Vaxcyte prices IPO at $16

Vaxcyte (PCVX) has priced its IPO of 15,625,000 common shares at $16.00/share, for expected gross proceeds of $250M.

Underwriters’ over-allotment is an additional 2,343,750 shares.

Trading kicks off today.

Closing date is June 16.

https://seekingalpha.com/news/3582515-vaxcyte-prices-ipo-16

Agios reports positive mitapivat data in sickle cell disease

Agios Pharmaceuticals (NASDAQ:AGIO) announces that clinical proof-of-concept has been established based on a preliminary analysis in Phase 1 trial of mitapivat (AG-348), an oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase-R enzymes in patients with sickle cell disease.

Mitapivat has been shown to decrease 2,3-diphosphoglycerate and increase adenosine triphosphate, and through this mechanism, it may reduce hemoglobin S polymerization and red blood cell sickling.

The study has enrolled nine patients to date. Seven of eight (88%) of patients experienced a hemoglobin increase, with five of eight patients (63%) achieving a hemoglobin increase of ≥1.0 g/dL from baseline (range 1.0-2.7 g/dL).

Adverse events reported were generally consistent with those previously reported in pyruvate kinase deficiency or that are to be expected in the context of sickle cell disease.

Pharmacodynamics and biomarker data support mitapivat’s proposed mechanism of action.

The company is focused on advancing mitapivat to pivotal development, with the goal of initiating a pivotal study next year.

https://seekingalpha.com/news/3582535-agios-reports-positive-mitapivat-data-in-sickle-cell-disease

Quidel nabs BARDA funding to develop test for respiratory viruses

Quidel (NASDAQ:QDEL) secures the Biomedical Advanced Research and Development Authority (“BARDA”) funding of $635,000 to support the development of a point-of-care diagnostic assay that potentially tests for four respiratory viruses: SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV). The respiratory virus panel would be developed to run on Quidel’s Sofia 2 flagship instrument.

The funding will run through April 2021 with he goal of achieving an FDA Emergency Use Authorization for the test.

https://seekingalpha.com/news/3582542-quidel-nabs-barda-funding-to-develop-test-for-respiratory-viruses

Centene sees FY 2020 revenue as high as $112B

Centene (NYSE:CNC) has updated its 2020 financial guidance.

Total revenues are expected to be $109.5B to $111.9B.

EPS is expected in the range of $3.06 to $3.20.

Non-GAAP EPS is expected to be $4.76 to $4.96.

https://seekingalpha.com/news/3582539-centene-sees-fy-2020-revenue-high-112b

Wounded In Action From Covid-19

In our battle against SARS-CoV-2, we have mobilized as if we were at war with an alien invader. But this enemy is not from outer space. We and SARS-CoV-2 spring from the same source, the deep reservoir of all life on earth. Each species, struggling to survive.
With humans and SARS-CoV-2 that struggle binds us together, as we happen to be the choice ecological niche for this particular virus—conveniently numerous, crowded together, and traveling freely across continents.

Normally when we enter into battle, we count both the dead and wounded. But in this struggle, we tally only the infected and the dead. Yet a far greater toll is being paid in those wounded by the virus, who will never be whole again. Rarely do we even mention this growing tide of suffering.
Thanks to a recent story in the Washington Post we can now put faces to a few of our wounded survivors. Each is part of the Covid-19 recovery mosaic, lungs that will never breathe easy, foggy brains and paralyzed limbs, failing kidneys, hearts that swell and veins that burst.
Covid-19 is no mild cold that kills just a few, nor is it a mirror of the flu from which most recover intact. It is a deadly disease to some, and the beginning of debilitating lifelong disability for many others. It is high time we heard the voices of our wounded and extended our hand to help.
https://www.forbes.com/sites/williamhaseltine/2020/06/10/wounded-in-action-from-covid-19/#1737bc22bde4

Amazon’s Coronavirus Testing of Workers Remains Rare Move By Employer

News this week that Amazon this summer has begun testing its workers for the coronavirus strain Covid-19 even in a pilot program is a rare move among U.S. employers, health benefits consultancy data shows.
Amazon says it has for weeks been looking at ways to test workers while “distributing masks to employees, using disinfectant spray and conducting employee temperature checks” at operations sites and grocery stores across the country. And CNBC was the first to report that the online retail giant plans “to test its fulfillment center workers for coronavirus after several outbreaks at its warehouses.”
Amazon confirmed Wednesday evening the “small scale pilot is currently taking place at a handful of sites in the U.S.”
“A next step might be regular testing of our employees, and we’ve started our first small-scale pilot,” Amazon spokeswoman Rachael Lighty said Wednesday evening. “We don’t know exactly yet how it’s going to shape up, but we continue to believe it’s worth trying.”

What Amazon is piloting is more than most other employers are planning even as the country prepares to re-open for business amid the COVID-19 pandemic.

Last month, the human resources consultancy Mercer said just 4% of those responding to a “return to the workplace” questionnaire say they are planning to conduct serology screening for antibodies to the Coronavirus strain COVID-19. And just 3% of employers say they plan to “screen for the presence of the virus.”
The Mercer survey is considered a snapshot into the thinking of employers as they grapple with myriad workplace issues as “shelter in place” orders end this month in several states and employers weigh whether to allow workers to return to their job sites.

The CNBC report said Amazon’s goal “is to test the bulk of the company’s warehouse workers every two weeks,” the story said. “Workers would test themselves with nasal swabs, using a video for guidance, with a clinical professional supervising.”
Any testing effort done by employers would be costly, which is why some analysts say companies are unwilling to begin testing their workers or are slow to implement such diagnostic testing strategies.
The cost of swabbing and testing all Americans for the coronavirus strain Covid-19 plus the price tag for testing them for virus antibodies could be as much as $44 billion a year, a new analysis released Wednesday said.
“Diagnostic testing would cost between $6 billion and $25 billion a year, and antibody testing would cost between $5 billion and $19 billion a year,” the report from the Wakely Consulting Group, funded by the health insurance lobby America’s Health Insurance Plans (AHIP), says. “These estimates include both the cost of the tests, as well as affiliated health care services (e.g., provider visit, urgent care visit) for administering the tests.”
https://www.forbes.com/sites/brucejapsen/2020/06/10/amazons-coronavirus-testing-for-workers-remains-rare-move-by-an-employer/#6c9a279839b8

3 stages to COVID-19 brain damage identified by neurologists

The Journal of Alzheimer’s Disease has just published a paper with a comprehensive review of the COVID-19’s effect on the nervous system which classifies brain damage caused by COVID-19 into three stages. One of the authors, nationally-recognized neurologist Dr. Majid Fotuhi, MD, Ph.D., who is the medical director of NeuroGrow Brain Fitness Center in Northern Virginia and an affiliate staff at Johns Hopkins Medicine, encourages the adoption of this three-stage classification, calls for more research on COVID’s long-term effects on the brain, and stresses the need for patients to receive a brain MRI before leaving the hospital.

“We are learning that a significant number of hospitalized COVID-19 patients have various degrees of brain impairment. As a medical community, we need to monitor these patients over time as some of them may develop cognitive decline, attention deficit, brain fog, or Alzheimer’s disease in the future. There is a lot we can do to promote brain healing in COVID-19 patients, but first we must understand the nature and severity of their neurological deficits. At the patient level, getting a baseline MRI before leaving the hospital is imperative so that we have a starting point to evaluate and treat them,” explained Fotuhi.
In the just published paper, Dr. Fotuhi and his colleagues warn about neurological issues in patients who suffer from COVID-19, including stroke, seizures, confusion, dizziness, paralysis, and/or coma. Already, two dozen case reports are revealing the impact of COVID-19 on the brains of patients. In fact, one study from Wuhan, China, showed that 45% of patients with severe COVID-19 illness experience marked neurological deficits. Another study from France showed 84% of ICU patients with COVID-19 have positive abnormalities on their neurological examination, and that 15% of patients who leave the ICU have residual “dysexecutive function,” which involves poor attention and difficulty with decision-making and controlling behavior.
The paper proposes the adoption of a three stage “NeuroCovid” classification scheme to provide a basis from which to build on future hypotheses and investigations regarding SARS-Cov2 and the nervous system. These stages include:

• NeuroCovid Stage I: The virus damage is limited to epithelial cells of nose and mouth and the main symptoms include transient loss of smell and taste.
• NeuroCovid Stage II: The virus triggers a flood of inflammation, called cytokine storm, which begins in the lungs and travels in the blood vessels throughout all body organs. This cytokine storm leads to the formation of blood clots which cause small or large strokes in the brain.
• NeuroCovid Stage III: An explosive level of cytokine storm damages the blood brain barrier, the protective insulation layer in blood vessels of the brain. As a result, blood content, inflammatory markers, and virus particles invade the brain and patients develop seizures, confusion, coma, or encephalopathy.

Fotuhi points out that many patients with COVID-19 may have no noticeable neurological symptoms at first; but in some cases, patients may present with neurological symptoms even before they have fever, cough, or shortness of breath. In addition to having an MRI while at the hospital, he stresses that patients will need to be monitored in a few months after their hospitalization.
“Our experience with previous forms of coronaviruses suggest that in the long-term patients may develop depression, insomnia, Parkinson’s disease, memory loss, or accelerated aging in the brain,” elaborated Fotuhi. “For those recovering from COVID-19, I recommend regular exercise, eating a heart healthy diet, reducing stress, and improving sleep; these are critical ways patients can rejuvenate their brain and minimize having poor outcomes in the future.”
These interventions, along with targeted brain training and neurofeedback therapy, are the main features of Dr. Fotuhi’s 12-week Brain Fitness Program. As published in the Journal of Prevention of Alzheimer’s Disease (2016), 84% of elderly with cognitive impairment who complete this brain rehabilitation program gain improvements in their brain function and many of them experience growth in the parts of their brain for learning and memory. These findings were similar for patients who gained recovery from their persistent post-concussion syndrome. The program will now be tailored for patients suffering from post-COVID neurological issues.
A Harvard- and Johns Hopkins-trained neurologist and neuroscientist, Dr. Fotuhi is widely regarded as an authority in the field of memory, Alzheimer’s Disease, concussion treatment, ADHD, and increasing brain vitality at any age.

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COVID-19 threatens the entire nervous system

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More information: Majid Fotuhi et al, Neurobiology of COVID-19, Journal of Alzheimer’s Disease (2020). DOI: 10.3233/JAD-200581

https://medicalxpress.com/news/2020-06-stages-covid-brain-neurologists.html