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Double dose may be required.
2017 Catalyst:
Initiate Phase 2/3 clinical trial in Alzheimer’s (6/12 month, randomized, double-blind,
placebo controlled)
From corporate presentation.
N - CEO's compensation.
N+1 - Lack of adequate funding to run trials.
N+2 - Just general whining by both sides of the isle.
I guess these topics could be all bundle as FUD. Someday we will look back and have a good laugh about some of the silliness posted here and marble at some of the most insightful and balanced opinions which hopefully will come true.
Long and strong.
So true.
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https://insiderfinancial.com/anavex-life-sciences-corp-nasdaqavxl-just-gave-investors-a-big-discount/148954/
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Anavex Life Sciences Corp. (NASDAQ:AVXL) Just Gave Investors A Big Discount
ByChris SandburgPosted on July 24, 2017 SHARE TWEET SHARE EMAIL COMMENTS
The small cap biotechnology space has a reputation for being incredibly volatile and – by proxy – incredibly risky for the uninitiated investor. It didn’t get this reputation for no reason. Companies can move hundreds of percentage points on new inputs in either direction and can do so with practically no warning. Further, and often, fresh information isn’t even required to induce volatility. Market making, institutional buys and sells and a whole spectrum of other types of underlying activity (some ethical, some not) can bring about large moves rooted purely in shares changing hands and having nothing to do with underlying operational advance or decline.
We have just seen an example of the latter in Anavex Life Sciences Corp. (NASDAQ:AVXL).
Early last week, the company traded for a little over five dollars a share. At the opening bell on Friday, this had dipped to $4.86 a piece – a decline, but nothing substantial. By lunchtime that day, however, Anavex had crashed to $3.60 a share, and more than 25% decline on the session open price. No news was released by the company (other than what amounts to an inconsequential new hire) and there were no new filings with the SEC.
Anavex has since recovered some of its lost market capitalization and will open up this week at $4.21. That’s not bad, but it is still a discount to the Friday open and – as pointed out – one that hasn’t come about on the back of any negative operational release.
So what happened?
In a word, manipulation. The source of moves like this is all about big fish taking advantage of the retail market and, specifically, the portion of the retail market that have stop losses in place in and around the current share price. A large sell order triggers a bunch of stop losses, which in turn, pushes price down and triggers yet more stop losses. The cycle continues until price finds a bottom. By that time, those who placed the initial sell order have covered that position for a tidy profit and the retail base who had their stop losses triggered are flushed out of their exposures.
Anyone who has been in the space for a while will know that these sorts of moves are just something you have to accept as a biotechnology investor. This same group of traders will also know that they serve up an opportunity to pick up an exposure to the company question at a discount. Prior to this decline, and to use Anavex as an example, the company was trading for market capitalization of more than $300 million. It now goes for a capitalization of $175 million, despite nothing changing fundamentally. The difference in valuation here is the discount on offer, with a position at current prices translating to an exposure to what will almost certainly be a recovery near-term as markets rebalance and as traders take a position at current rates in anticipation of operational developments driving price higher.
For those new to this company, there are plenty of said developments slated to head press over the coming 12 months, most of which we have addressed in previous coverage here. Anavex is one for which we have held a long-term bullish bias based on the companies technology and its application of this technology to a range of unmet needs in healthcare (first and foremost, Rett syndrome), and the latest share price development has no impact on said long-term bias.
So, to sum this up, the bottom line is that the only thing that has changed for Anavex is its market capitalization and for anybody that doesn’t yet have an exposure to this company, current prices represent a nice discount to a long-term upside revaluation. Anyone who does have an exposure already might want to consider adding to that position (if they haven’t already) and averaging down on the cost of their overall allocation.
Fellow longs: this is just a reminder of what we have going. Nothing has changed about the science or planned trials. Fudsters out in force. Don't let them scare you.
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https://alzheimersnewstoday.com/2017/06/12/anavex-life-sciences-presents-new-information-on-alzheimers-therapy-anavex-2-73/
Anavex Life Sciences Presents New Information on Its Alzheimer’s Therapy Anavex 2-73
June 12, 2017 by Daniela Semedo, PhD In News.
Click Here to receive Alzheimer's News via e-mail
Anavex Life Sciences has presented new information at a New York conference on Anavex 2-73, which prevented further decline in Alzheimer’s patients’ mental capacity in a clinical trial last year.
Dr. Christopher U. Missling, Anavex’s president and chief executive officer, made the presentation at the Jefferies 2017 Global Healthcare Conference in New York City on June 9.
Anavex 2-73 addresses the misfolded proteins involved in several neurodegenerative diseases, including Alzheimer’s. It prompts the sigma-1 and M1 muscarinic receptors to help cells clear misfolded proteins.
In preclinical-trial studies before the Phase 2a trial, the company said Anavex 2-73 prevented, stopped, and even reversed Alzheimer’s.
In November 2016, the company reported that Anavex 2-73 prevented further decline in mental capacity in 32 people with mild to moderate Alzheimer’s. The objectives of the Phase 2a study (NCT02244541) were to establish the safety and the maximum dose of Anavex 2-73 that patients could tolerate. During the 41 weeks of treatment, oral doses ranging from 30 mg to 50 mg were well-tolerated, without causing adverse reactions.
Two of the trial’s secondary objectives were seeing how patients would respond to each dose level and determining whether the therapy could improve cognitive function. Another objective was to determine the drug’s bioavailability, or proportion that entered circulation. That proportion is one indication of whether a therapy will work.
Researchers used a number of tools to measure patients’ cognitive function: the Mini Mental State Examination; Cogstate battery; electroencephalographic activity; the event-related potentials, or ERP score; and the Alzheimer’s Disease Co-operative Study-Activities of Daily Living Inventory (ADSC-ADL) scale.
Researchers also evaluated ANAVEX 2-73 as an add-on therapy to Aricept, the current standard of care for the palliative treatment of Alzheimer’s. Palliative treatment refers to therapies that focus on maintaining quality of life.
The trial’s key finding was that none of the 32 patients who were treated experienced cognitive decline. Measures of brain activity, depressions and daily functioning were also stable during the treatment period.
Anavex is currently inviting patients to take part in an open-label Phase 2 extension study (NCT02756858). Researchers will continue to make Anavex 2-73 available to patients with mild to moderate Alzheimer’s who participated in the previous trial. This extension study will last 52 weeks.
This April, the company reported that its drug compounds reversed Alzheimer’s-related cognitive deficits in mice and improved processes connected with the disease. The presentations took place at the 13th International Conference on Alzheimer’s & Parkinson’s Diseases. They dealt with the treatments Anavex 2-73, Anavex 3-71, and Anavex 1-41.
Good for you in picking up cheap shares. I added to my pile as well.
For those in doubt about upcoming trials, a clear message was sent with yesterday's PR:
"I am impressed with Anavex and its potential CNS platform drug, ANAVEX 2-73, which has shown encouraging clinical safety data combined with promising preclinical anti-seizure data," said Andrew J. Cole, M.D., F.R.C.P.(C.), Director of the Massachusetts General Hospital Epilepsy Service and Professor of Neurology at Harvard Medical School. “I look forward to advising the company as it’s about to initiate three clinical trials with significant unmet needs.”
Dr. Andrew J. Cole
Dr. Andrew J. Cole is Director of the MGH Epilepsy Service, Chief of the Division of Clinical Neurophysiology and Epilepsy and Professor of Neurology at Harvard Medical School. He graduated from Dartmouth College Magna Cum Laude and Dartmouth Medical School. He trained in Neurology and Clinical Neurophysiology at the Montreal Neurological Institute, and then moved to Johns Hopkins University School of Medicine where he was Assistant Professor of Neurology. He came to Massachusetts General Hospital in 1992 where he started and developed the MGH Epilepsy Service and founded the MGH Pediatric Epilepsy Service. He has published extensively in clinical neurology, epilepsy, clinical neurophysiology and basic neuroscience. In addition to research and clinical work, Dr. Cole lectures frequently throughout the United States and internationally, and has been a visiting professor at numerous institutions in the U.S.A. and abroad
Are you kidding me? Someone with his credentials would not be quoted as such if he did not believe in the science and have evidence that the trials are in preparation and it is only a matter of time before they are launched. My belief is that we will have meaningful news within the next 2 weeks. Just an opinion as I know no more than what we all know.
Cheers!
Over time the market finds the right balance. If we have the goods, as most on this board believe, we will have many times AXON's market cap.
Today is a reaction from those who still had hope for a late AAIC entry. Once the sellers show up the MM's take advantage of it and scoop up stop loses as far as they can see. For every seller there is a buyer.
Let's enjoy the weekend and hope that we get positive news soon. Only a matter of time.
Cheers
From the oracle of Omaha:
We simply attempt to be fearful when others are greedy and to be greedy only when others are fearful.
This is a shake down of those who were hopping for late presentation at AAIC. They are gone and I hope some of the whiners here will go to. What remains is true investors who will be handsomely rewarded in due time. My boat is loaded but just added another 10k.
Mama said there would be days like this. This too shall pass.
Mp,
There might be some marginal institutional investors who may bail out. They usually place small bets and do get impatient and move on. The stronger organizations, especially those who bought-in recently, know what they were getting into. Have no doubt that in the QA sessions and 1-on-1 sessions at the investor conferences, they put Dr. M. under the microscope. they were able to look him in the eyes and asked probing questions. They made their assessment about the CEO and might have even received tid bits, without blatant violation of SEC rules, that gave them the confidence to go back to their colleagues and make the recommendation to invest significant capital on a very risky/early-stage Bio.
This does not guarantee anything, they can be wrong and often are, but it is a clear positive signal when seasoned pros make the commitment and they tend to be in for the long haul, or until a significant negative event forces them to unload.
Obviously, as we are, they expect to receive regular investor updates. Some may even contact the CEO to check in from time to time. They do have a slight advantage over retail since they have the leverage to get management's attention.
No news is sometime good news. Anavex is no longer trying to prop up PPS with fluffy PR's. That was the MO and did help to raise cash but it is no longer how the Dr. is playing the game. Expect "meaningful" news only going forward. Hopefully soon; my believe is that we will hear something within the next 2 to 3 weeks.
GLTY and all longs.
Lots of discontent, understandably, because of the lack of "big news", not attending AAIC, no PK readout, etc.
I remain calm because I do believe that we will have 3 trials initiated in 2017. I still believe that Rett will be done in time to have some conclusions before year-end. This will do a lot for the PPS, one way or the other. I am betting on good results.
In the meantime, we might get surprised with a partnership announcement, as many here speculate likely with BIIB for MS. Good catalyst for PPS increase.
That is just my opinion as I have no more information than anyone else here. Each of us needs to make the choice of continuing to believe the narrative that we have been holding on to for years or bail out and cut the anxiety and possible loses, while risking missing out on something very special from a financial standpoint. The science will prove out good or bad regardless of who the investors are.
Whining on a message board does nothing for anybody. You either believe or you don't. If you have doubts, either sell or buy some puts to hedge your bet. Biotech investing is not for the faint of hearth.
GLTY
Sell sell sell. Take your self out of this misery.
Dude,
At least do some DD before posting stuff.
The biotech's big sell revolves around azeliragon, which Pfizer dumped after a trial using a 20-mg dose was stopped after signs of cognitive worsening developed in patients. But the company, run by Stephen Holcombe with former Pfizer CEO Jeff Kindler acting as executive chairman--says the 5-mg dose demonstrated an improvement for a key ADAS-Cog score on cognition, and that's the window it's shooting for among patients with a mild form of the disease.
"This is a very, very tight window between what could be a good effect and what is certainly a very bad one," noted biotech blogger Derek Lowe, "which is surely why Pfizer dropped the compound like it was giving off gamma rays and has not returned to it."
I am certainly feeling very good about upcoming catalysts for our lil Anavex.
You have a great weekend as well.
Flying,
Nyet. I may be wrong but I believe Anavex and the Rett foundation need to inform the public when the trials are about to start. Certainly when the FDA accepts the protocol it becomes a public document. There is no way to keep it secret.
Indeed.
Pharmaceutical Companies Sponsor Clinical Trials, But Don't Directly Conduct Them
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John Lechleiter, CONTRIBUTOR - Opinions expressed by Forbes Contributors are their own.
Much of the news people hear about pharmaceutical innovation has to do with clinical trials. So I’m writing a series of posts about these trials, which underlie regulatory approval of new medicines.
The cost of developing medicines is a hot topic in health care. A recent Tufts study put the average cost to develop a new medicine at more than $2.5 billion. Many people don't realize that 60% of those costs are in clinical trials.
These trials provide information about the safety and efficacy of potential medicines, about how they should be used and who can benefit from them. Without this information, the molecules we discover and develop in our labs have no value.
So it may surprise you to learn that pharmaceutical companies don’t actually directly conduct clinical trials.
Clinical studies can be sponsored, and funded, by pharmaceutical companies – and most are. But they are carried out by independent organizations and professionals, following designs and protocols (Dr. Fadiran's job) agreed upon by all parties and approved by ethical review boards.
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3 trials will be initiated this year. Book it!
Ditto.
I agree about not being scripted. He, like us, is a believer and has done a great deal of DD. Nice summary he provided about the explosive potential of Anavex.
News on the horizon.
Listen carefully. Nothing that we don't already know but it is good to hear the bullish view from a seasoned investment professional.
https://www.moneyshow.com/video/10850/2017-top-picks-mid-year-update-tom-bishop//?scode=015363
BI Research is edited by Tom Bishop, who developed the roots of the BI Ranking while earning his MBA in finance from Cornell University. He has been actively investing in the stock market for over 40 years. So, unlike many on Wall Street, the editor isn't wet behind the ears, having experienced several bear markets and countless 10-20% corrections since 1969.
BI Research began publishing in 1981 and has been published continually with the same editor since that time. Tom does all the research himself using a fundamental approach and his time tested BI Ranking System. He and BI Research have been written about in Forbes, The Wall Street Journal, The New York Times, Fortune, Money, Barron's, Business Week, and countless local papers like the Miami Herald.
https://insiderfinancial.com/heres-what-were-looking-for-from-anavex-life-sciences-corp-nasdaqavxl-near-term
Regular readers will know that Anavex Life Sciences Corp. (NASDAQ:AVXL) is one we’ve repeatedly come back to over the last twelve months plus. The company is a development stage biotechnology play that hasn’t had the easiest ride of late, with the difficulties primarily rooted in some unjustified (and in many cases outright incorrect) coverage of the stock across the financial press.
Against these headwinds, however, and in line with our coverage, Anavex has slowly but steadily appreciated in value.
In September last year, the company went for $2.51. By the start of this year, it had broken $4 a piece. At the end of May, Anavex hit session-close highs of $6.14 and has since corrected to current levels at $5.37.
We think this dip is a nice opportunity for current shareholders to load up on a few extra shares or, for those not yet in the stock, to pick up an exposure. Further, we’re looking at a couple of near-term events as potentially closing the gap on highs and getting this one moving back in line with the overarching upside momentum.
For those new to the company, Anavex’s development program is rooted in an asset called ANAVEX 2-73. The mechanism of action is something we’ve looked at in detail in the past but by way of a quick refresher, is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. The idea is that by restoring homeostasis, the drug can halt the degeneration of the cells associated with neurological conditions (Rett’s, Alzheimer’s, Fragile-X etc.) and potentially even reverse the conditions in question.
So, the latest news detailed some preclinical results from an investigation into the potential application of ANAVEX 2-73 in a condition called Angelman syndrome. This one’s an autism spectrum disorder that occurs in one in 15,000 live births and it’s characterized by severe cognitive and physical impairments, including ataxia, intellectual disability, speech impairment, sleep disorders, and seizures.
It’s a big unmet need and the latest data suggests that ANAVEX 2-73 could be effective in treating it. The results indicated that ANAVEX 2-73 administration significantly reduced audiogenic-induced seizures, which are a debilitating symptom that affect more than 80% of sufferers.
This is the deep pipeline, of course. What we’re looking at as really driving value is the near term initiation of a pivotal study in an Alzheimer’s indication and – shortly before this initiation – some expanded data derived from a phase II study in the same indication.
Alzheimer’s is an incredibly tough condition to target. Most treatments go after protein buildup in one form or another and, with its attempt to return brain cells to homeostasis, Anavex is turning conventional theory on its head. This is one of the primary reasons (we suspect) that the company has taken so much media flak along its development pathway.
If the data reads out as positive when it hits press, it’s going to be a game changer. There’s probably already enough evidence in hand to justify a pivotal initiation, but some supportive long-term data would definitely shore up the existing numbers and potentially pave the saw for a Special Protocol Assessment (SPA) for the trial with the FDA in the US.
So that’s what we want to see – strong long-term follow-up data followed by a successful pivotal protocol submission (ideally with an SPA involved) and – beyond that – the initiation of the pivotal that’s really going to start drawing speculative volume towards Anavex.
Cash is strong (around $23 million at March 31), the balance sheet is nice and clean and there is a raft of big name institutions (Blackrock, Vanguard, Park West, Knoll) with a stake in Anavex’s, and 273’s, success.
Catch up with the whole story: check out our previous coverage of AVXL here.
We will be updating our subscribers as soon as we know more. For the latest updates on AVXL, sign up below!
Image courtesy of AJC1 via Flickr
Disclosure: We have no position in AVXL and have not been compensated for this article.
Wonder how many partnering meetings Dr. M. was a participant of. All we needed is 1, the right one, to get the fireworks going.
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The final day of the 2017 BIO International Convention wrapped up with the Scientific American WorldView Super Session, the BIO Talent Connect career networking event presented by BioSpace, Start-Up Stadium, and finished the week out with a record-breaking total of 41,408 BIO Partnering meetings!
It is a fact because it was stated so in a presentation. I happen to believe, you don't. That is cool.
Fact: 32 patients in AD trial sleep better since taking A-273.
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It’s estimated that around three-quarters of people living with Parkinson’s disease also suffer from a sleep disorder. A good night’s sleep is essential for everyone, but even more so for people living with a chronic disease to help the body repair and restore itself.
https://parkinsonsnewstoday.com/2017/06/22/parkinsons-disease-sleep-disorders/?utm_source=PAR+E-mail+List&utm_campaign=6bcb71f60d-RSS_WEEKLY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_62dd4fb5e3-6bcb71f60d-72193369
THE USES OF GENOMIC INFORMATION
The development of personalized healthcare approaches depends substantially on the strength of the hypothesis being developed, said Jane Fridlyand of Genentech. Where a strong diagnostic hypothesis exists, a strong scientific rationale allows for patient selection through all stages of development. This situation can provide a relatively fast development path and a relatively straightforward path to approval.
Without a strong diagnostic hypothesis, patient selection is much more difficult. In that case, retrospective data exploration and planning for future data collection need to be emphasized, Fridlyand said.
In many cases, a biomarker and drug have been developed, but it is not clear in which population the drug will work. In this situation the three key challenges are label-enabling trial design and analysis, biomarker cutoff and refinement, and multiple biomarkers and multi-marker tests. The developers of drugs and diagnostics need to decide which patient populations should be tested. These decisions ultimately depend on the scientific rationale and clinical context, Fridlyand said. Key questions include:
What is the clinically meaningful treatment benefit level?
What is the magnitude in benefits between diagnostic-positive and diagnostic-negative patients?
What is the risk benefit evaluation in diagnostic-negative patients, and what are their unmet medical needs?
Read outs late 2017 or early 2018, likely for Rett and Parkinson's. Nanoseconds in drug development timelines.
Nidan,
He repeated it today, the data is being thoroughly analyzed to target the right subjects and reduce trial risk. My opinion is that this will lead to faster approval and that the benefit will apply to a larger pool; but why take the risk in the rial? Smart cookie we have at the helm.
No, the Dr. was very assertive: "We will initiate Rett, Parkinson's and AD 2/3 this year." Read outs possible by year end. I believe this (read outs) applies to Rett and Parkinson's which are only 12 weeks in duration.
I heard nothing to make me concern that there have been any set backs. Slow but steady.
Yes, Rett and Parkinson's this year.
Dado,
Plenty to be super excited about. Yes there are risks and nothing is guaranteed, but we just received confirmation that there are no setbacks so far and the plan continues to evolve accordingly.
For those who have not done so, please check it out:
http://wsw.com/webcast/jeff105/avxl/index.aspx
Well said. The Dr. has a plan because he knows he has the goods. He is an honest man.
Yes, yes, yes, and yes.
All is good on the Western front. Long, long, and long..
I like your BIG rather than my timid big. Cheers!
Good day, in agreement with you.
The fact that the Dr. continues to deliver the message that we are progressing with trials and that results to date have been positive is a reassuring message to us. He would be wearing an orange suit if he continued to misrepresent what he knows. I believe Missling is too smart and an honest to expose himself to that. The BOD would also be liable.
You might be right about the reaction to the presentation being a yawn. In fact, that is what I expect and my reason for posting is to temper expectations to avoid disappointment.
Keep in mind that this type of conference is done to spread the word to new potential investors. We, AVXL believers, are watching the series everyday and nothing goes by that we don't know about. Most of the general public or investors don't know diddly about it. The Dr. is working hard to change that.