the damage. COR388 could be doing the same function if P. Gingivalis is causing the body to produce excess peroxynitrite in the body.If multiple diseases (including P. Gingivalis) are causing the body to produce excess peroxynitrite then Anavex 2-73 could be the solution to all patients in preventing oxidation and Anavex 2-73 would end on top of COR388. However, early data has also shown that drugs that limit the formation of peroxynitrite such as Anavex 2-73, Trappsol Cyclo and GV-971 lead to improvements for short periods of time of around 6 months.
The best clue as to whether COR388 or Anavex 2-73 will end as the first-line treatment will be when Anavex reports its phase 2/3 results in the second half of 2022. If Anavex 2-73 achieves a response in more than 50% of the patient population it would put Anavex one step ahead of Cortexyme in patients. (It's all about whether Oxidation and Nitration is upstream or downstream from P. Gingivalis on the disease progression.) If oxidation and nitration is yet another subset like P. Gingivalis of what causes patients to develop Alzheimer's disease, Anavex could easily crater and become the less likely option to treat Alzheimer's disease. For example, assume in a placebo-controlled environment only 30% of patients respond to Anavex 2-73 vs the 50% to COR388. It could therefore be assumed 50% of Alzheimer's patients get the disease because of P. Gingivalis while 30% of patients get it from excessive oxidation and nitration in the brain with the remaining 20% unknown. In this imaginary case both Anavex 2-73 and COR388 would be at the same level in disease progression treating different samples of the whole population with Anavex treating the smaller subset while Cortexyme treating the larger subset.
Cassava Sciences takes the lead
With the 12 month open-label data still showing continual improvement in cognition of Alzheimer's patients, Cassava Sciences has taken the lead as the most promising treatment for patients going forward. All patients with Alzheimer's disease have misfolded Filamin A proteins that Simufilam helps repair. That's a fact. Then, Simufilam has a safety profile unlike any other which means it's likely to be taken by almost every patient if approved. Since every patient suffers cognition deterioration and Simufilam is the only candidate that's improving cognition over a long period of time, it's likely to become the standard of care going forward. More likely however, is that Simufilam will be taken as a combo with other treatments. COR388 only achieved a 57% slowdown and not a reversal of cognition decline. Therefore, it's likely that COR388 will be combined with Simufilam if approved while eradicating P. Gingivalis presence in patients. Same goes with Anavex 2-73.Bull Case for Cassava Sciences
The bull case for Cassava Sciences lies with the fact that's likely to become a standard of care for nearly 100% of patients regardless of whatever else drug comes into the market. Just like in oncology, it's very likely that the best results for patients will arise from a combination of treatments. And Simufilam seems to be the foundation for which all combinations will arise from given its safety profile.In my last article, I mentioned the possibility that Cassava Sciences could even get early approval in 2022 as interim data becomes available to the FDA or based on the results of 12 month placebo-controlled data. I expect Simufilam to be in the market between March 2023 and February 2024. I will use the safest scenario which is that the FDA will feel a lot of pressure to give conditional approval after the 12-month placebo-controlled data. With most treatments in development and on the market only showing progress for 6 months the FDA is likely to give early conditional approval based on the first data set. Allowing all patients to be on Placebo for an 18-month period could put those patients at risk of permanent cognitive decline even if later on they are put on Simufilam.
Summary
There's still much we don't understand about Alzheimer's disease and that's a very sad reality. The need for better treatments is very real and every data readout from Anavex, Cortexyme, Cassava Sciences and many more companies to come will put us one step closer to getting more answers. Don't invest more than 5% of your capital on any of these companies as the risk is too big but the payoff if any of them succeed will more than make up for the possible losses. My hope for these companies is that they succeed and that their investors can reap rewards and patients can find hope. It has been an epic week of Cassava Investors and sometimes in life there's something called Karma. -
Det er jo bare en amatør som skriver i Seeking Alpha så hans råd er lige så godt/skidt som enhver andens:
Jose Solorio
Disclosure: I/we have a beneficial long position in the shares of AUPH, SAVA, CRTX, CLVS, BHC, BKSY, BLI, CCXI, CRWD, FIVN, FLXN, FUTU, LC, LMND, PBYI, PCRX, PLTR, SKIN, SUPN, TIGR, UEC, UWMC, VIAC, OPAD, VLTA 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.
Additional disclosure: I don't hold a PHD in biotech. I do this research for my own investment purposes and share it with you as I understand it. It's your responsibility to gather information from multiple sources, consult an investment advisor, and be disciplined on position allocation. I diversify usually among 25 different investments to preserve capital. Strong concentration will lead to poorer returns overtime.
Man skal passe meget på med hvad man læser på S.A. og lave sin egen research/konklusioner.
Næste uge er der måske en artikel der fremhæver AVXL over SAVA, sikket en AVXL invester, ligesom den artikel i dag var skrevet af en SAVA investor.
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Anavex Ny forskning understøtter Anavex's tilgang vedr. Sigma-1!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8559442/
Denne afhandling er lidt langhåret, men understøtter tilgangen, at stimulering af Sigma-1 receptorer generelt spiller en væsenlig rolle i behandling på CNS området.
Anavex 2-73, 3-71 og 1-41har alle også denne egenskab + andre funktioner.
Det illustrerer også hvor kompleks CNS området er og der sandsynligvis skal en bred vifte af behandlingsmuligheder til for at bekæmpe CNS relaterede sygdomme - der er plads til flere forskellige præparater på markedet.
Vigtig er dog, at disse præparater evner at bryde blod/brain barrieren og samtidig ikke giver uønskede bivirkninger - disse kriterier synes alle præparater i Anavexs pipeline at opfylde.Also, ANAVEX2-73, sigma-1 and muscarinic receptor agonist, reversed the scopolamine- and dizocilpine-induced spatial memory impairments, and this effect depended on sigma-1 and muscarinic receptors (Espallergues et al., 2007; Villard et al., 2011a). Thus, the above studies suggest that muscarinic receptors are more important for short-term memory, while sigma receptors are more engaged in long-term memory formation.
ANAVEX2-73 also ameliorated the spatial and emotional learning deficits in mice injected with Aβ25-35 peptide, also showing neuroprotective properties by decreasing the level of lipid peroxidation and blocking tau hyperphosphorylation (Lahmy et al., 2013; Villard et al., 2011a). However, as mentioned earlier, this effect may be mediated not only via sigma-1 receptors, but also muscarinic receptors. The same results were observed for another aminotetrahydrofuran derivative, which stimulates sigma-1 receptors - ANAVEX1-41 (Villard et al., 2009). Moreover, a compound with a similar pharmacological profile, AF710B, improved recognition and spatial memory in aged McGill-R-Thy1-APP rats by reducing amyloid plaques, normalizing the microglia distribution and synaptophysin levels
Bevis på short manipulation!
Håber dommen bliver MEGET hård, så andre vil tænke sig om en ekstra gang, da denne form for manipulation underminere tilliden til aktiemarkedet og typisk rammer den lille investor!
SEC har for en gangs skyld gjort deres arbejde!Anavex er efter min mening sat op til The Perfect Storm - med et større antal ventede nyheder over de næste få uger og generelt ny positiv fokus på CNS
området generelt!
Får vi evt. deltagelse på CTAD og andre kommende større konferencer den næste tid, med forhåbentlig gode resultater - så tør jeg ikke spå om kursen, uden at komme til at virke useriøs!
Vi har dog set mange eksempler på, hvordan BP har fået stigninger i deres MC på 10-20 milliarder $ på nyheder, der svarer til det vi potentielt har i vente for Anavex de næste uger/ måneder!Alt forudsat, at skidtet virker - uden bivirkninger!!!
PS: Får vi nogle afgørende nyheder indenfor de næste uger, tænker jeg at starte en ny November tråd!
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Tasso, må jeg forslå at vi kalder den jule tråden hvis de kommer med godt nyt? Det er jo næsten den bedste jule gave man kan tænke sig, ha-ha.
Ja vi så denne uge med a stødt stigning op og endte på kurs 23, så det tyder på at "hele verden" er nok klar over at Anavex snart kommer med nyhede, "The Perfect Storm" som Tasso sagde er et perfekt udtryk om vores nuværende situation synes jeg.
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