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The beauty of Anavex is there is no
Competition. Every disease starts with cellular imbalance.. so cellular homeostasis is the Alpha drug.
However ,
Annovis does have an incredible drug
That saves nerves.. I believe the combination of the two
Can save many many people.
Some disagree..
I would like to see some preclinical work in transgenic mouse models
McM what are your thoughts (or anybodys) on this post. I am a little behind in this sector.
Bourbon_on_my_cornflakes Friday, 05/21/21 06:49:11 PM
Re: None 0
Post #
311006
of 311051
WHAT IS THE P-VALUE THE FDA REQUIRES??????
"the ANVS401-treated group compared to the placebo group at 25 days showed an improvement of 3.3 points, or 22% (p= 0.13)."
ISN'T P-VAL OF 0.05 OR LESS NORMALLY REQUIRED BY THE FDA??????
MAYBE SOME WALNUTS WOULD HELP?????
Not a threat to AVXL?
Great company..
Ceo has already started and sold one biopharm..
Will always keep the shorts and longs guessing..
Is it for sale or isn’t it?
Haha.. good luck to longs!!!!!
just kidding McMagyar, but now there are eyeballs on this thing, for good or ill.
Axonal Transport for Alzheimer? Interesting.
Hurry up, millions to make using Grandma as a lab mouse!
Public offering. That’s why it dropped! Never fails to fxck up a great run!
Wouldn’t worry we will hit 200 plus watch.
You will be in gravy by EOY..
bought 4700 shares avg price 94.23. I think I want my money back.
* * $ANVS Video Chart 05-21-2021 * *
Link to Video - click here to watch the technical chart video
Same I suspect another 100 percent run Monday. Still way undervalued at this point. Maybe hit mid 100s Monday ?
Sold someday playing with house money now
And Friday delivers.....
...favorable results.
$ ANVS
congrats have a great weekend
I made a ton of money
Thanks Crude.. I think they should move this teleconference up.. or include more Firms and aanalysts!
crude ...thx for the info
Kiwi
Wow took a two hour nap and now $$$$. Solid run. $100+ next.
$150.00+ by next Wednesday presentation. May 26
Annovis' Parkinson's disease treatment ANVS401 shows promise in mid-stage trial
May 19, 2021 Annovis Bio, Inc. (ANVS)
By: Aakash Babu, SA News Editor
Annovis Bio (NYSE:ANVS) announces positive results from its double-blind, placebo-controlled mid-stage trial for ANVS401, its lead drug candidate for the treatment of Alzheimer's disease (AD) and Parkinson's disease (PD).
The levels of inflammatory markers in PD patients treated with ANVS401 were "significantly lower" than before treatment, the company said.
The trial measured four inflammatory markers that are very prevalent in the brains of AD and of PD patients. Each of the markers showed statistically significant reduction after 25 days of treatment with ANVS401 as compared to baseline.
The company said that the full study data, including a dose ranging analysis in 40 PD patients, is anticipated in July or August of this year.
Annovis Bio believes that the data and prior clinical results support the potential advancement of ANVS401 into late-stage studies, which the company is targeting in late 2021.
Annovis had filed an application with the U.S. FDA to receive orphan drug designation for ANVS401, for the treatment of AD in persons with Down syndrome, last week.
NEXT WEDNESDAY > Annovis Bio to Participate in Alzheimer Disease Panel Presented by Maxim Group LLC and Hosted by M-Vest on May 26th, 2021
4:31 pm ET May 20, 2021 (Newsfile) Print
Berwyn, Pennsylvania--(Newsfile Corp. - May 20, 2021) - Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced CEO Maria L. Maccecchini , Ph.D., will participate in the Alzheimer Disease Panel, presented by Maxim Group LLC and hosted by M-Vest, on Wednesday May 26th, 2021, at 11:00 a.m. ET.
The panel discussion, led by Dr. Jason McCarthy, Maxim's Senior Managing Director of Biotechnology Equity Research, and including other voices in the healthcare industry, will cover exciting topics in AD drug development.
To access the panel discussion, please RSVP.
Webinar Details:
Panel Session Title: Alzheimer Disease Panel
Date and Time: Wednesday May 26th, 11:00 a.m. Eastern time (8:00 a.m. Pacific time)
Presented by: Maxim Group LLC | Hosted by: M-Vest
Moderated by: Dr. Jason McCarthy
Click Here to reserve your seat
About Annovis Bio
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD) and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have two ongoing Phase 2a studies: one in AD patients and one in both AD and PD patients. For more information on Annovis, please visit the company's
No great find tho
Did he mention this other orphan drug co.?
CUBT?
ANVS on Seeking Alpha:
Annovis Bio shares rise on positive data from ANVS401 Alzheimer's disease trial
May 21, 2021
Annovis Bio, Inc. (ANVS)Annovis Bio, Inc. (ANVS)
By: Aakash Babu, SA News Editor
Annovis Bio (NYSE:ANVS) announces promising results from a double-blind, placebo-controlled study of ANVS401, its lead drug candidate for the treatment of Alzheimer's disease (AD) and Parkinson's disease (PD).
Shares up more than 13% premarket.
Patients treated with ANVS401 for 25 days showed statistically significant cognitive improvement as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11).
From baseline to 25 days in the ANVS401-treated group, ADAS-Cog11 improved by 4.4 points, a statistically significant improvement of 30% (p=0.04).
Additionally, the ANVS401-treated group compared to placebo group at 25 days showed an improvement of 3.3 points, or 22% (p= 0.13).
This is the first double-blind, placebo-controlled study that shows cognitive improvements in AD patients as measured by ADAS-Cog and functional improvements in PD patients as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), the company said.
The safety profile of ANVS401 in the interim analysis was consistent with prior safety data that shows it to be safe at 80 mg once a day in humans. There were no adverse events that could have been ascribed to the drug treatment.
Assuming successful completion of its ongoing Phase 2a study, the company anticipates to advance ANVS401 into late-stage studies by late 2021.
Agreed!
Annovis needa to fast track to adjunctive trials with anavex.
Anavex and annovis should be married..
Soon
Orphan drug fast track in place.
That is a great post.
Beautiful news.. took long enough
I follow this Grizz Adam’s guy on Yahoo. He’s called like 10 stocks ? How this and PDSB. He called it yesterday ?
Unreal
Annovis Shares Spike To Session High, Halted On Circuit Breaker Up 61%
Great! Big Pharma will be negotiating with ANVS. HUGE $$$$$ will be heading to ANVS >>> $150.00 +
I purchased another 15k shares hope it was a good idea
Annovis Announces Results From Double-Blind Placebo-Controlled Study Of ANVS401 Showing Statistically Significant Cognitive Improvement, Measured By Alzheimer's Disease Assessment Scale-Cognitive Subscale 11
8:06 am ET May 21, 2021 (Benzinga) Print
Annovis Bio Inc. (NYSE:ANVS), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced new results from a double-blind, placebo-controlled study of ANVS401, its lead drug candidate for the treatment of AD and PD. Patients treated with ANVS401 for 25 days showed statistically significant cognitive improvement as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11). The 11-part test is one of the most frequently used tests to measure impaired cognition in clinical trials for AD.
Dr. Maria L. Maccecchini, CEO of Annovis Bio, explained: "We previously reported that ANVS401 significantly increased speed, coordination and motor function in PD patients in this trial. We set up this study to measure the toxic cascade leading to nerve cell death and loss of function and its reversal in AD and PD. Since the study was powered to investigate changes in biomarker levels, not to demonstrate efficacy, we believe these results are that much more impactful."
Efficacy
From baseline to 25 days in the ANVS401-treated group, ADAS-Cog11 improved by 4.4 points, a statistically significant improvement of 30% (p=0.04).
Additionally, the ANVS401-treated group compared to placebo group at 25 days showed an improvement of 3.3 points, or 22% (p= 0.13).
This is the first double-blind, placebo-controlled study that shows cognitive improvements in AD patients as measured by ADAS-Cog and functional improvements in PD patients as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).
"The results from the first cohort of 14 AD and 14 PD patients, show that the drug is effective in both diseases," stated Dr. Maccecchini. "Seeing efficacy in both patient populations supports our hypothesis that the impairment of axonal transport, the information highway of the nerve cell, affects nerve cells in the same way in both diseases. The toxic cascade in neurodegeneration begins with high levels of neurotoxic proteins, which impair axonal transport, increase inflammation and eventually lead to nerve cell death and permanent loss of cognition and function."
Axonal Transport
High levels of neurotoxic proteins lead to impaired axonal transport, which is responsible for the communication between and within nerve cells. By inhibiting the translation of multiple neurotoxic proteins, ANVS401 improves axonal transport, reduces inflammation, protects nerve cells from dying and leads to better cognition and function.
Figure 1
To view an enhanced version of this graphic, please visit:
https://orders.newsfilecorp.com/files/7656/84812_dddd92333490aadb_001full.jpg
On the left (Figure 1) there are three pictures of axonal transport through an axon (arm) of a nerve cell. The first picture shows the axon of a normal healthy nerve cells: the black dots depict information packages which flow smoothly from the left to the right. In the middle is the arm of a sick nerve cell. The information packages stop, then move, then stop again. At the bottom, the same sick nerve cell is treated with ANVS401 and the information flow is re-established. This shows in a very visual way, how normalizing axonal transport increases the flow and re-establishes normal function.
Comparison to Other Studies
In 2019, Biogen reported the data from its EMERGE study, a double-blind, placebo-controlled large phase 3 study and showed an improvement of 1.4-points in ADAS-Cog13 over one year.
In February 2021, Cassava reported in an open-label phase 2 study a 1.6-point improvement in ADAS-Cog11 over six months.
With ANVS401 in a double-blind, placebo-controlled study, Annovis Bio is reporting statistically significant improvements in ADAS-Cog11; specifically, a 4.4-point improvement, when the same people are measured at baseline and 25 days later. We also see a 3.3-point improvement when at 25 days we compare placebo to treated in less than one month. While we do not know how ANVS401 will affect cognition after more than one month of treatment, the present results show promise that the drug may improve or stop the course of AD.
Safety
The safety profile of ANVS401 in the interim analysis was consistent with prior safety data that shows it to be safe at 80 mg once a day in humans. There were no adverse events that could have been ascribed to the drug treatment.
Interim Analysis
Annovis Bio's ongoing Phase 2a study is designed to treat a combined total of 68 patients for four weeks with the Company's lead compound, ANVS401. The first 14 PD plus 14 AD patients, whose data are reported here, have finished treatment and their biomarkers are being measured. Recently, Annovis Bio reported the results of the measurement of inflammation in the first 14 PD patients using four biomarkers. The last 40 patients are being treated with different doses to determine the optimal dose. The study compares, in both patient populations, how nerve cells die by measuring all the steps in the toxic cascade leading to nerve cell death and how ANVS401 reverses the toxic cascade and recovers normal brain and body function.
Next Steps
The cerebral spinal fluid and plasma samples of the 14 PD and 14 AD patients who completed treatment are continuing to be analyzed to measure the reversal of the toxic cascade with additional data expected to be reported in the next two months. The full study data, including a dose ranging analysis in 40 PD patients, is anticipated in July or August of this year.
Following completion of the Phase 2a trial, Annovis Bio will request a meeting with the FDA to present the results of the trial and its chronic toxicology study in animals. Annovis Bio believes today's data and prior clinical results support the potential advancement of ANVS401 into late-stage studies, which the Company is targeting in late 2021, assuming successful completion of its ongoing Phase 2a study.
Also confirms good data
The Orphan Drug route is the quickest and least expensive way to get to market.
As Annovis and Anavex both believe their drugs may help alleviate suffering within the Autism Spectrum, they should form
an alliance and begin pre clinical testing
as adjunctive therapies..
It is very exciting to offer hope!
Annovis Bio files for FDA orphan drug designation for ANVS401, shares rise
May 13, 2021
)By: Aakash Babu
Annovis Bio (NYSE:ANVS) announces that it has filed an application with the U.S. FDA to receive orphan drug designation for its lead drug candidate, ANVS401, for the treatment of Alzheimer's disease (AD) in persons with Down syndrome (DS).
Shares up nearly 8% premarket.
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.
The special status would qualify ANVS401 for certain benefits and incentives, including seven years of marketing exclusivity, once it gets regulatory approval.
DS occurs in about 1 in 700 newborns and about 200K people in the U.S. have the condition. People with DS often experience a gradual decline in cognition as they age, which can lead to AD.
Annovis had announced positive results of an interim analysis from study of ANVS401, in March.
Thanks Trader..
Good stuff
This guy on Yahoo named Grizz is like the stock god of bios said the results will be in 2-3 weeks.
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