Anavex Ny tråd feb. 2023 - Nyt Parkinsonforsøg i Australien!
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De er lidt ligeglade med investorerne lige nu. De har præsenteret gode data for markedet/investorerne. Markedet ville så noget andet end, hvad logikken sagde.
Biotech er bl.a. videnskabsfolk og de vil gerne breake nyhederne på konferencer med stor bevågenhed.
Gad vide om det som Mayomobile gætter på holder nemlig, at AAIC 2023, der afholdes i Amsterdam, er stedet hvor vi får hele datapakken fra AD forsøget ?
AAIC | July 12-15, 2026 | Alzheimer's Association
The Alzheimer's Association International Conference is the world's largest forum for the dementia research community. London, UK, and online.
AAIC | July 12-15, 2026 | Alzheimer's Association (aaic.alz.org)
Ser vi nu starten på det jeg venter mig mere af - stiginger.
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Det er vel ret vigtigt at nævne når vi snakker om Anavex og AAIC 2023.
Hvis jeg som ny i denne tråd læser det som du skriver i indlæg 112426, så fremgår det som om at Anavex deltager og at det blot er indholdet som mangler at blive offentliggjort.
Jeg er selv investeret i Anavex (og nok egentlig også for meget med 1100 stks ift min normale risikoprofil), men ønsker blot at formodninger ikke fremstår som realiteter herinde.
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Anavex Sammendrag fra webcast den 26. april 2023.
"Question: What do the promising results of ANAVEX
2-73 mean for potential Alzheimer's disease patients, and what are the criteria for selecting patients for the clinical trial?Answer: The clinical trials have shown that patients with significant Alzheimer's disease who received ANAVEX
2-73 actually reversed their cognitive impairment and improved their activities of daily living, rather than just slowing the decline. This is an exciting result that shows the potential for patients to change the course of their disease pathology."Missling holder stadig fast i, at nogle patienter faktisk blev bedre og ikke bare fik bremset udviklingen af Alzheimer!
Med tanke om, hvad han må have af viden om detaljerne fra AD fase 2/3 forsøget på dette tidspunkt, så er det noget af en påstand at komme med!
50 mg gruppen må have nogle superresponder der har bekræftet dette - ellers står Missling til en alvorlig anklage om vildledning! -
Novo Nordisk ' Anavex ' Eli Lilly ' Biogen ' Brain+
Helge Larsen kigger bl.a. på regnskab fra Novo Nordisk og på Anavex og udviklingen inden for medicin mod alzheimers og demens.
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Det rigtigt men i indlæg 112440 skrives der jo netop, at det ikke vides endnu...
Men vi jo også kendte for mange lange tråde
Håber seriøst der snart kommer skred i tingene, ellers ender vi med at bliver overhalet indenom, som trådstarter også skriver
-Anavex udvalgt blandt 100vis af stoffer/kandidater-God lang weekend til jer alle
Mvh
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Det er da først efter at jeg spørger, at det bliver kommenteret at det endnu ikke vides. Det er derfor at jeg beder om at det bliver udpenslet til en anden gang. Jeg er givet vel farvet af at have læst indlæg på Ihub, Twitter, Facebook og her hvor det flere steder fremgår som stensikkert at Anavex deltager med et indlæg.
Jeg frygter at snakken om AAIC blot er et håb som ikke materialiserer sig, men vi får at se. Det viser endnu engang hvor ringe Anavex IR er.
I lige måde
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Igår udkom der en ny artikel hos Seeking Alpha fra Lane Simonian som kan anbefales at læse.
Lad os håbe at han har ret i følgende.
Anavex has stated that its phase 2b/3 clinical trial results complement and are consistent with its phase 2a trial results. For those who were not titrated down, the company most likely knows that the 50mg group (which largely corresponds to the high concentration group in the phase 2a trial) did better than the 30mg group in the phase 2b/3 trial. Why Anavex still has not provided data for both groups (after untangling the titration issue) remains a mystery. It could be that Anavex is concerned that the number of participants remaining in the 50mg after dropouts and down titrations is not large enough to gain full approval from the Food and Drug Administration (FDA). The FDA could still grant accelerated approval allowing for the sale of blarcamesine while requiring a larger (and perhaps more lengthy trial) to firmly determine efficacy and safety. Anavex may also approach other regulatory agencies in Australia and Europe, for example, before or while engaging with the FDA in hopes of earlier approvals there.
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Sund livsstil og sygdomsbekæmpelse er big business - men er det også værd at investere i? Bodil Johanne Gantzel spørger de to erfarne investorer, Lau Svenssen og Helge Larsen, der i studiet stiller op til debat om både den aktuelle markedsstemning og mulige interessante investeringer på lidt længere sigt.
Du kan i dagens afsnit høre mere om blandt andre Bakkafrost, Mowi, Grieg seafood. Nordic Halibut, Anavex, Genmab, Brain+, INSW, Norden, Pfizer, Novo Nordisk, Siemens Energy, Mercedes Benz Group, Ambu, Mærsk og Biogen.Podcast: https://www.euroinvestor.dk/podcast/millionaerklubben-der-er-penge-i-sundhed
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Tak Helge for omtalen af Anavex, selv om du selvfølgelig skulle advare omkring early stage virksomhed og US biotech generelt.
Lytter man til direktøren i Anavex, så bliver han mere og mere selvsikker. Han utrykker sig bl.a. om, at firmaet nu er parat til at være kommerciel.
På kommende gf bliver ny formand for den nyetablerede bestyrelse kørt på plads.
Spændende profil:
https://stocktwits.com/Trainguy1/message/526623559Den kommende frigivelse af 50 mg gruppen i AD fase 2b/3 tror jeg bliver signalet til shorternes overgivelse og gerne massakre.
AAIC medio Juli en mulig begivenhed eller evt. noget i forbindelse med regnskabet i morgen.
Vi kommer tættere på hver dag
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Anavex Q2 rapport.
Har 153,5 mill. $ på bogen pr. 30. marts 2023 (øget fra 149,2 mill. $) - stadig ingen gæld!
Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results
Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study; allowing initiation of discussions with regulatory agencies for Accelerated Approval Pathway for ANAVEX®2-73 (blarcamesine) in Alzheimer’s disease with convenient oral treatment On track to
Stock Titan (www.stocktitan.net)
Positiv webcast, dog uden nogen kritiske spørgsmål.
Igen ingen angivelser af tidpunkter for de forskellige milepæle.Missling bekræfter, at man på baggrund af at andre selskaber har opnået acc. godkendelser på baggrund af biomarkører i Alzheimer, så agter Anavex at gå samme vej med de sidste nye positive resultater.
Får Anavex en acc. godkendelse, så kan man få 2-73 på markedet mens man udfører et P4 kontrolforsøg.Så alt tegner positivt - men Anavex er nok begrænset af at kunne uddybe tingene, indtil de komplette AD data offentliggøres i en Peer Review.
Tålmodighed endnu en gang!
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Anavex 10 Q rapport for Q2 - 2023.
Solgte aktier under Lincoln Park aftalen:
2.075.000 aktier til kurs 8,75 $.
Forsætter den fornuftige strategi med at have ca. 150 mill. $ på bogen - giver handlefrihed til udvikling, produktion og til at få produkterne på markedet, uden at være afhængig af BP mm.
Hele 131 mill. $ må der om nødvendig endnu hentes i aftalen - burde være tilstrækkelig indtil vi forhåbentlig snart får indtægter fra evt. salg af 2-73.
Fratrækkes beholdningen, så er hele Anavex`s Pipeline værdiansat til 570 mill. $ - til sammenligning øgede LLY deres MC med hele 22 milliarder $ på deres fase 3 data i AD, hvor 31 % skal forvente hjerneblødninger ved en moderat forbedring af AD symptomer?During the six months ended March 31, 2023, the Company issued to Lincoln Park an aggregate of 2,159,080 (2022: 0) shares of common stock under the 2023 Purchase Agreement, including 2,075,000 (2022: 0) shares of common stock for an aggregate purchase price of $18,152,500 (2022: $0) and 9,080 (2022: 0) commitment shares.
At March 31, 2023, an amount of $131,847,500 (September 30, 2022: $0) remained available under the 2023 Purchase Agreement.
Eneste deltagende analytiker Jones Trading hævede deres kursmål fra 54 $ til 58 $.
https://www.tipranks.com/stocks/avxl/forecast -
Kopieret fra et indlæg på Ihub:
Tom Bishop talked to Anavex post CC. Here are his comments.
Anavex's (AVXL $9.20, +9%) (... and wow, Aris is up 25% this morning, I'll hit that next!) quarterly release and conference call was this morning. And after speaking with the Company and clarifying a few issues, there were some exciting revelations. First and foremost, the Company now believes, after 5 months of evaluating the data, that the data from the resent Phase 2b/3 Alzheimer's trial, and especially the data from the improvement in surrogate biomarkers that are associated with the pathology of Alzheimer's are strong enough that it intends to apply to the FDA for approval of A2-73 based on the "Accelerated Approval Pathway." Now this doesn't just mean the process moves along more quickly while it now does a full phase 3 trial. This means conditional approval for commercial sale of A2-73 based on the data already collected from the Phase 2b/3 trial, especially that based on improvement in the various Alzheimer's disease pathology biomarkers, along with the cognitive and other improvements in functional data itself. And then a confirmatory study would be done while the drug is already approved. Recent Alzheimer's drug approvals (Biogen and Lilly) have all utilized this pathway and evidence of improvement of various biomarkers for Alzheimer's disease. So this is rather exciting as there is a reasonable chance now that the Company could get approval relatively soon without waiting to first conduct a full blown Phase 3 trial. No guarantees on this, but very encouraging re the potential time line to market acceleration. Here is something more on this pathway-"The pathway specifically allows FDA to approve drugs based on a determination that the product has an effect on certain surrogate endpoints or intermediate clinical endpoints. Surrogate or intermediate endpoint can be based on a laboratory measurement (like blood glucose level for diabetes), radiographic image (like tumor size reduction), physical sign (like blood pressure for cardiovascular disease) or other measure. For instance, reduction of viral load in HIV patients, reduced tumor size in cancer patients or alleviation of symptoms can all be used to show a treatment's benefit to patients. Congress has clarified, through statute, that the accelerated approval pathway does not alter the standards of evidence required for approval.
After a medicine is granted accelerated approval, companies are required to conduct, and provide updates on, confirmatory trials and the FDA is required to make this information publicly available.
Companies are required to conduct confirmatory studies of medicines granted accelerated approval and are subject to reporting requirements on the status of these studies. The FDA is required to track, and make publicly available, progress of confirmatory trials."Remember that the safety data is much better than those Alzheimer's drugs recently approved that can cause brain swelling/bleeding (maybe even death) and the need for periodic/expensive MRI's to monitor this. AND A2-73 is an oral formulation not infusion therapy. So all things being equal, what are you gonna take?
Now the other cool thing here is, as announced in a press release last week, the Company has filed for a patent covering A2-73's use to lower high blood pressure. As you might expect, when patients came in for periodic trial evaluations, they got their blood pressure taken. And the Company noticed that those coming in with high blood pressure saw that drop back into the normal range! So while the Company is a ways off from pursuing this indication on its own, if it can claim this side benefit, in addition to the Alzheimer's benefits above ... like I said, which one are you gonna choose? Duh. (I also recall some potential benefits regarding improved sleep, I hope we get data on that also.) It's like how they have discovered lately that some of the diabetes drugs (Eli Lilly's in particular)) cause significant weight loss! So now these diabetes drugs are in short supply because other people are taking them just for weight loss. So A2-73, if approved, could then potentially be prescribed off label for blood pressure, or at least more likely advertised as a side benefit. The blood pressure data has not been disclosed but perhaps will be in the full release in a medical journal that will cover all the things we have been waiting for (30 vs. 50 mg, ADL and COG, sigma1 normal gene vs. the variant, all the other biomarker data ... ).
Elsewhere, I believe they are at last getting very close to announcing the Phase 3 Parkinson's disease trial initiation, in addition to the full A2-73 data release, plus in H2 the Rett Pediatric data. While this seems to move very slowly the Company is meticulous in its approach, avoiding the pitfalls so many companies fall into with their failed clinical trials and I would remind everybody once again that they have never failed one of their clinical trials. They have all been successful in showing efficacy, and that consistency itself tells you something. Small wonder Dr. Missling reiterated in closing that "... looking forward we're very excited about the Company's potential as well as to build the bio-marker driven precision medicine studies..."
There was more meat on the bone than today's stock market reaction gives credit for (it was down in the pre-market but I see as I finish this that it is now up 8%, still ... plenty of room ahead)- Buy. -
God morgen fra Thailand.
Her er mere fra Tom Bishop:
(05/17/22) Anavex: Drug Pipeline Progress
Anavex (AVXL) released its Q1 results and went through the list of projects currently in the pipeline, reports Tom Bishop, small cap expert and editor of BI Research.
(05/17/22) Anavex: Drug Pipeline Progress (www.moneyshow.com)
Han er positiv og det er jeg også.
Vi kommer langsomt tættere på en godkendelse og jeg er overbevist om at den kommer, måske RETT først?
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Ja helt enig Fandel er dog lidt i tvivl om hvordan de vil prissaette 2-73 i de sjældne sygdomme hvis de er godkendt for AD og de som et eksempel tager 12.000$ om året for en daglig pille? Missling har nogle meget høje tal for RETT behandling, var det ikke 140.000 eller 170.000$ om året? Det kan han nok ikke forlange hvis AD er godkendt og meget billigere for behandling.
Her er en ret interessant artikel med navnet: Targeting Sigma Receptors for the Treatment of Neurodegenerative and Neurodevelopmental Disorders
Anavex's 2-73 og 3-71 er nævnt ret prominent.
https://link.springer.com/article/10.1007/s40263-023-01007-6#Sec13
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