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Wow Doc, are you a medical doctor or a doctorate in investment finance or BOTH? Where did you get the details of the overall AVXL spread trade? Don't tell me - "...from the Najarian brothers on FastMoney" :)
Me rooting for Anavex on Monday...
Gggooooooooo....AVXL!!!!
[click to enjoy!]
I don't understand why some of us are celebrating the vote of approval for new shares. As a shareholder since 2015 all the issuance since have been unequivocally dilutive. There is no question of trust. It's procedural to ask once mgmt is close to end of runway and does not signal a greater likelihood of future success.
mrplmer, frrol took offense to my 'simple rule' claim and I offered him the following explanation. I share it with you just to be clear:
I sarcastically call it a simple rule because I find it to be the case so often, it seems like no matter what valuation model whoever uses that multiple is persistent. I have followed biotech since HGSI got it's 1st approval and have looked up countless biotechs since on Yahoo finance. The consistency of that multiple can be statistically proven for sure.
I sarcastically call it a simple rule because I find it to be the case so often, it seems like no matter what valuation model whoever uses that multiple is persistent. I have followed biotech since HGSI got it's 1st approval and have looked up countless biotechs since on Yahoo finance. The consistency of that multiple can be statistically proven for sure.
Investment banks have a simple rule esp. when they are in business with, or seeking future business from, a biotech company:
Target price = 2x current market price (or avg over month)
I assure you SAVA will reach $12 first before they get to $97.
It will stay at around $49 for a while because the secondary got priced there. They got lucky with the pop given current mkt conditions and will get to maintain a lower float through pivotal results than Anavex going forward in all likelihood.
Perceptive may not be the #1 biotech focused HF by AUM.
Perceptive may not have been the #1 performer in 2020 among biotech focused HFs.
Perceptive certainly is among the top 5 biotech focused HFs,
Perceptive is certainly regarded in the biotech community as the #1 biotech HF and draws the most eyeballs in the community.
Perceptive may have the best 5 year track record among biotech HFs and among the highest win/loss ratio & slugging rate.
Don't know if Perceptive added this quarter or not. My feeling is they will wait for the first Rett approval as a validation of the platform to position big for Alzheimer's. They can afford to wait so as not to be seen as too early and potentially wrong in a very difficult indication.
Anavex steadily moving into the big league...
Larger investment bank coverage, a step up from longstanding Maxim to whom we owe our gratitude.
Perhaps the biggest development of all in my book...
A nibble by the #1 biotech hedge fund, Perceptive Advisors!!!
To me this is an endorsement. I have noted in the past, they gobig if the nibbled on biotech then meets their expectations and they can also go huge thereafter. Their largest holdings are close to a billion each.
The price action was coordinated churn and some short covering helped by a Barrons focus article on Alz & SAVA news. The latter reminds me of AVXL's P2a news in 2015 that ran it up to $11. Chump change compared to the heady times we live in now where the word trillion slips off our tongues like 'hey yo.' It's not just SAVA & AVXL that popped. I see 3 other Alz stocks that did the same thing to different degrees.
Barrons has an Alzheimers story pumping everything else besides $AVXL. For those who can jump the paywall:
https://t.co/YKCHo9uruF?amp=1
The Coming Alzheimer’s Crisis—and What to Do About It $CYCN, $ANVS, $SAVA, $INMB, $ACIU
Someone posted on Yahoo MB (HT David Graham):
Did anyone here check out Cassava Science's (SAVA) p2a reults at CTAD on Dec 5th? They've got their stock running hard for a full month since.
Feels like AVXL in July 2015 and wondering if I should short SAVA here.
Still got to look into # patients and duration of study.
Tau reduction p<0.01 in ALL patients? WOW! HUH?
Mention of publishing a peer reviewed paper (whatever became of AVXL's paper?)
Amazing how 2 co's AVXL & SAVA are pursuing the same indication and yet use completely different language/terminology to describe pathology/process.
Initial take - it's not convincing to me but I've only spent 2 minutes on it.
-----------------------------------------------------------
- New Data Shows Clinical Evidence of Target Engagement and Target Validation –
- Company Expects Data Publication in a Peer-reviewed Medical Journal –
AUSTIN, Texas, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (SAVA), a clinical-stage biopharmaceutical company focused on Alzheimer’s disease, today announced additional clinical data from a Phase 2a study of PTI-125, its investigational drug candidate for Alzheimer’s disease. Company scientists presented the new data during a late-breaking oral presentation today at the 12th International Conference on Clinical Trials on Alzheimer’s Disease (CTAD), in San Diego, Ca.
Consistent with over 10 years of basic research and pre-clinical data, the new data show clinical evidence of PTI-125’s mechanism of action and drug-target engagement, including:
Improvements in biomarkers of Alzheimer’s disease in plasma and lymphocytes;
Consistency across biomarker improvements in CSF, plasma, and lymphocytes;
Significant reductions (p<0.01) in both nitrated and phosphorylated forms of tau protein;
Evidence that each individual patient showed biomarker responses to PTI-125;
Evidence that PTI-125 reversed the shape of altered filamin A in lymphocytes;
Early clinical validation of the drug target – altered filamin A – as a facilitator protein between amyloid beta and both neuroinflammation and tau pathology.
Cassava Sciences expects to publish a manuscript of these new clinical data in a peer-reviewed medical journal.
“Today’s data milestone is exciting because it provides additional support for the clinical benefits of slowing down both neurodegeneration and neuroinflammation in patients with Alzheimer’s,” said Remi Barbier, President & CEO of Cassava Sciences. “We’re eager to gain more insight on the effects of PTI-125 in Alzheimer’s after we conclude, in 2020, an on-going Phase 2b study.”
Details of CTAD Presentation:
Title: “One-Month Oral Treatment With PTI-125, A New Drug Candidate, Reduces CSF and Plasma Biomarkers of Alzheimer’s Disease.”
Presentation Type: Late-Breaking Oral Presentation
Presenter: Lindsay H. Burns, PhD, VP Neuroscience
Date/Time: Thursday, December 5th at 6:00 pm Pacific time
Location: Hilton Bayfront, San Diego
The CTAD presentation is available on-line at CassavaSciences.com under the ‘Investors’ page.
PTI-125 targets both neurodegeneration and inflammatory components of Alzheimer’s disease. As previously reported, in a Phase 2a study funded by the National Institutes of Health (NIH), open-label treatment with PTI-125 for 28 days significantly improved key CSF biomarkers of Alzheimer’s pathology, neuroinflammation and neurodegeneration (p<0.001).
Cassava Sciences is now evaluating PTI-125 in a confirmatory Phase 2b study. This blinded, randomized, placebo-controlled, multi-dose study is enrolling approximately 60 patients with mild-to-moderate Alzheimer’s disease. The primary endpoint is improvement in biomarkers of Alzheimer’s disease from baseline to Day 28. Top-line study results are expected in 2020.
About PTI-125
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain, which slows neurodegeneration and exerts powerful anti-neuroinflammatory effects.
Cassava Sciences is also developing an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives significant scientific and financial support from NIH.
The underlying science for Cassava Sciences’ programs in neurodegeneration is published in prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH has awarded Cassava Sciences two research grants following an in-depth, confidential review of its science and technology. These two grant awards represent up to $6.7 million of non-dilutive financing.
I've been tuned out for 3 months now and as we close out another year with very little to show in terms of trial results, I'm left wondering...
Why did the Alzheimer's p2b and other trials have to wait for the completion of biomarker & RWE analysis with Ariana, et. al. if none of its findings were to be applied to screening for patients in these subsequently started trials??? The Alzheimer's p2a part a completed in July 2016.
None of the outcomes of ANY of these trials (that have pending results) will be influenced by these biomarker/RWE studies.
Were the biomarker/RWE analyses to determine whether or not to pull the plug on further trials? All they will do is produce some nice-to-have additional data which Missling might use to do repeat trials on subgroups if the current studies fail.
It's been one massive boondoggle! All my other biotechs have demonstrated progress. The only saving grace is Missling hasn't burnt money like most other CEOs and share price has been more-or-less perserved despite ATM activity.
Oct.2018 video: Alz. p2/3 450 patient recruitment (Channel 9 Australia)
Patient: Michael Haber
https://bit.ly/2oJOGhV
Old one, George. Love the "taking out the garbage" joke tho!
George, at this time any US recruitment for Anavex's A2-73 in Rett is probably competing with GW Pharma's Epidiolex (cannabidiol) and Ketamine (Case Western & Cleveland Clinic.)
https://twitter.com/Rettsyndrome/status/1166485677736943625
Update (ref. ClinicalTrials)
EPI-743 P2 trial completed; was conducted at the University of Siena, Italy
Ketamine recruiting sites as follows: (girls 6-12 years old)
University of Alabama Birmingham School of Medicine Recruiting
Children's Hospital Colorado Recruiting
Rush University Medical Center Recruiting
Boston Children's Hospital Recruiting
Children's Hospital of Philadelphia Recruiting
Vanderbilt University Medical Center Recruiting
Doc, Are you encouraged with what you see or feel it's inconclusive at this point. I know it's early days / prelim. data and all that. What does your gut instinct say?
Trofinetide didn't/hasn't gone anywhere (despite stat sig) because a -16% RSBQ probably isn't strong enough given the nature and preponderance of side-effects to deal with.
A minimum dose of A2-73 is effecting a -31.3% dRSBQ which reduces to -22.4% if the outlier is thrown out or -24% if the outlier is capped at -30. Commercially viable given no side effects and no other treatments?
Yes, the GABA & glutamate correlations are not incontrovertible with this limited data but do hint at greater explanatory power at higher n.
All said, a higher titrated dose & the <18 trial should produce stronger results?
Blarcamesine vs. Trofinetide: Just so everyone knows the NUMBERS...
RSBQ-Total % change measure:
A2-73 5mg qd (po)/7 weeks: -16,-16,-24,-26,-30,-76 (mean=-31.33%)
NNZ-2566 200mg/kg bid/7? weeks: mean=-16% (lousy side effects: diarrhea, vomiting)
https://bit.ly/2mHy2P0
F1ash, you're right about slide 13, only to an extent. I would counter by saying the 1 data point is a super-responder bordering on a hyper-response of -76% RSBQ change albeit an uncontrolled experiment; the other responses of -15% progressing to -30% change is not bad at 5mg. I wonder if -76% means three-quarters of the way back to normalcy - that would be amazing for a physiology cumulatively insulted for over 18 years.
Besides there are many factors that could turn the data into compelling evidence:
* current dose just 5mg will titrate up by at least a multiple despite lower than avg body weight
* reporting at week 7 seems to be the standard (as with Trofinetide) but results could continue to improve beyond week 7
* a similar/proportional dose over 7 weeks should certainly produce better results in <18yr olds
* 5mg on 6 patients has apparently already produced results that are stronger & statistically better than Trofinetide (the only near competitor). The powered up studies to come should produce better stats.
ElsaSara, it's not a theory. PDD is listed in ClinicalTrials.gov as ONE trial conducted at 25 locations in Spain & Australia. So data won't be released until all recruitment is complete & data processed. While the website still shows the status of ALL sites as "Recruiting", the last update posted was on Aug. 6th. So Spain could well have finished since.
Pretty lame Zacks Research note running up to Alzheimer's day, Sep. 21. Sifts through garbage and totally ignores Anavex. Any ideas on how to clue in Kinjel Shah?
https://finance.yahoo.com/news/6-small-drug-stocks-focus-140202295.html
pval's meeting threshold for efficacy is great for the following reasons:
* on a cohort of JUST 6 patients; hope it's replicated consistently in the remainder of the active sub-group vs. placebo
* for the 18-36 age range; should see a stronger signal in < 18yr group
* after JUST a 7-week period; longer duration could improve efficacy signal esp. because the MOA is restorative and brings about normalization
* JUST a 5mg dose means YUUUUUGE therapeutic window as we know patients can take upto 50mg
They should make it a point to release full trial data as we want to see co-primary endpoints and performance of the placebo arm. Not sure why they didn't wait a week longer to release FULL data.
I read the Wall and I clearly see the writing "Anavex-Eisai".
Gives Anavex the opportunity to retain US rights and grow into a BP.
It is Harald's moment.
If Harald/Harold are interchangeable in one's mind, most parents might recall "Harold and the Purple Crayon" - 'about a curious four-year-old boy who, with his purple crayon, has the power to create a world of his own simply by drawing it.'
https://en.wikipedia.org/wiki/Harold_and_the_Purple_Crayon
Talon38, I think it was just to maintain continuity in financing arrangements but worth noting the prior shelf of $100mm (not sure if fully used) has been upped to $250mm. With milestones so close it does kind of give the impression you suggested.
OK, that adds up, but how was the LP agreement done before the shelf registration?
F1ash, help us all out...
You said...
In citing Biogen's predicament, when you said 'let's see what happens in the coming weeks...', it struck me as curious that Missling all of a sudden after ages brought up the topic of 'licensing' at Janney for no apparent reason at all esp. at this juncture when we're focused on a couple of p2 readouts. I'm not necessarily suggesting anything.
Well, I see it as good in a way, it gives the appearance then, they have set aside the $250mm for more opportunistic future use rather than to keep the lights running at their offices.
In my experience ATM's (esp. active ones) are like bloodsuckers to SP in the absence of positive catalysts that keep a stock 'in play' to effectively counter the ATM draw.
I think they suspended/retired a 100mm shelf from 2015 and introduced this ATM with LP on Jun 7 (part of $250mm shelf) in its place.
So they are ready to start nibbling into the giant $250mm shelf already and potentially at these low levels. Didn't see this announced on Jun 7.
Eisai have got to be lunatics if they continue to hang their hat on the last one. That's why Hampel was probably brought in.
NEWS: Biogen's stock falls after co. and Eisai to discontinue late-stage trial of Alzheimer's treatment
https://on.mktw.net/2kfW16z
BIIB has been toast for a while and this is prob. the last nail in their existing Alz. gameplan.
I can imagine Hampel telling Eisai, "Now, look here folks...on the other hand we have..."
AVXL should have been up at least 20% on this news.
We have come a long long way in understanding the MOA and selectivity of A2-73 in Alzheimer's since 2015. This is all new uncharted territory that past BP sausage factories had no clue of. Amazing for such a small company to uncover all this on such low budget.
https://t.co/dl3QOEE8Io?amp=1
Neuro-Monday:
ACAD +63% EARLY stop for +ve efficacy in dementia-related psychosis
NTRP -77% no prizes for guessing right
SAVA -12% on surprisingly GOOD ALZ results for a co. with a dubious past
AVXL +6%! where's the recruitment updates, Chris??? 2 months behind est. now!