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.
Today will be a very very very good day for AVXL stock!!!!
Good lick and DOG bliss,
§
That's 3-71 §
BINGO! ...es gonna be good! §
Chemical & Engineering News: Latest News:
ANAVEX 2-73 is a novel tetrahydrofuran that exhibits high affinity and selectivity to sigma-1 receptors and synergistic action with muscarinic receptors.
https://www.wordnik.com/words/tetrahydrofuran
Introduction of spiro heterocyclic compounds:
In 1900, Bayer created the first spiran described as a bicyclic
hydrocarbon connected by a single carbon.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjIn7nPisfNAhWq5YMKHRvzAI8QFggeMAA&url=http%3A%2F%2Fshodhganga.inflibnet.ac.in%2Fbitstream%2F10603%2F34762%2F13%2F13_chapter5.pdf&usg=AFQjCNFEE95mj_IY4dFL70ifWYP0dCY0-Q&sig2=6jDQR77x7ffbv5Lsc_Q-LA
Go figure...
Anavexpiran™
§
I'm sorry counselor, I rested my case a while ago. I have read all that stuff.
I am now reading fascinating info on the structure and function of voltage-gated sodium and potassium channels. Do you think 2-73 helps regulate post-translational modification of tau within the membrane, preventing cleavage and phosphorylation?
Fascinating!
§
Yes and not yet.
Macfarlane, as lead investigator on the Prana P2a that failed:
"Professor McFarlane has been overseeing the trial of the drug at Caulfield Hospital, part of a worldwide study, and Kelvin is one of the participants. "He's been with us for 14 months and is a poster child for success in clinical trials", Professor McFarlane said."
"The preliminary results are incredible. "In people with mild Alzheimer's disease it slowed the rate of progression by about 30% compared to people who took the placebo", he added."
http://www.7perth.com.au/view/today-tonight-articles/today-tonight-alzheimers-trial
Macfarlane, as lead investigator on the Anavex P2a:
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-dr-stephen-macfarlane
"Believe nothing you hear, and only one half that you see" -Poe
§
The statement, "stop autistic kids from shaking" was general, yes. The boy I cared for would go into head shaking when sensory-overwhelmed. Dissociative and very Parkinson-like, imo.
The possibility of A2-73 as a treatment for the 'autism spectrum' was more my point.
You suffered a TBI, I believe. The possible ramifications of S-1 agonists and neuronal protection via comatic-induced inflammatory response is intriguing.
I think they should start administering the 19-144 metabolite IV to comatose patients immediately and realize it is hippocampal neuronal inflammation that shuts down the synaptic network and subsequently, the cortex region.
The natural neurologically-protective shutdown that occurs with severe TBI can be ameliorated with proper NA channel modulation at the cellular level, imo.
This is aside from the properties that prevent cleavage of AB monomers, resulting in protein conglomerations. That is a result of the sodium channel disruption within the mitochondria-ER membrane.
I have a theory...
§
Excellent post! I agree and will go into this (eventual) data release very heavily weighed on the cash side of my II. If the data supports a robust adaptive P3 I will recapitalize the position.
The regular session volume was right at 1MM. They did trade 2.6MM AH @ 4.55
This was good for us. The pps rise will come in subsequent sessions. We are getting the attention we deserve.
§
ADHD is environmentally-caused, autistic-type behavioral resposes, imo. I have done the research or I would not post my beliefs that arise from it.
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&cad=rja&uact=8&ved=0ahUKEwiKlM72_sHNAhVq64MKHRdrCFsQFgg4MAM&url=http%3A%2F%2Fwww.intechopen.com%2Fdownload%2Fpdf%2F32131&usg=AFQjCNEQITfuUIwfgQRkfD9-QdID7O_08A&sig2=ouarJsSXmj7KghGhoAps8g
NA channel dysfunction is a proven pathological process in ASDs and mixed sigma/Mx ligands target these processes.
Let's discuss further. I cared for an autistic kid years ago and the sparkle in his eye was a compelling mystery when it would suddenly go dark. He was much better when he ate high cholesterol foods, fwiw.
§
I like your assessment. MMs can borrow shares, make RPT trades, balance over time, etc.
Thanks JBG for continued diligence. No increase is a good sign, as either there are no contracts to pay with shares or the co feels petty cash is adequate and shareholder value is priority.
I'm hoping float shrinkage combined with the retail % that I can personally account for will make for a great rise on demand, upon a good data release.
Xena: I say final dip was sellers giving up on anything above 4.60, as dictated by the "HUGE ARTIFICIAL BULWARK ASKS @$4.60", which is placed via algo to balance the VWAP. Look at JAZZ, did the opposite. MMs may accumulate, but the profit comes from .00003 per trade on the release volume. That is their incentive to keep spreads tight and facilitate trades, aka keeping an orderly market.
http://www.investopedia.com/ask/answers/031115/why-volume-weighted-average-price-vwap-important-traders-and-analysts.asp
What happens if we give this drug to autistic kids and they stop shaking? We may be closer to 'miracle' than we think.
Anavex is quietly doing what this company is screaming about.
http://alzheon.com/
§
Sure, it could still drop back down very easily. We would probably add more volatility to the sector than visa versa. I think a fact of life is the 12 & 26 week results will make or break this company...unfortunately. Many can attest to that being the ugly reality to baby biotech investing. So come AAIC time it's going to be do or die, I'm afraid. Sort of the old $1 or $10 situation
I don't expect stellar results now, but I do think we will get A2-73 approved in the long run and the benefits of long term use will become apparent. Success with A2-73 and the pipeline could pay off huge for a long time.
Re: the 1-41 question:
It's affinity toward M2&3 may make it more useful in cancer, so it is reserved for that indication. Why the concern? The only connection to 2-73 is it was a precursor and it's findings were used as a comparative to the improved profile of 2-73 in the publications. Hepartes would have sold it off to raise cash for their terribly expensive laboratories.
ven69: For what, a day? Again, ifyoucantbeatem...just be prepared to short along with them. I strongly advocate a healthy short position when necessary to hedge the long. And I don't really combine options which adds more layers. Clay's picks are always big up-movers so falling the next day 90-95%(of the time) has less to do with him and more just normal market reactions. Make sense?
§
Looks like about 2.6MM after close, or 8% of the O/S. That will be good for price stability and it may start following the index(s) closer. Bad for traders because the volatility lessens and we start trading more like, say, MSTX...lots of 100s back and forth on the four decimal trades. Yuk!
Looking at the other Russel Health Care inclusions I'm seeing mostly no difference and much more large volume to the down side than big moves like we had. So I can't draw any blanket conclusions and can only go with my gut and say AVXL is very much in demand by those who might have been waiting for this catalyst to participate. Like, tutes that can't buy under $5, unless there is index inclusion. What do you think Xena?
ps- Claytrader means nothing. He does videos for big movers to the upside. Sure, there may be followers who do well shorting his picks but a handful of iHubbers are not going to bring us down.
§
woah...!!! Nice MOC for the big boys. Welcome to the index peeps!
§
Big fat AONs @ 4.10? Works for me!
The MMs only do what they're told. BREXIT is nothing but a fantastic buying opportunity.
Word! §
TomP1: The $150,000,000 S3 is still on the shelf. If Missling was able to craft a deal like this with LPC, I think he will be able to negotiate a collaboration, making it unnecessary.
"The Offerings
We may offer and sell, from time to time, in one or more offerings, the securities that we describe in this prospectus having a total initial offering price not exceeding $100,000,000 at prices and on terms to be determined by market conditions at the time of any offering.
On October 21, 2015, the Company entered into a purchase agreement (the “ Purchase Agreement ”) with the Selling Security Holder (such transaction, the “ Financing ”), pursuant to which the Selling Security Holder agreed to purchase from us up to $50,000,000 of our Common Stock (subject to certain limitations) from time to time over a 36-month period. In connection with the Financing, the Company also entered into a registration rights agreement with the Selling Security Holder (the “ RRA ”) whereby the Company agreed to file a registration statement, of which this prospectus is a part, with the U.S. Securities and Exchange Commission (“ SEC ”) covering the shares of the Company’s Common Stock that may be issued to the Selling Security Holder under the Purchase Agreement.
After the registration statement, of which this prospectus is a part, is declared effective, the Company may, from time to time and at its sole discretion, direct the Selling Security Holder to purchase up to 50,000 shares of our Common Stock on any such business day, provided that in no event shall the Selling Security Holder purchase more than $2,000,000 worth of our common stock on any single business day, plus an additional “accelerated amount” under certain circumstances. Except as described in this prospectus, there are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our Common Stock to the Selling Security Holder. The purchase price of the up to 50,000 shares that may be sold to the Selling Security Holder under the Purchase Agreement on any business day will be based on the market price of our common stock immediately preceding the time of sale as computed under the Purchase Agreement without any fixed discount. The purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, forward or reverse stock split, or other similar transaction occurring during the business days used to compute such price. We may at any time in our sole discretion terminate the Purchase Agreement without fee, penalty or cost upon one business day’s notice.
The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions by, among and for the benefit of the parties. The Selling Security Holder has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company’s common stock.
In consideration for entering into the Purchase Agreement, the Company issued to the Selling Security Holder, 179,598 shares of Common Stock as a commitment fee and shall issue up to 89,799 shares pro rata, which commitment fee shares are also being registered hereunder, when and if, the Selling Security Holder purchases at the Company’s discretion the $50,000,000 aggregate commitment. The Purchase Agreement may be terminated by the Company at any time at its discretion without any cost to the Company.
This prospectus provides you with a general description of the securities us and the Selling Security Holder may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that will describe the specific amounts, prices and other important terms of the securities.
The prospectus supplement also may add, update or change information contained in this prospectus or in documents we have incorporated by reference into this prospectus. However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness."
I know...proof's in the pudding.
§
Oh yes...I meant amplify, enhance, intensify..."aggrandize the pluripotent modulator!!!"
§
Slide 14 - "AV2--73
Normalizes
the
Impairment
in
Associa2ve
Learning
Characteris2c
of
Fmr1--KO2
mice"
It looks like the WT-A2-73 mice did slightly better than the WT.
Panel 3 of this poster shows WT/AN2-73 mice doing significantly better in water maze learning test than the WT/Water mice.
http://www.anavex.com/files/1311_Poster_Val_Def_final.pdf
Slide 14 again showing attenuation of learning skills in WT mice.
"AV2--73
Reverses
Hyperactivity
of
Fmr1--KO2
mice
to
Normal"
Nice results, here.
https://www.grc.org/programs.aspx?id=15073
https://www.grc.org/programs.aspx?id=16504
Starting to sandbag a whole lot of outside interest. We need to see some follow-through, starting with favorable 12 week data. Bring it on Terminator!
§
What is it...Acid?
If he means Missling will give a presentation in support of the generous preclinical study, but will not indicate any firm developments other than "P2 in preparation" and the stock will trade down afterwards...I tend to agree. The market obviously expects 'CURE!' and 'BILLION DOLLAR PARTNERSHIP!' or nothing at this point. The little redhead will receive no quarter after last year.
We are long overdue for some gloat fodder.
§
I see. Thank you, I always learn and am grateful for your info and corrections. The regs are too much to decipher, so I'll just keep fingers crossed and eyes open.
§
Well...don't know if it was a filing leak pop, but I'll take the six digit profits vs holding for a 1:8 to remain listed and get sold for 38¢ anyway.
Well worth that month of bid sitting!
You were talking about AF's tweet, I was following the thread. Sorry, did I need a winkie ?
Yes, ODD status is meaningless. That is why there is a Congress devoted to it and the biggest developers are a bunch of worthless biotech scams:
http://www.orphan-drugs.org/2014/10/30/top-20-orphan-drug-companies-2020/
Here we go!
§
They also stated, "Patent applications are necessarily published 18 months from filing". I believe Orveko was referring to this older patent which should get published soon.
U.S. Pat. App. No. 13/777,471
“Sigma-Receptor Ligands with Anti-Apoptotic and/or Pro-Apoptotic Properties Over Cellular Biochemical Mechanisms, with Neuroprotective, Anti-Cancer, Anti-Metastatic and Anti-(Chronic) Inflammatory Action”
Not yet published
Identical to parent U.S. Pat App. No. 12/522,761 / U.S. Pub. No. 20100069484
Another patent app I watch, 14/534698, recently got abandoned. It contained this info which I felt supported the A2-73 MOA:
[0007] There is also pharmacological evidence implicating activation of muscarinic receptors as a potential therapeutic approach to schizophrenia. For example, the muscarinic antagonist scopolamine, which is used to treat motion sickness, produces cognitive impairment and delusions of the type seen in schizophrenia. (Ellis et al. Int. J. Neuropsychopharmacol. 9:175. 2006). More selective M1 agonists have been suggested to potentiate glutamate signaling which could help exert a therapeutic effect. (Jones et al. J. Neurosci. 28:10422. 2008). In a double-blind placebo controlled trial of schizophrenic patients using xanomeline, which has preferential activity at the M1 and M4 receptors, alleviation of schizophrenia was observed. (Shekhar et al. Am. J. Psych. 165: 1033. 2008). However, because xanomeline also bound to subtypes of receptors other than M1, a number of various serious side effects were observed including GI side effects, cardiac side effects and problems with hyper-salivation.
[0008] To date, nobody has been able to harness the approach of employing muscarinic agonists because of the side effects associated with the agents' binding certain muscarinic receptor subtypes. A need exists for a method of using muscarinic agonists and for a medicament employing such muscarinic agonists that would allow for the therapeutic effects associated with activation of muscarinic receptors, but with fewer side effects.
More evidence that side effects have been keeping Mx compounds from successful development. So far A2-73's saftey profile is excellent. Enough so that it seems the company feels it is safe for infants. It could even supplant diazepam for it's indications there...febrile seizures, etc.
Alzheimer's, Parlinson's, Epilepsy, TBI, Huntington's, ALS, Stroke, MS, Rett, FTD, CDKL5, Dimentia with Lewy Bodies, Autism, Tourette, Cerebral Palsy, Coma, Down Syndrome, Prion Diseases, West, Diabetes, MD, Schizophrenia...dare I say Zellweger Syndrome?
§
$1 is possible. It wouldn't stay there, of course. The company is aggressively promoting itself, and I think they waited until things were lined up to do it, so we might not see months of silence and slow drifts down. Sales for the Q should be impressive and yet they do not have to rely on pumping that ahead of time. Nice to see.
I will buy 18s if it sinks there and certainly sell some 35s!
GLTA
§
Anavex Announces U.S. FDA Orphan Drug Designation for ANAVEX 2-73 for Treatment of Infantile Spasms
Jun 22, 2016 07:00:00 (ET)
NEW YORK, June 22, 2016 (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 diseases including Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reports the U.S. Food and Drug Administration's Office of Orphan Product Development has granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of infantile spasms.
"Infantile spasms marks the second Orphan Drug Designation for our ANAVEX 2-73 program, following the Orphan Drug Designation received for the treatment of Rett syndrome," said Kristina M. Capiak, Vice President of Regulatory Affairs for Anavex.
The FDA's Office of Orphan Products Development advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those affecting fewer than 200,000 people in the United States. The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.
About Infantile Spasms
An infantile spasm is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms at a time. Infants may have dozens of clusters and several hundred spasms per day. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.
Infantile spasms occur in roughly 2-3 per 10,000 live births, with peak incidence at 6 months of age and less than 10% of cases presenting after 12 months of age. Neurological and/or developmental outcomes in patients with infantile spasms are usually poor. Children with symptomatic spasms more frequently exhibit neurological deficits and cognitive and developmental delays.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex's lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer's disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson's Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson's disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson's disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company's most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matt Haines
River East Investor Relations, LLC
917-733-9297
Email: mhaines@rivereastir.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
Email: jabraham@jqapartners.com
§
Yes. How 'bout you? §
Will settlement open the door to sale of Alphatech Spine? Medtronic is licking it's chops.
Loaded and ready for good things in ATEC!
§
It is a direct agonist to the Sigma 1. I believe it is an allosteric antagonist to the Mx receptors, though Dr Hooper claims it an M1 agonist. This may be based on the A1-41 precursor compound data.
http://seekingalpha.com/article/3691666-story-behind-alzheimers-disease-anavexs-approach-treating
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjWgJTVrrnNAhVLK1IKHbs2D5sQFggeMAA&url=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F20829307&usg=AFQjCNGoi9ry2RDBoC56Yojj8VEzu_unhw&sig2=Jp4BNQ7bsyaQG21La31thQ
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0ahUKEwjWgJTVrrnNAhVLK1IKHbs2D5sQFggoMAE&url=http%3A%2F%2Fwww.anavex.com%2Fwp-content%2Fuploads%2F9A9B8DB2.pdf&usg=AFQjCNEOvyV9fUTRXjBeg689bUH0IsqKGA&sig2=zmqZn7WHOgKBfZTHinjfUw&cad=rja
Here is the affinity chart:
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=10&ved=0ahUKEwiJiajPp7nNAhUOVFIKHevQAMoQFghcMAk&url=http%3A%2F%2Fipimediaworld.com%2Fwp-content%2Fuploads%2F2014%2F03%2Fthe-anticipated%25E2%2580%25A6pdf.pdf&usg=AFQjCNHjXJGxFnV4TOIY2VxZ0kGy1HYiqA&sig2=WL9sbQi9RWLQGo0zH6Cp0g&cad=rja
It would be nice if Dr Hooper would re-join the discussion.
§
Heptares is part of Sosei, which does trade on the Tokyo exchange, 4565:JP. Here are a few posts I did on the subject:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122479682&txt2find=heptares
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122652549&txt2find=heptares
I'm not allowed to work this weekend, so reply on Monday and we can chat further. Other great board members will probably have you covered by then!
Best to all!
§