]ImmunityBio and NantKwest to MergeImmunityBio and NantKwest to Merge, Creating a Leading Immunotherapy and Cell Therapy Company (agreement to merge in a stock-for-stock transaction.)
Merged entity brings together 11 Phase II / III clinical trials across oncology and infectious disease that use combined immunotherapy platforms
Together, ImmunityBio and NantKwest will have a broad, clinical-stage pipeline – including 13 assets in clinical trials and 11 in Phase II to III – as well as a robust early stage pipeline to address other difficult to treat cancers.
Broad late-stage pipeline for solid tumors including bladder, lung, breast, and pancreatic in addition to infectious disease programs for HIV and COVID-19
Transaction Details
The transaction is structured as a tax-free 100% stock-for-stock merger, with ImmunityBio to reverse merge with NantKwest. Under the terms of the agreement, ImmunityBio shareholders will receive a fixed exchange ratio of 0.8190 shares of NantKwest for each share of ImmunityBio owned. Upon completion of the transaction, on a fully diluted basis, ImmunityBio shareholders will own approximately 72% of the combined company and NantKwest shareholders will own approximately 28% of the combined company, on a fully diluted basis.
The transaction, which is expected to close in the first half of 2021. Following the closing of the transaction, the combined company will assume the ImmunityBio name and continue to be listed on the NASDAQ exchange. However, the combined company ticker symbol is expected to be changed to IBRX.
finance.yahoo.com
ImmunityBio Announces Primary Endpoint Met of Phase 2/3 Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS with 72% Complete Response Rate
QUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with 59% probability of patients maintaining complete response for at least 12 months
Over 85% of patients in this study have avoided a cystectomy to date
Breakthrough status for ImmunityBio’s superagonist Anktiva N-803 in this indication
Biologics License Application filing anticipated in second half of 2021
finance.yahoo.com
Biotech
Lilly to acquire Prevail for $22.50 per share in cash Lilly to acquire Prevail for $22.50 per share in cash (or an aggregate of approximately $880 million) payable at closing plus one non-tradable contingent value right ("CVR") worth up to $4.00 per share in cash (or an aggregate of approximately $160 million), for a total consideration of up to $26.50 per share in cash (or an aggregate of approximately $1.040 billion).
Acquisition will establish a gene therapy program at Lilly, anchored by Prevail's portfolio of neuroscience assets, and will broaden Lilly's commitment to use novel modalities to attempt to address otherwise fatal genetic forms of neurodegenerative disease.
Gene therapy is a promising approach with the potential to deliver transformative treatments for patients with neurodegenerative diseases such as Parkinson's, Gaucher and dementia
The acquisition of Prevail will bring critical technology and highly skilled teams to complement our existing expertise at Lilly, as we build a new gene therapy program anchored by well-researched assets. We look forward to completing the proposed acquisition and working with Prevail to advance their groundbreaking work through clinical development."
finance.yahoo.com
Easy 10%er upcoming Consolidation at LQDA in range of their all time low after FDA issued the biotech company a CRL due to COVID restrictions. After speaking with regulators at the FDA, The company expressed this CRL had nothing to do with the underlying data. Options activity has been healthy. I believe price will increase from here, which is why I have started a position and continue to add on any meaningful dips (eg yesterday, the company issued PR for $200 mln mixed securities shelf offering) causing week hands to sell. Stop loss under previous low, friends. let’s go!!
Disclaimer: this is not recommendation to buy or sell, this information is to be used for educational purposes only. Trade at your own risk.
BioCardia Anticipates DSMB Feedback on Interim Data1. BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial
BCDA today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling nationwide for infusion of BioCardia’s CardiAMP™ autologous cell therapy to the myocardium. The DSMB is then anticipated to provide its written feedback approximately 24 hours later. BioCardia plans to provide an announcement pre-market on December 17 , 2020 summnarizing the feedback and outlining the next resulting steps.
The CardiAMP Heart Failure study has been approved by the FDA to enroll up to 260 patients at up to 40 centers. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with ischemic heart failure . The FDA has said that the trial qualifies as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need.
www.globenewswire.com
2. BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
today announced it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about December 16, 2020, subject to the satisfaction of customary closing conditions.
finance.yahoo.com
Arvinas Nearly Doubles on Promising Cancer Drug ResultsArvinas Nearly Doubles on Promising Cancer Drug Results
The test results show the Arvinas drugs' potential for treating breast and prostate cancer, Cantor said.
Arvinas (ARVN) - Get Report shares blasted off Monday as Cantor Fitzgerald offered bullish comments on the biopharmaceutical company after it reported positive news on its breast and prostate cancer treatments.
“For ARV-471, interim Phase 1 data show potential for best-in-class safety and tolerability, estrogen receptor (ER) degradation superior to that previously reported for the current standard of care agent (fulvestrant), and robust efficacy signals in heavily pretreated patients with locally advanced or metastatic ER positive / HER2 negative (ER+/HER2-) breast cancer,” the company said in a statement.
The test results show ARV-471’s potential as the best-in-class potential estrogen receptor degrader, Cantor analyst Alethia Young wrote in a commentary cited by Bloomberg. The results are “very encouraging and demonstrated ARV-471 was active,” Young wrote. She has an overweight rating and a $66 price target on Arvinas.
“The efficacy signals include one Response Evaluation Criteria in Solid Tumors (RECIST) confirmed partial response (PR), two additional patients with unconfirmed PRs, and a clinical benefit rate (CBR) of 42%,” Young said.
Separately, Cantor said that “for ARV-110, the ongoing dose escalation portion of the Phase 1/2 trial in men with metastatic castration-resistant prostate cancer (mCRPC) has provided additional evidence of anti-tumor activity and patient benefit, including a prostate specific antigen reduction of more than 50% (PSA50) rate of 40% in a molecularly defined patient population.”
Further, “Arvinas has initiated a Phase 2 dose expansion to explore a two-pronged development strategy, including the potential for accelerated approval in molecularly defined, late-line patients, and broader development in less-heavily pretreated mCRPC patients with fewer androgen receptor (AR)-independent mechanisms of tumor resistance,” Young said.
Oppenheimer Upgrades Arvinas Inc. (ARVN) to Outperform, Following Clinical Update
www.thestreet.com
www.streetinsider.com
Solid Biosciences Announces $90 Million Private PlacementSolid Biosciences Announces $90 Million Private Placement
Solid Biosciences has entered into a securities purchase agreement with a select group of institutional investors and accredited investors for a $90 million private placement, which is expected to close on or about December 15, 2020, subject to the satisfaction of customary closing conditions.
The private placement includes new investors Suvretta Capital Management, LLC and Aspire Capital Fund, LLC and existing investors, including RA Capital Management, Perceptive Advisors, LLC, Bain Capital Life Sciences, EcoR1 Capital, LLC, Boxer Capital, and Ikarian Capital, LLC, as well as certain board members and executive officers.
In this private placement, the Company is selling 24,324,320 shares of common stock at a price of $3.70 per share.
The Company expects to use net proceeds from the private placement to fund research and development expenses, including the advancement of SGT-001, and for working capital and other general corporate purposes.
finance.yahoo.com
And just like that, Sangamo $SGMO is back at ATH market capSangamo Therapeutics is committed to translating ground-breaking science into genomic medicines with the potential to transform patients’ lives using gene therapy, ex vivo gene-edited cell therapy, and in vivo genome editing and genome regulation.
Still holding on!We entered CGEN last week hoping for a rise to 15. The biotech sector (IBB) was breaking out and our model was picking up a potential reversal signal. So far the trade has been flat to down. We will be stopped out on any close below 12 but for now we are holding strong.
Ingenuity Trading Model is an algorithm used in- Stock, Forex, Futures, and Crypto markets. The model is a Geometric Markov Model : Focuses on reversal and continuation wave structures
In probability theory, a Markov model is a stochastic model used to predict randomly changing systems. Markov Models are used in all aspects of life from Google search to daily weather forecast. The randomly changing systems we focus on are the equity, futures, and forex markets. The geometric element of the model is the fractal sine wave structure you can find on any chart you look at across any market and across all time dimensions.
Our model focuses on the current sine wave formation (current state)- geometric price formation along with its volume and volatility over a given time period and using that information to predict the future state- future price movement. For questions or more information feel free to contact me in the comment section or via private chat. To view the entire portfolio and track our performance visit our site.
Vaccibody $VACC leaping to ATH after releasing #Covid19 Data Vaccibody reports promising preclinical data with a second-generation COVID-19 vaccine and announces its infectious disease strategy
● Vaccibody demonstrates promising pre-clinical data with its second-generation COVID-19 vaccine candidate, VB10.COV2
● VB10.COV2 induces rapid, strong and long-lasting neutralizing antibodies and multifunctional, dominant CD8+ T cell and Th1 CD4+ T cell responses in mice after a single dose
● Vaccibody will present the pre-clinical data and its broader infectious disease strategy during a webcast on Friday December 11 at 10 am CET
Example of a failed Model reversal signal It was a big biotech week with many signals including CGEN, SEGN, BMRN but this one failed to hold. No Model is perfect and anyone who isn't trading with a rules based model will always underperform in the long run. No strong emotions for winners so the same must be applied to losers. We will certainly get another shot at this.
Ingenuity Trading Model is an algorithm used in- Stock, Forex, Futures, and Crypto markets. The model is a Geometric Markov Model : Focuses on reversal and continuation wave structures
In probability theory, a Markov model is a stochastic model used to predict randomly changing systems. Markov Models are used in all aspects of life from Google search to daily weather forecast. The randomly changing systems we focus on are the equity, futures, and forex markets. The geometric element of the model is the fractal sine wave structure you can find on any chart you look at across any market and across all time dimensions.
Our model focuses on the current sine wave formation (current state)- geometric price formation along with its volume and volatility over a given time period and using that information to predict the future state- future price movement. For questions or more information feel free to contact me in the comment section or via private chat
MSB - Updated AnalysisI hope you find my analysis useful.
From what I can see, price seems to be holding within the trend channel (bullish sign)
The moving averages are beginning to cross, and as you can see in the past, when that occurred, price rose (bullish sign).
Price needs to hold above the lower trend channel and break past the .786 fib to confirm bullish price action.
Stock is very news sensitive, price may rise in anticipation of an announcement and come crashing down if the announcement is lackluster.
Trade with caution, but from what I'm seeing, right now is a good time to either average in or enter the trade for a decent risk-vs-reward scenario.
*Not financial advice*
*Just my opinion*
*All investing and trading involves risk*
Moderna says they have a vaccine, ask for emergency approvalModerna announced today it would request the United States & Europe an emergency authorization for their vaccine. If my sources are correct.
As usual most of the mainstream media are unable to relay the information correctly, according to them the demand has already been made some posted at the same time say "will", and some only mention the FDA (the US one).
From their own site: "FDA has told Company to expect VRBPAC meeting for mRNA-1273 likely on December 17, 2020"
investors.modernatx.com
The FDA is the very competent very legit administration that authorized the Redemsivir after all of the final results (showing how bad it was) had been published, reviewed, circulated...
"These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of mRNA-1273 observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; "
"In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees "
Sell hype, but hey, make sure you are covered.
The price gapped by 13%, went up 4% 2 minutes after the announcement, is up 50% in the last 3 days.
Moderna investor news release is 50 lines long. Investors of course also read the latest 10Q published the 30 October available here and 400 pages long:
investors.modernatx.com
Impressive! These investors are very fast readers!
"We are expending significant efforts to further the rapid development of this potential vaccine and expect to continue to do so over the next 12 months."
Authorized and distributed by december? 12 months? Distributed, maybe obligatory, still in development? These words should not be in the same sentence.
Hey maybe I am just a plebe and it is typical for this to happen, I really need a medical advisor at some point. Dad! He sells pills and vaccines for big pharma, perfect candidate.
If (jk there is no if) - When I get rich I will need advisors in all areas I just cannot deal with that much info and misinformation, and correlations, and risks, and so on.
Hey and rich people will be able to afford real science and real medical treatments while the plebes get the untested vaccines with coinflip long term effects.
They are turning healthcare into a consumer thing, it is not about healing the sick but distributing (for a cost) supplements and medications and prevention vaccines to everybody.
I do not know if this will, or can, continue. Medical doctors are against (I think) turning the population into drugged zombies. The sheep well I am not sure about the sheep, I think the "silent majority" just obeys and follows no matter what - this is what they have done for all of history.
If they make progress to sell products to make people that go into old age have better quality years then it could work out but still not sure because those that cannot afford it are not going to accept this, people see healthcare (at least today) as a basic human right.
Anyway let the fomoers and gamblers fomo and gamble, I strongly think this is very very early, and the worse the greedy corporations and their liberal-bourgeois buddies in governments behave (how they handle this vaccine for example), the longer it will take for people to forget and the biotech bull market / revolution to comeback and go up. People have goldfish memories so it won't take an entire lifetime either, 5 to 20 years to complete a bear market then start an uptrend. Well too many variables, we will see later, for now we observe and wait. Let's see what happens with this new tech.
The biotech revolution (crisis, collapse, rebuilding)Hello
I still think the next bull market will probably include biotech, high tech, renewable energy.
After a violent bear market there might be a new peak civilisation, in the past they all happened during climatic peaks (Babylonians, Egyptians, Romans, Europeans/British empire), I do not know if the cause was rather the heat or the CO2 itself.
Now the roman republic had those big socialist issues, the assassination of Caesar 1 year after he reduced the number of romans on bread welfare (conspiracy theory, his position surely has not helped) and then after civil wars here comes the Roman empire, 17 years after Caesar assassination so ye it might take a while. The roman empire peak is considered to be around 250 AD, but we are not after the peak we are after catching the uptrend early on.
Right now I only see very short term speculation as making sense. It could be 3 decades or more before getting real investments, things take a great amount of time.
Pretty sad we'll all be old by then. It could come faster, in particular from the emerging world.
Scientific research is very correlated to GDP, and looking at the number of papers published we can see the US continues to lose dominance, and all european countries and Japan are not in an uptrend, while China, Iran (yes Iran), middle east & african countries are on double digit growth. Another reason than GDP is westerners (and japanese) are encouraged to work in finance & business (the best ones I mean) whereas in poor countries their best most shiny glamorous goal is PHD and such.
In France since the 1790s (the revolution) universities got destroyed and rebuilt, and the best students go to "grandes écoles" (tertiary education schools) that mostly creates managers & engineers. When I was a student the word "university" really had a smell of poop and all the double digit IQ trolls that smoke in class and don't care go there. Populist/socialists want "equality" and "no discrimination" and "everyone welcome" (zero selection) and so on so universities stay trash. The revolutionaries were so mad they chopped off the heads of many recognized scientists (Lavoisier worked as a tax collector and back then people really hated taxes they did not ask for more).
US universities are an absolute joke as the world must have learned by now. No selection, no elitism means a decline in quality. Gender studies, wokism, politicized science and dogmas do not produce progress, actual science does! The UK seems to be the same.
On top of universities being absolute crap in the west (France since the revolution, UK & US since what... the 2000s? It was a progressive decline), the people that make the decisions do not bother reading papers with a critical mind, you got actual doctors that would much rather read the newspaper, if me an engineer specialized in electronic payments that gambles on currencies can read those papers and in at most a few hours figure out the basics about specific issues they should really be able to. And these authorities are completely disconnected from reality, anyone that disagrees with anything they say no matter how idiotic it is gets called "conspiracy theorist", they are stuck inside the most ridiculous dogmas.
On that subject, to make things more "practical", here is a great example:
=> "Authorities" step their foot down and angrily claim that genetics is not essential and funding should go to a more immediate need which is aids research because "wE hAvE tO sAvE LiVeS" (typical politician argument with work with the 100 IQS and does not let people disagree with, who would say "no let's leave them to die we have more important things to do")
=> Genetic research comes up with a cure for Aids.
=> 🤡
Did these politicians get held accountable? Of course not! Half of them are dead, most of the other half is now doing something else, the public has obviously forgotten and does not even understand any of this anyway. This is very real. And it is a big deal.
One other issue with healthcare is the horrendous economic model.
The grandchildren of singers will own the rights I don't know 70 years later but hey, someone makes a great discovery and first it costs a fortune to get an authorization (making sure only very big centralized companies can afford those) then "bEcAuSe hEaLtH iS nOt FoR pRoFiT" I think they have 5 years (don't quote me here) to sell it before all the generic treatments can come. So the business plan is broken. Then you have all these old medications (Chloroquine...) that are cheap and no one wants to experiment on them, big pharma won't because they won't get their money back, and the government won't because as they have proven for the past 10,000 years they are useless and terrible and slow.
In the US since the recession (2008) workers have gone from mostly working in small businesses (it lasted for generations) to mostly working in big or very big ones, and covid is the euphoria in this bubble with small and medium sized businesses dying and huge ones making record profits. So the entire capitalist system is bound to go boom.
More specifically, in the domain of health the whole process has to be reworked. Hey, and who created all the problems once again? This duhsdhjing government!
It's always their fault. Everything is entirely their fault ALL THE TIME. And we really have reached a point where they are complete sheep and idiots that get their info from the freaking media, from some idiot that thinks a lost plane might have entered a black hole is their source. You thought they were getting super military grade data? Hahaha no they get it from some biased newspaper that has no clue what they are writting about. At that point they are even recruiting representatives by placing surprises in Christmas crackers and mentally disabled people that struggled to wait tables end up in congress.
Another issue is accountability, french government say they'll pay for vaccine secondary effects so first of all the people that produce those do not do that much testing, second governments either, and third there are I think about 100 official (god knows how many unofficial) cases of people with very bad secondary effects from the H1N1 vaccine and none has gotten any of the money promised by the governments that would "cover" for the pharma industry (eager beavers, I wonder how many of them laughed and belittled skeptics also calling them "antivaxxers", I might be an idiot "antivaxxer" but I don't randomly drop down and sleep in the middle of the street so who's the idiot now?). They're pushing now what is not just a new vaccine but a entirely new tech, as interesting as it is just... mass vaccinating people with something entirely new is as stupid as it gets call me anti-vaxx all you want history will not be kind to them. Vaccine, or any medicine is just like an investment, if the risk reward stinks you avoid it. (Theorical example) Taking a vaccine that kills 5 in a million and cripples 100/1 million to prevent an illness that kills & cripples no one is idiotic.
Science in general has been a hoax, or a religion if you prefer, for a while and the public is only now hearing about it, so things might actually start to move.
Of course today's useless politicians have done nothing about it they are even a major part of the problem and they will pretend to be the solution after the lowest of the low dumbest "dumb money" is aware of the issue. We're talking ripple investors at that point, even ripple investors understand at least healthcare is in a crisis.
There is a problem with who is getting the financing (the dogma sheep not the innovative free thinkers), how the info is distributed (decorated genius gets censored, dum dum parrot gets broadcast to the world), the rights to medication or call it intellectual property, the accountability of secondary effects.
I do not know biotech very well, and it might be way early (or not, I have no idea), but I am sure of 1 thing I will get my info from innovators at the forefront of progress not from broken media that can't even repeat correctly 10 years later.
Unless we fall into complete communism and as long as these issues I described (the economic model) get improved - this can take a very long time and I do not know how to predict how long it takes for the info to reach certain people's brain - there will be a phenomenal expansion in the healthcare business.
Even if the west goes insane, the world is not restricted to it. Let it decline, the Middle East & China will take over.
It may take time but we are not in antiquity anymore, it could go very fast, still as Warren Buffet so wisely said some things cannot be rushed it still takes 9 months to get a baby from a woman, but hopefully the whole process will take less than a century.
I wish I could find a good chart on Roman gdp/capita to see how fast it went up and so on, wouldn't that be great, please let me know in the comments if you have one. All I know is Egypt & Italy were rich, Gauls were poor plebes, and the rest was in between.
The contaminated blood scandal, the thalidomide distribution scandal (called a wonder drug at the time), they are going to look like minor boring stories compared to what is coming. The entire system is broken. History will not be kind to the dogma people, and I will be proven right as usual :/
Buy Signal: 13.04Ingenuity Trading Model used in- Stock, Forex, Futures, and Crypto markets. For Stops and overall trade management join the club.
The model is a Geometric Markov Model :
In probability theory, a Markov model is a stochastic model used to predict randomly changing systems. Markov Models are used in all aspects of life from Google search to daily weather forecast. The randomly changing systems we focus on are the equity, futures, and forex markets. The geometric element of the model is the fractal wave structure you can find on any chart you look at across any market and across all time dimensions.
Our model focuses on the current wave formation (current state)- geometric price formation along with its volume and volatility over a given time period and using that information to predict the future state- future price movement. For questions or more information feel free to contact me in the comment section or via private chat
Entry of the gladiatorsWonderful bullish news! There is a vaccine. The economic activity can soon go back to normal. The question now is how do we make it obligatory?
Crazy antivax conspiracy theorists are saying that because it is a rushed & untested vaccine and entirely new technology that affects ARN and contains heavy metals that can breach the blood-brain barrier we should let people choose if they want to take it. Haha ridiculous, they probably think the earth is flat am I right? We have no other choice, if we do not all take the vaccines millions will die, they do not only put themselves at risk by refusing to take it but they also put others at risk.
You know why we can trust pharmaceutical giants even though there is a major scandal every 2 weeks where they caused harm to make money?
Because there are now laws that make them immune against any consequences if there are long term negative effects.
Isn't that great? So now they can work with a clear mind and only focus on producing a vaccine as fast as possible to maximize profit without having to worry about any annoying long term side effect!
And officials clearly have our best interest at mind even though they might have a few millions in conflict of interests.
Why do I know this? Well the fact that Philippines have kicked out and want to punish Sanofi for selling to them an extremely dangerous & inefficient vaccine against Dengue, while the European Union have fully allowed this vaccine which we'll have the pleasure to get access to if we get a Dengue outbreak in Europe because they do not believe in conspiracies and want people to be healthy.
Of course Ursula has our best interests at mind. So does Joe. The Philippines are just conspiracy nuts and anti-China racists obviously.
Ok yes, every single child out of hundreds that took the Dengvaxia dropped dead and so what? Never heard of coincidences? Just because there is a correlation does not mean there is a crazy conspiracy theory silly. Children die all the time in the Philippines as it is a third world country.
People are losing their minds simply because Germany has passed an infection protection law, ridiculous, they say it reminds them of the 1933 enabling act.
It's not the same silly, it is called "infection protection law" not "enabling act to solve the distress of the people", see? Entirely different.
Schlomo Goldstein is hiding in a cellar; this is insane! People have gone completely paranoiac! And they don't believe in science and facts but primitive conspiracies. Schlomo should get on that train for his own good. The stories that "people are never seen again" and "the german government is sending all jews to concentration camps", how crazy does this sound to you? How can people imagine such insanity?
Independent fact checkers have been to Auschwitz and Dachau and gave these vacation camps a 5 ✡️ out of 5. The official claim from our independent fact checking sources is "The vacation camps of Auschwitz and Dachau are wonderful places and all of our independent fact checkers financed by facebook had a great time there, we are giving them a full recommendation".
See? There is nothing to worry about. We are on our way to a great time of peace, prosperity, and health.