Shares of genetic data miner23andMe Holding(NASDAQ:ME)surged in early trading Tuesday -- up 11.5% as of 10:10 a.m. EDT.
If you own shares of the recent special purpose acquisition company (SPAC) IPO, you can thank Credit Suisse for that.
Last night after close of trading, analysts at the Swiss investment bank initiated coverage of 23andMe stock with an outperform rating and a $13 price target, as StreetInsider.com reports.
"23andMe offers investors a platform that enables novel discoveries into the causes and potential treatments of a wide variety of diseases at unprecedented statistical power," explained a Credit Suisse analyst. In particular, the analyst said the company boasts a "uniquely differentiated ... genetic database" containing over 11 million customer samples, a database that's "not easily replicated" (because customers who signed up with one company to learn their genealogies, providing their genetic data almost as an afterthought, are unlikely to feel a need to do so a second time with a second company). 23andMe has also found that its customers are amenable to being contacted again and again with follow-up questions that further improve the quality of the data the company possesses.
Going forward, Credit Suisse expects 23andMe to leverage these advantages as it collaborates with pharmaceutical giant GlaxoSmithKline, its "exclusive strategic partner," and to potentially share in the profits as Glaxo uses 23andMe's data to validate more than 40 new potential drug candidates.
That being said, it may take time for these bets to pay off for 23andMe shareholders. In the meantime, the stock has shown declining revenue for two years running, presumably as it exhausts the pool of customers willing to hand over their genetic data in exchange for clues to their ancestry. For 23andMe right now, this really looks like a race between customer test revenue that is dying out and drug research revenue that has yet to really kick in.
To Pursue Prophylactic Treatment Against SARS and Influenza for Daily Use as an OTC Product --
Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS and anti-viral indications, today announced that it has received a written pre-investigational new drug (pre-IND) response from the U.S. Food and Drug Administration (FDA) for MMS019, its patented and proprietary high-density molecular masking spray under development for use as an anti-viral barrier product. Virpax believes the results of the pre-IND response support further research on MMS019 as an intranasal protective that may limit transmission of the viruses to others. Virpax expects to move forward and pursue a New Drug Application (NDA) for MMS019 as a once daily intranasal treatment. The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs. The Company has engaged Syneos Health to assist with the optimal clinical trial design based on an efficient timeline.
"We are very pleased with the response from the FDA. We believe that the initial pathway to move forward with the development of MMS019 has been clarified," said Anthony P. Mack, Chairman and CEO of Virpax. "The pre-IND meeting provides an opportunity for open communication between the Sponsor and the FDA to discuss the IND development plan and to obtain the FDA’s guidance for clinical studies for the new drug candidate. As our development program proceeds, we will define the strategy for our drug-device combination product candidate, MMS019, for use in an over-the-counter setting as we look to support a consumer-friendly OTC indication."
Virpax previously announced that it has completed in-vitro, ex-vivo (human mucosal cells) and in-vivo trials for this product candidate. MMS019 demonstrated inhibition of viral replication of SARS-CoV-2 and influenza in animals at much higher ranges than what is encountered by humans in the nasal passages; no adverse effects were observed during the studies. In addition to inhibition of viral replication, the animal studies also demonstrated decreased levels of the virus in animal brain tissue, a potentially important observation as recent studies have shown neurological conditions with survivors of severe Covid.
Pfizer Inc. on Monday said it priced a sustainability bond of $1 billion of 1.750% senior notes due 2031.
The company said net proceeds will finance or refinance research and development related to the Covid-19 vaccine, capital expenditures connected with the manufacture and distribution of the vaccines and other projects with environmental or social impacts.
The offering is expected to close on Aug. 18.
Citigroup Global Markets Inc., Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are the offering's joint book-running managers, Pfizer said.
All of New York State’s 450,000 health care workers in hospitals and nursing and other settings are required to get the coronavirus vaccine by Sept. 27 to help curb the spread of the COVID delta strain, Gov. Andrew Cuomo announced Monday.
The order issued by the state Health Department covers staffers at privately run and public hospitals, nursing homes and other elder care facilities and congregate settings.
There will be narrow exceptions for medical or religious reasons.
The order acknowledges what The Post has reported in recent months: that an unacceptably high rate of medical workers remain unvaccinated at hospitals and nursing homes.
About 75 percent of the state’s 450,000 hospital workers have completed their vaccination series — in most cases getting two doses.
That means one of every four hospital workers is unvaccinated.
New York nurses prepare to treat COVID-19 patients at the Veterans Affairs Medical Center in Manhattan.Robert Nickelsberg/Getty Images
Meanwhile, just 68 percent of the state’s 145,500 nursing home workers — serving frail, elderly residents most susceptible to contracting COVID – got jabbed.
That means one of every three nursing home staffers is unvaccinated.
More than 54,000 New Yorkers have died from COVID-19, according to the John Hopkins University Coronavirus Resources Center.
About 16,000 residents in nursing home and other facilities for the elderly were killed by the bug.
About 75 percent of New York hospital staff have been vaccinated.ANGELA WEISS/AFP via Getty Images
Cuomo — who is stepping down on August. 25 amid sexual harassment scandals — said his successor, Lt. Gov. Kathy Hochul, was briefed prior to the announcement.
“The Delta variant is spreading across the nation and across New York — new daily positives are up over 1000% over the last six weeks, and over 80 percent of recent positives in New York State are linked to the Delta variant,” Cuomo said.
“We must now act again to stop the spread. Our healthcare heroes led the battle against the virus, and now we need them to lead the battle between the variant and the vaccine.”
Kathy Hochul will become the governor of New York on Aug. 25, 2021.Lev Radin/Pacific Press/LightRocket via Getty Images
Cuomo earlier ordered state government employees and MTA and Port Authority staffers to get vaccinated for COVID-19 by Labor Day.
Health Commissioner Howard Zucker said, “While we have made tremendous progress in getting New Yorkers vaccinated, this pandemic is far from over and more must be done. The data and science tell us that getting more people vaccinated as quickly as possible is the best way to keep people safe, prevent further mutations, and enable us to resume our daily routines.
“This mandate will both help close the vaccination gap and reduce the spread of the Delta variant. I want to thank all New York State’s healthcare workers for stepping up once again and showing our state that getting vaccinated is safe, easy, and most importantly, effective.”
Groups representing hospital and nursing home industry management endorsed the vaccine mandate as sound public health policy.
“Greater New York Hospital Association supports New York’s decision to make the COVID-19 vaccine mandatory for all health care workers,” said GNYHA president Kenneth Raske.”
New York’s mandate will help ensure that hospitals and other health care providers can deliver the best care for patients while keeping their workers and communities safe,” Raske said.
The vaccine requirement “makes total sense,” said Michael Balboni, executive director of the Greater NY Health Care Facilities Association, representing nursing homes in the metro area.
Dr. Howard A. Zucker, commissioner of the New York state Department of Health, speaks during a press conference on COVID-19.MICHAEL M. SANTIAGO/POOL/AFP via Getty Images
He said the vaccine mandate will help “protect the residents, the families and other staffers.”
The health care workers union — Local 1199 of the Service Employees Union — had no immediate comment. The union has resisted a vaccine mandate.
The state Health Department has also authorized a third COVID-19 vaccine dose for New Yorkers with compromised immune systems, following the Centers for Disease Control and Prevention’s recommendation last week. Eligible New Yorkers can receive their third dose 28 days after the completion of their two-dose vaccine series.
Groups representing hospital and nursing home industry management endorsed the vaccine mandate as sound public health policy.
“Greater New York Hospital Association supports New York’s decision to make the COVID-19 vaccine mandatory for all health care workers,” said GNYHA president Kenneth Raske.COVID-related hospitalizations skyrocketed from 352 a month ago to 1,722 as of Sunday — a 400 percent increase, according to a GNYHA analysis of state data.A week ago, there were 1,345 hospitalizations, they said.
“New York’s mandate will help ensure that hospitals and other health care providers can deliver the best care for patients while keeping their workers and communities safe,” Raske said.
The vaccine requirement “makes total sense,” said Michael Balboni, executive director of the Greater NY Health Care Facilities Association, representing nursing homes in the metro area.
He said the vaccine mandate will help “protect the residents, the families and other staffers.”
The health care workers union — Local 1199 of the Service Employees Union — had no immediate comment. The union has resisted a vaccine mandate.
Mayor Bill de Blasio on Monday rolled out details on the COVID-19 vaccine requirement for many indoor settings in the five boroughs that will take effect Tuesday and will be enforced in mid-September.
The proof of vaccine to enter requirement, dubbed the Key to NYC, will apply to indoor restaurants, bars, museums and movie theaters, but not to places such as office buildings, community and senior centers as well as outdoor dining set ups.
On Sept. 13, the city will begin issuing fines — $1,000 for first offense and $2,000 for the second — to indoor businesses that fail to ensure their venues are off limits for those who remain unvaccinated.
“The Key to NYC is an approach that makes clear the power of vaccination. It is the ultimate encouragement to get people vaccinated,” de Blasio said Monday morning during his daily virtual press briefing, held remotely from City Hall.
As the mayor takes measures to combat the recent uptick in COVID-19 cases driven by the spread of the highly contagious Delta variant in the five boroughs, he’s in recent weeks framed the policy as a way to encourage New Yorkers to get their jabs by ensuring that being inoculated against COVID-19 is needed to participate in society in New York City.
“We want people to enjoy the fullness of the city, but you’ve got to be vaccinated to do it,” de Blasio said.
Mayor Bill de Blasio explained the vaccine plan — called “Key to NYC” — will take effect on September 13.Paul Martinka
“I’m absolutely certain this is going to motivate a lot of people to get vaccinated,” he added. “It’s going to be a reason for people to get vaccinated, particularly young people.”
To spread the word and educate local businesses about the new program, first announced Aug. 3, City Hall will on Tuesday launch a $10 million public awareness campaign, de Blasio said. The PSA effort ahead of the start of city enforcement will include radio, TV, digital, social media and subway live boards, according to the mayor’s office.
In addition, de Blasio announced that he’s signing an executive order Monday codifying the policy.
David Burke, one of Brooklyn’s most prominent restaurateurs, said Tuesday morning he supports it.
“It’ll keep the industry from being shut down again. Plus, it will give the public a sense of security when dining out, which will encourage more people to do so,” said Burke at the mayor’s press conference. “So I think it’ll be good for business.”
Art Depole, who co-owns a Mooyah Burgers, Fries, and Shakes franchise in Midtown, predicted the new initiative would spur a “free-for-all” in which “customers and restaurants aren’t really going to know what’s happening with this.”
But some businesses have already started requiring proof of a jab to enter, and it hasn’t caused problems.
New York City residents will have to prove vaccination status with their cards or apps like the Excelsior Pass and others.NY Governor's Press Office via AP
At Tito Murphy’s in Hell’s Kitchen, which began enforcing the vaccine mandate Monday, the rule has so far been kept without hiccups.
“It’s working well,” said a hostess at the restaurant. “A lot of people appreciate it, and those who aren’t as concerned are sitting inside. Those who are sitting inside are glad too.”
Customers are mostly proving that they have received a shot by displaying a picture of their vaccine card on their smartphone and New York City and state applications, she said.
“I’m not happy or unhappy,” said the hostess of her views on the new rule. “It’s what’s needed to keep the restaurant afloat.”
The following types of establishments will be required to ask for proof of vaccination for entry.
Movie theaters
Live music and concert venues
Museums and galleries
Aquariums and zoos
Professional sports stadiums and arenas
Convention centers
Exhibition halls
Performing arts theaters
Bowling alleys
Recreational game centers, arcades, and pool & billiard halls
Casinos and adult entertainment
Restaurants and bars
Catering halls and event spaces
Hotel banquet rooms
Cabarets and nightclubs
Cafeterias
Grocery stores with indoor dining
Bakeries and coffee shops
Fast food and quick service eateries with indoor dining
Gyms and fitness centers, and fitness class venues
Pools
Dance studios and sports classes
People showing their vaccine cards before entering “Springsteen on Broadway” in Times Square on July 10, 2021.Photo by Alexi Rosenfeld/Getty Image
The following indoor settings are not required to bar unvaccinated people
Dining where food consumed elsewhere, like fast food eateries
Businesses that opt to get rid of indoor seating
Residential buildings
Office buildings
Childcare programs
Pre k-12 public and non-public schools and programs
Senior centers
Churches hosting Sunday potlucks or similar events
Community centers
Charitable food services
Catering at a home
A mother and son showing the Excelsior Pass on their phones before entering a show at the The Shed on April 2, 2021.Photo by ANGELA WEISS/AFP via Getty Images
How can you prove that you’re vaccinated?
A picture of your Center for Disease Control vaccination card
NYC COVID Safe App
New York State Excelsior App
The actual CDC vaccine card
A photo or hard copy of an official vaccination record of a COVID-19 vaccine administered outside the United States, including AstraZeneca/SK Bioscience, Serum Institute of India/COVISHIELD, Vaxzevria, Sinopharm, or Sinovac.
Can kids under 12, who are not yet eligible for a shot, go to movies, indoor restaurants and museums with vaccinated parents?
Yes. De Blasio, the day after he announced the vaccination requirement, clarified that the ban on unvaccinated people entering eateries and entertainment venues will not apply to children under 12.
“If you’re going out with your whole family and your kids are not yet vaccination age, of course they can come along,” the mayor said on Aug. 4.
Unvaccinated kids will need to wear a mask while not eating, said de Blasio.
“We welcome kids, of course, to restaurants and movie theaters, etc. Wear a mask, that’s a smart thing to do,” he said on CBS that morning. “And hopefully sooner, five to-11-year-olds will be eligible for vaccination on top of that, but we don’t want to separate families, we want families to enjoy stuff together.”
City Hall confirmed Monday that children under 12 can accompany an adult who has received a COVID-19 shot.
Who else is not subject to the new mandate?
Anyone entering for a minimum amount of time required for a short period of time, like to use the bathroom, and pick up or place an order
Performing artists who do not live in New York City
Members of professional sports teams who do not live in the five boroughs and compete in an event in an arena or stadium
Staffers who accompany singers and other artists or athletes as part of their regular job and who live outside of New York City
The Biden administration is set to announce that Americans who got a COVID-19 vaccine shouldreceive a booster shoteight months after becoming fully vaccinated, officials said late Monday.
The booster doses would likely not be made available until mid-to-late September, after the Food and Drug Administration (FDA) is expected to grant full approval to the two-shot Pfizer-BioNTech vaccine, sources told the Associated Press.
The announcement, which could be made as soon as this week, would be the clearest signal from health officials that the coronavirus is endemic in the US — and that flu season is now “flu and COVID-19 season” for the foreseeable future.
The decision comes three days after an advisory panel from the Centers for Disease Control and Prevention (CDC) voted unanimously to recommend COVID-19 booster shots for those aged 12 and older with compromised immune systems — including people who have received solid organ transplants.
The CDC previously recommended that immunocompromised individuals should get a booster shot.Bloomberg via Getty Images
The expected announcement will also come amid a surge of cases and hospitalizations brought about by the highly contagious Delta variant, which accounts for almost all new infections in the US, according to CDC data.
In July, the CDC and FDA put out a joint statement in response to Pfizer and BioNTech saying they would seek approval for a booster dose within weeks.
“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating the country such as Delta,” the statement said, later adding: “Americans who have been fully vaccinated do not need a booster shot at this time.”
About 1 million Americans have already gotten a third COVID vaccine despite being fully vaccinated.Bloomberg via Getty Images
Since then, data from Israel has indicated declining effectiveness from the Pfizer vaccine against severe disease and hospitalizations in elderly patients, leading health officials in that country to begin administering booster shots to people aged 50 and older.
Approximately 1 million Americans have taken matters into their own hands and gotten additional shots despite being fully vaccinated, officials say.
Currently, 168.7 million Americans are considered fully vaccinated against COVID-19, approximately 60 percent of those eligible to receive vaccines.
A scathing Op-Ed in theWall Street Journalconcludes that SARS-CoV-2 "was most likely uncontained in a laboratory where it was being worked on, and that it escaped unintentionally."
Authored by former CDC Director Dr. Robert Redfield and NYU clinical professor Dr. Marc Siegel, the Op-Ed calls out the Chinese government for preventing the CDC from visiting Wuhan, China or the Wuhan Institute of Virology in early 2020 - which forced US investigators to "put together the circumstantial pieces of the puzzle on our own."
The doctors note:
On Sept. 12, 2019, coronavirus bat sequences were deleted from the institute’s database. Why? It changed the security protocols for the lab. Why? It put out requests for more than $600 million for a new ventilation system. What prompted this new need?
In January 2020 two hypotheses emerged about the origin of the novel coronavirus: that it began in a bat, then infected another animal before spreading to humans in a Wuhan “wet market,” where wild animals are sold for meat; or that it emerged from the Wuhan laboratory. The wet-market story was pushed by the Chinese CDC and the World Health Organization. Public-health leaders argued that Covid-19 was like SARS and MERS, earlier coronaviruses that emerged from bats and spread through an intermediate animal.
But neither of those viruses has ever evolved to the point where it can transmit efficiently from one human to the next. There have been fewer than 10,000 cases of each virus world-wide since SARS was discovered in 2003 and MERS in 2012. What virus comes out of a bat cave and infects humans by the millions? It’s not biologically plausible. If instead it evolved slowly over many years in nature, how come no one knew of it? -WSJ
What does bear investigation, they write, is the hypothesis that SARS-CoV-2 was "taught" to infect humans using humanized mice (grafted with human tissue and immune cells) in order to test whether the virus's 'cleavage site' was manipulated to more easily infect a human cell.
They also note a "growing body of circumstantial evidence" supporting the lab-leak theory - including info gleaned by the US State Department that Wuhan lab workers fell ill with Covid-like symptoms in the fall of 2019.
The story of SARS-Cov-2 started long before January 2020. We believe the virus was most likely uncontained in a laboratory where it was being worked on, and that it escaped unintentionally.A Harvard study of satellite images revealed a shutdown of traffic around the Wuhan lab in the late summer and early fall of 2019. Weeks later, in late September, the hospital parking lots were filling up.
There were hallmarks of scientific arrogance and failures in the containment system. China’s CDC initially appeared to be out of the loop but later became a key messenger, selling the natural-origin and wet-market theory. Another apparent misdirection was several key scientists’ insistence on a narrow definition of “gain of function” research to include remodeling, overt bioengineering, shaping or constructing a virus. As far as we’re concerned, if a virus is taught to or evolves in a lab to infect human tissue more efficiently, that’s gain of function. -WSJ
According to the doctors, there is a 'global need' to know the truth, because it affects how we approach the problem, and "variants are emerging rapidly that continue to change the game. All this is in keeping with a virus that more likely jumped from a bat to a lab, not to a rat or a rabbit."
Until we know what happened in Wuhan, Redfield and Siegel have called for a moratorium on so-called 'gain-of-function' research while authorities carefully craft policy to avoid the next pandemic.
