The FDA has issued Emergency Use Authorization (EUA) for Centogene’s (NASDAQ:CNTG) SARS-CoV-2 RT-PCR test.
The company’s SARS-CoV-2 RT-PCR test is intended to be used with samples of the upper respiratory tract (oropharyngeal swabs).
Thursday, July 2, 2020
Herbalife +4.3% as health trends attract new bull
Citing an “increased interest in overall health and fitness, rather than in weight-loss products only.,” Argus upgrades Herbalife (NYSE:HLF) from Hold to Buy with a $54 price target.
Analyst John Staszak notes that Herbalife’s expanded product line takes advantage of this trend, and the company’s distributors have used Zoom and other new technologies to reach customers during the pandemic.
Staszak raises his 2020 EPS estimate from $2.80 to $3.16 and lifts 2021 EPS from $3.30 to $3.60.
Moderna down after report COVID-19 vaccine trial is delayed
Moderna (NASDAQ:MRNA) has slid 4.8% after a Stat News report saying a trial of the company’s COVID-19 vaccine has been delayed.
The 30,000-patient Phase 3 study was set to begin July 9, but changes to the protocol are pushing back the expected start. It could still come in July as the company looks “close to being on target,” according to one investigator.
The delay is a potential hurdle in the company’s ambitious plan to have key data by Thanksgiving, Stat News notes.
For now, Pfizer (PFE +2.7%) and BioNTech plan to start a 30,000-patient study of their own later this month; AstraZeneca (AZN +0.6%) and Oxford will start a similar-size trial in August; and Johnson & Johnson (JNJ +0.4%) in September.
Global Blood Analyst Sees 60% Upside On Falling Sickle Cell Med Concern
Shares of Global Blood Therapeutics Inc GBT have materially underperformed the broader biotech group, rendering its valuation attractive, according to Goldman Sachs.
The Global Blood Analyst: Analyst Paul Choi upgraded Global Blood from Neutral to Buy and increased the price target from $91 to $103.
The Global Blood Thesis: The launch dynamics of Global Blood’s sickle cell disease drug with a haemoglobin endpoint; emerging competitive threats; COVID-19 headwinds; and the regulatory path in Europe have been acting as overhangs on the stock, Choi said in a Wednesday upgrade note. (See his track record here.)
Physicians are now willing to prescribe recently approved new SCD therapies such as Global Blood’s Oxbryta and Novartis AG’s NVS 0.02% Adakveo, the analyst said.
These drugs also focus on long-term organ damage that can result from persistently low hemoglobin levels, he said, citing Goldman’s proprietary survey and key opinion checks.
Between the two, Oxbryta is preferred twice as much as Adakveo, Choi said.
Despite the promise shown by pyruvate kinase-R therapies such as mitapivat in early SCD studies, they are unlikely to displace Oxbryta, the analyst said.
“Also, with clarity on the regulatory path in Europe emerging, we see the opportunity for a differentiated product vs. hydroxyurea.”
The analyst outlined the following as catalytic events:
- Oxbryta first-year launch curve in 2020
- HOPE 72-week VOC data due in mid-2020
- Updates on EMA filing in the first half of 2021
- Initiation of inclacumab pivotal study in the first half of 2021.
Experts fear July 4 weekend will exacerbate coronavirus spread
Experts worry that the COVID-19 pandemic in the U.S. will worsen after the Fourth of July weekend, when millions of people gather across the country during one of the busiest travel periods of the year.
Memorial Day weekend — when people flocked to beaches, pools, parties, restaurants and bars after a weeks-long lockdown — helped spur many of the outbreaks the U.S. is seeing across parts of the country.
But now the stakes are even higher.
The U.S. is reporting record-high daily case counts, driven largely by outbreaks in the south and west. Several states are experiencing more severe outbreaks than they saw two months ago.
“I am very concerned, especially given this coming weekend, that the same types of spikes, the same types of surges could be seen not just in the places that are currently experiencing surges, but in places that have already experienced surges, and in ones that haven’t yet,” said Joshua Barocas, assistant professor of medicine at the Boston University School of Medicine.
The U.S. is averaging 40,000 new cases a day, exceeding the numbers seen in May. This is partially because of increased testing, but the percentage of tests coming back positive is also going up, an indicator of a growing outbreak.
While more than 50 percent of new COVID-19 infections in the U.S. are recorded in four states: Texas, California, Arizona and Florida, dozens of other states are also seeing increases both in cases and the percentage of tests coming back positive.
“My biggest concern with the Fourth of July is that in Arkansas, we have more than three times as many active cases now as we did in Memorial Day weekend,” said Nate Smith, secretary of health at the Arkansas Department of Health.
“The same activities are going to be associated with a higher risk of acquiring COVID-19 so we need to be more vigilant this time than we were Memorial Day,” Smith said.
Most states are open now and relying on people to stay at least 6 feet from others or wear masks when that is not possible to slow the spread of COVID-19.
Experts hope people follow those guidelines over the weekend and hold their events or gatherings outdoors, where the risk of transmission is lower than inside.
“If the vast majority of people enjoy the weekend safely, spend more time outside, wear masks, socially distance, wash their hands and use hand sanitizer, then I think it will be a much safer weekend and we wouldn’t see those increases,” said Rachel Levine, secretary of health at the Pennsylvania Department of Health.
“If people are in restaurants, bars or other locations, they’re in large crowds, they’re crowding together and not social distancing, that would pose a threat,” Levine said.
However, it appears the willingness to wear a mask or maintain a distance from others is declining as states lift lockdowns.
A Gallup Poll released Monday showed 73 percent of people “always” or “very often” practice social distancing, compared to 93 percent who said the same in April.
Governors in California, Texas, Michigan, Arizona, Florida and other states have in recent days ordered closures of bars in some areas as experts warn crowded indoor settings are a dangerous source of spread in communities.
California and Florida are also closing beaches in hot spots, but experts worry travelers from those areas could spread the disease throughout the country. Los Angeles is also prohibiting fireworks displays.
Ahead of Independence Day — historically one of the busiest travel days of the year — officials and experts are not only urging people to follow social distancing guidelines but to also stay close to home to prevent spreading the virus to other areas or bringing it back home after the holiday.
A growing outbreak in Pennsylvania’s Allegheny County was seeded by young adults who traveled to areas of the South and then came back home to congregate in bars and restaurants without masks, Levine said.
New York, Connecticut and New Jersey are so far the only states to issue quarantine requirements for travelers arriving from certain parts of the country with increasing COVID-19 cases.
Projections released Wednesday by the PolicyLab at the Children’s Hospital of Philadelphia forecasts significant virus spread over the next four weeks in existing hot spots, including Houston and Miami, and in other areas like Kansas City, Mo., and Philadelphia, largely due to increased travel and lack of adherence to social distancing and mask wearing.
“COVID doesn’t respect any geographic boundaries, in that if you’re traveling to the beach and there are a large number of infected individuals there, you can bring it back with you,” said Gregory Tasian, an associate professor of urology and epidemiology at the University of Pennsylvania Perelman School of Medicine.
“This is made more problematic since there is no universal policy on mitigation strategies in terms of mandatory social distancing or universal masking. When you have that natural travel that occurs, COVID becomes more difficult to control,” he added.
New York county issues subpoenas to people refusing to talk to contact tracers
Officials in New York’s Rockland County said Wednesday they are being forced to issue subpoenas to compel people to speak to contact tracers about a coronavirus outbreak because they are not speaking voluntarily.
The country’s health commissioner, Patricia Rupert, said at a news conference that subpoenas are being issued to eight people who were infected at a recent party in Clarkstown, N.Y., north of New York City, but who are refusing to cooperate with contact tracers seeking to interview them to determine who else they were in contact with and could be at risk of spreading the virus.
The drastic step of issuing subpoenas in a contact-tracing investigation illustrates a problem officials have cited around the country, that many people are not answering their phones or cooperating when contact tracers try to talk to them.
Public health officials say contact tracing is a key step in slowing the spread of the coronavirus. The process interviews infected people about who they have been in contact with so that those people can be notified and asked to quarantine for 14 days to prevent further spread of the virus.
Rupert said the host of the party in question was symptomatic with coronavirus but held the party anyway. At least eight people have been infected and officials are trying to figure out if more were exposed.
“We are not receiving the necessary cooperation when we contact those who are positive for COVID-19 or those who had been at some of these gatherings,” Rupert said. “My staff has been told that a person does not wish to or have to speak to my disease investigators. They hang up, they deny being at the party, even though we have found their name from another party attendee, or a parent provides us with the information.”
“Many do not answer their cell phones and do not call back,” she added. “Sometimes parents answer for their adult children and promise that they have been home consistently, when they have not been. This must stop.”
The frustrations have now led to subpoenas, she said.
“Unfortunately I am now forced by these circumstances to send subpoenas to the individuals who are required to cooperate with us,” Rupert said. “Failure to comply will be costly: $2,000 per day.”
Ed Day, the county executive, added that officials are not looking to get anyone into trouble, only to speak to them to find out who else might be infected to help slow the spread of the virus.
“We want people to do the right thing for their neighbors,” and voluntarily speak to health officials, he said, but are resorting to subpoenas when that did not happen.
He said he will not “have the health of our county compromised because of ignorance, stupidity, or obstinance.”
U.S., EU advocacy groups warn against Google’s purchase of Fitbit
Twenty advocacy groups from the United States, Europe, Latin America and elsewhere signed a statement Wednesday urging regulators to be wary of Google’s $2.1 billion bid for fitness tracker company Fitbit Inc (FIT.N) because of privacy and competition concerns.
The 20 organizations – which include the U.S.-based Public Citizen, Access Now from Europe and the Brazilian Institute of Consumer Defense – argued that the deal would expand the already considerable clout in digital markets of Alphabet Inc’s (GOOGL.O) Google.
Acquiring Fitbit would give Google such intimate information about users as how many steps they take daily, the quality of their sleep and their heart rates.
“Past experience shows that regulators must be very wary of any promises made by merging parties about restricting the use of the acquisition target’s data. Regulators must assume that Google will in practice utilize the entirety of Fitbit’s currently independent unique, highly sensitive data set in combination with its own,” the groups said.
Australian and Canadian groups were among the signatories.
A Google spokeswoman said the tech wearables space was crowded.
“This deal is about devices, not data,” she said. “We believe the combination of Google’s and Fitbit’s hardware efforts will increase competition in the sector.”
Google announced the deal in November to take on competitors in the crowded market for fitness trackers and smart watches. Fitbit’s market share has been threatened by deep-pocketed companies like Apple Inc (AAPL.O) and Samsung Electronics Co Ltd (005930.KS).
Australia’s competition authority said this month that it may have concerns about the deal and would make a final decision in August.
EU antitrust regulators will decide by July 20 whether to clear the deal with or without concessions or open a longer investigation.
In Washington, Google is under antitrust investigation by the Justice Department, a congressional committee and dozens of states for allegedly using its massive market power to harm smaller competitors.
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