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Biogen, Eisai and Lilly and their high cost and possibly dangerous drugs to attack symptoms rather than causes show that Anavex and other companies still have a future in the quest for Alzheimer's treatment!
Eisai is pushing Leqembi in Japan and putting money ito the new blood tests to tell of amyloid plaque before the Alzheimer's symptoms are visible. Treatment is over $20,500 a year and requires evasive tests now. Its efficacy is only 27% over placebo. That there may be second thoughts about the "mab" treatmeants and their side effects is evident in the FDA additional requirements for Lilly's drug. It appears that the bar is low at the FDA and Anavex may ready to submit a NDA application as the MMA process proceeds with the EMA.
https://asia.nikkei.com/Business/Pharmaceuticals/Eisai-Biogen-Alzheimer-s-therapy-to-cost-about-20-000-per-year-in-Japan
Alzheimer's future sales forecast....that is shortly in our future starting in Europe!
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Despite Leqembi's launch pains, Eisai projects Alzheimer's med will reach $8.8B in the long run
By Fraiser Kansteiner
By Eisai’s 2026 fiscal year—which ends in March 2027—the company figures its Alzheimer's disease drug Leqembi can bring home 290 billion Japanese yen (nearly $2 billion) in global revenues. Come fiscal year 2032, those sales could potentially swell to a whopping 1.3 trillion yen ($8.8 billion). In the near term, the company is dealing with some launch hurdles.
Mauismart....heal quickly, my right hip send its best.
Nidan....I made this point before and I'm usually not into "conspiracy theories", but see the article below on "BlackRock". Fink has about 6.6 mil shares/$34 mil with us, but....14.25 mil shares/$3.15bil with Biogen and 64 mil shares/$50bil with Lilly. Guess who he is interested in seeing succeed. The article below outlines how he has been involved with Blackrock picking winners and loses in the market because of ESG factors. While not over environmental issues, is not a stretch that a huge company like BlackRock is putting its foot on the market to protect the $Billions it has on the "Mabs". Anybody else have a good reason for our shares being so undercut with 2-73/3-71 having multiple clinical successes in seriously worldwide diseases? Its not because Anavex is not playing the game properly!
https://www.foxbusiness.com/politics/blackrock-admits-esg-advocacy-could-prove-bad-business?dicbo=v2-rOtGF2r
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Steady/Investor....drug approval by the national agencies is a very complicated process and has many factors of which trial length and size are just two of the variables. Below is a synopsis (long) of the FDA decisions on NDAs going back to June of last year. Some of the trials were short and a few had relatively small numbers of patients, A number of the drugs dealt with rare diseases/conditions. Some were rejected because of 3rd party manufacturing deficiencies. A number of them had to have continued review of data or requested such. All in all the NDA process was not easy and required some background knowledge and gamesmanship of the process by the submitting company (which we have). This is a good primer for Anavex. By the way, our prime example, Keytruda, was mentioned several times by itself and in combination with other drugs. A competitor for 3-71 falls by the wayside at the beginning of the article!
Again, this is long and should be perused when you have time.
https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=296268142&_hsenc=p2ANqtz-9K3fctEhuwvmdJM7bsesYIlp_APuUf_nSFmd69A9bdtG2Paqj5ktCWa_SPqiJsrTTUjslAr3vqTJwlEsnkw6op16xiiQ&utm_content=296268142&utm_source=hs_email
Plex....open up the story "12 $10 stocks that will triple" Then Hit "Story Continues" and its the 11th stock.
Somebody is buying with nearly 1.5m shares being traded a day....possibly the next quarters figures will continue to show the % of institutional shares continue to grow!
A positive article this morning as we switch direction in the market!
https://finance.yahoo.com/news/12-10-stocks-triple-181401608.html
Thanks Pog.... for your positive enthusiasm!
Thanks Pog....for endorsing the WWT!
Steady....still think that the Rett's parents and the over 90% of the little girls who are carrying on with our drug not to mention the adult patients, will give the FDA incentive to either approve a submitted NDA or outline a P4. They have approved other troubled submissions in the recent past and in our case we have a "safe" drug, not like "Aducanumab" which Biogen just dropped (never approved by the EMA). We may get some help from a future partner if they are in the wings!
Reyeton....go to the MJFF website under Anavex to see what is currently being studied.
Angela Nilsson is heading up the MJFF study of Anavex 2-73 for Parkinson's. Over the years she has been involved in a number of studies into the Sigma-1 role in neuroscience.
https://portal.research.lu.se/en/persons/angela-cenci-nilsson
https://www.michaeljfox.org/grant/neurorestorative-effects-sigma-1-receptor-agonist-model-parkinsons-disease
Despite all the ringing of the crying towel.....Our institutional holdings are up to 32+% last quarter with the big three, Blackrock, Vanguard and Statestreet at 6,67mil, 4.46mil and 3.64mil shares respectively! What do you want to bet they are buying at the depressed pricing which they have a hand in creating.
Xena....thanks for being such a warrior. You always fight the good fight on this site and others. You speak as an investor, but more so as champion for those who battle with serious disease. It is obvious that you have deep concern for others and that sympathy and support come from what your medical history has has taught you. It is sad that some members of this board oppose you out of negativeness towards our company's efforts to meet the needs of others. As a former football player, I realize that there are thousands in the stands that loudly voice there demands, but it is those on field that have committed theirselves to the game. Victory is for those in the game and not the stands!
May you have tailwinds and a clear flight above the clouds!
Talon
Article on 2023 VC and M&A activity. Certainly, as the EMA considers our MMA for Alzheimer's this year we will have to close the deal with a BPharma partnership for production, distribution and sales well in advance of approval (very positive plan). Look down near the bottom of the article and the estimate for the $'s in 2024 doubles 2023!
https://www.biospace.com/article/cancer-and-neuroscience-led-2023-vc-m-and-a-investment-in-biopharma/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=294133785&_hsenc=p2ANqtz-9cDlOdPzMqwIM0DP_tY2a_TTv3QJHUu8-0sxNVfOnvk-UgMfQ4-Ud8CqZASB3C1_ws-bL4OBKI9P3b0NbeUEhi_oAbnw&utm_content=294133785&utm_source=hs_email
Just a simple request my friends. When I changed to this board almost eight years ago it was because the Yahoo stock board had become almost entirely personal bickering, The Ihub board in contrast was about the stock and current biotech issues. Maybe it's beause that drug development trials are long and very laborious, but that old bickering has become more prevalent on our board and much of that personally vindictive. It wouldn't hurt if we became more considerate of each other with less attacks and negative comments on others' positions. That doesn't mean there can't be reasoned debate, just honor your opponent's person and opinion. And the old adage "if you don't have something positive to say, don't say it" holds sway in the way we speak to each other. Enough preaching!
Power....Good questions and I haven't heard this point addressed before. I think Dr, Kaufman is discussing this and other aspects with the FDA presently.
The FDA and the FEDS have been much more aggressive in their programs to attack "cancer" than they have neurological diseases. Maybe it is the fear of the more immediate consequences of cancer and that it can strike at younger ages while neurological diseases effect individuals when they are older. Research that points to much earlier onset of Alzheimer's and other diseases of the mind and nervous system may shift emphasis in the future....let's hope so!
In reading the 10-Q on the Rett Syndrome trial it doesn't seem so negative. The end point that was missed was a subjective survey yet 91% of the girls were enrolled in the OLE. Many drugs have these hurdles with the FDA and the clinical process is carried on. Just ask Biogen and Eisai! Anavex and the FDA are working towards a successful treatment of these young girls.
The 10-Q on Rett Syndrome follows:
Rett Syndrome
In February 2016, we presented positive preclinical data for ANAVEX®2-73 in Rett syndrome, a rare neurodevelopmental disease. The data demonstrated dose related and significant improvements in an array of behavioral and gait paradigms in a mouse model with an MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome. The study was funded by the International Rett Syndrome Foundation (“Rettsyndrome.org”). In January 2017, we were awarded a financial grant from Rettsyndrome.org of a minimum of $0.6 million to cover some of the costs of a multicenter Phase 2 clinical trial of ANAVEX®2-73 for the treatment of Rett syndrome. This award was received in quarterly instalments which commenced during fiscal 2018.
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In March 2019, we commenced the first Phase 2 clinical trial in a planned Rett syndrome program of ANAVEX®2-73 for the treatment of Rett syndrome. The clinical trials are being conducted in a range of patient age demographics and geographic regions, utilizing an oral liquid once-daily formulation of ANAVEX®2-73.
The first Phase 2 trial, (ANAVEX®2-73-RS-001), which took place in the United States, was completed in December 2020. This trial was a randomized double-blind, placebo-controlled safety, tolerability, PK and efficacy trial of oral liquid ANAVEX®2-73 formulation in 25 adult female patients with Rett syndrome over a 7-week treatment period including ANAVEX®2-73-specific genomic precision medicine biomarkers. The primary endpoint of the trial was safety. The dosing of 5 mg ANAVEX®2-73 was well-tolerated and demonstrated dose-proportional PK. All secondary efficacy endpoints of the trial showed statistically significant and clinically meaningful response in the Rett Syndrome Behaviour Questionnaire (“RSBQ”) response, when compared to placebo, in the intent to treat (“ITT”) cohort (all participants, p = 0.011). 66.7% of ANAVEX®2-73 treated subjects showed a statistically significant improvement in RSBQ response as compared to 10% of the subjects on placebo in the ITT cohort (all participants, p = 0.011). ANAVEX®2-73 treatment resulted in a sustained improvement in Clinical Global Impression Improvement (CGI-I) response throughout the 7-week clinical trial, when compared to placebo in the ITT cohort (all participants, p = 0.014). Consistent with previous ANAVEX®2-73 clinical trials, patients carrying the common form of the SIGMAR1 gene treated with ANAVEX®2-73 experienced stronger improvements in the prespecified efficacy endpoints.
The second, international trial of ANAVEX®2-73 for the treatment of Rett syndrome, called the AVATAR trial, commenced in June 2019. This trial took place in Australia and the United Kingdom using a higher dose than the U.S. based Phase 2 trial for Rett syndrome. The trial was a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of ANAVEX®2-73 in 33 adult patients over a 7-week treatment period including ANAVEX®2-73 specific precision medicine biomarkers. Based upon the input from the successful U.S. Phase 2 Rett syndrome trial (ANAVEX®2-73-RS-001), we updated the endpoints for the AVATAR trial (ANAVEX®2-73-RS-002) to appropriately assess the clinically meaningful outcome following International Conference on Harmonization (ICH) guidelines. These updates were approved by the respective regulatory authorities in the U.K. and in Australia, respectively, where the AVATAR trial was conducted.
The data from the AVATAR trial was released in February 2022. The clinical trial met all primary and secondary efficacy and safety endpoints, with consistent improvements in primary efficacy endpoint, RSBQ response (p = 0.037), and secondary efficacy endpoints, Anxiety, Depression, and Mood Scale (ADAMS) (p = 0.010) and CGI-I (p = 0.037) response. Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms. Convenient once daily oral liquid doses of up to 30 mg of ANAVEX®2-73 were also well tolerated with good medication compliance. All patients who participated in the trial were eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol and subsequent Compassionate Use Program.
The very first trial of ANAVEX®2-73 in pediatric Rett syndrome patients, the EXCELLENCE trial, completed enrollment in February 2023. This randomized, double-blind, placebo-controlled Phase 2/3 trial in pediatric patients with Rett syndrome included trial sites in Canada, Australia, and the United Kingdom. 92 pediatric patients with Rett syndrome between the ages of 5 through 17 years were treated daily with up to 30 mg ANAVEX®2-73. Participants were randomized 2:1 (ANAVEX®2-73:placebo) for 12 weeks, followed by a week 16 safety visit and topline results from this trial were announced in early January 2024.
After 12 weeks, the study showed improvement on the key co-primary endpoint RSBQ, which is a detailed 45-item questionnaire for assessing multiple Rett syndrome characteristics by the patients’ caregivers. The other co-primary endpoint, the CGI-I, which represents a less granular assessment by the site investigators using a seven-point scoring (one=“very much improved” to seven=“very much worse”), was not met.
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In an ad-hoc analysis, using the predefined mixed-effect model for repeated measure (MMRM) method, after 12 weeks of treatment, ANAVEX®2-73-treated patients improved LS Mean (SE) -12.93 (2.150) points on their RSBQ total score compared to LS Mean (SE) -8.32 (2.537) points in placebo-treated patients. The LS Mean difference (SE) of -4.61 (2.439) points between treated and placebo groups did not reach statistical significance (n=77; p=0.063). ANAVEX®2-73-treated patients demonstrated a rapid onset of action with improvements at 4 weeks after treatment with a RSBQ total score LS Mean (SE) -10.32 (2.086) points in the drug-treated group compared to a LS Mean (SE) -5.67 (2.413) points in placebo-treated patients. The LS Mean difference of -4.65 (2.233) points between treated and placebo groups was statistically significant (n=77; p=0.041).
The key secondary endpoint, the ADAMS, trended favorably. In the same analysis, scores for all RSBQ and ADAMS subscales improved over the course of the study. Collectively, the RSBQ and ADAMS demonstrated improvements in multiple areas, impacting positively in particular repetitive movements, nighttime disruptive behaviors and social avoidance.
A preliminary review of the safety results indicates there were no new safety signals in the EXCELLENCE study, reinforcing the favorable and manageable safety profile observed with ANAVEX®2-73 to date.
All patients who participated in the trial were eligible to receive ANAVEX®2-73 under a voluntary open label extension protocol.
A high enrollment rate in the OLE of over 91% and the high level of requests for the Compassionate Use Program (93%) provide solid numerical evidence for the reported positive Real World Evidence (RWE) from patients with Rett syndrome under Compassionate Use Authorization. Families whose children were previously on drug or placebo in the placebo-controlled trial commented favorably on the improvement of their child’s daily life due to ANAVEX®2-73 treatment in the Compassionate Use Program.
The drug industry is a very competitive market....just look at the market's advertisements starting at each evening news programs. These of course are approved drugs, but getting development news is also very important to biotechs. So new drug development needs to stay in the pubic eye. Here is one article from last summer. Anavex needs to continue the public relations effort! The second article is from today with one of the companys only in early clinical stages.
https://www.biospace.com/article/companies-to-watch-12-late-stage-contenders-in-neurodegenerative-disease/
https://www.biospace.com/article/five-alzheimer-s-data-readouts-to-watch-for-in-2024/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=292811519&_hsenc=p2ANqtz-_JpdwTCrsblMZDgmGPeOP_RUNJboSy0s-QCjxyGK2nUk8E0zHJvAqPbS7HRNEvlnbEK58TaWCqzZKvqbD178Lu8UKRHw&utm_content=292811519&utm_source=hs_email
The whole Market is down on the FEDs dampening rate cuts! Except NIVDIA up $27 on 50 mil shares!
Pog....Anavex has been cleared by the EMA to file for NDA for Alzheimer's, has further tests for Parkinson's in progress with MJFF, has significant Rett OLE data being/to be presented to the FDA, the beginning of a P2 starting for 3-71, and several other disease trial candidates in the wings...significant progress internationally for a biotech with under 50 employees. Please supply us with the names of other small biotech with equal international scope.
That the premise of small biotechs not facing pharmaceutical/market pressure from BP and MM is what is "absurd".
I agree with you that Anavex has been ineffective with its PA efforts and that fact should be made evident to management. That short coming is a consequence of the ugly legal experience early in the company's history.
Plex/Power...I too have wondered about our stock's poor market response despite good progress of 2-73 and 3-71 in multiple serious diseases. Much has been said about laying this negative progress at the foot of our CEO and the company's staff management. I have noted before that our success in Alzheimer's, Parkinson's, MS. Schizophrenia, Retts and other diseases threatens many big Pharmas. Could there be blowback and manipulation by powerful elements controlling the markets who are deeply invested in our big market competition? I have watched a video ad which tied ALADDIN, BlackRock/Vanguard/ StateStreet, ESG investment and connection with the currant Administration(FDA) as powerful market factors. This will certainly be met with calls of radical speculation, but there may be more than a little truth behind our company with good science and $150 mil in the bank being treated so poorly with over a million shares traded most days!
Anyone's thoughts
Merck "Keytruda" is the most lucrative and widely used drug for cancer. It is my guess that Merck may look at 2-73/3-71 as similar drugs with similar wide uses in the neurology arena.
"Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023"
A way to sign up for our Parkinson progress thru shakeitup.org.
https://shakeitup.org.au/new-treatment-shows-clinical-benefit-in-patients-parkinsons-disease-dementia/
What about Merck?
Merck still in the market for deals in the $1B to $15B range, CEO says
Our dealings several years ago with Biogen in evaluation of 2-73 for MS was doomed at the time because of the future competition between 2-73 and Aducanumab(Aduhelm) for Alzheimer's. The money and controversy Biogen (not to mention the departure of their CEO and chief scientist) experienced over Aducanumab/Aduhelm shows you how fickle bioscience is. That we have carefully developed 2-73 and will soon see the results in the reduction of human suffering and investment returns is heartening!
https://www.biospace.com/article/biogen-axes-alzheimer-s-drug-aduhelm-to-focus-on-leqembi-in-resource-realignment-/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=292226770&_hsenc=p2ANqtz---r78D1cATwgNULA73MTYrW5NAnNPEXufwdxL8vCuCJsuULh4LtvRhVJBwYTjnpoNzrN2XX0EUB-_FzjZHw9p-tgE33Q&utm_content=292226770&utm_source=hs_email
Second QTR......I hope!
A little more info on the evolving new test for Alzheimer's
https://www.foxbusiness.com/lifestyle/alzheimer-blood-can-be-gamechanger-for-early-detection
The evolving new blood evaluation for Alzheimer's may trigger a much larger number of actual and potential people with the disease. It will lead to possible millions who will take 2-73 as a simple pill for the disease or prophylactically for prevention. The noninvasive pill form of our drug with no significant side effects will deal quickly with a significant increase in the number of actual/potential Alzheimer's patients! All we need will be a very large and worldwide partner who can produce/distribute/sell our drug. Think we will see that partner appear when we apply for a new drug status with the EMA.
Power....It was down from the last reporting:
Institutional Ownership: 13D/G Filings
This table shows a history of the 13D/G filings made by the investor and/or investor group. Note that the share values in this table are not directly comparable to any numbers shown in the 13F table (if any).
File
Date Effective
Date Form Prev
Shares Latest
Shares ?Shares
(Percent) Ownership
(Percent) ?Ownership
(Percent)
2024-01-22 2024-01-22 13G/A 5,812,605 3,642,702 -37.33 4.44 -40.48
2023-02-09 2023-02-09 13G/A 3,834,034 5,812,605 51.61 7.46 48.02
2022-02-09 2022-02-09 13G 3,834,034 5.04
I'm not stuttering......I'm having trouble deleting the second post...oh well, just emphasis on the good news!
Good day....we are up nearly 8.5% this morning. Institutional ownership is nearly 32% with the big three ( Blackrock, Vanguard and Statestreet) owning $17.45 mil shares as of the last reported quarter. It will be quite a short squeeze with the shorts at over 20mil shares!
Steady....share your frustration and the constant bickering is why I came to this board from Yahoo some years ago. Hope we could agree that besides investment the motivation for us being with Anavex is the belief that our drugs can effectively ease the pain of serious diseases attacking children to elderly in society. We can differ on questions of national/international medical management and our company's business actions, but lets be polite and considerate of each other in the process. Thanks for your positive inputs.
Talon
Cres....over the 8 years I've been invested in Anavex there has never been expenditures near $50M/yr...more like under $15-20M.
Cres.....as a comparison, investigate what Biogen did to get Aducanumab approved (with more than a large hand from the FDA). It came down to endpoints that it could get past (amyloid plaque) rather than efficacy against Alzheimer's! There has been substantial RWE in the RETT girls. You can second guess the company on clinical tactics, but 2-73 has been effective in older Rett women and arguably on the pediatric side also.
Cpap....We've probably been neighbors (distant) at one time. Flew C-141s out of Charleston and our son was born there 50 years ago....my how time flies! Have faith in our investment which is not just that , but a statement that we believe that our drugs will truly serve society which from children to seniors are in the clutches of terrible diseases. The medical and investment hurdles seem endless, but success is not only financial, it is life giving to those who are less fortunate than us!
Keep your hope my friend.
Talon
Negative news is always quicker to be aired. Although this article contains Anavex's reasoning for coming up short on the one endpoint it is one of several on Biotech websites that has carried the negative news. It seems they much quicker to report negative rather than positive Anavex progress. The PR release just prior to the JPM presupposes, as some have said, that CM has some very optimistic words for the attendees.
https://www.biospace.com/article/anavex-s-stock-nosedives-after-posting-trial-results-for-rett-syndrome/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=288627796&_hsenc=p2ANqtz-_izMh-Ol2xy047YgqLMbpm73LKB1NRFmFCgQY5v1uyW1bwLh4wgXAOeinYQaE3_8x-7tk8jeGSBrFVIH15Ov8ksa7fNg&utm_content=288627796&utm_source=hs_email