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That is one awesome hammer candle on the daily chart today!
Hopefully, those that were shook out today bought back in.
AVXL has a legitimate chance to own the Alzheimer's disease market, IMO. The first data from their Phase 2 trial was so much better than anything anyone else has ever reported.
The data was only for the first 12 patients and for only 36 days. Still, it's shown that 2-73 is working 4X better than donepezil, the current standard of care over that time period. AVXL should be given a hard look.
Some info -
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
https://au.news.yahoo.com/video/watch/29015798/new-pills-offer-hope-for-alzheimers-sufferers/#page1
"It's like being in the dark and someone switched the light on."
http://www.endevr.com/dementia/New-drug-might-help-prevent-slow-or-reverse-Alzheimer-s
Findings in a recent peer-reviewed scientific journal reveals that our lead drug, ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.
AVXL - $1.46
Original message -
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115196936&txt2find=avxl
Missling stated earlier in the year that he would release the Part A topline data. I would be very surprised if we don't get it as soon as he has it. Sept - Oct
I do think we'll get data sooner than the end of the year. Originally, Missling stated that top line results would be reported in September. He didn't say partial top line results, so, I figure he meant for all 32 of the patients.
It's possible that the trial has backed up a little and he won't have the remainder of the top line results until October.
Then we can expect the full Phase 2A Part A results at the end of the year.
My wag.
We better hope that the lawyer abides by that. Otherwise he could tell the Seeking Alpha writer anything that comes to mind and it would be published.
UNREAL!!!
The message board myth of a "patent issue" is given new legs!
No myth here -
July 24, 2015 interview with Anavex CEO Christopher Missling -
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
Here are a few of Dr. Misslings replies -
CM - No. All patents are irrevocably assigned or owned by Anavex.
CM - There is no patent dispute. Dr Vamvakides is required according to amended 2012 license agreement if requested by Anavex to comply with signing IP related paperwork. If Dr Vamvakides decides not to comply with the request, it does not change the course of the filing.
CM - There is no patent dispute. There is no hurdle.
Thank You and good luck to you -
May the dead horse be less severely beaten in the future!
Yes, I agree that message board myth and FUD can unsettle some long term investors. That's why I'm posting. The definitive rejection of the myth and FUD came directly from Anavex's CEO on July, 24th -
July 24, 2015 interview with Anavex CEO Christopher Missling -
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
Here are a few of Dr. Misslings replies -
CM - No. All patents are irrevocably assigned or owned by Anavex.
CM - There is no patent dispute. Dr Vamvakides is required according to amended 2012 license agreement if requested by Anavex to comply with signing IP related paperwork. If Dr Vamvakides decides not to comply with the request, it does not change the course of the filing.
CM - There is no patent dispute. There is no hurdle.
WARNING ... the subject matter of the following post is not related to a message board myth -
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
https://au.news.yahoo.com/video/watch/29015798/new-pills-offer-hope-for-alzheimers-sufferers/#page1
"It's like being in the dark and someone switched the light on."
Of course there is, in message board lair.
75% of the posts today addressed and proliferated the fantasy.
No, CEO Christopher Missling set the record straight.
This message board fabrication of a "patent issue" will still be posted on message boards long after the patent has been awarded to Anavex and the FDA has approved 2-73.
The traders will not let message board myth die.
WARNING ... relevant post -
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
Thank you for the outstanding sleuthing.
Great Info!!!
Message boards are the ideal place to fabricate an issue.
Your contribution is duly noted.
July 24, 2015 interview with Anavex CEO Christopher Missling -
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
Here are a few of Dr. Misslings replies -
CM - No. All patents are irrevocably assigned or owned by Anavex.
CM - There is no patent dispute. Dr Vamvakides is required according to amended 2012 license agreement if requested by Anavex to comply with signing IP related paperwork. If Dr Vamvakides decides not to comply with the request, it does not change the course of the filing.
CM - There is no patent dispute. There is no hurdle.
July 24, 2015 interview with Anavex CEO Christopher Missling -
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
Here are a few of Dr. Misslings replies -
CM - No. All patents are irrevocably assigned or owned by Anavex.
CM - There is no patent dispute. Dr Vamvakides is required according to amended 2012 license agreement if requested by Anavex to comply with signing IP related paperwork. If Dr Vamvakides decides not to comply with the request, it does not change the course of the filing.
CM - There is no patent dispute. There is no hurdle.
Agreed, Dr. Missling's background makes him ideally suited for the challenges ahead -
Christopher U. Missling, MS, PhD, MBA
Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
Large shareholder too. He will do what's best for shareholders.
Link to poster - http://goo.gl/8p4BoC
Yes, I remember, Abbvie bought PCYC for $21 billion.
I would have loved to have bought PCYC for under a buck in ~2009, I think it was.
Partnership example - PCYC was in early and mid-stage studies when they partnered with Janssen Biotech (JNJ) -
Pharmacyclics Scores Big With Janssen Biotech Deal
Dec 12 2011, 10:13 by: The Burrill Report | includes: JNJ, PCYC
By Marie Daghlian
Janssen Biotech, a unit of Johnson & Johnson (JNJ), is paying Pharmacyclics (PCYC) $150 million upfront for rights to co-develop and market its lead anti-cancer compound PCI-32765. The first-in-class oral Btk inhibitor blocks signaling in a critical pathway needed for tumor growth and proliferation. It is currently in early- and mid-stage studies across a variety of blood cancers, including non-Hodgkin’s lymphoma.
In addition to the upfront payment of $150 million, Sunnyvale, California-based Pharmacyclics will be entitled to receive up to $825 million in development and regulatory milestone payments. The companies have agreed to share development costs for oncology and other indications, excluding inflammation and immune-mediated conditions, with Pharmacyclics paying for 40 percent of the costs and Janssen picking up the rest. The partners will share profits equally in a 50/50 profit-loss agreement. Both companies will book revenue, Pharmacyclics in the United States and Janssen in the rest of the world.
The deal is expected to be slightly dilutive to Johnson & Johnson's 2011 earnings per share on the order of approximately 4 to 5 cents. William Hait, global head of cancer therapeutics for Janssen, said in a statement that PCI-32765 has broad applicability and the partnership is an “opportunity to bring a new form of oral therapy to patients with B-cell malignancies.”
Pharmacyclics has no marketed products. Its first product candidate, an injectable cancer drug, was rejected by U.S. regulators in 2007. Although the deal gives Pharmacyclics a hefty upfront payment, investors were not thrilled by the deal. Several analysts issued downgrades for the company citing its lack of revenues, and a market cap almost equal to the potential deal size.
In addition to the ongoing Alzheimer's Phase 2A trial, AVXL will start an epilepsy trial next. Check out the "robust anti-seizure effects" from the preclinicals below-
http://www.anavex.com/?post_type=news&p=1460
Anavex Releases Promising Full Preclinical Epilepsy Data at Antiepileptic Drug Trials XIII Conference
Company’s lead Sigma-1 agonist, ANAVEX 2-73 demonstrates robust anti-seizure effects in well established preclinical seizure models
NEW YORK, NY – May 18, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, revealed full preclinical anti-seizure data for its lead drug candidate, ANAVEX 2-73, in a presentation on Friday, May 15, 2015 at the Antiepileptic Drug Trials XIII Conference. ANAVEX 2-73 demonstrated convincing data in three well-established and according to experts highly predictive preclinical anti-seizure models with potentially more favorable side effect profile than currently marketed epilepsy drugs. The cognitive-enhancing features of ANAVEX 2-73 might be a differentiating factor since seizures cause neuro-cognitive impairments, which can be worsened by current epilepsy medications.
The strong performance of ANAVEX 2-73 was also confirmed in combination with three generations of epilepsy drugs currently on the market.
“With epilepsy, Anavex’s goal is to reduce or eliminate seizures with the fewest potential side effects. We are pleased to take this opportunity to interact with the epilepsy community so that we can effectively translate our preclinical data for potential clinical practices,” said Christopher U. Missling, PhD, President and CEO of Anavex. “There is a significant unmet need in epilepsy treatments. One-third of all pediatric and adult epilepsy patients are resistant to current treatments and many infants with rare, catastrophic forms of epilepsy experience low tolerability as well as co-morbidities. ANAVEX 2-73 is currently in a Phase 2a clinical study for Alzheimer’s, with expected preliminary data expected around the Q3 2015 timeframe. With recent research revealing the link between epilepsy and memory loss, the Company is encouraged to continue exploring this additional indication.”
ANAVEX 2-73 for Epilepsy
ANAVEX 2-73 exhibited dose-dependent significant anti-convulsive action by providing almost complete to complete protection from tonic seizures in three established seizure models.
•In maximum electroshock (MES)-induced convulsions, 30 mg/kg ANAVEX 2-73 provided 90% protection. In pentylenetetrazol (PTZ)-induced convulsions, the same dose provided 85% protection. In a semicarbazide (SCZ) model, the same dose was able to delay the tonic seizures from 56.9 seconds to 99.2 seconds. In (PTZ)-induced convulsions, 60 mg/kg ANAVEX 2-73 had a long-lasting effect with 100 % seizure protection after both 4 and 6 hours, respectively.
ANAVEX 2-73 demonstrated robust synergistic effect in combination with three drugs currently on the market.
•With Ethosuximide (ETS) (Zarontin®), a first-generation antiepileptic drug, the combination of 10 mg/kg ANAVEX 2-73 and 200 mg/kg ETS provided 80% protection in MES-induced convulsions, while no protection at all was observed at the same dose of ETS alone. In the (PTZ)-induced convulsion model, the combination of 10 mg/kg ANAVEX 2-73 metabolite and 200 mg/kg of first line anti-epileptic drug Valproic acid (VPA) (Depakene®) showed 92% protection from tonic seizures, compared with modest 12.5% protection when 200 mg/kg VPA was administered on its own. In combination with the newer-generation anti-epileptic drug gabapentin (Neurontin®), ANAVEX 2-73 metabolite also showed a statistically strong effect in the reduction of seizures, compared to gabapentin alone. In the MES test, the combination of 5 mg/kg ANAVEX 2-73 metabolite with 100 mg/kg gabapentin resulted in 90% protection from tonic seizures as compared to 40% protection with 100 mg/kg gabapentin alone.
In order to test for potential side effects often seen with epilepsy drugs currently on the market, ANAVEX 2-73 was assessed in preclinical depression as well as mobility models. In both the forced (Porsolt) swim test and the open-field test, ANAVEX 2-73 showed clear anti-depressant effects and no signs of sedation. In the chimney test, ANAVEX 2-73 yielded no statistically significant motor impairment within the effective dose range.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule that targets sigma-1 and muscarinic receptors, which have shown in preclinical studies to reduce stress levels in the brain. ANAVEX 2-73 is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial of ANAVEX 2-73 was successfully completed and showed no safety issues or toxicity signals. A total of 22 healthy male volunteers received single ascending oral doses of ANAVEX 2-73 to determine the maximum tolerated dose and investigate what, if any, side effects may result. ANAVEX 2-73 was well tolerated even at the highest tested dose of 55 mg. Study participants did not exhibit any serious side effects, nor was there any study discontinuation due to adverse events. In addition, ANAVEX 2-73 demonstrated a pharmacokinetics (PK) profile to potentially support once-daily oral dosing.
About Epilepsy
Epilepsy is the most common serious neurological disorder, affecting people of all ages. It is a term used for recurring seizure disorder, a condition that is characterized by the tendency for an individual to have repeated nervous seizures (interruption of normal brain activity). Epilepsy is considered to be a spectrum disorder that can cause other health problems, including cognitive impairments, with a wide range of seizure types and control varying from person to person. The greatest unmet needs in epilepsy remain the inadequate control of seizures that occur in 20% to 30% of drug-treated epilepsy patients, effective treatments for related orphan indications like Dravet or Lennox-Gastaut Syndrome, rare forms of epilepsy, and therapies with reduced co-morbidity, translating into a significant market opportunity. The global epilepsy market was estimated at $4.2 billion in 2012 and is expected to grow to $5.35 billion by 2022, with more than 50% of sales coming from the United States.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are 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 data 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 convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. 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
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
You've got guts talking down cheerleading when for months you have been cheerleading for a move to the downside.
Incorrectly, I might add. I hope you can see how your constant cheerleading would piss people off!
Alzheimer's Disease - Test Your Medical IQ
http://www.medicinenet.com/alzheimers_disease_quiz/quiz.htm
No, I'm not under the impression you are out -
It sure sounds like you are ready to get out though and that a little coaxing from a TA fortune teller just might do the trick.
This board is littered with posts from traders that missed the move from the .40s to where we trade now. Example -
I thought the content of your post was very interesting. I'd love to see AVXL partner and get up front and milestone payments. Just the ticket for a quick up list to the Nasdaq.
May not happen until the end of Phase 2A though.
That April pullback was before this blockbuster news -
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
Have another beer!!!
I just added at .794 -
The tiny market cap here is just too appealing!
I hope all other AVXL shareholders are as excited as I am regarding the huge "cushion" the early Phase 2 trial data provided us.
ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
4 times higher than donepezil(Aricept). 50% higher would have been extraordinary news! Big "cushion" in case future results aren't quite as good. Although, they may be better once the dosing regimen is optimized.
Looking out to the 6 month comparison, check out the P300 Change graph on the poster - http://goo.gl/8p4BoC
The trajectory of the Anavex 2-73 line is leaving the donepezil line in the dust. 4 times higher may escalate into 6 times or 8 times at the 6 month mark.
So how are the patients doing -
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
http://www.anavex.com/?post_type=news&p=1491
Nice to have the pullback out of the way -
Green the rest of the week!!!
The fake doctor has arrived!
Dr. Missling compared valuations too. Makes sense to compare -
Dr. De - Give our readers 5 reasons investors would be interested in AVXL.
CEO Christopher Missling -
1.Alzheimer's disease is a significant unmet need since no cure has been found yet.
2.ANAVEX 2-73 and pipeline targets novel mechanism of action further "upstream" of the Alzheimer's disease pathology by targeting Sigma-1 receptor and muscarinic receptors, which is believed to increase cellular plasticity and reduce oxidative stress, inflammation, abeta generation and tau hyperphosphorylation. All these effects are believed to be relevant to reduce Alzheimer's disease pathology.
3.Safety profile of ANAVEX 2-73 is clean based on Phase 1 and interim Phase 2a data.
4.Anavex management team and Scientific Advisory Board, consisting of Alzheimer's disease experts like Jeff Cummings, Paul Aisen, Norm Relkin.
5.Valuation still very attractive compare to AXON.
AXON has a market cap of ~1.5 - 2.0 billion. It's pretty well known that IF they get approval from the FDA, their drug will provide minimal benefit.
Considering the above, I see zero irrational exuberance here.
That's why we aren't at $20.00 a share -
Last week Anavex released data that showed that they may have the miracle drug for Alzheimer's Disease.
Knowing that, do you really expect AVXL to trade like every other company out there?
I don't!!!
That's a possibility. Who knows? Bob Stocks mentioned that articles (on low price stocks, I think) have to include possible negatives in order to get published.
Dr De's Opening Thoughts: Last week
The previous week was important for biotech investors in many ways. Last week saw the AAIC phase 2a trial result announcements from Anavex (OTCQX:AVXL) for its Anavex 2-73 class drugs, which showed excellent trial results for Alzheimer's. This is about the only drug that I have come across for AD for which I would dare to use that often-futile word, "cure."
http://seekingalpha.com/article/3359015-premarket-biotech-digest-gilead-earnings-tomorrow-praluent-other-approvals?isDirectRoadblock=false&uprof=
What don't you understand about this -
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
KKD - So, until you get the patent assigned to you, you cannot begin the Anavex Plus trial, correct?
CM - No. All patents are irrevocably assigned or owned by Anavex.
Canoepaddler, thanks to you and everyone else that mentioned this post -
DD - Updated Collection Of Recent Articles And Videos
The post is a sticky and I will add all of the exciting future AVXL articles and videos as they happen.
DD - Updated Collection Of Recent Articles And Videos With The Most Recent First:
Go to Anavex.com for press releases and more info on the Company
http://seekingalpha.com/article/3354415-interview-with-dr-christopher-missling-ceo-of-anavex?auth_param=d2ta:1ar4d6c:74ced639ac1ecb22d9cbea5192bcfa90
KKD - So, until you get the patent assigned to you, you cannot begin the Anavex Plus trial, correct?
CM - No. All patents are irrevocably assigned or owned by Anavex.
http://seekingalpha.com/article/3354385-anavex-may-actually-cure-alzheimers
Anavex May Actually Cure Alzheimer's
https://au.news.yahoo.com/video/watch/29015798/new-pills-offer-hope-for-alzheimers-sufferers/#page1
"It's like being in the dark and someone switched the light on."
http://www.heraldsun.com.au/news/victorians-first-to-trial-breakthrough-brain-booster-pill/story-fni0fiyv-1227453139615
A PILL to treat Alzheimer’s disease is four times more effective than the current treatment in boosting the brain power of patients.
“We’ve also had patients and their carers reporting improvements in their thinking, increased alertness and improvement in their organisation and independence,” Prof Macfarlane said.
http://thestockradio.com/otcqx-avxl-anavex-life-sciences-corp-ceo-pres-christopher-missling-2050.html
http://www.anavex.com/
Corporate Presentation - Spring 2015
http://www.endevr.com/dementia/New-drug-might-help-prevent-slow-or-reverse-Alzheimer-s
Findings in a recent peer-reviewed scientific journal reveals that our lead drug, ANAVEX 2-73 has the potential to prevent, stop, slow or reverse the disease, in addition to treating its symptoms.