ANAVEX NY TRÅD 2022 - positive resultater for 3-71!!!
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AVATAR Report Updated to Include Webcast Notes
Honestly, after finally hearing the webcast, I'm not sure how there is any controversy regarding Anavex's late-notice 'endpoint switch'.
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Anavex. Affejning af Adam F false and untrue!!!
Anavex Life Sciences | Advancing Therapies for Alzheimer’s and Parkinson's Disease
Anavex Life Sciences (Nasdaq: AVXL) is a biopharmaceutical leader advancing targeted CNS therapies through innovative therapeutic discovery and development.
Anavex Life Sciences (www.anavex.com)
IN RESPONSE TO PUBLIC COMMENTS AND FOR CLARIFICATION:
The statements made by Adam Feuerstein from STAT News are false and untrue -
Anavex. Seeking Alpha - købs mulighed!!
Anavex: Misunderstood Data And Possible Positive FDA Meeting Can Lead To Great Trade Opportunity
Conclusion
Despite the risk laid out above, I feel that Anavex Life Sciences is a good long-term biotech to own. That's because it achieved statistical significance in the phase 3 AVATAR study in adult females with Rett Syndrome. Again, the worst-case scenario is that the FDA requires another study which may delay approval for a year or two. However, I don't believe this is a high probability based on the trial meeting all the endpoints of the study, along with an excellent safety profile for Anavex 2-73. There are so many other indications for Anavex 2-73 as well, which provides additional shots on goal. Not only that, but I also stated that they have 3 other drugs in the pipeline being developed which are: Anavex 3-71, Anavex 1-41 and Anavex 1066. I believe that the data was misunderstood, which led to a lower share price upon initial reaction. However, I provided proof on why the data highlighted above leads me to believe that the FDA will likely allow for an approval pathway for Anavex 2-73 for the treatment of adult females with Rett Syndrome.
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Anavex: Misunderstood Data And Possible Positive FDA Meeting Can Lead To Great Trade Opportunity
Feb. 01, 2022 11:37 PM ETAnavex Life Sciences Corp. (AVXL)2 Comments3 Likes
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Terry Chrisomalis
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SummaryPositive results reported from the phase 3 AVATAR study using Anavex 2-73 for the treatment of adult females with Rett Syndrome; Primary endpoint of RSBQ AUC met with statistical significance.
Positive results from phase 3 AVATAR study, along with prior positive results from phase 2, being taken to FDA to discuss potential approval pathway for patients with Rett Syndrome.
Results from the phase 3 study, using Anavex 2-73 for the treatment of patients with Alzheimer's Disease are expected 2nd half of 2022.
The global Alzheimer's market is expected to reach $25 billion by 2027.
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ipopba/iStock via Getty ImagesAnavex Life Sciences (AVXL) just posted positive top-line results from its phase 3 study known as AVATAR. This was a late-stage study using Anavex 2-73 for the treatment of adult females with Rett Syndrome. The primary endpoint of the study was met when compared to placebo. Not only that, but all secondary endpoints were met. Despite this solid clinical data, the stock traded lower when the news was announced. With the stock trading lower, this creates a great buying opportunity. Why? It is because the company is going to meet with the FDA and discuss data it obtained from a prior phase 2 study and this phase 3 AVATAR study. The reason to do this would be to determine a possible approval pathway. Whether or not the FDA agrees on an approval pathway remains up in the air, but the data released by Anavex speaks for itself. The bottom-line is that the primary endpoint was met. What also will come to consideration is that there are no FDA approved drugs for Rett Syndrome. At worst, which may or may not happen, is that the FDA may want another study. On the other hand, if the FDA agrees that the data is solid enough to warrant approval, then Anavex will be able to file for regulatory approval. This is only one indication in the pipeline as well. It is using Anavex-273 for the treatment of patients with Alzheimer's Disease (AD) and Parkinson's Disease (PD). The point here is that these other shots on goal are large market indications.
A Much Needed Treatment For Those With No Alternatives
Anavex announced positive results from its phase 3 AVATAR study using Anavex 2-73 (Blarcamesine) for the treatment of adult females with Rett Syndrome. Rett Syndrome is a rare genetic mutation that affects brain development in girls. It is quite to notice it at first, because it is not observed in the first few months. Once it does come into play, those who have this rare disease experience:
Loss of motor skills over time
Loss of speech
Loss of muscle movement
What's bad is that in the first 6 to 18 months, everything is fine with brain development in girls and then all of a sudden they lose all those 3 abilities I noted above. How can this be? Another item to note is that it mainly occurs as a result of a de-novo mutation of the MeCP2, CDKL5, and FOXG1 genes. De-novo meaning that the mutated gene is not inherited, but occurs spontaneously. Boys can possibly get Rett Syndrome, but it is very rare. More than likely clinical studies focus on recruiting girls with Rett Syndrome, because it is more prevalent for them to have it. MeCP2 is the gene to focus on for these patients, because it is needed for brain development. As such, those with Rett Syndrome have this gene mutated and it eliminates the potential for the brain to function properly.The positive results from the phase 3 AVATAR study offer hope to these patients who desperately need a treatment. This late-stage study recruited a total of 33 adult female patients with Rett Syndrome. All of them were positive for the MeCP2 gene which when mutated causes brain development problems. The trial met the primary endpoint and all secondary endpoints as well. The primary endpoint of the study, which was RSBQ AUC, was met with statistical significance. What is "RSBQ" and why is it important for this patient population? RSBQ stands for "Rett Syndrome Behaviour Questionnaire". It is done by a caregiver of the patient in which neurobehavioral symptoms observed in these patients are rated based on a scale. The total possible points represent the sum of the 45 items with a maximum score of 90 points. Each item is scored on a Likert scale of "0" to "2" points, with 8 subscales measuring items like:
Breathing issues
Repetitive face movements
Hand behaviors
Body Rocking and expressionless face
General Mood
Night-time behaviors
Fear/Anxiety
Walking/Standing
The final outcome was that adult female patients given Anavex 2-73 achieved a statistically significant improvement in RSBQ AUC of 72.2% compared to those on placebo with only a 38.5% improvement. This improvement, noted with statistical significance was achieved with a p-value of p=0.037. The secondary endpoints themselves of "ADAMS" behavior symptoms score and CGI-I response were also statistically significant as well. The drug was also tolerable and safe. Treatment emergent adverse events (TAES) were similar across those who took Anavex 2-73 and those who took placebo.The thing is that these results are solid. Not only was treatment safe/tolerable, but all endpoints of the study were met. With a Rett Syndrome population that has no treatment alternatives, I believe that an upcoming meeting with the FDA should go quite well. Current treatment options only try to treat the individual symptoms themselves. For example, patients:
Taking medications for sleep issues, breathing issues and tight muscles
Physical therapy for joint and walking issues
Speech therapy for learning non-verbal communication
Support services for job training/learning
If a daily oral liquid of Anavex 2-73 can help these patients improve on all these measures, then I don't see why the FDA wouldn't want to help advance this forward. Anavex is expected to meet with the FDA to discuss this clinical data and, based on what I see, I believe there is a good chance that the FDA will allow an approval pathway forward. As a worst-case scenario, the FDA may request one additional study if it feels that the data is not enough. But in my opinion, it wouldn't matter, because it can be seen that Anavex's drug works in treating these patients.Additional Shots On Goal With Multiple Candidates To Reduce Risk
I believe based on safety/efficacy data noted above, there is an approval pathway for Rett Syndrome for FDA approval eventually. However, Anavex 2-73 has other possible opportunities in other indications as well. It is being used to treat patients with Alzheimer's Disease and Parkinson's Disease. The Alzheimer's Disease indication is being explored in a phase 3 study, while the Parkinson's Disease study completed two phase 2 studies. The global Alzheimer's market is expected to reach $25 billion by 2027. The only major risk with this indication is that it is a huge gamble. That's because about 99% of Alzheimer's clinical trials fail. On the other hand, I believe that Anavex 2-73 may do better for patients with Parkinson's Disease (PD). It is expected that results from the phase 3 study, using Anavex 2-73 for the treatment of patients with AD, will be released by the 2nd half of 2022. This sets up another huge catalyst for the stock as well, besides the FDA meeting for the Rett Syndrome data. With respect the Parkinson's Disease program, two phase 2 studies have been completed as noted directly above. Anavex will submit this data to the FDA to seek regulatory guidance. If the FDA feels that the data is good enough to advance another study, it may give a green light for a phase 3 study for patients with PD. Anavex 2-73 is also being advanced in another phase 3 study treating patients with Fragile-X syndrome, along with two preclinical indications of Angelman's Syndrome and infantile spasms. This doesn't even include the other candidates in the pipeline, which are Anavex 3-71 (Neurodegenerative diseases), Anavex 1-41 (Neurodegenerative diseases/stroke/Depression) and Anavex 1066 (visceral pain/acute and neuropathic pain).
Financials
According to the 10-K SEC Filing, Anavex Life Sciences had cash of $152.1 million as of September 30, 2021. It only used $30.4 million of its cash to fund its operations for its fiscal year 2021. The increase in cash was driven by two different financing events. The first was an At-the-Market (ATM) agreement with Cantor Fitzgerald & Co. and SVB Leerink LLC as well. During Fiscal 2021, it sold 5,634,576 shares of common stock to generate net proceeds of $76.7 million. The other cash raise occurred on June 24, 2021, whereby Anavex sold 2,380,953 common shares of stock at a price of $21 per share. It raised $46.9 million in net proceeds from this offering. It believes that it has enough cash to fund its operations beyond 12 months of the filing of its 10-K financial statement. Of course, it likely won't wait to raise cash up to that point. If anything, I believe it may raise additional cash by mid-2022. With Alzheimer's data coming shortly thereafter in the 2nd half of 2022, it would be risky to wait to raise cash afterwards. Despite huge confidence for the Alzheimer's study, the rate of failure is huge at 99% for these types of studies.
Risks To Business
The first risk to make note of would be the use of Anavex 2-73 in patients with Rett Syndrome. I think the data is solid, which I have laid out above why this is the case. Therefore, I believe that the FDA may allow the company to have an approval pathway going forward for this program. What also may be possible is that it will need to see another study, so the upcoming FDA meeting does remain a risk with respect to this program. The second big risk would be the phase 3 trial readout of Anavex 2-73 for the treatment of patients with AD. This late-stage study is expected to have a data readout in the 2nd half of 2022. As I alluded to above, the failure rate is huge for Alzheimer's studies. Therefore, there is no guarantee that the primary endpoint will be met for this phase 3 study. Lastly, I predict a cash raise before the trial readout for the Alzheimer's study. I don't believe that it will gamble on the notion that it will succeed in the phase 3 AD study and then be able to raise cash afterwards. I think it will be done beforehand.
Conclusion
Despite the risk laid out above, I feel that Anavex Life Sciences is a good long-term biotech to own. That's because it achieved statistical significance in the phase 3 AVATAR study in adult females with Rett Syndrome. Again, the worst-case scenario is that the FDA requires another study which may delay approval for a year or two. However, I don't believe this is a high probability based on the trial meeting all the endpoints of the study, along with an excellent safety profile for Anavex 2-73. There are so many other indications for Anavex 2-73 as well, which provides additional shots on goal. Not only that, but I also stated that they have 3 other drugs in the pipeline being developed which are: Anavex 3-71, Anavex 1-41 and Anavex 1066. I believe that the data was misunderstood, which led to a lower share price upon initial reaction. However, I provided proof on why the data highlighted above leads me to believe that the FDA will likely allow for an approval pathway for Anavex 2-73 for the treatment of adult females with Rett Syndrome.
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Sikke en rodet dag i går, hvis Missling havde PR'et ændringerne da de blev lavet sidste år kunne vi sikkert have undgået det uretfærdige fald.
Han virker lettere verdensfjern og giver ikke mange PR's.Jeg håber at han vil stå skoleret foran bestyrelsen og at han har lært af fadæsen hvis han skal blive i firmaet ellers er det ud af vagten efter min mening.
Han gir CRO skylden hvilket er en lidt dårlig undskyldning.Han vil forhåbentlig give en PR i dag ved åbnings klokken så vi kan komme videre.
Ham der A. Frankenstein er totalt skruppelløs og er totalt ligeglad med det uetiske i det han gør, jeg håber at dårlig karma rammer ham hårdt en dag.
Gudskelov ar data gode, rigtig gode er det er det eneste der tæller i sideste ende.
Jeg håber at flere store finanshuse vil snart begynde at dække Anavex med en købs anbefaling på min 50$.
Det bliver rigtigt spændende hvad der sker med kursen i dag, op over 10% after market lover godt og jeg tror stærkt på at vi går godt op.
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Fiercebiotech.com indeholder en fin opsummering af mulige rationelle forklaringer i en på den reaktion vi så på offentliggørelsen af RETT dataene, se
https://www.fiercebiotech.com/biotech/anavex-touts-very-large-phase-3-win-for-rett-syndrome-drug-2-weeks-after-moving-study-s -
Hmmm..
Lidt over 80.000 handlet aktier i AH er ikke det vilde, men hvis data er som skrevet, så er der kun en vej..
Jeg handlet ind sidste uge, og forventer ikke at skulle supplere yderligere.Jeg afventer at der kommer klarhed over fadæsen i går
Nu har AVXL efterhånden været med i gamet længe nok, og burde har styr på hvordan fakta data og markedsudmeldinger skal præciseres korrekt, det er lidt til den amatøragtige side.Man har tidligere udtalt at aktionærer de er vigtige for selskabet, så burde man snart kunne forvente at deres pr-afdeling kan finde ud af at håndtere markedsinformation som profesionelle aktører.
information til market skal være præcis og forståeligt udmeldt, så alle os som ikke har den fornødne viden har fået det skåret ud i pap, vi skal ikke screene alle mulige sites for at finde hoved og hale i data og udmeldinger, så er det at folk selv begynder at drage deres egne konklusioner og gætteriet begynder.
Op på hesten igen/Anavex i en nøddeskal
Mvh
Torben
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Anavex Anavex price target raised to $42 from $39 at H.C. Wainwright!
Eller ca. 280 % over nuværende kurs på aktien!
Mon ikke der kommer flere udmeldinger fra analytikerne i løbet af dagen!Forventer også en helt klokkeklar PR fra Anavex her kl. 13.00 - med affejning af de løgnagtige påstande fra Adam F...! - ikke kun et par linjer på deres hjemmeside eller på twitter.
Egentlig burde Anavex sagsøge og stille ham til ansvar eller som minimum anmelde sagen til SEC.
Bortset fra den økonomiske skade, kan sådanne usande udtalelser gøre det sværere at få et produkt godkendt eller trække processen i langdrag, så nødlidende patienter forhindres eller må vente endnu længere på en effektiv behandling!Hvis flere har lyttet til ham, kan disse investorer have mistet mange penge.
Anavex faldt f.eks næsten 20 % en overgang, hvor den måske burde have været oppe med 50 % (eller 100 % svarende til ACAD stigning i MC)- dvs. en MC forringelse på 70 % eller ca. 700 mill. $ - denne regning burde sendes til Adam F..., samt en bandlysning fra alle aktieplatforme og 10 år i spjældet!- Dette var kun den milde version jeg havde i tankerne:)
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AF refererer jo blot til clinical trials, der korrekt nok fik ændret endpoints to uger før datafrigivelse. At manden nok ved bedre er en anden sag.
Tror faktisk ikke man kan komme efter ham.
Men man kan jo spørge sig selv hvordan så mange uvidende investorer hopper på den påstand ?
Anavex er selv delvis årsag i misseren og må gøre det bedre i fremtiden.
FDA bør jo om nogen vide bedre, hvorfor det ikke får betydning for godkendelsesprocessen.
Ro på og lad data sive ind hos profferne så kommer stigning i aktiekursen.
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Skal man sige noget positivt om dagen igår, så er det at vi fik det flush-out man typisk ser i en nedadgående trend som Anavex har været på i et par måneder. Det kunne tænkes at en god del nervøse, kortsigtede investorer solgte fra og vi forhåbentlig kan se fremad, og opad, herfra.
Jeg supplerede selv yderligere med en 20% andel i $10.60 i går.
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Jeg tror det bliver meget svært at komme efter Frankenstein, han sagde "måske" i hans Twitter og det er jo ikke ham der direkte banker kursen ned, men en reaktion på hans meddelelse. Hvordan kan det bevises?
Desværre ikke meget at gøre.
Der er nogle som styrer ham, der er mørke kræfter på spil tror jeg.
Han har vist nok arbejder for Kramer fra Mad Money.
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Anavex En ting er, at AF fordrejer ændringen af endpoints ( mod bedre viden, hvis han har fulgt bare lidt med i casen ) - noget andet er, at han udtaler, at forsøget derfor er slået fejl!
Denne konklusion kan han umuligt være kommet til 3 min. efter Anavex PR vedr. Avatar.
Dette er efter min mening bevist manipulation mod bedre viden.
Nu har han jo fået at vide, at det hele er på foranledning af FDA, så har skal han trække udtalelsen tilbage og beklage misforståelsen.
Dette er langt fra første gang AF laver disse numre - mere reglen end undtagelsen.Er dog helt enig i, at Anavex har forsømt løbende at holde os aktionærer og div. hjemmesider opdateret - dette kunne langt henne ad vejen, have forhindret unødige spekulationer og sårbarhed over for negative kræfter.
Forhåbentlig har Anavex og Missling lært noget fremadrettet!
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AF virker stadig som han mener det er en fejl. fra twitter;Translaton: $AVXL refuses to answer questions about why it changed the endpoints of its AVATAR clinical trial just weeks before disclosing results.
Company offers no evidentiary proof that FDA is aligned with the changes.
Onward!
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Håber virkelig at historien i går giver plads til eftertanke hos Missling og den øvrige ledelse i selskabet.
Det er vel egentlig fuldstændig uforståeligt at et møde med FDA, der resulterer i en ændring i et studie design IKKE udløser en pressemeddelelse og/eller anden form for markedskommunikation. Det er jo ikke en inferiør hændelse/afgørelse, hvilket ikke kun Feuerstein men også mere seriøse biotech journalister som fx. Annalee Amstroong, der skriver til Fierce Biotech, noterer.
Missling & co. kunne lære lidt af "bedste" hos ANVS
der viser hvordan det bør gøres, se
https://finance.yahoo.com/news/annovis-bio-announces-positive-fda-140000827.html -
Super spændende produkt, som firmaet er ved at udvikle, men aktien virker lidt som en skummel meme-stonk. Flyver ned på gode nyheder, fyldt med FUD på Twitter, der leder tankerne hen på måden folk snakker om kryptovalutaer. Og så en ledelse, der ikke engang kan finde ud af at kortslutte en simpel kommunikationsfejl. Ret vildt. Forstår godt, at folk ikke gider at være med. Virksomheder med gode produkter er kun så god som deres ledelse. Virker ret ærgerligt, da det de forsker i er nogle sygdomme, som mange ville have gavn af behandlingstilbud for. Men når den ikke engang stiger på hamrende god data, hvorfor er det så præcis, man skal være aktionær i det her?
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Enig...........
Hvis de data er korrekte, så det sgu vildt nok at ingen kan se lyset...
Det virker noget dystert mørk og særdeles underligt, at man ikke med det samme går på barrikaderne og fremlægger 100% valide fakta/data og hermed forsvare sit livsværk igennem mange år....Selv i et volatilt market som nu, ville korrekte data af denne kaliber give en større optur, og det er det der kan undre.
Nå jeg bliver dog stadigvæk hængende, også selv jeg stille og roligt begynder at miste interessen for Missling og Co.
Mvh
Torben
Som skrevet jeg skal ingen steder, men er bare lidt træt af anavex og deres historik.
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Anavex ... De er en trussel for mange store Pharma, hvorfor big money gerne vil lukke munden på dem.
Der er penge nok i kassen og poison pille på plads.
Har svært ved at se, at de ikke vinder på sigt.
De har svaret på AFs påstand med false and untrue. Ikke behov for yderligere dialog med den mand.
Man skal være opmærksom på, at der pludselig kan dukke en retssag op imod dem for fejlen på clinical trials. Endnu et kneb fra den sorte verden til at skræmme investorerne.
Anavex skulle begynde med at udlicencere Blarcamesine i Rett til et stort Pharma udenfor US så vil der komme tiltro til projektet.
Shorterne har måske så mange penge, at de kan holde kursen indtil AD resultaterne i håb om manglende succes her.
Tålmodighed.
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