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.
Worth noting - The hurdle we're attempting to cross is essentially on the ground. We're not attempting to exceed or replace a highly effective treatment option.
University of Minnesota Medical Study on current AD treatments.
The researchers findings suggested that few existing treatments have clear evidence of benefit in treating dementia:
Two prescription drugs — cholinesterase inhibitors and memantine — slightly reduced cognitive decline for up to 6 months;
Cholinesterase inhibitors slightly reduced reported functional decline for up to 6 months;
For both of these effects, the difference in effectiveness between the drug and placebo use was too small to know whether benefits are of clinical importance;
The evidence for drugs specifically used for behavioral and psychological symptoms of dementia was insufficient for the researchers to draw conclusions about benefits and harms;
The evidence for over-the-counter supplements was almost entirely insufficient to draw conclusions for any outcomes;
Few studies reporting on cognition and function were longer than six months, and few reporting on behavioral and psychological symptoms were longer than 12 weeks, which makes the longer-term effects of the medications unclear.
“We found that the SOC drugs that are FDA-approved for Alzheimer’s have very modest effects,” says Dr. Fink. “And the effects they have are for symptoms only.”
Fink explained that the medications are not disease-modifying drugs, and cannot slow or stop the progression of dementia.
For what it's worth it appears to be business as usual next week at HQ...
Rare CNS & Neurodevelopmental Drug Development Summit
November 28-30 Boston, MA.
November 30 - 1:45 pm Implementing Genetic Analysis in Clinical Trials to Illuminate Genetic Biomarkers in Rett Syndrome
Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Science
Synopsis
* Implementing and executing clinical trial protocol for genetic analysis
* Exploring whole blood transcriptomics analysis
* Analysis of clinical endpoints and biomarkers of response
We all get what's going on. It's a predictable pattern for MM to dramatically drive the price down before news especially if they believe good news is imminent. Taking out stops and scaring small retail holders provides shares they've been commissioned to obtain. It's simple and effective.
I'm always amused when there's a burst of interests from a subset on the board who's concerned about my personal financial interests and are suddenly trying to save me from myself. Thanks I guess.
As far as the paid goon AF is concerned I believe the Peer Reviewed component of the upcoming data release is intended to blunt naysayers.
While I don't follow AVXL competitor SAVA that closely, nor wish them ill, I do see their headlines cross my biotech news monitor occasionally. I find the timing of yesterdays action to raise funds intriguing. Like... Let's push a $50M raise through before December 1st just in case there's material change in the current AD landscape. Just a theory.
AUSTIN, Texas, Nov. 18, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) (the “Company” or “Cassava Sciences”), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that it has entered into a definitive agreement with several healthcare-focused and other institutional investors for the purchase of 1,666,667 shares of its common stock, at a purchase price of $30 per share, for gross proceeds of approximately $50 million, in a registered direct offering. The closing of the offering is expected to occur on or about November 22, 2022, subject to the satisfaction of customary closing conditions.
Saw one of the SEC Commissioners on Charles Payne show a couple of weeks ago. He ask very nicely if the SEC had any plans to address ongoing market manipulation. She responded with wide eyes... We're not aware of any recurring market manipulation.
Another Federal agency corrupted to benefit the powerful and disenfranchise all others. Problems are now too deeply entrenched to ever be corrected.
NWBO... They've certainly survived some very hard times. I picked up 1,000 shares just to see what will happen Monday.
Hoping AVXL has an easier road to success.
"This lull is market-maker-driven."
Added during todays drop. Shares that won't see the inside of a MM's account.
"Hard to say what position Anavex takes
1. distribution and marketing
2. co-promotion = salesforce
3. full partner for AD and Parkinson"
If #3, the numbers get crazy in a hurry assuming a big Pharma can park their ego, fully grasp the market potential and have calculators with a ridiculous number of zeros. Per Barons the 20 biggest Pharma companies are sitting on roughly $300B in cash, Pfizer for example, $27B primarily via Covid riches.
A sophisticated Pharma partner brings broad insider FDA relationships and much needed muscle to get a product to market much sooner. Let's assume discussions are already underway.
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.
"Biogen will partner with or own Anavex. This is 100% fact."
I assume you were going for the negative reaction this assertion would garner from the board.
I do believe Anavex will have multiple big pharma suitors based on solid AD results, but I seriously doubt Biogen will be in the competitive mix. With their (Biogen) checkered corporate history and situational ethics, logic suggests they won't be.
SA article dated November 8 posted on IV sub-board AVXL - Prime.
https://seekingalpha.com/article/4554672-anavex-life-sciences-pivotal-moment
Author - Lane Simonian
Passing on as information only...
Dude who monitors the trading bot dial has obviously dozed off...
New SA article on upcoming CTAD. Posted on IV sub-board "AVXL Prime".
https://seekingalpha.com/article/4552130-trading-ideas-on-the-upcoming-ctad-2022-conference
Give credit where it's due... They have absolutely put a tight lid on any inadvertent slips or excited utterances before December 1st. One might think there is activity behind the scenes they can't divulge.
Best ever AD clinical TLD 12/1 followed closely by an announced partnership with a large Pharma partner to help facilitate and accelerate needed regulatory actions leading to mass marketing and distribution of 2-73 for targeted AD populations.
Might not be the day the earth stood still, but let's hope so.
Bourbon... Hopefully you're not feeling any similarities with the unfortunate roller coaster ride some of us on this board took with Advaxis. Say it ain't so.
G.B.
When at first you don't succeed try, try again...
Biogen and Eisai make plans to take another Alzheimer’s drug to the FDA next year
The companies have said their experimental therapy, called lecanemab, slowed cognitive decline by 27% in a Phase 3 clinical trial. The drug also appears to help people with day-to-day functions, like managing their finances, taking care of household responsibilities, and being able to leave their homes, executives said Tuesday during an earnings call.
“Lecanemab administration showed a highly statistically significant reduction in clinical decline as early as six months which expanded over the 18-month study period on an absolute basis, consistent with a disease-modifying effect,” Michel Vounatsos, Biogen’s outgoing CEO, told investors this week.
The new data, which was announced late on Sept. 27, revitalized Biogen’s stock, which closed Sept. 28 at $276.61, a 78% increase over the previous day’s closing price, following the disastrous launch in 2021 of Aduhelm, the controversial treatment for the same disease.
“Lecanemab could be a commercial success,” SVB Securities analyst Danielle Brill told investors on Tuesday, though she cautioned against viewing the drug as a savior for Biogen. “Given [Alzheimer’s disease] is a lower-margin opportunity, and economics are split with partner Eisai, we think it’s unlikely that lecanemab alone can offset the revenue cliff [Biogen] is facing over the next several years.”
Aduhelm’s failures
Much of Biogen’s stock performance over the last few years has been tied to the therapies the company is developing with Eisai to treat Alzheimer’s disease. Investors first pinned their hopes on Aduhelm, which was approved in 2021.
However, Medicare coverage of the drug, as well as others in its therapeutic class, has been restricted amid broader questions about Aduhelm’s price tag — $56,000 a year at launch, now about $28,200 a year — and about how well it works. The company said in May that it would scrap its commercial plans for the drug and let go of CEO Vounatsos. Aduhelm generated only $1.6 million in sales in the third quarter of 2022 and $4.5 million so far this year.
Eisai takes the lead
The companies, which have a 50/50 profit-sharing agreement, appear to be taking a different approach with lecanemab. Eisai is expected to share additional data about the drug on Nov. 29 at the Clinical Trials on Alzheimer’s Congress in San Francisco, and it, not Biogen, will be filing for full approval of the drug in the U.S. in the first quarter of next year. It was Biogen that applied for approval of Aduhelm back in 2020.
The Japanese drugmaker is also taking the lead in talks with the Centers for Medicare and Medicaid Services about coverage of lecanemab, Biogen told investors. The FDA is expected to make a decision on accelerated approval as soon as Jan. 6, and that means the therapy would fall under the same rules as Aduhelm, which is considered “noncoverage” because access is limited to patients participating in clinical trials, according to Mizuho Securities analyst Salim Syed.
Biogen also reminded investors during the call that Eisai has final decision-making authority and will set the price for lecanemab.
The company also told investors it is preparing its commercial and manufacturing capabilities to get ready for a launch if and when the drug is approved. A new manufacturing facility in Solothurn, Switzerland, will largely focus on making therapies for Alzheimer’s disease, including lecanemab.
Biogen’s stock is up 12.7% so far this year, while the broader S&P 500 SPX, +1.63% has declined 20.3%.
Saturday afternoon light reading... Feuerstein picks his battles more carefully these days.
From Substack:
"When Pfizer announced Dr. Scott Gottlieb - who had resigned as commissioner of the Food and Drug Administration just months earlier - would be joining its board, Feuerstein’s salty take was not surprising:
Twitter - It's going to be pretty cool to watch
all those $PFE drugs win FDA
approval on mouse data.
Feuerstein’s joking prediction of three years ago has turned out to be right. In August the FDA approved the bivalent boosters from Pfizer based on data from eight mice.
Can’t make it up.
One might think the fact the federal government has essentially become a promotional partner of the mRNA vaccine companies would encourage drug industry and investigative reporters like Feuerstein to ask hard questions about the vaccines.
One would be wrong.
These days, though, Feuerstein has a somewhat different attitude towards Gottlieb, as a reverential interview from September 2021 reveals. It’s full of hardball questions like:
You have this unique position now – you were in government, you’re no longer in government. You sit on many different seats of power and access. Do you ever think about going back in?"
Feuerstein obviously realized it's not smart to screw with big pharma monsters like Pfizer with former FDA commissioners on their Board. Much easier to dump on small biotechs for a living.
The full article is available on Substack.
Mayo seems like a decent chap...
I'm officially in. Will be good to have boots on the ground close to the action on December 1st.
Posted on ST... TDAmeritrade Market Analysis video from today. They've discovered some strange phenomena (Anavex) but can't pronounce it.
https://tdameritradenetwork.com/video/anavex-life-sciences-avxl-surges-on-alzheimer-s-clinical-trials
I found myself chuckling as they stumbled through Anavex background as they're clearly struggling to get up to speed on the company they've never heard of.
Agree... I added a few hundred shares today at $11.91 and felt I was getting a good price.
I appreciate the wisdom of tamping down irrational exuberance for now. I agree the news no matter how good before or on December 1st will be viciously attacked by AF and his flying monkeys, as they appear motivated (paid) to act out as professional naysayers.
However, I'm opting for optimism. The world is desperate for good news. A medical solution that strikes a proven meaningful blow against ALZ and promises to upgrade the current SOC will be met with worldwide enthusiasm.
A small 15 minute time slot to shock the world... CTAD may wish they'd provided a bigger presentation window.
Posted on IV (AVXL Prime subgroup)
https://finance.yahoo.com/news/cassava-sciences-announces-initiation-open-131500478.html
SAVA may well have an inferior ALZ solution, but they certainly understand the importance of creating a steady stream of news to generate public interests in their medical initiative.
Quote - "It won't be long now..."
Linus Van Pelt from the Pumpkin Patch
Parkinson article posted on IV (AVXL Prime forum). AVXL referenced.
https://medium.com/parkinsons-uk/whats-going-on-with-research-into-parkinson-s-390b446f0559?
SA piece posted by Trainguy1 on ST.
https://seekingalpha.com/article/4544152-eli-lilly-donanemab-nearing-end-anti-amyloid-drugs
Presumptuous of me to advise smart BiiB investors, but I wouldn't sit on my gains too long.
Lilly appears blissfully unaware there are any alternative AD treatments not focused on amyloid plaque reduction anywhere in the pipeline. They're pounding the drum loudly on donanemab, signaling confidence it will gain FDA approval in the near term.
None of the amyloid plaque purveyors thus far have achieved much clinical success. Yet Lilly assumes their AP Tau reduction AD approach will prevail. I think this often happens when you are extraordinarily big and have incredibly deep pockets.
Not everyone is going to be right and someone is going to have a lot of explaining to do.
Shorts are clearly delighted about the absence of an NDA filing which is getting harder and harder to understand or explain.
For a company poised to rock the foundations of the medical science world between now and December, we are holding our cards very close.
The competition?
I'm intrigued by the frequent discussions about SAVA on various AVXL discussion boards. In scanning all the usual SAVA forums there's virtually no mention of AVXL. Either we're sneaking up on SAVA from behind and their investors are blissfully ignorant of AVXL existence or they're not spending much time and energy thinking about who they're up against.
I also found it interesting, even with the recent rise in SAVA price, fully 30% of SAVA shares are shorted. Were I holding a large amount of SAVA, that would be troubling.
Ultimately, both companies will rise or fall based on the strength of their science and trial outcomes. My bet is heavily weighted toward AVXL.
Insider buying thoughts...
Not to be a contrarian, but insider buying can have a variety of calculated motivations. Aside from indicating a strong belief in the company mission, it can also be an effective way to gain leverage and valuable concessions from the Board by demonstrating "I'm putting my money where my mouth is" now pony up what I want.
It's a signaling ploy and a secondary data point for investors, not always to be taken at face value.
Interesting patent thoughts posted by an individual on the IV AVXL Prime board...
Re: Patent estate
I didn't make it through the whole list but the ones I saw were all US patents and patent applications. They hopefully have corresponding filings internationally.
Without really studying all the prior art there's no way to know how strong the patents are, but they appear to me to have useful claims. I was happy to see many applications for particular crystalline forms of A2-73. This is a common big pharma way of building additional patent years onto what is becoming an old molecule. If they show that a particular crystalline form (isomorph) is superior in terms of formulation or stability or whatever and secure a patent on that form, then that is a substantial barrier to others selling A2-73. It is a barrier because the new seller would have to be sure that at no point in their production of A2-73 did they have even a few crystals of the patented form in their process.
In addition, if AVXL can get A2-73 through FDA approval they would be entitled to 5 years of New Chemical Entity exclusivity because the molecule has not been approved for any medical use before. That is independent of any patent and would give AVXL time to build a large market for their drug. You only get NCE once so it will be good if AVXL can get AD, Rett and PD all approved within a small time window. There would be a new NCE period for A3-71 (or whatever their follow-on version is named) if they got it approved.
"Or license blarcamesine and run combo trials to raise the Phoenix."
I agree with this thought. If an amyloid plaque evangelist is successful in pushing a solution past the FDA, blarcamesine will quickly become a hot combo commodity. Not the alternative we want, but a Plan B interim option.
"That also goes for investors who have sunk millions of dollars into that theory."
Excellent outline of current prevailing AD medical dogma.
I'd suggest investors, big pharma and the Federal Government, via scientific grants, have $Billions (with a very large B) of sunk cost in amyloid plaque research. Agree, they won't let go of current hard wired AD beliefs easily with the possibility that years of scientific research effort and investment are potentially circling the drain.
Irrefutable positive outcomes achieved via a different medical approach is the only thing that will ultimately break amyloid plaque fever.
We'll know fairly soon.
The AD SOC since '96... A Pfizer cash cow for over 20 years.
Moving the needle to a better SOC seems well within reach, strongly reinforced by personal observations of a family member who was prescribed Aricept with very modest benefits and demoralizing side effects. The term "temporary reprieve" is referenced in the following Aricept description. That's the limited benefit we observed.
"Aricept (donepezil) is an oral medication used to treat the symptoms of dementia caused by Alzheimer’s disease (AD). It is marketed by Eisai in collaboration with Pfizer.
The most common adverse effects caused by Aricept recorded in clinical trials include nausea (sickness), diarrhea, insomnia (trouble sleeping), vomiting, muscle cramps, fatigue, and anorexia (loss of appetite).
How Aricept works
Aricept is thought to increase acetylcholine levels in the brain by preventing the breakdown of acetylcholine. This can increase the communication between remaining healthy nerve cells in the brain, and provide a temporary reprieve from dementia linked to Alzheimer’s by improving cognition and function.
Aricept does not treat the underlying cause of the disease, and therefore does not cure or stop its progression.
Aricept in clinical trials
Aricept has been extensively studied in clinical trials for the different stages (mild, moderate and severe) of AD. To measure changes in cognition (thinking and memory ability) and the ability to carry out daily tasks, tests such as the two-part Alzheimer’s Disease Assessment Scale (ADAS) are used.
Aricept was approved by the U.S. Food and Drug Administration (FDA) in November 1996 to treat mild to moderate AD. One of the trials instrumental in this approval of the drug was published in the scientific journal Neurology. The results showed a significant improvement in ADAS-cog score in Aricept-treated patients compared to placebo, but improvements did not persist after the Aricept treatment ended, suggesting that Aricept had a positive effect on managing symptoms, but no effect on the underlying disease.
Aricept became the first treatment approved to treat all stages of AD in 2006, when its use was extended to patients with severe Alzheimer’s.
Observations by Michele Grant from another message site echoing, in part, RedShoulder's most recent post.
* The remaining ReTT trial is for 5 to 17 year olds, which I would call juvenile or pediatric instead of adolescent.
* The only current competitor for a ReTT treatment (Acadia) subjected many of their patients to vomiting & diarrhea, which is not a side effect of 2-73. Additionally, 2-73 appears to be more efficacious based on top line results.
* Anavex's 509-person Alzheimer's trial is scheduled to finish before any other phase 3 trial registered with the FDA.
* The PDD OLE data set should be complete about the same time the phase 3 Alzheimer's data set is complete.
Pharma has been executing an "all in" strategy and has collectively sunk billions in amyloid plaque reduction research. Tough pill to swallow if they're wrong...no pun intended.
Very nice job on your summation of the call. More concise than the actual call.
Improved Q&A too.
I'm assuming george may have taken the day off so I'm posting a notable retrospective article from August 2020. The significance being Australian Health Regulators (TGA) provided their approval for compassionate use of 2-73 at the completion of the five year Phase 2a trial. You can likely project some patients have now been taking a form of 2-73 for up to seven years. Compassionate use may have primarily targeted trial participants, but it's hard to believe word of mouth wouldn't prompt doctors outside the trial from requesting compassionate access to 2-73.
"Anavex Life Sciences Receives TGA Special Access Scheme Approval for ANAVEX®2-73 (blarcamesine) for Alzheimer’s Disease Patients
Compassionate Use Special Access Scheme Approval for Alzheimer’s Patients to Continue Treatment with ANAVEX®2-73 (blarcamesine) after Completing the 5-Year ANAVEX®2-73-003 Phase 2a Clinical Study
August 05, 2020 16:05 ET | Source: Anavex Life Sciences Corp.
NEW YORK, Aug. 05, 2020 (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 patients from the ANAVEX®2-73-003 phase 2a Alzheimer’s disease trial will continue treatment with ANAVEX®2-73 (blarcamesine) via the Australian Government Department of Health - Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme following completion of over 5-years daily dosing of ANAVEX®2-73 (blarcamesine) and recommendation by their physicians.
The TGA approved the Special Access Scheme Category B applications based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that ANAVEX®2-73 (blarcamesine) may benefit patients. Anavex will facilitate continued access to ANAVEX®2-73 (blarcamesine) through the Special Access Scheme at the physicians’ request.
“We are honored to support medical professionals and their patients seeking treatment for Alzheimer’s disease and who have very few medical options,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical ANAVEX®2-73-002/-003 studies are exploring the long-term effect of daily treatment with ANAVEX®2-73 (blarcamesine) over 5 years, however it is pleasing that physicians have requested extended treatment of their patients with ANAVEX®2-73 (blarcamesine) beyond these 5 years.”
The Special Access Scheme:
Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies." 1
1 https://www.tga.gov.au/form/special-access-scheme
We continue to fly too far under the radar. As someone suggested in an earlier post, the competition is real.
The included link from a July '21 article in Medical Startups list 33 recent ALZ Disease startups with funding in excess of $2B all chasing the most valuable medical treatment in history. Add them to the companies currently running 172 ALZ clinical trials listed in the NIH drug development pipeline summary, including 47 phase III efforts. All clamoring for favorable FDA attention.
To the extent circumstances allow, let's hope Dr M has a strong sense of urgency and is acting with all due haste.
https://medicalstartups.org/top/alzheimers/