Anavex Ny tråd feb. 2023 - Nyt Parkinsonforsøg i Australien!
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Jeg solgte mit indehav i Axsome for at positionere mig i Anavex, da jeg ikke forventede at den ville bevæge sig meget mere efter FDA godkendelsen af Auvelity sidste år. Desværre (for mig) er den steget lidt yderligere, men man skal huske på at forløbet for Axsome var ret rodet da FDA oprindeligt ikke kunne give en godkendelse i 21. Spørgsmålet er om dette har en indvirkning på deres udtalelse.
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Lilly's Solanezumab Fails In Alzheimer's Prevention Trial
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Artikel i Seeking Alpha med titlen:
Anavex: Many Questions Answered, A Few Still Left, But Things Are Progressing Well.
Skrevet af nogle der kalder sig Avisol Capital Partners, en tidligere dyrlæge og en kræft læge (mennesker) og bliver fulgt af over 16.000 personer.
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Anavex
Spænende kursudvikling fra start i dag. Længe siden vi ikke er startet med en masse salg.
Anavex Life Sciences Appoints Former FDA Lead Neurology Statistician as Vice President Head of Biostatistics
NEW YORK, March 09, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the appointment of Kun Jin, Ph.D., as Vice President, Head of Biostatistics. Dr. Jin will draw on h
Yahoo Finance (finance.yahoo.com)
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Anavex Langt om længe en bekræftelse af ansættelsen af den nu 3. tidligere FDA ansat - Jin med 27 års hos FDA.
Lige en hilsen fra de norske pister.
"I'm honored to be joining Anavex and I am very much looking forward to helping guide the Company to secure access to better healthcare outcomes for families around the world," said Dr. Jin. "There is such a significant unmet medical need around the globe caused by Alzheimer's disease, Parkinson's disease, and neurodevelopmental diseases like Rett syndrome and Fragile X syndrome. Anavex has a cutting-edge technology that can make a great deal of difference to those patients. I believe I can make a substantial contribution at this very important time in the Company's transition towards commercialization."
Mere end 14 dage efter den seriøse investor fik kendskab til ansættelsen, fik Anavex taget sig sammen til at indvie resten af markedet med denne væsentlige tilgang - nu mangler de så bare lige også at fortælle om at 2-73 er særligt udvalgt i Australien til et nyt og delvis sponsoreret fase 3 forsøg i Parkinson!
- Nuvel, så tror Dr. Jin han kan bidrage til, at 2-73 kan komme på markedet og gøre en stor forskel for mange typer CNS patienter - som tidligere nævnt, havde Dr. Jin sikkert kunne få en langt større løncheck, hvis han havde valgt en BP fremfor lille Anavex!
Lilly: 1100 patienter, 4 1/2 år og millioner af $ spildt på endnu et ubrugeligt fedtfjernelsesforsøg!
SAVA: Endnu et "indsider" opkøb, der puster kunstig liv i aktien.
BIVI: Mit efterhånden store frimærke i AD viser positive takter, men er stadig flere år efter vores kære Anavex.Ser mest frem til PDD OLE på den korte bane.
Ellers er tålmodighed bare forsat påkrævet!
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Jeg læser det mere som en forfremmelse.
Han blev ansat 1. januar og nu forfremmet eller fået en titel.
Mon ikke han de sidste to måneder har vist sit værd mht analyse af ad-studiet. Han vil sikkert også fremstå som medforfatter til den peer review artikel vi venter på.
Anavex kender data nu og ville ikke sende denne pr, hvis det hele var noget skidt.
Hvis citatet i meddelelsen skal tages for gode vare, er vi på rette vej: Anavex has a cutting-edge technology that can make a great deal of difference to those patients. I believe I can make a substantial contribution at this very important time in the Company's transition towards commercialization.
Og som sædvanlig holdes aktien i et jerngreb.
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Anavex Ja dr. Jin har sikkert i den sidste tid haft mulighed for at se potentialet i 2-73 - og er ikke løbet skrigene væk efterfølgende.
Havde et andet, ikke i den grad shortet biotekselskab som Anavex, kunne præsenterer en tidligere højprofileret FDA ansat, så havde vi nok set en mere fair og retvisende afspejling i kursen!
De 22,6 % shortandele holder presset, så længe omsætningen/interessen for aktien ikke er større. -
Noget for at dulme nerverne:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171417357 -
Vi har Scilicon Valley Bank i US.... Ikke som LMB som startet finanskrisen i 2008 men nogle mener at som 16 største bank i US kan det kommer store skvulp på de finansielle markeder, efter de nu er blevet lukket, og der derfor er helt slukket, lad os håber de var nogle onde shorter
Mvh
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Anavex Bekræftelse - ingen penge i SVB!!
FORM 8-K pr 10. marts 2023:
Anavex Life Sciences Corp., a Nevada Corporation (the "Company") confirms that it does not hold any deposits or securities or maintain any accounts at Silicon Valley Bank.
8-K Material Event Mon Mar 13 2023
Anavex Life Sciences Corp. (AVXL) SEC Filing 8-K Material Event for the period ending Friday, March 10, 2023
Last10K.com (last10k.com)
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Tasso1 Godt at vide...
Nu var mit indlæg mere omkring aktiemarket generelt, lad det ikke blive en dominoeffekt ! mon ikke nogle bliver ramt et eller andet sted i kæderne, så må man håber det kan inddæmmes til de få...Når man tænker tilbage på corona-start og frem til nu, så er det nogle kedelige år vi har være vidne til krig Corona inflation prisstigninger, og nu har vi så måske Kina som også kan være med til endnu mere geopolitisk uro.
Det gode nyhed er, at vi ved alle, at på den anden siden af det hele, bliver det hele godt igen
Mvh
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Anavex Endnu en positiv artikel fra Motley Fool!
Wall Street Thinks This Small-Cap Stock Can Quadruple in Value
"it's hard not to understate the significance of Anavex 2-73 and what it could mean for the business. Approval of the treatment would not only give the company a source of revenue for years to come, but it could potentially make Anavex an appealing acquisition target"
The consensus analyst price target for Anavex is $41.80.
Wall Street Thinks This Small-Cap Stock Can Quadruple in Value
Small-cap stocks with promising growth prospects can have substantial upside. But they often come with risks, as their modest valuations also suggest that they are relatively unproven businesses.
(www.nasdaq.com)
Hurtigt overblik for den nye investor!
Anavex står nu til at have 38 ansatte og 5 nye jobopslag.
De styrker sig forsat på alle områder og ligner ikke nogen, som tvivler på at deres videnskab får succes i sidste ende.
Men der er godt nok stille omkring status på de forskellige processer - så indtil da minimal omsætning og en kurs, der stort set bare følger resten af markedet.
Sendte en mail om de ville kommenterer på det nye Parkinson forsøg i Australien - men som ofte Inge tilbagemelding - der må dog komme en PR, når forsøget påbegyndes.Tålmodighed tålmodighed!
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Anavex Positiv Seeking Alpha artikel.
Buy Anavex For Its Likely Positive Alzheimer's Disease Data
SummaryThe ANAVEX2-73-AD-004 trial was mostly positive.
A reputable journal article on the missing data would allay fears of a 'spin'.
If the company's lead drug candidate did slow functional decline due to AD compared to the placebo, FDA approval is almost assured.Fuld tekst - hvis linket skulle fejle!
Buy Anavex For Its Likely Positive Alzheimer's Disease Data
SummaryThe ANAVEX2-73-AD-004 trial was mostly positive.
A reputable journal article on the missing data would allay fears of a 'spin'.
If the company's lead drug candidate did slow functional decline due to AD compared to the placebo, FDA approval is almost assured.Anavex Life Sciences Corp. (NASDAQ:AVXL) is a small (~$700 million market cap) clinical-stage biopharmaceutical company developing treatments for Alzheimer's disease ("AD"), Parkinson's disease ("PD"), Rett syndrome and other central nervous system diseases (Figure 1). In its February 7 quarterly report, Anavex listed the following key near term pipeline data updates:
AD: Full data ANAVEX2-73-AD-004: Potentially pivotal Phase 2b/3 clinical trial
PD dementia: Data of 48-week open label extension ("OLE") Phase 2 study
Publications: Several clinical publications involving blarcamesine, ANAVEX3-71 and Rett syndrome Burden of Illness study
Investors should be familiar with these catalyst events to build a complete picture of the two core programs and make informed decisions in the near-term (within 1-3 months).Figure 1. Anavex Therapeutic Candidates
Anavex Therapeutic Candidates
Anavex Corporate PresentationDuring December's Clinical Trials on Alzheimer's Disease (CTAD) Congress 2022, Anavex announced positive topline results from its Phase 2b/3 ANAVEX2-73-AD-004 trial of oral blarcamesine for the treatment of mild cognitive impairment and mild AD (collectively known as early AD). The company claimed that blarcamesine "met" the primary endpoints ("PEP") AD Assessment Scale-Cognitive subscale (ADAS-Cog) and AD Cooperative Study-Activities of Daily Living Scale (ADCS-ADL), as well as key secondary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB). 'Met' typically means the results were statistically significant. A lot of information was shared (Table 1), yet actual results for ADCS-ADL were not.
Table 1. ANAVEX2-73-AD-004 Top Line Data
Placebo
Blarcamesine
Baseline Characteristics (Full Analysis Set),
mean (standard deviation)
170
338
Mini-Mental State Examination Score
23.11 (2.69)
23.57 (2.92)
ADAS-Cog
30.25 (8.93)
28.75 (8.67)
ADCS-ADL
66.48 (7.08)
66.72 (7.59)
CDR-SB
4.10 (1.76)
3.81 (1.73)
Intent-to-Treat ("ITT") Population,
mean (standard error)
ADAS-Cog, baseline
29.18 (0.61)
27.62 (0.5)
ADAS-Cog, Week 48
33.26 (0.98)
30.36 (0.83)
CDR-SB, baseline
4.11 (0.14)
3.78 (0.1)
CDR-SB, Week 48
5.61 (0.26)
4.89 (0.17)
Safety Population
161
301
Any treatment emergent adverse events (TEAE), n (%)
113 (70.2)
248 (82.4)
Serious TEAE, n (%)
15 (9.3)
47 (15.6)
Adverse Events ≥7.5%
Dizziness
9 (5.6)
76 (25.2)
Confusional State
4 (2.5)
40 (13.3)
Fall
16 (9.9)
21 (7.0)
Click to enlarge
After 48 weeks among randomized patients (the ITT population), blarcamesine significantly reduced cognitive decline compared to placebo as measured with ADAS-Cog by 45%; the treatment difference in mean score change of -1.85 points (p=0.033). Mean baseline scores for patients who took blarcamesine were 27.62, which worsened to 30.36 after 48 weeks of treatment, or an increase of 2.26 points, a correctly calculated figure according to Chief Executive Officer Christopher Missling. Blarcamesine also slowed decline of cognition and function assessed by the CDR-SB compared to placebo (-1.11 vs 1.52), a treatment difference of -0.42 points (p=0.040), representing 27% reduction.Non-head-to-head trials aren't really comparable. That said, blarcamesine's ADAS-Cog scores appear in line (Table 2) with Biogen's (BIIB) Aduhelm and Leqembi (co-commercialed with Eisai (OTCPK:ESALY)), which received marketing authorization, and Eli Lilly and Company's (LLY) donanemab, which could've but was rejected on a technicality. However, blarcamesine can't be approved on the basis of ADAS-Cog alone, because according to the FDA's guidance document on AD, "An integrated scale that adequately and meaningfully assesses both daily function and cognitive effects in early AD patients is acceptable as a single primary efficacy outcome measure." ADAS-Cog only measures cognitive effects, not function.
Table 2. ADAS-Cog Endpoints in AD Trials of Approved and Approvable Drugs
Study
Approved dose
Study duration
n
Placebo
Difference
% Difference
p
EMERGE
Aduhelm 10 mg/kg every four weeks
78 weeks
547
5.16
-1.40
-27%
0.01
ENGAGE
Aduhelm 10 mg/kg every four weeks
78 weeks
555
5.14
-0.59
-11%
0.258
TRAILBLAZER-ALZ
donanemab
52 weeks
93
2.37
-0.84
-35%
donanemab
76 weeks
93
4.77
-1.86
-39%
lecanemab 201
Leqembi 10 mg/kg biweekly
79 weeks
398
4.90
-2.31
-47%
0.017
Clarity AD
Leqembi 10 mg/kg biweekly
18 months
859
5.58
-1.44
-26%
<0.001
Click to enlarge
CDR-SB is an acceptable PEP. Indeed, Aduhelm and Leqembi were controversially approved on the strength of their statistically significant 22% and 27% reduced declines, which were comparable to blarcamesine (Table 3). As discussed in the preceding article, investors should note that the absolute score differences compared to placebo demonstrated by Aduhelm, Leqembi, and blarcamesine on the CDR-SB scale that ranges from 0 to 18 were 0.39, 0.45 and 0.42 points, respectively, which cannot be detected by clinicians. These lackluster results led the Centers for Medicare and Medicaid Services ("CMS") to implement a National Coverage Determination (NCD) denying coverage of Aduhelm and future monoclonal antibodies targeted against amyloid (including donanemab), outside of clinical trials. CMS upheld its decision after Leqembi's approval under the rationale that "to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary [emphasis supplied]. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective." As Sigma-1 receptor agonist and muscarinic receptor modulator, blarcamesine is exempt from the NCD, for now. Nevertheless, the small molecule can't be approved for its CDR-SB performance either, since it was only a secondary endpoint in ANAVEX2-73-AD-004.Table 3. CDR-SB Endpoints in AD Trials of Approved and Approvable Drugs
Study
Approved dose
Study duration
n
Placebo
Difference
% Difference
p
EMERGE
Aduhelm 10 mg/kg every four weeks
78 weeks
547
1.74
-0.39
-22%
0.012
ENGAGE
Aduhelm 10 mg/kg every four weeks
78 weeks
555
1.56
-0.03
-2%
0.833
TRAILBLAZER-ALZ
donanemab
52 weeks
93
1.21
-0.59
-49%
donanemab
76 weeks
93
1.58
-0.36
-23%
lecanemab 201
Leqembi 10 mg/kg biweekly
79 weeks
398
1.50
-0.40
-26%
0.125
Clarity AD
Leqembi 10 mg/kg biweekly
18 months
859
1.66
-0.45
-27%
<0.001
Click to enlarge
Financials and Takeaways
Anavex has one of the stronger cash positions among biotechs at $143.6 million with no debt. The latest quarterly burn was $13 million, comprising general and administrative expenses of $3.3 million and larger research and development expenses of $12.1 million, slightly offset by grants and tax incentive credits. Even if the company does initiate 4 clinical trials as planned, their funds should be sufficient for at least 12 months as forecast. Therefore, any price near-term movement will be mainly due to clinical developments. An article on the Phase 1 study of ANAVEX 3-71 in healthy volunteers probably won't move the needle at this time, but a confirmation from the OLE of the Phase 2 which demonstrated proof-of-concept in PD dementia could, depending on endpoints presented. But really, the company's future boils down to one critical catalyst.Publication in a peer-reviewed journal of the full ANAVEX2-73-AD-004 data is much awaited in the AD world. To say that ADCS-ADL is crucial is an understatement. A trial with two PEPs needs statistical significance on both to be positive, so anything short of p<0.05 in the ITT population would demote the trial from "pivotal" to "supporting". A dose-dependent reaction would be nice but not necessary. Aside from this co-PEP uncertainty, any not yet reported serious safety issue is another risk. Overall, it is more likely than not that ADCS-ADL is indeed positive and not fudged by management, making Anavex a Buy. Traders looking to hedge should probably look further ahead in the option chain to at least July 21 at the earliest and straddle the most popular $10 strike. Prices are unlikely to stay at that level no matter which direction the data flows.
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