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AVXL Market Cap 989 M
SAVA Market Cap 973 M
I doubt if they will ever cross again. AVXL has several news events due in 2H. SAVA not so much.
Source:
https://finance.yahoo.com/quote/AVXL?p=AVXL&.tsrc=fin-srch
$13 printed.
sumbuysumsell ; that's a thick book, which could induce sleep without the use of drugs.
sumbuysumsell, you lost me at the picture.
FooBarAndGrill, you lost me at the pictures.
Sources of reliable Due Diligence for new eyes:
New investors looking for reliable no pump Due Diligence information on Anavex (AVXL), I recommend the 3 pinned messages (formally yellow stickies) at the top of the index lists of posts. These are independent compilations and informed opinions not affiliated with the company:
1) Projected Blarcamesine Revenues & Market Cap; plus a wealth of other data and important details. Composed by Mayo.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169304554
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2) A report given by Dr. Randi Hagerman, a recognized leader WW for CNS conditions and treatments. Composed by tradeherpete.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168422630
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3) An extensive list of a wide range various topics with links, compiled DD, and recent posts. Compiled by XenaLives.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166917727
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GL with the DD; and fell free to ask the well informed board questions for a variety of opinions and facts.
RedShoulder
Take note of the trends of AVXL and it's nearest competitor:
AVXL 11.91 +0.87 Gain+7.88%
At close: 04:00PM EDT
SAVA 24.43 -2.06 Loss-7.78%
At close: 04:00PM EDT
AVXL Market Cap 921,941 M
SAVA Market Cap 979.172M
Not only did the gains diverge symmetrically, But both MCs are about to cross soon.
Logic dictates that some of those funds flowing out of SAVA are going into AVXL. Any SAVA investor doing due diligence will discover the lengthy AVXL portfolio of conditions that the Anavex's drugs treat; plus the multiple drug portfolio.
Vol- now over a Million.
A surprise PR this quarter could be the release of the PDD/PD OLE data showing improvement continued though the end date and data collection.
I'm waiting to see what the PDD/PD OLE will show. If the improvement continues to the end date then this stock will fly on that stock news, mainstream health news, and finance news.
The Ph-2 showed +90% on high dose cohort improved, a never been done feat with any other drug.
Low dose cohort held at the same level, did not get worse.
The placebo cohort continued the expected decline rate.
PD/PDD is a Billion dollar WW market.
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"How Many People Suffer from Parkinson’s Disease?
While there is no definitive answer to this question, it is estimated that at least one million people in the United States suffer from Parkinson’s disease, and roughly six million worldwide. Parkinson’s disease is second only to Alzheimer’s disease as the most prevalent neurodegenerative disease."
Source:
https://parkinsonfoundation.org/about-parkinsons-disease?gclid=EAIaIQobChMIv_zC8M_i-AIVu25vBB2NiAaqEAAYASAAEgLAbvD_BwE
I'm not expecting a PR next week since it is a shortened holiday week where many fund managers and retail will be on vacation.
OTOH, I expect that Mayo's updated SOTC analysis of Anavex will make the rounds next week and get the attention of new eyes in retail and institutes (and maybe some shorts too).
Mayo's SOTC updated analysis of Anavex:
https://www.sotcanalytics.com/update-compendium
Mayo, I have updated the Yellow Sticky of your SOTC analysis of AVXL to the latest version.
Many thanks for the huge amount of time and effort you have put into the AVXL analysis. IMO, it is the top due diligence information available to all.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169304554
Barron's: The SPDR S&P Biotech ETF (ticker: XBI), which tracks small- and mid-cap biotech stocks, fell 33.7% in the first half of the year, which ended on Thursday. That’s far worse than the S&P 500, SPX –0.28% which was down 20%. The iShares Biotechnology ETFIBB +0.82% (IBB), which tracks larger biotech names, fell 22.8%.
The month of June, however, saw a resurgence for the XBI, which climbed 8% as the S&P 500 dropped 8.2%. The IBB rose 0.8%.
And for the past two weeks, biotech has been on something of a hot streak: Since June 15, the XBI is up 17.1%, while the S&P 500 is up just 1.4%.
https://www.barrons.com/articles/biotech-stocks-returns-market-51656680762?siteid=yhoof2
AVXL record short interest 06/15/2022 9,497,126
https://www.nasdaq.com/market-activity/stocks/avxl/short-interest
I get AVXL Up for the week at or close to $2.12
Closed at $10,17 and Monday it opened $8.05
Source Yahoo Financials and chart:
https://finance.yahoo.com/quote/AVXL?p=AVXL&.tsrc=fin-srch
Current record size short data: 8,908,532 shares shorted.
You have to wonder when the AF and his ass.ociates that shorted the Avatar TLD good news will start to cover; among all the other shorts.
What will be their max pain they deserve before they start covering?
I'm looking for a possible short squeeze if the SP and Vol keeps in the rally mode though the rest of June (only 5 trading days) and into July.
It's going to be glorious.
Seven reasons the beleaguered biotech sector is now a ‘buy’
Last Updated: June 18, 2022 at 7:33 a.m. ET
https://www.marketwatch.com/story/seven-reasons-the-beleaguered-biotech-sector-is-now-a-buy-11655475446
XBI SPDR S&P Biotech ETF in oversold territory, especially since Nov 1, 2021
(click on the 1 year chart):
https://finance.yahoo.com/quote/XBI?p=XBI&.tsrc=fin-srch
After Hours Vol very high for first 11 minutes:
Consolidated Last Sale $8.47
After-Hours Volume 540,321
After-Hours High $8.47
After-Hours Low $8.47
https://www.nasdaq.com/market-activity/stocks/avxl/after-hours
ACADIA Pharmaceuticals:
Advisory Committee vote:
Does the available evidence support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population?
Y: 3
N: 9
Another one bites the dust, and will have a much lower SP on the Tuesday open.
Regarding Anavex foreign trials; a FDA Perspective on International Clinical Trials:
---------------------------------------
Foreign Clinical Trials (FCTs)
• Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a
Sponsor to submit FCTs data
• In 1975 provisions that permit submission of FCTs data not conducted under an IND were codified in 21CFR312.120.
• Since then medical product discovery & development have become increasingly
globalized
---------------------------------------
OIG Report: • Over half of all clinical trial sites are outside the U.S.
• % of non -U.S. clinical investigators conducting trials under INDs has doubled over the last decade
------------------------------------
OIG Report: • 80 % of applications for drugs & biologics contain data from ex
-U.S. studies
• 78 % of all subjects were enrolled outside the U.S.
• 87 % of all subjects in recent biologics trials were enrolled outside
the U.S.
-------------------------------
Pushing & Pulling Forces
U.S.
• Difficulty recruiting patients – Fewer feel need to participate
• Higher standard of care
• Mistrust (historical infamy Tuskegee trial)
• Requirement for larger # of Pts
• Insurance precluding participation/HIPAA
• Higher costs: clinical care/ Operational/ documentation & training)
Non U.S.
• Reduced cost or economic drivers (clinical care/Operational/training)
• Motivated subjects & investigators
• Rx naïve subjects willing & eager to participate
• Faster recruitment rates/ short timeline
• Availability of large # of patients
• Countries and institutions trying to attract research and clinical trials
• Availability of CROs focused on global trials
• Less regulatory red tap
-----------------------------------
Foreign Study Conducted Under IND
• When a study is conducted under an IND but is located outside of the United States, the study still must comport with all relevant FDA regulations as if it were
being conducted within the United States
• A Sponsor is not required to conduct an FCT under an IND in order to use it as
support for an NDA or IND
-----------------------------------
Acceptance of Foreign Clinical Data
• FDA Accepts Foreign Clinical data from studies not conducted under an IND if the following conditions are met:
I. Study was conducted in accordance with Good Clinical Practice (GCP)
II. FDA is able to validate the data from the study through an onsite inspection.
----------------------------------
Sponsor shall submit to FDA a description of actions taken to ensure research
conformed to GCP:
– Defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data &reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected
---------------------------------
Supporting information
1. CI's qualifications
2. Description of the research facilities
3. Summary of the protocol & results of the study &, should FDA request,
case records
4. Description & details of the product/drug used
5. Information showing that the study is adequate &
well controlled
7. Name & address of the IEC, a summary of the IEC's decision
8.A description:
– how IC was obtained
– what incentives, if any, were provided to subjects in the study
– how the sponsor(s) monitored the study
– how CIs were trained to comply with GCP
---------------------------------
Validation of Data: Onsite Inspections
• Help to ensure the protection of rights, safety and welfare of research participants
• Help to ensure data that are submitted in marketing applications are fit for purpose
– For regulatory decision making (Approval)
– As evidence base for clinical use of drug (Label)
• Allow evaluation of compliance with FDA regulations
-------------------------------
Finite inspection resources
• Breadth of international inspections coupled with finite inspection resources
result in inspection of a limited number of sites
• Despite the large portion of clinical studies being conducted abroad, the OIG 2010 Report found that the FDA only inspected 0.7% of all foreign clinical sites in 2008, compared to 1.9% of all domestic clinical sites.
------------------------------
Final Thought
“Wherever you stand, the majority of clinical trials are being conducted elsewhere, and yet we all as regulators use these data to allow or disallow marketing of a product, and physicians and patients use these data to decide to use or not use a
medicine.”
Fergus Sweeney, EMA
“Today we recognize that to successfully protect U.S. public health, we must think,
act, and engage globally.
Our interests must be broader than simply those within our own borders.”
Margaret Hamburg, FDA
Commissioner
--------------------
FDA link:
https://www.fda.gov/media/91849/download
Nice find TTT, thanks for the link.
Fragile X has an unmet need for treatment, and will be 5 times the revenue of Rett.
https://onlinelibrary.wiley.com/doi/10.1002/ajmg.a.62853
XBI had a good day 71.21 +2.44 (+3.55%)
XBI still in the oversold category, likely more up days to come which is good since AVXL tracks the XBI unless there is news.
IhidefromtheX, that is good news. Good luck with the Proton Therapy. It's good to hear your making progress with masses being eliminated.
Powerwalker, now that I have looked deeper into it, I completely agree.
Completion date of the last Alzheimer patient treated to end the Phase-2b/3 trial, and showing the work to arrive at this 'approximate' date,
The PR release on June 8th 2021 states...... "today announced that it has exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2b/3 study in Alzheimer’s disease."
Since we have no other data, I'm taking June 8th 2021 as the last patient to start the 48 week trial (this should be close). There were 29 weeks after June 8th to the end of 2021. To complete the 48 week trial after the last patient started - that 29 weeks rolls into 2022.
That computes to completing the 48 week trial in 2022 minus 29 weeks completed in 2021 to equals19 weeks left to finish the 48 week trial in 2022, that counts out to the trial completing on May 8th 2022.
These calendars have the days numbered from the start of the year:
https://www.123freevectors.com/2021-calendar-with-week-numbers-180500/
and ................
https://www.123freevectors.com/printable-2022-calendar-with-week-numbers-218858/
(NOTE: These are my own personal calculations, I am not claiming this is the exact date but it should be close. They could have started the last patient 'before' putting out this PR; the question begs to why put out this PR if the last patient had not started. But it is also possible that they actually started the last patient 'after' the PR, however that seems out of sequence to me. In either case May 8th should have been close.
Since Missling promised a PR release of the trial ending it should be days away and not weeks. The PR seems late to me IMO, however the last patient could have started weeks after the PR release.
------The June 8th PR: -----------------------------------
Anavex Life Sciences Announces Exceeding of Enrollment Target for the Precision Medicine ANAVEX®2-73 (blarcamesine) Phase 2b/3 Clinical Trial in Patients with Alzheimer’s Disease
NEW YORK, June 08, 2021 (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 it has exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2b/3 study in Alzheimer’s disease. The Company expects to announce topline results from this study by mid-2022.
The study includes a prespecified precision medicine biomarker, SIGMAR1 gene expression, which demonstrated correlation with direct measures of clinical benefit, cognition and activities of daily living and function in a previous Phase 2a Alzheimer’s disease study.1
The double-blind, placebo-controlled 450-patient Phase 2b/3 ANAVEX®2-73 clinical study in patients with Alzheimer's disease exceeded enrollment beyond 450 patients at 52 sites across North America, Europe and Australia using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.2
This multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of two different once daily oral ANAVEX®2-73 (blarcamesine) doses or placebo.
ANAVEX®2-73 is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.3
PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.4
“A significant unmet need exists currently for Alzheimer’s disease patients worldwide given the lack of available adequate therapeutic interventions, and we are excited to have exceeded enrollment of this study for ANAVEX®2-73," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "Given ANAVEX®2-73’s convenient oral route of administration we believe it has the potential to deliver broad clinical utility."
Anavex Life Sciences’ product portfolio includes small drug molecule lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
About ANAVEX®2-73-AD-004 Clinical Study (ClinicalTrials.gov Identifier: NCT03790709) and OLE ANAVEX®2-73-AD-EP-004 Clinical Study ATTENTION-AD (ClinicalTrials.gov Identifier: NCT04314934)
ANAVEX®2-73-AD-004 clinical study is a Phase 2b/3 double-blind, randomized, placebo-controlled, 48-week safety and efficacy trial of ANAVEX®2-73 for the treatment of early Alzheimer’s disease. The Phase 2b/3 study is expected to enroll approximately 450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision medicine biomarkers identified in the previous ANAVEX®2-73 Phase 2a study (ANAVEX2-73-002, NCT02244541). Primary and secondary endpoints will assess safety and both cognitive and functional efficacy, measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase 2a Alzheimer’s disease study previously demonstrated dose dependent improvement in exploratory endpoints of cognition (MMSE) and function (ADCS-ADL).5 ANAVEX®2-73-AD-EP-004 is the 96-week open label extension of the placebo-controlled Phase 2b/3 ANAVEX®2-73 study.
https://finance.yahoo.com/news/anavex-life-sciences-announces-exceeding-110000303.html
"Blarcasemine - Rett - working on getting compassionate use approval"
Very interesting.
Thanks DFRAI for passing along this note from the Annual Meeting,
A logical opinion and it agrees with my sentiment: "it just has to be good enough and that bar is set very low."
Rett doesn't have a bar, and with AD and PD the SOC bar is in the grass.
Tom Bishop of The MoneyShow "Anavex: Drug Pipeline Progress" on 'TalkMarkets'.
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.
These projects include the pediatric Rett trial and Alzheimer’s trial that is still expected to read out in H2. The company is still planning to meet with the FDA to get going on a Phase 3 Parkinson’s trial, still planning the Parkinson’s imaging trial, and it is still having $153 million in cash, enough for four years..............
Based on the conference call, the company is showing increasing priority (now #3 behind Alzheimer's disease and Rett) and excitement for moving ahead on Fragile X due to strong/convincing data from animal models for Fragile X, including biomarkers and ADAM score (it will be presenting on this at a conference in July), and also because Fragile X is a huge, unmet need that is 7 times the size of the Rett Syndrome population. The company is working on designing a potentially pivotal study that it hopes to propose to the FDA in H2.
Also — and this is new — there is an Investor Day planned for June 21 at which the company will take a deep dive into its pipeline, which is growing. Nibble for the longer-term, if you dare. I can’t guarantee the shares won’t go lower for no good reason, but this remains an enticing price with the goal line growing ever close
https://talkmarkets.com/content/stocks--equities/anavex-drug-pipeline-progress?post=355487
bio I completely agree with that, even so Anavex's cut of the AD revenue pie for just that one indication would be impressive.
I'm looking forward to the day that AD partner event is announced.
Since Anavex is completing it's potentially pivotal Alzheimer Ph- 2b/3 trial any day now, I thought I would look back and see what the markets valued a FDA approved Alzheimer drug and Biogen is the only example in recent history.
What will the AVXL MC and SP be worth once A2-73 Blarcamesine is approved?? We have this bit of history as a guide only, and Biogen's drug was valued at a $26 Billion MC.
(Importantly considerer the safety factor and cognitive efficacy advantage Anavex has, which is a small pill and not an IV infusions along with some imaging cost plus time and travel.)
November 26, 2021, 1:29 PM EST
Insurers have pushed back at paying for the $56,000-a-year drug, and earlier this week, new details on a brain-swelling side effect following a patient death fueled further declines in the stock.
The biotech stock has plunged more than 40% after reaching a six-year high in June, when Aduhelm was approved. The decline has wiped out more than $26 billion in Biogen’s market value."
bloomberg.com/news/articles...
The big short positions made in the $10 range on the excellent Rett Avatar news hammered down with blunders pumped by A.F. and his followers, may start to cover soon if they want out with a gain. We could maybe see some welcomed short covering volume buying.
Time will tell and that time is not far off.
LBSR, the first part of this year has been light on good news PRs, however once the PR comes out that Anavex has completed thePh-2b/3 Alzheimer trial phase, and that new gets widely circulated in the days and weeks after the release, I think that starts the run up for the remainder of the year. Should be pretty good times for longs.
GL Moon Man on your trades and core building. I think you have a nice trade/core building balance going for you.
Today for the first time since the many AVXL buys I've made over the years, I got lucky and bought shares at the LOD in the opening minutes at $8.82, as a result of the blind squirrel effect and putting in the order before the opening bell.
Nice chart, looks like today will make it 4 green candles in a row,
That chart looks ready to run to the $17 - $20 range on good news.
AVXL is up in the 5% -6% range today so far on low volume.
AVXL up over $9 and 5% gain with red everywhere else. I think we are seeing the 'Alzheimer PR in May' effect.