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Delta Means Beta Testing Alpha Strategies in Biotech (NVAX, MRNA, DYAI, PFE, JNJ, BNTX, AZN, IBB)

The Delta variant has become an increasingly important variable for capital markets over recent weeks. The key issue isn’t that Delta evades our current vaccine solutions. It doesn’t. But it does represent an example of how that might someday be…

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The Delta variant has become an increasingly important variable for capital markets over recent weeks. The key issue isn’t that Delta evades our current vaccine solutions. It doesn’t. But it does represent an example of how that might someday be the case: Delta is far more contagious than prior variants, and it is materially different in many ways, which suggests we may be facing a variant before too much longer that demands new vaccine technology in short order to prevent a return to the darkness of the pandemic era.

While the CDC and WHO don’t want vaccine producers to start talking about booster shots because they are afraid (probably rightly) that it will disincentivize some people from getting vaccinated with current vaccine solutions, the conversation on eventual boosters is clearly penciled in as we consider the upcoming year. 

In other words, as Mark Twain may have said it, reports of the death of this pandemic have been greatly exaggerated.

This perspective defines one of the most important playing fields in the stock market today, with massive implications for stocks like Novavax, Inc. (NASDAQ:NVAX), Moderna Inc (NASDAQ:MRNA), Dyadic International, Inc. (NASDAQ:DYAI), Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), BioNTech SE – ADR (NASDAQ:BNTX), AstraZeneca plc (NASDAQ:AZN), and iShares Biotechnology ETF (NASDAQ:IBB).

We take a closer look at some of the more interesting names in the space below.

Novavax, Inc. (NASDAQ:NVAX) focuses on the discovery, development and commercialization of vaccines to prevent infectious diseases. The company has become increasingly interesting as a play on the idea that vaccinating EM populations could be untenable on the mRNA vaccine model. Obviously, Delta has intensified this idea.

NVAX provides vaccines for COVID-19, seasonal flu, respiratory syncytial virus, Ebola, and Middle East respiratory syndrome.

Novavax, Inc. (NASDAQ:NVAX) recently announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the United Kingdom in the New England Journal of Medicine (NEJM). The final analysis confirmed an overall efficacy of 89.7% with over 60% (half) of the cases caused by the B.1.1.7 (Alpha) variant, and a 96.4% efficacy against non-B.1.1.7 (non-Alpha) variants which represents strains most similar to the original virus.

“We continue to be very encouraged by data showing high levels of efficacy against even mild disease, and that NVX-CoV2373 offers strong cross-protection against both the B.1.1.7 (Alpha) variant and non-B.1.1.7 (non-Alpha) variant strains which are widely circulating,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “This publication also reinforces the reassuring safety and efficacy profile shown in studies of our vaccine to-date and underscores the potential for NVX-CoV2373 to play an important role in solving this ongoing global public health crisis.”

If you’re long this stock, then you’re liking how the stock has responded to the announcement. NVAX shares have been moving higher over the past week overall, pushing about 18% to the upside on above average trading volume. Shares of the stock have powered higher over the past month, rallying roughly 8% in that time on strong overall action. 

Novavax, Inc. (NASDAQ:NVAX) managed to rope in revenues totaling $447.2M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 13143.4%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($2B against $1.2B).

 

Dyadic International, Inc. (NASDAQ:DYAI) is the one you want to watch. The rest of the stocks in this list have already seen massive influxes in investor interest. But DYAI has a vaccine platform in play based on possibly game-changing biotech, and it hasn’t broken through yet. However, as the narrative develops, this seems like one that could start gain a share of the spotlight. It may be the only credible name left in the legitimate vaccine space that hasn’t yet seen that spotlight, which makes it interesting.

It’s also interesting because its vaccine platform is based on a biotech thesis that really has genuine advantages in terms of costs involved in production and distribution.

Dyadic International, Inc. (NASDAQ:DYAI) engages in developing a gene expression platform for producing commercial quantities of industrial enzymes and other proteins. It focuses on further improving and applying its proprietary C1 technology, which is used in the discovery, development, and manufacture of biologic medicines and vaccines. 

The company recently announced findings from the Zoonotic Anticipation and Preparedness Initiative (ZAPI) project which has been published in VACCINES, a leading peer-reviewed scientific journal.

“Zoonotic diseases represent a serious global threat to human and animal health. The majority of newly evolving pathogens are zoonotic viruses. Safe and effective vaccines that can be developed rapidly following an outbreak are required to effectively combat these diseases. The efficacy, protection and safety data reported from the ZAPI study further supports the mounting library of data – demonstrating a novel approach for the C1 expression platform to be broadly applied for rapid development and manufacturing of vaccines for both human and animals”. Dr. Tchelet further commented “we anticipate additional partnerships and external collaborations which will serve to further advance our commercial objectives”.

According to the release, the successful ZAPI program focused on the following goals to enable the delivery of targeted vaccines for humans and animals, as well as therapeutic antibodies for hospital use, rapidly following a future disease outbreak by identifying the best protective subunit vaccines and neutralizing antibodies against potential new zoonotic diseases or strains, such as bunyaviruses (i.e., Rift Valley fever virus and Schmallenberg virus) or coronaviruses (i.e., Middle East respiratory syndrome coronavirus or MERS Co-V); defining optimal manufacturing technologies and processes for these vaccines and antibodies to enable high-volume production capacity; obtaining alignment with regulatory authorities and policy makers; and securing pre-approval of new vaccine and antibody manufacturing methodologies for future emerging zoonotic viral diseases.

Dyadic International, Inc. (NASDAQ:DYAI) pulled in sales of $461K in its last reported quarterly financials. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($27.2M against $2.6M). However, the commercial opportunity is still ahead in this name. The technology in play for DYAI appears to be truly disruptive, especially given the context of an evolving pandemic reality that we face.

 

Moderna Inc (NASDAQ:MRNA) engages in the development of transformative medicines based on messenger ribonucleic acid (mRNA). 

The company’s product pipeline includes the following modalities: prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics.

Moderna Inc (NASDAQ:MRNA) recently announced that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) have agreed to purchase and distribute an additional 50 million doses of Moderna’s COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022.

“We thank the MHLW and Takeda for their support and for partnering with us to bring our mRNA COVID-19 vaccine to Japan,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We remain committed to making our vaccine available around the world as we seek to address the pandemic.”

The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 30% in that timeframe. Shares of the stock have powered higher over the past month, rallying roughly 45% in that time on strong overall action. 

Moderna Inc (NASDAQ:MRNA) managed to rope in revenues totaling $1.9B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 22989.8%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($7.7B against $8.4B, respectively).

Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. We may be compensated for posting this content on our website by EDM Media LLC. For questions, comments or suggestions please contact ir@edm.media.

The post Delta Means Beta Testing Alpha Strategies in Biotech (NVAX, MRNA, DYAI, PFE, JNJ, BNTX, AZN, IBB) appeared first on Wall Street PR.

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International

Are We Falling As Rome Did?

Are We Falling As Rome Did?

Authored by Julie Ponese via The Epoch Times,

3, 2, 1… Timber! A Philosopher’s Take on the Collapse of Our…

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Are We Falling As Rome Did?

Authored by Julie Ponese via The Epoch Times,

3, 2, 1... Timber! A Philosopher’s Take on the Collapse of Our Civilization

The clock seems to be ticking.

Growing disparities in wealth, a housing and gas crisis, transhumanism galloping over the horizon, heroized incivility, and the constant threat of viruses, the “cures” for which may be worse than the diseases. Global politics feels eerily apocalyptic these days and, in our own little worlds, many of us are so lost, so unmoored from the comforts of our pre-pandemic lives, that we don’t know which end is up or what the future will hold. Investigative journalist Trish Wood recently wrote that we are living the fall of Rome (though it’s being pushed on us as a virtue).

I wonder, are we falling as Rome did? Is it possible that our civilization is on the verge of collapse? Not imminent collapse, perhaps, but are we taking the initial steps that civilizations before ours took before their eventual downfalls? Will we suffer the fates of the Indus, the Vikings, the Mayans, and the failed dynasties of China?

As a philosopher, I need first to understand what we mean by “civilization” and what it would mean for that thing to collapse.

This is a significant conceptual hurdle. “Civilization” (from the Latin civitas, meaning a body of people) was first used by anthropologists to refer to a “society made up of cities” (Mycenae’s Pylos, Thebes, and Sparta, for example). Ancient civilizations were typically non-nomadic settlements with concentrated complexes of persons who divided labor. They had monumental architecture, hierarchical class structures, and significant technological and cultural developments.

But just what is our civilization? There isn’t a tidy line between it and the next in the way the Mayans’ and the Greeks’ coexistence was defined by the ocean between them. Is the concept of Western civilization—rooted in the culture that emerged from the Mediterranean basin over 2,000 years ago—still meaningful, or has globalization made any distinction between contemporary civilizations meaningless? “I am a citizen of the world,” wrote Diogenes in the fourth century B.C. But of course, his world wasn’t quite as vast as our own.

Now for the second issue: civilization collapse. Anthropologists typically define it as a rapid and enduring loss of population, socio-economic complexity, and identity.

Will we suffer a mass loss of population or socio-economic complexity? Perhaps. But that isn’t what concerns me. What I really worry about is our loss of identity. I worry that we’ve lost the plot, as they say, and that with all our focus on the ability of science to save us, we’ve lost our ideals, our spirit, our reasons for being. I worry we are suffering what Betty Friedan called “a slow death of the mind and spirit.” I worry that our nihilism, our façadism, our progressivism are incurring a debt that we may not be able to pay.

As the eminent anthropologist Sir John Glubb wrote (pdf), “The life-expectation of a great nation, it appears, commences with a violent, and usually unforeseen, outburst of energy, and ends in a lowering of moral standards, cynicism, pessimism and frivolity.”

Think of a civilization as the top step on a staircase, with each stair below having fallen away. Western civilization today is built largely on the foundational ideals of ancient Greece and Rome that endure long after their physical structures and governments disappeared. But they endure because we find them meaningful. They endure through literature and art and conversation and ritual. They endure in how we marry, how we write about one another, and how we care for our sick and aging.

One lesson history tries to teach us is that civilizations are complex systems—of technology, economics, foreign relations, immunology, and civility—and complex systems regularly give way to failure. The collapse of our civilization is almost certainly inevitable; the only questions are when, why, and what will replace us.

But this brings me to another point. Early in its usage, anthropologists started using “civilization” as a normative term, distinguishing “civilized society” from those who are tribal or barbaric. Civilizations are sophisticated, noble, and morally good; other societies are uncivilized, backward, and unvirtuous.

But the old distinction between civilization and barbarism has taken on a new form in the 21st century. It is from within our own “civilized” culture that emerges an inversion of the concepts of civility and brutishness. It is our leaders, our journalists, and our professionals who ignore the standards of rational discourse, who institutionalize hatred and incite division. Today, it is the elites who are the true barbarians among us.

Taking a cue from Walt Whitman, who thought his own 19th century America was waning, “We had best look our times and lands searchingly in the face, like a physician diagnosing some deep disease.”

If our civilization collapses, it won’t be because of an outside attack, like Bedouin charging in from the desert. It will be because of those among us who, like parasites, destroy us from within. Our civilization may collapse and it could be due to any number of factors—war, the economy, natural disasters—but the silent killer, the one that may get us in the end, is our own moral catastrophe.

The ultimate problem, therefore, is not interpersonal; it’s inner-personal. If our civilization is collapsing, it’s because something in each of us is collapsing. And we need to rebuild ourselves first, brick by brick, if we are to have a chance of rebuilding ourselves together.

Tyler Durden Wed, 09/28/2022 - 22:20

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Economics

DryEyeRhythm: A reliable, valid, and non-invasive app to assess dry eye disease

Dry eye disease (DED) is a condition characterized by an array of different symptoms, including dryness, ocular discomfort, fatigue, and visual disturbances….

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Dry eye disease (DED) is a condition characterized by an array of different symptoms, including dryness, ocular discomfort, fatigue, and visual disturbances. This condition has become increasingly common in recent years owing to an aging society, increased screen time, and a highly stressful social environment. There are about 1 billion people, worldwide, who have DED. Undiagnosed and untreated DED can lead to a variety of symptoms, including ocular fatigue, sensitivity to light, lower vision quality, and a lower quality of life. Given the widespread prevalence of the condition, this can further lead to reduced work productivity and economic loss.

Credit: Juntendo University

Dry eye disease (DED) is a condition characterized by an array of different symptoms, including dryness, ocular discomfort, fatigue, and visual disturbances. This condition has become increasingly common in recent years owing to an aging society, increased screen time, and a highly stressful social environment. There are about 1 billion people, worldwide, who have DED. Undiagnosed and untreated DED can lead to a variety of symptoms, including ocular fatigue, sensitivity to light, lower vision quality, and a lower quality of life. Given the widespread prevalence of the condition, this can further lead to reduced work productivity and economic loss.

 

Despite the obvious disadvantages of DED, a large portion of the population remains undiagnosed, which ultimately leads to increased disease severity. DED is currently diagnosed through a series of questionnaires and ocular examinations (which can be invasive). But this method of diagnosis is not ideal. DED examinations do not always correspond with  patients’ subjective DED symptoms. Furthermore, non-invasive and non-contact dry eye examinations are required in the COVID-19 pandemic. These flaws point to a need for a simple, reliable, and accessible screening method for DED to improve diagnosis and prognosis of the disease.

 

To answer this need, a research group, led by Professor Akira Murakami and Associate Professor Takenori Inomata of the Juntendo University Graduate School of Medicine, developed a smartphone application called DryEyeRhythm. “DryEyeRhythm leverages the cameras in smartphones to measure users’ blink characteristics and determine maximum blink interval (MBI)—a substitute for tear film breakup time, an important diagnostic criterion of DED,” explains Associate Prof. Inomata. “The app also administers Ocular Surface Disease Index (OSDI) questionnaires, which are also a crucial component of DED diagnosis.

 

To validate the usefulness of the app, the research team conducted a prospective, cross-sectional, observational, single-center study, the results of which have been published in

The Ocular Surface (available online on 25 April 2022 and published in volume 25 in July 2022).

 

For their study, the team recruited 82 patients, aged 20 years or older, who visited the ophthalmology outpatient clinic at the Juntendo University Hospital between July 2020 and May 2021. The participants completed the Japanese version of the OSDI questionnaire (J-OSDI) and underwent examinations for MBI, both via the app and via other analysis techniques.

 

The study revealed that the J-OSDI collected with DryEyeRhythm showed good internal consistency. Moreover, the app-based questionnaire and MBI yielded significantly higher discriminant validity. The app also showed good positive and negative predictive values, with 91.3% and 69.1%, respectively. The area under the Receiver operating characteristic (ROC) curve—a measure of clinical sensitivity and specificity—for the concurrent use of the app-based J-OSDI and MBI was also high, with a value of 0.910. These results demonstrate that the app is a reliable, valid, and moreover non-invasive, instrument for assessing DED.

 

Non-contact and non-invasive DED diagnostic assistance, like the kind provided by DryEyeRhythm, could help facilitate the early diagnosis and treatment of patients, as well as, DED treatment through telemedicine and online medical care,” says Associate Prof. Inomata. The research team plans to further validate its results by conducting a multi-institutional collaborative study in the future. They are also planning to obtain medical device approval and insurance reimbursement for the smartphone application.

 

The development of DryEyeRhythm is crucial step forward toward the management of DED and improving vision and quality of life among the population.


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Spread & Containment

A rapid, highly sensitive method to measure SARS-CoV-2 in wastewater

Wastewater-based epidemiology (WBE) has been shown to be an excellent means of understanding the spread of SARS-CoV-2 in communities. It is now used in…

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Wastewater-based epidemiology (WBE) has been shown to be an excellent means of understanding the spread of SARS-CoV-2 in communities. It is now used in multiple areas across the world to track the prevalence of the virus, serving as a proxy for determining the status of COVID-19. Of particular importance is that WBE can be used to estimate the prevalence of COVID-19, including asymptomatic cases. However, one of the major drawbacks of WBE for SARS-CoV-2 has been that the traditional method was not very sensitive, and low viral loads could not be reliably detected.

Credit: Hiroki Ando, et al. Science of the Total Environment. August 8, 2022

Wastewater-based epidemiology (WBE) has been shown to be an excellent means of understanding the spread of SARS-CoV-2 in communities. It is now used in multiple areas across the world to track the prevalence of the virus, serving as a proxy for determining the status of COVID-19. Of particular importance is that WBE can be used to estimate the prevalence of COVID-19, including asymptomatic cases. However, one of the major drawbacks of WBE for SARS-CoV-2 has been that the traditional method was not very sensitive, and low viral loads could not be reliably detected.

A team of scientists from Hokkaido University and Shionogi & Co, Ltd., have developed a simple, rapid, highly sensitive method for the detection of SARS-CoV-2 in wastewater. The method, EPISENS-S, which does not require specialised equipment, was described in the journal Science of the Total Environment.

During the COVID-19 pandemic, Japan has had the lowest number of cases per capita. Thus, the viral loads in sewage have also been lower, and much more difficult to evaluate using established WBE methods—due to their low sensitivity. Prior work by the research team showed that the SARS-CoV-2 virus was associated with solids in sewage, so they focused on developing a method to analyse the solid phase of wastewater.

The method they developed, EPISENS-S, involves centrifuging collected wastewater samples to separate all the solids in the samples. The solids were then treated with a commercially available kit to extract all the RNA; the RNA was then reverse transcribed and amplified to obtain a substantial amount of DNA copies. A separate set of samples was subjected to treatment with polyethylene glycol followed by RNA extraction and reverse transcription to synthesize DNA: the method that is currently widely implemented in Japan. The DNA obtained from each of these methods was subjected to quantitative PCR (qPCR).

The team found that the EPISENS-S method is approximately 100 times more sensitive than the polyethylene glycol method. They used EPISENS-S to conduct a long-term analysis of wastewater from two sewage treatment plants in Sapporo city, and found that there was a high correlation between changes in RNA concentrations in the collected samples and changes in the number of reported cases in the city. EPISENS-S can also detect and quantify the Pepper mild mottle virus (PMMoV), which is associated with fecal matter and is used as an internal control.

EPISENS-S provides a way to track COVID-19 cases that are asymptomatic, as well as those that have not been clinically confirmed. In addition, it has great potential to continue tracking the prevalence of SARS-CoV-2 as vaccination rates increase. Finally, EPISENS-S could also be adapted to track other viral diseases with low infection numbers and viral loads.


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