active long
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Fireman....thanks for your compassionate concern for our Rett girls. There are other benefits than monetary for investing in our stock!
Nidan.....it is a very compact meeting with the gentleman from the FDA only using 10 min. Probably a lot of side discussion on the Anavex and Acadia trials (scuttlebutt). But, the Rett families will be pushing to accelerate the drugs because of the known results. The question of side affects may be discussed if there is anecdotal information from the families or friends.. No indication of either company or other gene related therapy representatives present at this stage.
Partnership....is it possible that today's PR about the change of Auditor could be related to an new alignment or as a consequence of a request by a potential partner?
"“We would like to thank BDO USA LLP for the services they provided for almost a decade. We are pleased to announce that Grant Thornton LLP will be our new auditors in the evolution of Anavex as we embark upon the next stages of our Company’s growth plans,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
This article from BioSpace cites some interesting research which may be pertinent to 2-73/3-71 in Alzheimer's and ALS.
-----
https://www.biospace.com/article/research-roundup-new-insights-into-alzheimer-s-and-more/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=205819292&_hsenc=p2ANqtz--cM4P8FiYg1yrmPjNF85cCLLKSUZtsu7veFU3eGMdakyM1MxAbglmfj0jFUxcPiRI855sWFFxNys-Ga89wMQadHAqA-Q&utm_content=205819292&utm_source=hs_email
Scientific studies at the Mayo Clinic and Stanford which may lead to the future application of 3-71:
-----
https://www.fiercebiotech.com/research/discovery-als-and-dementia-mechanism-points-new-treatment-strategy?utm_source=email&utm_medium=email&utm_campaign=LS-NL-FierceBiotech&oly_enc_id=6344A1822112C6Z
Interesting segment on "60 Minutes" tonight. They took up 2/3 of the program investigating neural attacks of US Govt employees around the world including the controlled area around the "White House". The current head of the CIA was interviewed and his Agency is is seriously looking at the occurrences and their debilitating effects on our government employees. Although the head of the CIA would not state the cause as it was under investigation, 60 Minutes postulated that the neural effects (vertigo, nausea, confusion, head pain) may be caused by powerful microwave apparatus used by unknown agents of a foreign power. These damaging microwaves were directed at aural and optic nerves which then transmit direct to the brain. Warfare directed at the brain......do you think that 2-73 may become a DOD defensive weapon in future neurological warfare???? As a pilot, I could see this as a dangerous aspect of conflict in the future.
Boi....we need Anavex to put Acadia/ Nuplaxid on the back burner with 2-73 efficacy for PDD and Alzheimer's. Acadia is using Biogen's playbook in finding any track to get however small a market share.
-------
https://www.fiercepharma.com/pharma/after-shocking-fda-about-face-acadia-revives-nuplazid-narrower-alzheimer-s-focus?utm_source=email&utm_medium=email&utm_campaign=LS-NL-FierceBiotech+Tracker&oly_enc_id=6344A1822112C6Z
The last report in 2021 Acadia 42M shares....Anavex 0. Quantify "much".
---------
From a 15 DEC 2021 assessment of Baker Bros top holdings:
ACADIA Pharmaceuticals Inc. (ACAD):
ACADIA Pharmaceuticals focuses on the development and commercialization of small molecule drugs aimed at unmet medical needs in central nervous system disorders. The company features extraordinary revenue growth, at a 3-year CAGR of 31.67.%. The bottom line has never been positive, with losses widening even as sales are growing.
In March, Acadia had announced deficiencies identified by the FDA about its marketing application for Pimavanserin in hallucinations and delusions associated with dementia-related psychosis. Shares plunged by a massive 45%, and they have yet to recover since then. While the company maintained its 2021 net sales guidance of between $510 million – $550 million, the business seems incapable of meeting investors’ past expectations.
This is one of the fund’s highest conviction picks, as Baker Bros still owns around 26% of the company’s shares, which have been held since 2010. While the fund has made great gains since, the recent plunge has definitely compressed its unrealized gains, as the position was held stable once again.
That's Acadia ACAD....it's late here on the West Coast. Congratulations RAMS....from 9 to 10 in the last 2 minutes. Great game.
Baker Brothers ....know your enemy/competitor. It may surprise you that the second largest Baker Bros' holding is Arcadia ACDA at 42+ MILLION SHARES. Take a look at Arcadia's website and you will see it is our main competitor with Nuplazid for Alzheimer's/Parkinson psychosis and Trofinetide for Rett Syndrome and other drugs for non-opioid pain relief. The situation with Baker Bros should certainly be reversed with the success of 2-73 in Rett Syndrome and Alzheimer's this year. Maybe there is a reason to have 2-73 approved for adult Rett.
-----
https://www.holdingschannel.com/all/stocks-held-by-baker-bros-advisors-lp/
------
https://www.acadia-pharm.com/pipeline/early-stage-clinical-programs/
In April 2021, the FDA issued a Complete Response Letter (CRL) to indicate that they have completed their review of the sNDA and has determined that the application cannot be approved in its present form. Acadia is immediately requesting a Type A meeting to work with the FDA to address issues identified in the CRL. Read more here.
On December 20, 2021, Acadia announced that it plans to resubmit its sNDA for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia focused on Alzheimer’s disease psychosis (ADP). Resubmission of the sNDA to the FDA is planned for the first quarter of 2022. The resubmission is intended to demonstrate pimavanserin’s clinically meaningful benefit in ADP patients, without worsening of cognition or motor function in this elderly population. The resubmission will include data from two positive, placebo-controlled studies that prospectively met their primary endpoints: the pivotal Phase 3 HARMONY study and the -019 study. Additional analyses from HARMONY and -019 will also be provided that validate the primary conclusions from each study and address the concerns raised in the CRL. Read more here.
Ovid a competitor in Angelmen and Fragile X gets press over trying to keep their failed drug alive. Makes you question the medical press's search for noteworthy progress in the "orphan drug' area.
-----
https://www.fiercebiotech.com/biotech/ovid-pens-deal-to-offload-twice-failed-former-lead-program-positioning-healx-to-write-new?utm_source=email&utm_medium=email&utm_campaign=LS-NL-FierceBiotech&oly_enc_id=6344A1822112C6Z
Latest news on Alzheimer's competitor, Alzheon.....endpoint against "tau".
----------
https://www.biospace.com/article/alzheon-posts-positive-results-from-phase-ii-alzheimer-s-biomarker-trial-phase-iii-commences/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=203279584&_hsenc=p2ANqtz--xE2I-6USaWH_X6MmtAMbzjaFAD19y1Rmmkn2Kw0ldyUidxJ-j6-thXXX6wRfI4wzNqa4lbG8MSmK-dPXvB6EQ58DPUA&utm_content=203279584&utm_source=hs_email
Much analysis of Rett and management of the current trials and possible NDA submission. Although there are many well thought out points, they are "after the fact" view points. It would be wise to review again who is running the trial and trust his long history with the FDA...it should give us a bit of confidence in our discussions with the FDA and the EMA/AUS/GB officials.
"Dr. Walter E Kaufmann, Chief Medical Officer has over 20 years of experience in clinical studies with focus on developing novel therapies for genetic disorders associated with intellectual disability. Prior to Anavex, Dr. Walter Kaufmann’s was the Director of the Center for Translational Research at the Greenwood Genetic Center, where he also held the Ravenel Boykin Curry Chair in Genetic Therapeutics. He holds adjunct appointments at Emory University School of Medicine, where he is an Adjunct Professor of Human Genetics, and at the University of California Davis School of Medicine, where he is a Visiting Scholar in the Department of Neurology. Dr. Kaufmann is also an Investigator affiliated with the Massachusetts Institute of Technology’s Simons Center for the Social Brain. Before these academic appointments, Dr. Kaufmann was a Professor of Neurology at Harvard Medical School and a Professor of Pathology, Neurology, Pediatrics, Psychiatry, and Radiology at the Johns Hopkins University School of Medicine.
Dr. Kaufmann’s major focus of has been Rett syndrome, a field where he has published extensively on neurobiology and clinical aspects. He served as founder and leader of RettSearch, the international consortium of Rett syndrome clinical researchers. As such, he co-authored the current diagnostic guidelines for the disorder. He also edited the first clinical textbook on Rett syndrome, published in late 2017. Dr. Kaufmann has also served as Co-Principal Investigator of the NIH-funded Natural History Study of Rett syndrome (RDCRN program). Currently, he leads the Rett Syndrome Molecular Biomarkers Working Group for the Rettsyndrome.org foundation and the Rett Syndrome Behaviour Questionnaire Working Group. Dr. Kaufmann has played different roles, including site investigator, Principal Investigator, and DSMB member/chair, in almost 20 drug trials for neurodevelopmental disorders. In this context, he has been involved in virtually all neurobiologically-based drug trials for Rett syndrome.
Dr. Kaufmann has published more than 220 journal articles, most of them original publications. He has also served on several editorial boards and as reviewer for over 100 scientific journals."
AVXL up to $10.50 after-hours....not bad considering the bath that the markets took today. Optimism!
Decompress and have good time Fireman....the company and the FDA will wade through the future NDA process. Will pray for rain and snow on the West Coast to keep the fire season down this year. Enjoy the beach with your wife,
Cheers, Talon
The IBD article outling the FDA involvement in the biomarker change was cited by Yahoo Finance.
----
https://www.investors.com/news/technology/avxl-stock-dives-as-testing-discrepancies-cloud-rett-syndrome-drug/?src=A00220
Frrol....."no conspricy" then explain AF's immediately timed tweets and FierceBio's less than complete article on data release( nothing about the FDA's recommendation about modifying the study endpoints). BPhama does not have to be "evil", but is usually quick to use their ample resources to be competitive...think Biogen.
Nidan, Plex......I totally agree with you. There are powers in Pharma, Health Care and Wall Street that see AVXL's scope across many diseases as a threat to to their dominance. That they were ready with negative press and the 7M share "short" attack at the moment of the Rett PR shows that there is a concentrated and coordinated effort against our science. Hostile takeover or BPhama buy-in are surely close. Positive comments by Dr's in the field are a positive counter attack by Dr. Missling.
The Biogen and Biomarker syndrome is bringing in a larger Alzheimer's cast and there is big money flowing from BPHARMAS to BIOTECHS.
----
https://www.fiercebiotech.com/biotech/gsk-alector-has-big-pharma-backing-to-capitalize-a-big-moment-alzheimer-s-drug-development?oly_enc_id=6344A1822112C6Z
The entire alzheimers/denentia sector has been affected by the series of negative news and lack of visible positive drug development. With Anavex there is a bit of "guilt by association" with BIIB, CRTX, SAVA, ANVS and BIOTECH in general. It is up to AVXL to present data to the contrary....we can't float in a descending market. We won't, and when positive news comes, it will be from several directions. I'm an optimist because of the unblemished clinical history of our company.
An interesting "byline" from Yahooo Finance. I don't subscribe to Barron's. Can anyone fill in the details?
--------
"The Centers for Medicare and Medicaid may ensure the commercial death of Biogen’s controversial Alzheimer’s drug. And that leads at least one analyst to wonder if more radical steps need to be taken."
SAB....AVXL's sp just surpassed ANVS at $14.
Release the yoke......opposite rudder. Chris has control. Below is the $20B valuation of AVXL 2-73.
J P MORGAN discussions continue....more in the licensing and partnership vane this year. CM could be still talking in the next couple of weeks as there are a number of trials on the horizon.
.....
https://www.fiercebiotech.com/biotech/jpm-2022-reflection-last-year-licensing-tie-ups-trump-m-a-at-conference?oly_enc_id=6344A1822112C6Z
Is Biogen on the prowl. Just when the completion is taking a beating and the M&A prices may be attractive. SAVA, ANVS, AVXL?
-----
https://finance.yahoo.com/news/biogen-eyes-potential-acquisitions-stat-203444096.html
The dementia/Alzhemer's world is in turmoil and much to the credit of the FDA and Biogen. AVXL will have keep its clinical lead although Wall Street is not much help. The Rett data....when it is released....will give us impetus until P2/3 Alzheimer's dada arrives later this year. This an endurance run!!!
----
https://www.investors.com/news/technology/dnli-stock-biogen-is-not-the-only-alzheimers-company-facing-bad-news/?src=A00220
We are within $.10 of ANVS.....looking at our sp taking over 2nd place behind SAVA on the Alzheimer's drug waiting list. Little doubt we will be knocking on the FDA's door with a NDA first next year(2022).
From the MJFF Dec update. Not new news, but one of a number of Parkinson's initiatives/grants in this month's listings.
----
https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
Old....good reading list perspective as we finish 2021......think about all the things to be thankful for and encourage all you meet...especially on this board. Bless you in the New Year also.
Talon
Tradeherpete.....good positive comments. The board is showing a slight bit of "battle fatigue" and we need to lighten up on each other. We are behind a small biotech which is attacking some dangerous diseases and conducing a number of trials in countries around the world (US, AUS, CN, ENG, SP, NL, GE) and with three Medical Agencies (FDA, EMA, AUS). Along with the governments which are up to their necks in COVID, there is the coordination with the medical non-profits like the MJFF, Rett Syndrome Foundation, The Brain Institute and the Shake It Up Foundation and others. With the management of these trials and the interface with the Medical Agencies there is little time to write home. People recommend keep it in house until we partner for Alzheimer's...well with a biotech with around 30 people small talk with the investors is bound to suffer. Institutional investment is growing so the "Tutes" must be patient with the progress they see.
Chill!
List of the NIH/NIA initiatives under the ACTC. Everybody has an idea on how to curb Alzheimer's/Dementia. Some may turn out to be helpful, but 2-73/3-71 will probably push these other drugs and medical approaches to the background. Note "sleep" is a category of treatment that our drugs beneficially aid.
-------
https://www.nia.nih.gov/research/ongoing-AD-trials
Applaud the efforts of a number of us to give Anavex awareness of what is going on in legislation and NIH neurological disease funding programs. However, IMHO Anavex's former FDA middle management members, Fadiran and Laniyoni. will have been all over these CNS initiatives and Missling and the staff are working closely already with the FDA and NIH on clinical programs. Lets hope the lessons of the NIH's Alzheimer's Clinical Trial Consortium (ACTC) fixation on the amyloid plaque/tau programs will have been tempered by the currant Biogen debacle.
AVXL...$20 after-hours....A Joyous Christmas to all!
To all my brothers and sisters on this board....a Joyous Christmas as we remember the birth of the Christ child, and may our investment bring hope and health to many in the coming year.
Talon
Japan has just put the brakes on Biogen's Aduhelm. Both Lilly and Roche will be evaluating their simular amyloid plaque drugs as the market becomes more restrictive,
-----
https://www.fiercepharma.com/pharma-asia/biogen-eisai-hit-second-aduhelm-refusal-days-time-from-japanese-regulators?oly_enc_id=6344A1822112C6Z
With the upcoming release of positive Rett and PDD data this next year, Anavex wiii receive some very close scrutiny from the likes of of Lilly, Roche and Biogen. Each is pushing its amaloyd plaque reduction candidate for Alzheimer's and with probable sucessful results of the 2-73 P2/3 in summer/fall of 2022 there will be a rush to partner with Anavex. Each of these large pharmas has its own commercial intelligence arm and is fully aware of the worldwide $$'s involved with a potential valid Alzheimer's drug. Despite SAVA's citizen's petition for accelerated approval, the FDA is going to act conservatively after the Biogen episode. All Dr Missling must due is carefully satisfy the FDA/EMA/AUS requirements and the BPhama greed will do the rest....IMHO!
-----
https://www.fiercebiotech.com/special-report/fierce-biotech-s-top-10-data-readouts-2022-alzheimer-s-drugs
MF is turning on SAVA with "this is a stock to avoid"...will they turn to AVXL in the future when evaluating Alzheimer's candidates?
---
https://www.fool.com/investing/2021/12/18/3-stocks-that-turned-200000-into-1-million-in-2021/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
Sean Hannity's sit in host Rep Louie Gomhmert had Robert Kennedy Jr on about his new book about Fauci. It is a expose about Fauci's control of not only vaccines, but most big pharmasuaticals and the drug approval process in the FDA. Anavex's dealing with the FDA would more than likely come under Fauci's scrutiny because of the US and worldwide dementia market. What will come out of the FDA dealings with Biogen over Aduhelm being investigated by the Govt Inspector General ordered by interim FDA Commissioner Janet Woodcock. Time will tell and we'll see if Lilly progresses on the coattails of Biogen.
We see plainly why Chris Missling is doting all the "i's" and crossing all the "t's" and being very careful of 2-73's progress.
"Jul 09, 2021 · Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the U.S. agency and Biogen."
For all of the thoughts about the large volume toward the end of the day, nobody has explained why all the sellers or combined sellers sold at $.90 below the high of the day, If they were being sellers' knowledgable agents they missed the mark by nearly a dollar.
What is up with a more than doubling of the volume at the "bell"?? Everybody at happy hour?