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We'll see.. Look for contradictions on this. ..
Haruo Naito, CEO, Eisai, said in a statement that these results were “an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer's disease community,” adding that the “Clarity AD study results prove the amyloid hypothesis.” Biogen’s CEO, Michel Vounatsos, echoed those sentiments in a statement, saying that, “the study shows that removal of aggregated amyloid-ß in the brain is associated with a slowing of disease in patients at the early stage of the disease.”1
tredenwater2
/Perhaps an overlay or endpoint for endpoint with red highlighting would make it easy to compare. There is a reason why Dr. Missling switched to “reduction in decline”.
Good catch tredenwater2. IMO, AVXL (possibly w/a few others) will end up redefining the criteria, rules and methods by which dementia-AD-PD and other CNS diseases are defined and measured. If true, that alone will redefine the leadership methods, roles and responsibilities. Others may watch and learn. The leaders will lead.
FDA trial dart-boards are about to be obsoleted.
How are SAVA and the BIIB boys going to react when they see the news from AVXL?
Xena
my personal condition is under control because I know where the Psy-Ops are coming from.
Thx Xena...so, maybe some folks ain't gonna sleep well for next few days...what a shame. They can either wake early or just hide and watch.
Xena
This means that anything critical to stock valuation will have to be released pre-markett.
Xenalives
I'm a "conspiracy theorist"
What do we expect from Dr.M. on next Monday?
Anavex Life Sciences Corp.
Tue, November 8, 2022 at 7:00 AM
In this article:
AVXL
+7.69%
Anavex Life Sciences Corp.
Anavex Life Sciences Corp.
NEW YORK, Nov. 08, 2022 (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 that Christopher U Missling, PhD, President & Chief Executive Officer of Anavex will present at the Guggenheim 4th Annual Immunology and Neurology Conference 2022 on Monday, November 14, 2022, at 11:20 AM ET, to be held at the St. Regis Hotel in New York, NY.
A live audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. An archived edition of the session will be available later that day.[/quote]
Kitty
"Publish" where the average person goes to get "news".
To minimize potential impact of any AF hit piece. Huh, no clue, but I do have a meeting w/the AF food tester so let me see what he/she thinks.
Thanks tradeherpete
Top Line Data of ANAVEX®2-73 (blarcamesine) Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2b/3 in Patients with Early Alzheimer’s Disease (AD)
Date / Time: December 1, 2022 / 4:30pm PT
Presenter: A/Prof. Stephen Macfarlane, Principal Investigator
Session Title: LB8 - LATE BREAKING ORAL COMMUNICATIONS
thanks gbrown6332:
Reposting from IV AVXL Prime...
I like the summary rehash below of the list of things we can expect to hear at the CTAD on December 1st. And we'll have our man Mayo on the ground. Exciting times.
Coming soon - Nov 14,11:20 AM ET Guggenheim 4th Annual Immunology and Neurology Conf.
Anavex is presenting at the Guggenheim conference at 11:20 AM ET Nov 14th.
This conference is followed soon by the Dec 1st CTAD conference in San Francisco. They will present the phase 2b/3 trial for Anavex 2-73 (Blarcamesine) for Treatment of Early Alzheimer's Disease.
Brief Summary: (From CT Website)
Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality-of-life measures of both, patients and caregivers during treatment with ANAVEX2-73.
Roger that treden....we are in a good spot today, w/many to go.
BTW, cannot wait for the RSD choir to sing..."we are the world".
Wolf...
Zero chance of leak.
12.48+0.69 (+5.85%)
As of 09:32AM EST. Market open.
LEAKY,LEAKY...??
tredenwater2
JWC all its going to take is for Dr. Missling to agree to and announce a partnership. He will do so after he has sufficient data in hand to gain approval for Rett syndrome which will A) give us revenue and B) raise the pps which puts us better into a proper MC valuation. Until then unfortunately its going to be rough waves regardless of trial results.
Auto
...or anyone else,
plexrec
All the dot connecting has led to only one conclusion--dare I say again WGT
EB?
12.49 +0.32 (+2.63%)
After hours: 04:37PM EST .......Does this count??
Biogen has a shady history with partnerships. Look at Elan with Tecfidera and Idec with Rituxan. Both Elan and Idec got kicked to the curb as soon as the ink was dried on the partnership agreement. Be careful what you ask for.
So, something ..."“An increasing body of evidence suggests that age-related dysregulation of neuronal Ca2+ homeostasis may play a proximal role in the pathogenesis of AD as disrupted Ca2+ could induce synaptic deficits and promote the accumulation of Aß plaques and neurofibrillary tangles. Given that Ca2+ disruption is ubiquitously involved in all AD pathologies, it is likely that using chemical agents or small molecules specific to Ca2+ channels or handling proteins on the plasma membrane and membranes of intracellular organelles to correct neuronal Ca2+ dysregulation could open up a new approach to AD prevention and treatment.”
So maybe adding one of these small molecules to the Anavex treatment would improve results with more advanced AD patients!
< "we know, we know..." (Senge). Getting closer to "CAVU" ... "Ceiling and visibility unlimited on top".
Kentucky 123
Watch the volume and news outlets. Will it still be on the back page?
McM...
I don’t think he will be stealing MacFarlane’s thunder
Would we/WS recognize the (equivalent ) Penicillin- AHHHHAAA -Petri Dish Moment if we saw it? Or, are WS-BP's so intimidating they will CRUSH anyone who even looks like they may want to start yelling AAAAAHHHHAAAA?
https://seekingalpha.com/article/4554672-anavex-life-sciences-pivotal-moment
Tredenwater2
rising tide should raise ALL ships. Anavex may raise the bar making it a change or die moment for BP.
https://www.nature.com/articles/s41380-022-01831-0#Sec26
Aussies kicking arse...see stress connections...
Anavex has been and continues to surround all of the BP opponents. The beauty of this AVXL strategy is (so far) BP does not , "GET IT".
NEW YORK, Nov. 07, 2022 (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) disorders, today reports the U.S. Food and Drug Administration’s (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome.
believer
Yes yes indeed I do believe this time the shorty have to be really careful they can lose everything.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOONGS
EarthBard
Did I miss role of Ariana Pharma?
Whole blood transcriptomics analysis (RNAseq, 14,150 genes) was performed at baseline and end of study (Week 14). The KEM® platform was used to identify clusters of genes that show a correlated expression change across patients and timepoints. In addition, Ariana Pharma identified a novel gene network that is differentially expressed in Parkinson’s disease dementia (PDD) patients treated with ANAVEX®2-73 compared to placebo after 14 weeks of treatment.
Ariana Pharma’s CEO Mohammad Afshar comments: “This first AI-driven pathway analysis in Parkinson’s disease dementia allows us to understand the intersection between a specific drug and patient biology. It further illustrates the power of KEM® Explainable AI to accelerate and increase the probability of success of precision medicine translational drug development through the better understanding of gene pathways in specific indications.”
The identification of a gene network as the blarcamesine response pathway lays the foundation to better understand the mechanism of action at the molecular level of blarcamesine. It is thus unlocking characterization of responders based on molecular profiling, as well as identification of new indications in neurodegenerative and other disorders.
Dr.M. moves like a man w/o any stresses....he is out spreading science instead of being huddled in a dark place stressing out over a keyboard.....HUMMMM, what does he know that we do not know?
Stress on good soldiers, well, for a few more days at least......THEN....PARTY, PARTY, PARTY..
jmvho
I believe TGD will maintain radio silence on the results until 12/1. By doing so, he accomplishes the following:
1. He keeps the shorts at bay with no results to attack with AF style distortion pieces.
With everyday that passes this month the odds of a notice of a failed trial diminish. The last ten days of the month should be interesting to witness, to see which shorts blink and start to cover.
2. The 12/1 release of the TLD shortens the time frame until release of the confirming
peer review study, which should help to counter the activities of the shorts.
3. By waiting 'til after 12/1 TLD to release the half dozen or so expected other news releases, it adds a huge multiplier effect to the impact on each new indication mentioned; adding greatly to the calculation of Anavex's future value.
4. A constant barrage of press releases in December following positive TLD should knock the shorts on their rear ends.
Again, just guessing here, but if you know you are going to be attacked, this might be an effective way to deal with it.
jmvho
A2-73 is the gift that keeps on giving. I understand they are running A 2-73 tests on AVXL shorts with crappy attitudes, dose recommendations will be very high though.
30fold
I would also contend that AVXL, with an efficacious drug that will actually ease the public financial burden, will reward long term investors quite handsomely in any economic condition.
GeorgejjI...there is a lot more to this story, which you would find important. IMO.
Nidan, I agree 100%
A small molecule in clinical development has come into view in the last two years, named Anavex2-73 (Figure 1). It has shown impressive safety records in early stages of clinical trials. Anavex2-73 is a S1R agonist with moderate affinity and has produced impressive clinical results from double-blinded studies treating Rett syndrome and Parkinson disease dementia. Currently it is in a phase II/III trial for Alzheimer’s disease. However, neither the scientific nor the investment communities are fully endorsing the clinical results or the potential in AD treatment. Granted, there are thousands of agonists of S1R with higher affinities than that of Anavex2-73 and none of them have been proven to have significant clinical applications. Is Anavex2-73 unique?
https://www.biotechtoinvest.com/research/2022/5/15/the-answer-was-here-all-the-time-why-anavex2-73-can-stop-alzheimers-disease
A small molecule in clinical development has come into view in the last two years, named Anavex2-73 (Figure 1). It has shown impressive safety records in early stages of clinical trials. Anavex2-73 is a S1R agonist with moderate affinity and has produced impressive clinical results from double-blinded studies treating Rett syndrome and Parkinson disease dementia. Currently it is in a phase II/III trial for Alzheimer’s disease. However, neither the scientific nor the investment communities are fully endorsing the clinical results or the potential in AD treatment. Granted, there are thousands of agonists of S1R with higher affinities than that of Anavex2-73 and none of them have been proven to have significant clinical applications. Is Anavex2-73 unique?
https://www.biotechtoinvest.com/research/2022/5/15/the-answer-was-here-all-the-time-why-anavex2-73-can-stop-alzheimers-disease
Remember this?
ckent...
Which means they had to measure everyone's baseline coming into the OLE. They just have to compare the average baseline from both trials and they know the TLR without even needing to know who took what dosage in the P2b/3.
If this is possible, then they would have had a general idea of how good the data was before applying for the late breaking oral at CTAD.
Thoughts?
123tom
Yes, its my Core that I say I will never sell, but what a shame it would be to watch it evaporate in a crash. I plan to trim just a small piece to add dry powder ,just in case I have a chance to load up again at 3 dollars in a crash.
JKS3
I believe the move by SAVA is never intended to be in a courtroom. The intention, in my view, is to silence critics.
Ggambit53
Love it. I hope they get a billion dollar win. In any event AF will have to decide if he wants to step in a pile of DS or let the markets decide for themselves how to interpret results. Waiting to see if he or his lackies comment on the suit. My guess is we’ll just be hearing crickets. Gave us some cover. Thanks SAVA
...SAY IT AIN"T SO...
The lawsuit alleges: “Defendants placed personal enrichment over science, over the health of patients, and over the truth. Defendants saw an opportunity to manipulate a stock price and financially benefit from their ‘short positions’ by defaming a company developing a drug for people with Alzheimer’s disease, a condition that afflicts millions of people.