Anavex Ny tråd december 2025

[Søren]

ACCESS-AD spændende hvad betydning det får i forhold til Anavex og EMA !!!

#alzheimer | ACCESS-AD

Earlier this week, we were delighted to announce the launch of ACCESS-AD 🚀 Today, we’re sharing a short video that explains what our Innovative Health Initiative (IHI) project is about, and why it matters. #Alzheimer’s disease care in Europe is changing. New disease-modifying therapies are becoming available, but many health systems still face long diagnostic delays, uneven access to testing, and limited capacity for treatment and follow-up. ➡️ ACCESS-AD brings together 30 academic, clinical, industry and patient partners from across Europe and beyond, to help turn scientific innovation into routine clinical practice. Our shared mission is to support earlier diagnosis, safer treatment, better monitoring and more equitable access to care, regardless of where people live. 📹 This video gives a brief overview of how ACCESS-AD will work across countries and healthcare settings to support patients, clinicians and health systems Thanks for watching and stay tuned for updates as ACCESS-AD gets underway - and a huge thank you to all our fantastic partners, funders and supporters! Amsterdam UMC - Alzheimer Center Amsterdam Siemens Healthineers King's College London Gates Ventures. Alzheimer Europe Anavex Life Sciences German Center for Neurodegenerative Diseases (DZNE) Eisai EMEA Centre for Research & Technology Hellas (CERTH) Fakultní nemocnice v Motole Fraunhofer-Gesellschaft Hospital Clínic de Barcelona Stavanger University Hospital InRAD – International, practice-based registry for Alzheimer's Disease and other dementias Karolinska Institutet LMU Klinikum München Muhdo Health NICE - National Institute for Health and Care Excellence neotiv Neurimmune AG Pohjois-Savon hyvinvointialue Positrigo Region Stockholm Nestlé University of Navarra Universitätsklinikum Erlangen UCL University of Leicester Innovative Health Initiative (IHI) European Commission EFPIA - European Federation of Pharmaceutical Industries and Associations EuropaBio - the European Association for Bioindustries COCIR MedTech Europe Vaccines Europe

LinkedIn (www.linkedin.com)

Søren

[Tasso1]

Anavex Bill Gates er gennem Gates Ventures involveret i ACCESS-AD programmet.
Bill Gates far havde Alzheimer og han har derfor en særlig personlig interesse i at investerer i og udvikle en bedre behandling mod Alzheimer.
Fra tidligere interview med Bill Gates omkring hans interesse og investeringer i Alzheimer-området fremgik det, at han dengang ikke havde kendskab til Anavex og Blarcamesine - dette burde han have mulighed for nu?

ChatGPT:

Ja - det er korrekt, at Bill Gates (direkte eller indirekte) er involveret som partner i det nye ACCESS-AD-konsortium, men han er ikke den primære sponsor eller finansierer projektet alene. Her er hvordan det hænger sammen:

ACCESS-AD er et stort europæisk forsknings- og implementeringskonsortium lanceret for at forbedre Alzheimer-diagnose og behandling i Europa. Projektet er:
co-ledet af Amsterdam UMC, Siemens Healthineers, King's College London og Gates Ventures - det er investerings- og innovationsselskabet knyttet til Bill Gates (tidligere Microsoft) og hans private filantropiske initiativer.
finansieret gennem Innovative Health Initiative (IHI), et EU-program, hvor den primære finansiering kommer fra EU og industripartnere som medicotekniske firmaer og forskningsinstitutioner - ikke direkte fra Gates selv.

Gates Ventures er en privat organisation associeret med Bill Gates' filantropiske arbejde og investeringsaktiviteter. At den er med som partner betyder:
Bill Gates' netværk og ressourcer indgår i partnerskabet, men
projektet er ikke finansieret af Bill Gates personligt alene - hoveddelen af budgettet kommer fra EU-fonden (IHI) og de øvrige europæiske partnere.

Blarcamesine er hidtil det eneste stof/medicin, som er udvalgt til at skulle indgå i et klinisk studie, finansieret af ACCESS -AD programmet.
Eksisterende godkendte behandlinger indgår kun i et omfang, hvor der indsamles RWE-data.

Blarcamesine er et eksperimentelt, dagligt mundtligt lægemiddel der undersøges som led i ACCESS-AD-rammen. Det er udviklet til at påvirke cellulær funktion ved at aktivere SIGMAR1-receptoren og potentielt forbedre cellulær homeostase og bremse neurodegeneration i Alzheimer's sygdom. ACCESS-AD vil evaluere blarcamesine i en klinisk prediction study som led i projektets præcisionsmedicin.

[Søren]

Ikke så meget med Anavex at gøre --- Meeeeen alligevel tankevækkende, når man ser på de store selskabers Patentudøb og der økonomiske formåen med evt nye opkøb.

Ingen tvivl om at bliver blarcamesine godkendt --- så bliver det ikke kedeligt at være aktionær i Anavex.

Rapport fra i Sommer --- BMS er nævnt, de står til at miste meget fra 2030, så nogle er sultne
https://www.fiercepharma.com/pharma/firepower-aplenty-and-patent-cliffs-ahead-time-right-ma-activity-report

Og fra Naboen i Vest
https://www.dailymail.co.uk/health/article-15491085/Dementia-deaths-rising-faster-expected-NHS.html

Søren

[Tasso1]

Anavex Officiel bekræftelse af re-examination fra CHMP.

Nye rapportører udpeget den 14. januar 2026

https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-26-29-january-2026_en.pdf

3.5.2. Blarcamesine Anavex - Blarcamesine - EMEA/H/C/006475
Anavex Germany GmbH; treatment of Alzheimer's disease and dementia
Scope: Re-examination rapporteurs were appointed via written procedure on 14 January
2025
Action: For adoption
Opinion adopted on 11.12.2025. List of Outstanding Issues adopted on 18.09.2025. List of
Questions adopted on 25.04.2025.

Søger man tidligere procedure for re-examination, så kan vi forvente en revurdering fra CHMP i april/maj.
Re-evalueringsprocessen tager typisk 60 dage - hertil kommer så evt. Stop Clock for at sikre, at alle relevante data kommer med.
Så den 14. januar, hvor rapportørerne blev udpeget + 3-4 mdr. viker som et godt bud.

CHMP møder:

20. • 23. april 2026
21. • 21. maj 2026

Det kunne måske være en fordel med en re-examination først til maj, da dette ville øge muligheden for, at Anavex evt. kunne nå at få en tilbagemelding (forhåbentlig positiv) fra FDA - evt. en tilkendegivelse af, at Anavex kan indsende en formel ansøgning her. Dette ville, sammen med Blarcamesines udvælges til ACCESS-AD programmet, uden tvivl øge presset på den nye CHMP komite.

Lidt ønsketænkning - for vi er ikke på nogen måde i mål endnu!
Den potentielle gevinst i biotek er relativ meget stor - netop fordi risikoen også er tilsvarende stor!

[Søren]

Shorten er øget fra Dec til midt Januar med et mindre antal.

https://www.nasdaq.com/market-activity/stocks/avxl/short-interest

Søren

[Tasso1]

Anavex præsentation på AD/PD den 21. marts 2026 kl. 15.40-15.55 - København

Ser ud til at Anavex stiller med hele holdet, inkl. den nyansatte Prof. Wolfgang Liedtke.

Conference Calendar - 20th International Conference on Alzheimer’s and Parkinson’s Diseases: Mechanisms, Clinical Strategies and promising Treatments of Neurodegenerative Diseases

(cslide.ctimeetingtech.com)

ADVANCING ALZHEIMER'S DISEASE CARE: CONVENIENCE FOR BOTH PATIENTS AND FAMILIES WITH ORAL BLARCAMESINE WITH LONG-TERM TIME SAVED (ID 3484)
Presenter
Timo Grimmer (Germany)
Author(s)
Timo Grimmer (Germany) Nell Rebowe (United States of America) David Gould (United States of America) Juan C. Lopez-Talavera (United States of America) William R. Chezem (United States of America) Kun Jin (United States of America) Wolfgang Liedtke (United States of America) Christopher Missling (United States of America) Audrey Gabelle (France) Marwan Sabbagh (United States of America)
Lecture Time
15:40 - 15:55

Abstract
Aims
Currently no new convenient patient-centric oral disease-modifying treatments with long-term efficacy data are approved for Alzheimer's disease (AD) without the requirement of complex logistical resources and added personnel for drug administration and expensive safety monitoring.

Methods
Blarcamesine demonstrated in a placebo-controlled, 48-week Phase IIb/III trial (ANAVEX2-73-AD-004) promising clinical results (numerically superior to injectable infusion mAbs) with meaningful improvements on top of standard of care (donepezil, etc.) with slowed clinical progression by 36.3% (all patients) and 49.8% (prespecified patient group ~70% of population) at 48 weeks as measured by the primary endpoint ADAS-Cog13 and also on predesignated biomarkers. Blarcamesine demonstrated a strong safety profile with no neuroimaging-related side effects. There were no deaths related to the study drug. Externally matched control participants from the ADNI database were compared with participants over the combined 144-week period of ANAVEX2-73-AD-004 and its ATTENTION-AD open-label-extension (OLE) Phase IIb/III trial.

Results
Long-term data provide evidence of the significant beneficial therapeutic effect of blarcamesine, which positively separates from the ADNI control group with duration of treatment. ADAS-Cog13 difference −12.78 (P < 0.0001) with oral blarcamesine treatment compared to ADNI control group at Week 144. 77.4 Weeks (17.8 Months) 'time saved' with oral blarcamesine compared to ADNI. Furthermore, the advantage for the patient, family and physician is being helped timely without delays and constrains by cumbersome and limiting inconvenient complex diagnostics procedures allowing for quicker time-sensitive access with continued focus on the individual patient.

Conclusions
The impact on daily life is extended by time saved with oral Alzheimer's treatment blarcamesine¾here 17.8 months¾allowing for longer independence of loved ones¾with safer and better outcome¾while allowing efficiency, accessibility, and ease for patients and families.

[Søren]

Frisk fra Alzheimer Europa !!

Se organisationssiden for Alzheimer Europe
Alzheimer Europe
8.118 følgere
5t

Today, we launch a new report "The Prevalence of Dementia in Europe 2025", providing updated figures for the number of people living with dementia both for Europe as a whole (including EU as well as non-EU countries), as well as each of the countries within.

It builds on the work done for our 2019 Dementia In Europe Yearbook, in which we previously calculated the prevalence of dementia in Europe.

It applies prevalence estimates across 5-year age bands to UN World Population Prospects data 2024, for the years 2025 and 2050.

For 2025, there are an estimated 9,065,706 people with dementia living in EU27 countries and 12,122,979 for EU27 and non-EU countries combined.

For 2050, there will be an estimated 14,335,788 people with dementia in EU27 countries and 19,905,856 in EU and non-EU countries combined.

This means that, by 2050, the numbers are set to increase by 58% in the EU and by 64% across the whole of Europe.

The key message for EU and national decision-makers is that, with the number of people living with dementia increasing in this manner over the coming decades, they must act now, by investing sufficiently in health, care and social protection systems, providing adequate support for research, and implementing strong preventative interventions. Failure to do so can only exacerbate the challenges ahead.

NYT Patent til Anavex !!

WIPO - Search International and National Patent Collections

This patent search tool allows you not only to search the PCT database of about 2 million International Applications but also the worldwide patent collections. This search facility features: flexible search syntax; automatic word stemming and relevance ranking; as well as graphical results.

(patentscope.wipo.int)

Der er da noget for "Specialholdet" CHMP at tænke over hvis de tænker på at afvise Blarcamesine

Søren

[StraddleStrat]

I forbindelse med afvisningen fra CHMP så nager det mig stadigt med deres kritik af trial design.
De andre punkter, cancer og missing end point, syntes jeg der er gode logiske forklaringer på til at løse.
På det her trial design topic er jeg faldet over en diskussion med en tydeligt negativ person / shorter som trods alt havde en tese omkring det punkt:

@StraddleStrat The first problem is that the trial failed when the coprimary endpoints werent met. OLE data isn't going to rescue the pivotal trial as there's selection bias, no control arm, and no blinding.

The reason I'm sharing thoughts on the tipping point is because people seem to think that the only obstacle to overcome is the functional coprimary endpoint. They rightly believe that it shouldn't have been selected as it isn't useful for early AD, but they wrongly assume that the drug works otherwise. There's no proof of that. There's no proof of that because of what the tipping point analysis shows.

$AVXL showed cognitive benefit (p=0.008) but failed the functional endpoint (p=0.357). The EMA rejected it citing "methodological issues which raised concerns about the validity of the results.

A tipping point analysis asks: how much worse would dropouts need to perform for the benefit to disappear? AVXL answer: 1.9 points. If dropouts declined 5.4 points instead of 3.5, significance vanishes. But 5.4 is still 20% better than placebo-entirely plausible for patients who quit due to side effects.

This is a fragile result. Small, realistic changes flip the finding. Industry standards require implausibly unfavorable assumptions for robustness. AVXL's tipping point is entirely plausible. Therefore fragile.

The EMA can't trust a finding this dependent on unrealistic dropout assumptions.

Beklager den lange smører - er der nogle af jer kloge hoveder der har en mening eller erfaring omkring den her tipping point analyse / teori ?

[Steen 0]

Der syntes heller ikke være nogen succeshistorier fra patienter eller deres pårørende i medierne....?

[Solsen]

Succeshistorier er har der væretflere af. Men det ligger nu flere år tilbage. Men de lægges stadig op på Stockwits.

Som jeg forstår indgår ADL ikke i re-ex, men ADAS-cog 13, som var et af to primary endpoint. ADL udskiftes med co-endpoint CDR-SB med et højere krav til statistisk signifikans, som blev mødt.

Kopi af et indlæg Mayomobile lagde op i messengergruppen efter JPMorgan (mener jeg det var):

Amazing video - very important.

• No issues with manufacturing cancer risk, totally mute point by CHMP

• Company may present new statistical analysis for the multiplicity arguing a more stringent gatekeeping of 0.0167 instead of the original 0.025 (I confirmed that ADAS-COG13 and CDR-SB meet this threshold with ALL sub-populations and the ITT at 48-weeks.

• Inferred that the CHMP did not absorb all of Anavex’s analysis due to regulation constraints - more time will allow for this in the re-exam

• Could see a strategy where FDA and EMA both approve conditionally and help inform the confirmation trial endpoints/conditions together (but separately)

• If approved conditionally I would absolutely see BP take the leap to partner and help run the trial while simultaneously reaping interim commercialization $

[kalu]

enig StraddleStrat det jeg hæfter mig ved nu er at resultaterne for ABCLEAR subgrupper virker ret overbevisende også selv om der ikke var en del af den oprindelig protocol

[Søren]

En anden vinkel på Anavex og fremdriften.

Passer meget godt ind i min verden, med FDA C.Type møde i november. Hvis man skal lytte til andre skribenter/fora, ja, så går der 8-12 uger inden der sker noget med FDA og NDA -- det vil sige inden udgangen af februar senest.

Abstraher fra baggrunden i Videoen
https://www.youtube.com/watch?v=q3VsB3AxLeM

Søren

[Tasso1]

Anavex Kvartalsrapport mandag den 9. februar 2026.

Anavex Life Sciences to Announce Fiscal 2026 First Quarter Financial Results on Monday, February 9, 2026

Webcast and Conference Call To be Held Monday, February 9, 2026, 8:30 am ETNEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will

Yahoo Finance (finance.yahoo.com)

Fremlæggelse af den lovpligtige kvartalsrapport den 9. februar 2026 kl. 14.30 DK-tid.
Inkl. webcast via. Zoom:

Join our Cloud HD Video Meeting

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Zoom (us02web.zoom.us)

Forventer ikke meget nyt, medmindre vi får noget i den PR, der normalt udsendes kl. 13.00 samme dag.

Måske ser vi Mayo Mobil deltage i Q/A, som sidste gang.
Han burde måske kunne lokke lidt relevant information ud mellem linjerne eller bede om uddybende forklaring på evt. ny information - evt. noget omkring hvordan netop Blarcamesine er blevet udvalgt til ACCESS-AD programmet finansieret delvist af EU - især når CHMP/EMA (ligeledes finansieret af EU) hidtil ikke har været positive!

Øvrige evt. emner:

Status FDA og evt. indsendelse af en ansøgning her.
Status CHMP/EMA re-examination.
Status nye forsøg i Parkinson, Fragile X, Skizofreni mm.
Status evt. partneraftaler.

Sager som problemer med kopimedicin vedr. NOVOs nye pille, illustrerer nødvendigheden af, at det er nødvendigt med finansielle muskler, for også at kunne forsvare sig juridisk mod aktører, som vil forsøge at stjæle og udnytte enhvert hul i lovgivningen.
Anavex har løbende tilsyneladende forsøgt at beskytte sig med et utal af nye patenter.
En stærk partner ville her i højere grad kunne hjælpe med at holde div. aktører stangen, hvis og når Blarcamesine kommer på markedet en dag.

Nuværende aktiekursniveau trækkes bare ned med den øvrige negative stemning i markedet generelt.
De binære milepæle vi afventer er så afgørende for det videre forløb i casen, at nuværende kursniveau er ligegyldig.
Enten mangedobles eller halveres kursen herfra inden for de næste få måneder - alt afhængig af udmeldingerne fra især FDA og EMA.
Biotek investering i sin yderste konsekvens!

[Tasso1]

Anavex Tidlig PR. for kvartalsrapport.

Normalt får vi først en PR kl. 13 eller kl. 14.
For første gang har vi fået en kl. 12.?
Skal der gøres plads til en anden PR kl. 13?

Måske er der faktuelt nyt/fremskridt omkring status på de forskellige aktiviteter. Skal der f.eks. komme en partner på banen, må det snart være det rette tidspunkt - hjælp vedr. myndigheder og fremtidig udvikling af pipeline og evt. salg/logistik.
"Progressing collaborative initiatives and strategic partnership activities"

Økonomien er stadig positiv med penge på bogen til min. 3 års forsat drift.
Der er også kun solgt beskedende 5 mill. aktier i løbet af 2025, hvilket betyder minimal udhuling af aktiekursen.

Anavex Life Sciences Reports Fiscal 2026 First Quarter Financial Results and Provides Business Update | Anavex Life Sciences

Anavex Life Sciences reports Q1 fiscal 2026 financial results, clinical pipeline progress, and regulatory updates for blarcamesine in Alzheimer’s disease.

Anavex Life Sciences (anavex.com)

Webcast kl. 14.30 DK-tid.
Inkl. webcast via. Zoom:

Join our Cloud HD Video Meeting

Zoom is the leader in modern enterprise communications, with an easy, reliable cloud platform for video and audio conferencing, chat, and webinars across mobile, desktop, and room systems.

Zoom (us02web.zoom.us)

[StraddleStrat]

Ikke meget nyt under solen, men umiddelbart en positiv reaktion fra markedet. De rammer bedre paa omksotnings forventningerne og det lyder til at re-exam er fastlagt paa de tidligere diskuterest ABCLEAR sub-population paa ca. 70% af populationen

[Søren]

Markeds kommentar :
Oversat med Google

"Anavex Life Sciences Corporation rapporterer resultater for 4. regnskabskvartal 2025 med et ikke-GAAP EPS på -$0,06 (+57% år-til-år) og en omsætning på $0, hvilket overgår EPS- og omsætningsforventningerne. Virksomheden reducerer omkostningerne for at forlænge sin cash runway, da Alzheimer-lægemidlet blarcamesin gennemgår en afgørende EMA CHMP-genvurdering under et nyt rapportørteam, der forventes at løbe gennem 1. halvår 2026, med et FDA Type C-møde i januar, der understøtter en koordineret amerikansk regulatorisk proces ved hjælp af eksisterende AD-004-data.

Det primære fokus er fortsat oral blarcamesin til behandling af tidlig Alzheimers sygdom midt i igangværende regulatoriske interaktioner mellem USA og EU.

EMA's negative udtalelse er under formel genvurdering med henblik på betinget godkendelse, og processen forventes at finde sted inden midten af ​​2026.

FDA Type C-møde afsluttet; den fulde fase IIb/III-datapakke skal indsendes, tidslinje ikke offentliggjort.

Nettotabet i 1. kvartal var $5,7 mio. ($0,06/aktie), da F&U og G&A faldt betydeligt år-til-år.

Likviditet på 131,7 mio. USD, ingen gæld og en >3-årig runway ved nuværende afkast reducerer den kortsigtede finansieringsrisiko.
Driftsomkostningerne faldt primært på grund af færdiggørelsen af ​​en større blarcamesin-produktionsrunde og ANAVEX 3-71 fase II.
Access AD EU-konsortiumforsøg (AD006) vil køre et nyt placebokontrolleret blarcamesin-studie med fokus på biomarkører.
Virksomheden forbereder flere nye forsøg inden for Parkinsons sygdom, Fragile X, skizofreni og en ikke-offentliggjort indikation.
De eneste aktive studier i dag er udleveringsprogrammer til behandling af Rett syndrom og Alzheimers på tværs af flere geografiske områder.
Nøglerisikoen er regulatorisk usikkerhed: EMA-resultatet og FDA-forløbet for blarcamesin er fortsat uafklaret, og timingen er vag.
Blandet kvartal, drevet af stærk omkostningskontrol og en forlænget cash runway, men overskygget af regulatorisk usikkerhed for blarcamesin. Hovedbekymring: EMA-genvurdering og udefinerede FDA-tidslinjer skaber betydelig godkendelses- og timingrisiko for det ledende aktiv. "

Søren

[Søren]

Transcript:

Anavex (AVXL) Q1 2026 Earnings Call Transcript | The Motley Fool

Anavex (AVXL) Q1 2026 Earnings Call Transcript

The Motley Fool (www.fool.com)

Søren

[Søren]

D. Borel Capital har stadig troen

Anavex Life Sciences (AVXL) Stock Price, News & Analysis $AVXL

Should You Buy or Sell Anavex Life Sciences Stock? Get The Latest AVXL Stock Analysis, Price Target, Earnings Estimates, Headlines, and Short Interest at MarketBeat.

(www.marketbeat.com)

Anavex Life Sciences (AVXL) Stock Forecast and Price Target 2026 $AVXL

AVXL's current price target is $21.33. Learn why top analysts are making this stock forecast for Anavex Life Sciences at MarketBeat.

(www.marketbeat.com)

Highlights:

Key Points

Anavex has requested an EMA CHMP re-examination for oral blarcamesine after a negative opinion, a process requested Dec. 18 and expected to run through the first half of the year under a new rapporteur/co‑rapporteur; the re‑examination package will include Phase IIB/III AD‑004 data, open‑label extension data, Aβ‑Clear analyses and correlations with reduced brain atrophy to support conditional approval criteria.
The company said a January FDA Type C meeting was “very productive” and plans to submit existing ANAVEX2‑73‑AD‑004 data as part of a coordinated U.S. regulatory path, while also participating in the EU‑funded ACCESS‑AD program (AD006) to provide placebo‑controlled confirmatory and biomarker evidence.
Anavex ended the quarter with $131.7 million in cash, no debt, and used $7.1 million in operating cash this quarter, saying the lower R&D and G&A run rate gives it a cash runway of “more than three years”; net loss for the quarter was $5.7 million (‑$0.06 per share).
Interested in Anavex Life Sciences Corp.? Here are five stocks we like better.

Short-Squeeze Target Anavex Life Sciences Gains Traction

Anavex Life Sciences (NASDAQ:AVXL) executives used the company’s fiscal 2026 first-quarter earnings call to outline regulatory next steps for oral blarcamesine in early Alzheimer’s disease and to review a lower quarterly cash burn and operating expense base following the completion of prior-year manufacturing and certain clinical activities.

Regulatory and development update for blarcamesine

Chief Executive Officer Dr. Christopher Missling said Anavex remains focused on advancing its clinical pipeline, with oral blarcamesine positioned as the lead program in early Alzheimer’s disease. Missling said the company is “excited about the therapeutic potential” of the drug and intends to work with regulators in Europe and the U.S. to advance it as a potential treatment option.

→ 3 ETFs Designed to Survive the Next Market Crash

On the European front, management revisited the timeline following a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on the marketing authorization application for blarcamesine. Missling noted that Anavex requested a re-examination of the CHMP opinion on December 18, and said the re-examination is being led by a different rapporteur and co-rapporteur. In response to an analyst question, he described the process as a “60 + 60 day period” for the company to respond, followed by another approximately 60 days for review by the rapporteurs, adding that Anavex expects the re-examination process to last through the first half of the year.

Missling did not identify the new rapporteur and co-rapporteur, stating only that two countries among the 27 EU member states serve in those roles.

EMA re-examination: what Anavex said it will include

→ Google and Meta Just Rewrote Broadcom’s AI Story—While Shares Drop

During the Q&A, Missling said the re-examination package will seek to address criteria related to conditional approval, including seriousness of the disease, unmet need, clinically meaningful effects, mechanistic rationale (including genetic variants), and translational support, as well as the sponsor’s commitment to confirmatory study execution.

He said Anavex is including multiple data components in the re-examination, including:

Data from the Phase IIB/III ANAVEX2-73-AD-004 study
Data from the open-label extension (described as an “open-label study”)
Data related to the Aβ-Clear study population
Correlation between clinical efficacy and reduced brain atrophy

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Missling characterized the re-examination as, in part, a question of how to “repackage or re-articulate the strength of the package or of the data,” while also noting the company cannot guarantee an approval outcome.

FDA discussions and timing

In the U.S., Missling referenced feedback from a January FDA Type C meeting. He said the meeting covered potential pathways to support blarcamesine for Alzheimer’s disease and that “existing data” from the ANAVEX2-73-AD-004 program is expected to be submitted to the FDA as part of moving forward.

When asked about timing for a formal NDA submission, Missling said the company plans to advance its regulatory plan “once we are getting closer,” adding that the Type C meeting was “very productive.” He also said the FDA has meeting-request and scheduling requirements, and described the submission as being coordinated with a meeting request rather than simply sending data and receiving feedback.

Clinical interpretation and endpoints discussed on the call

Several questions focused on the CHMP’s stated rationale and Anavex’s view of the AD-004 results in genetic subgroups. Missling said the company would not criticize regulators, but reiterated Anavex’s interpretation that the trial met ADAS-Cog13, with greater significance in the SIGMAR1 wild-type population, and that CDR-SB was also superior in the wild-type group compared with the intent-to-treat population.

He said the ADCS-ADL endpoint was “the only one which was not significant,” though trending positively, and argued that the scale is not sensitive enough to detect changes in activities of daily living over 48 weeks in an early Alzheimer’s population. He also said that in the company’s described Aβ-Clear 3 population—referencing SIGMAR1 wild-type carriers with the COL24A1 wild-type gene—significance was reached “across the board” on ADAS-Cog13, ADCS-ADL, and CDR-SB, with what he called clinically meaningful effect sizes.

Missling added that Anavex requested involvement of the EMA’s Scientific Advisory Group (SAG) in the ongoing review process. He said the company will update the public once the process concludes and would not comment further while the re-examination is ongoing.

Pipeline activity and upcoming presentations

Missling highlighted Anavex’s participation as an industry partner in ACCESS-AD, a European Commission Innovative Health Initiative-funded program intended to accelerate adoption of diagnostic and therapeutic approaches for Alzheimer’s in real-world settings. He said blarcamesine will be evaluated in a placebo-controlled clinical prediction study within the program, including biomarker review (including autophagy signals) and efficacy assessments, and that Anavex plans to use the trial as part of its regulatory package to confirm efficacy in early Alzheimer’s disease. He indicated the target population is currently early Alzheimer’s disease, though it “could end up being a preventative also.” He confirmed the study corresponds to “AD006” on the company’s pipeline chart.

Regarding clinical activity underway, Missling said the only ongoing trial is a compassionate use program for Rett syndrome in Canada, the U.K., and Australia, along with compassionate use in Alzheimer’s disease. He said the company is planning studies in Parkinson’s disease, Fragile X syndrome, and another undisclosed indication, and also said it plans to continue a schizophrenia program. He clarified that a Parkinson’s disease trial has not yet started, distinguishing it from prior work in Parkinson’s disease dementia that he described as a basis for the planned Parkinson’s trial.

Missling also pointed to upcoming scientific communications, including an oral presentation at a March conference at Johns Hopkins University on findings that he said relate to biomarker relationships, correlations between clinical endpoints, and reduced brain-region atrophy with blarcamesine in early Alzheimer’s disease. He also cited planned publications on precision medicine patient populations from the AD-004 trial (including Aβ-Clear), a publication focused on the COL24A1 gene, and a Fragile X-related publication in a mouse model. In addition, he said ANAVEX3-71 is expected to be advanced toward pivotal clinical studies for schizophrenia-related disorders.

Søren

[Søren]

Noget der optager mig meget, er selve tidsplanen for re-exam.
Har ikke rigtigt kunne finde noget eller nogle på dette forum der har udtalt sig helt konkret.

Faldt over denne AI generet konklusion fra et andet fora !!
Har nogen ide på Tråden om det kan være rigtigt.

Missling har vel udtalt 60+60 dage.

AI forslag fra andet fora:

"Her er den forventede tidsplan for Blarcamesine-genvurderingen: Proceduretrin Forventet dato Indsendelse af begrundelse 9. feb. 2026 (Bekræftet) Nye vurderingsrapporter Tidlig til midt i marts 2026 (Intern CHMP-gennemgang) Videnskabelig rådgivende gruppe (SAG) Sidst i marts 2026 (Uafhængigt ekspertmøde) Mundtlig forklaring (hvis nødvendigt) CHMP-møde i april 2026 (Anavex forsvarer dataene) Endelig CHMP-udtalelse Møde 20.-23. april 2026 (Forventet afstemning)"
citat slut"

Spørgsmålet er også om den "forventede afstemning" er endeligt eller den bliver sendt videre til "EMA" ??

Søren
Kræver gode nerver de sidste dage at se på aktiekursen

[Søren]

BINGO --Nok ikke så galt at være aktionær i Anavex når vi har selveste Robert Kennedy med ombord

X (formerly Twitter) (x.com)

Og ACCESS-AD er med ombord
Godt nok fra den 17. december -- men en stemme der nok skal blive hørt.

Advancing Clinical Care and Equity through Scalable Solutions in Alzheimer’s Disease diagnosis and treatment | ACCESS AD | Project | Fact Sheet | HORIZON | CORDIS | European Commission

Alzheimer’s disease (AD) is a growing public health challenge in Europe’s ageing population. While Disease Modifying Therapies (DMTs) bring new therapeutic potential, fragmented care pathways, unequal diagnostic access, and healthcare limitations threaten their...

CORDIS | European Commission (cordis.europa.eu)

Søren