Deputy Chief Patricia Cassidy of the Jersey City Police Department has blood drawn to test for coronavirus antibodies in Jersey City, N.J., on Monday.; Credit: Seth Wenig/AP

The Food and Drug Administration is stiffening its rules to counteract what some have called a Wild West of antibody testing for the coronavirus.

These tests are designed to identify people who have been previously exposed to the virus. The FDA said more than 250 developers have been bringing products to the market in the past few weeks.

In a rush to make antibody tests available as quickly as possible, the FDA had set a low standard for these tests. Manufacturers were supposed to submit their own information about the accuracy of their wares, but the agency had no standards for what would be acceptable. Companies weren't allowed to claim the tests were authorized by the FDA, under initial guidance issued in mid-March.

Now the FDA is telling manufacturers that if they want their tests to remain on the market, they must meet minimum quality standards and submit a request for emergency use authorization, a temporary route to market for unapproved products when others aren't available. The EUA involves a lower standard than the usual FDA clearance or approval.

The FDA said 12 manufacturers have already opted to request EUA's for their products. More than 100 other producers have been talking to the agency about using this process, said FDA Commissioner Stephen Hahn. He spoke on a press call Monday. Companies have 10 days to submit that request.

"Our expectation is that those who can't [meet the new standard] will withdraw their products from the market and we will be working with them to help them do that," he said.

These tests are now so widespread that people can order them from lab giants Quest or LabCorp. The tests can cost more than $100. Though the FDA's original guidance calls for these tests to be run by a certified lab, the kits themselves are simple to use and have been readily available.

Despite the enthusiasm surrounding these tests, they have substantial limitations. Though people who test positive for antibodies have in most cases been exposed to the coronavirus, scientists don't know whether that means those people are actually immune from the coronavirus, and if so for how long.

"Whether this is the ticket for someone to go back to work [based solely on an antibody test result], my opinion on that would be no," Hahn said.

The tests may be more useful when combined with information from a standard coronavirus diagnostic test, or in someone who has symptoms, or if the results have been confirmed with a different antibody test. That "would dramatically increase the accuracy of those tests," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health

Antibodies are a potentially valuable research tool, and can be used to determine the prevalence of a disease in a population. In that circumstance, individual false results are less important. New York State used antibody tests to determine that about 20 percent of people in New York City have already been exposed to the coronavirus.

In California, researchers have attempted to measure the prevalence of the coronavirus in Los Angeles County and Santa Clara County in the Bay Area. Those unpublished results have garnered criticism because even a test that's more than 99 percent accurate can produce many false positive results when used to survey hundreds or thousands of people.

In the face of this criticism, the authors of the Santa Clara study have posted revised results acknowledging the high degree of uncertainty in their findings. Those findings haven't been peer-reviewed.

The emergency use authorization is only valid during the time of the national emergency. "Once the national emergency ends, the EUA authorizations end as well," Shuren said. Companies that want to keep marketing these tests will need to get them approved through the regular, more stringent FDA process.

FDA officials say they will continue to crack down on companies that falsely claim their tests are approved by the FDA, or that market them for home use, which isn't currently allowed.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Physical and occupational therapists carry bags of personal protective equipment on their way to the room of a COVID-19 patient in a Stamford Hospital intensive care unit in Stamford, Conn., on April 24. This "prone team" turns over COVID-19 to help them breathe.; Credit: John Moore/Getty Images

Intensive care teams inside hospitals are rapidly altering the way they care for patients with COVID-19.

The changes range from new protective gear to new treatment protocols aimed at preventing deadly blood clots.

"Things are moving so fast within this pandemic, it's hard to keep up" says Dr. Angela Hewlett, an infectious diseases physician at University of Nebraska Medical Center in Omaha and medical director of the Nebraska Biocontainment Unit. To stay current, she says, ICUs are updating their practices "on an hourly basis."

"We are learning at light speed about the disease," says Dr. Craig Coopersmith , interim director of the critical care center at Emory University. "Things that previously might have taken us years to learn, we're learning in a week or two. Things that might have taken us a month to learn beforehand, we're learning in a day or two."

The most obvious changes involve measures to protect ICU doctors, nurses and staff from the virus.

"There is a true and real probability of infection," says Dr. Tiffany Osborn a critical care specialist at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis. "You have to think about everything you touch as if it burned."

So ICUs are adapting measures used at special biocontainment units like the one at the University of Nebraska. These units were designed to care for patients affected by bioterrorism or infected with particularly hazardous communicable diseases like SARS and Ebola.

The Nebraska biocontainment unit "received several patients early on in the pandemic who were medically evacuated from the Diamond Princess cruise ship," Hewlett says. But it didn't have enough beds for the large numbers of local patients who began arriving at the University of Nebraska Medical Center.

So the nurses, respiratory therapists and physicians from the biocontainment team have "fanned out and are now working within those COVID units to make sure that all of our principles and protocols are followed there as well," Hewlett says.

Those protocols involve measures like monitoring ICU staff when they remove their protective gear to make sure the virus isn't transmitted, and placing infected patients in negative pressure rooms, which draw air inward, when possible to prevent the virus from escaping.

One of the riskiest ICU procedures is inserting a breathing tube in a COVID-19 patient's airway, which creates a direct path for virus to escape from a patient's lungs. "If you're intubating a patient, that's a much higher risk than, say, going in and doing routine patient care," Hewlett says.

So ICU teams are being advised to add several layers of protection beyond a surgical mask.

Extra personal protective equipment may include an N95 respirator, goggles, a full face shield, a head hood, an impermeable isolation gown and double gloves.

In many ICUs, teams are also placing a clear plastic box or sheet over the patient's head and upper body before inserting the tube. And as a final safety measure, the doctor may guide the tube using a video camera rather than looking directly down a patient's airway.

"It usually takes 30 minutes or so in order to get all of that equipment together, to get all of the right people there," says Dr. Kira Newman, a senior resident physician at UW Medical Center in Seattle. "and that would be a particularly fast intubation."

But most changes in the ICU are in response to an ongoing flood of new information about how COVID-19 affects the body.

There's a growing understanding, for example, that the infection can cause dangerous blood clots to form in many severely ill patients. These clots can kill if they block arteries supplying the lungs or brain. But they also can prevent blood from reaching the kidneys or even a patient's arms and legs.

Clots are a known risk for all ICU patients, Cooperman says, but the frequency and severity appears much greater with COVID-19. "So we're starting them on a higher level of medicine to prevent blood clots and if somebody actually develops blood clots, we have a plan B and a plan C and a plan D," he says.

ICU teams are also recalibrating their approach to ensuring that patients are getting enough oxygen. Early in the pandemic, the idea was to put patients on mechanical ventilator quickly to make sure their oxygen levels didn't fall too far.

But with experience, doctors have found that mechanical ventilators don't seem to work as well for COVID patients as they do for patients with other lung problems. They've also learned that that many COVID-19 patients remain lucid and relatively comfortable even when the oxygen levels in their blood are extremely low.

So many specialists are now recommending alternatives to mechanical ventilation, even for some of the sickest patients. "We're really trying now to not intubate," Osborn says.

Instead, ICU teams are relying on devices that deliver oxygen through the nasal passages, or through a mask that fits tightly over the face. And there's renewed interest in an old technique to help patients breathe. It's called proning.

"Instead of them being on their back, we're turning them on their front," Osborn says. The reason, she says is to open up a part of the lung that is collapsed when a patient is on their back.

This content is from Southern California Public Radio. View the original story at SCPR.org.

President Trump has said he wants to see the country begin to reopen. The pandemic crashed the economy by keeping people at home, leading to millions of job losses.; Credit: Pool/Getty Images

The White House coronavirus task force rejected detailed guidance drafted by the Centers for Disease Control and Prevention on how workplaces ranging from schools to bars to churches should resume operations to prevent the spread of the virus because it was viewed as "overly prescriptive."

President Trump has said he wants to see the country begin to reopen. The pandemic crashed the economy by keeping people at home, leading to millions of job losses. The White House task force issued guidelines on how to gradually and safely reopen but left decisions up to governors based on conditions in their states.

Experts have warned that a rush to reopen could have disastrous implications for containing COVID-19. Many businesses have said they want more details about how to do things safely.

The draft detailed guidance was provided to the task force in late April, a couple of weeks after it released its April 16 guidance to states for reopening.

The task force sought "certain revisions" to the CDC's detailed guidance, two administration officials told NPR. But revised recommendations were never returned to the task force.

The Associated Press first reported on the task force decision to shelve the detailed guidance. Copies obtained and published by the AP, The New York Times and The Washington Post revealed detailed, staged directions for child care centers, schools, camps, restaurants and bars, churches and mass transit providers about how to safely resume operations.

"I think many people would argue that it is not the role of the federal government to tell specific entities — whether they be schools or churches or businesses — how they should go about doing things because the nation is so diverse," one of the administration officials said.

The task force said that some of the points may be helpful, but they needed to "zoom out a little bit and not be so prescriptive," according to the official. The task force said they would welcome a new set of recommendations, but that never happened, the official said.

"Issuing overly specific instructions — that CDC leadership never cleared — for how various types of businesses open up would be overly prescriptive and broad for the various circumstances states are experiencing throughout the country," the second administration official said. "Guidance in rural Tennessee shouldn't be the same guidance for urban New York City."

The United States last month reached 1 million known coronavirus cases, representing one-third of all coronavirus cases worldwide. Nearly 74,000 Americans have been felled by the disease as of Thursday, according to data compiled by the Johns Hopkins Coronavirus Resource Center.

This content is from Southern California Public Radio. View the original story at SCPR.org.

No field trips. No game rooms. No teddy bears. These are some of the CDC's guidelines for reopening schools, childcare centers and day camps safely in places where coronavirus cases are on the decline.

The guidance, which also covers restaurants, churches and other public places, was obtained by The Associated Press, which reports that the White House tried to keep it from coming to light. The New York Times quoted Mark Meadows, the chief of staff, as being concerned that the guidelines were "overly prescriptive."

The CDC does not have authority to enforce its guidance, which is intended for public information only; the actual policy decisions are up to state and local governments. Schools are closed through the end of the school year throughout much of the country, with the exception of Montana, which welcomed a handful of students back this week. Child care protocols are different in different states.

But millions of parents need child care so they can work, and socialization and stimulation for children who have been confined to home by lockdowns for weeks on end. This is the guidance that summer camps and day cares have been waiting for to make decisions about reopening safely.

The guidance says that where coronavirus is spreading rapidly, child care should only serve the children of essential workers. This is the case today in much of the country, which the guidelines refer to as "Phase 1".

In Phase 2, programs can expand to serve all children with enhanced social distancing measures, and in Phase 3, with a lower risk, social distancing will continue.

Recommended measures include:

Handwashing;

Cloth masks for staff;

Regular disinfection of all surfaces;

Six-foot distance "if possible," head-to-toe positioning with bedding;

As much outdoor air as possible — open windows, fans;

Restricting mixing of groups;

Restricting visitors, and staggering dropoffs and pickups to reduce contact among parents;

Limiting sharing of materials like art supplies or toys. Disinfecting them in between use.;

Avoiding soft toys that can't be easily disinfected;

Not using common areas like dining halls or playgrounds if possible. If it is necessary, stagger visits and disinfect in between;

Adjust operations based on local health data;

Monitor absenteeism.

The guidelines also emphasize keeping attendance at such programs local, to limit children bringing the disease from high to low transmission areas.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Robert F. Kennedy's speech at the Ambassador Hotel. Sandi Gibbons the woman in the white dress on the bottom right.

She’s spent her life on both sides of the microphone.

For half of her career she was a reporter, finding herself in places like the Ambassador Hotel ballroom on the night Robert F. Kennedy was shot, and in the courthouse covering Charles Manson.

For the other half of her professional life, she spent a lot more time in L.A.’s courthouses as the spokeswoman for the L.A. County District Attorney’s office. She served three DAs, and now she’s hanging it up. Her retirement lunch was attended by three past and present DAs, with a fond message from a fourth, and as many of her reporter and DA friends could fit in the restaurant.

RELATED: Veteran reporter, DA spokesperson Sandi Gibbons is retiring

Sandi Gibbons has tales to tell, and here she recounts a few funny, moving and plain old perplexing ones from her life in court. And I can tell you from knowing her, she is one great dame.

Correction: Original headline spelled Sandi Gibbons' name "Sandy"

This content is from Southern California Public Radio. View the original story at SCPR.org.

U.S. Rep. Adam Schiff (D-CA) listens during a news conference in front of the U.S. Capitol.; Credit: Alex Wong/Getty Images

As we discussed last week on FilmWeek, entertainment industry professionals are among the hardest hit amid the stoppage of everyday work and life due to COVID-19. Whether you’re on camera or stage, or behind it, above the line or below it, production shutdowns mean that industry professionals who already rely on sporadic work as it’s available are left with few to no options for sustainable income. 

Last week, Congressman Adam Schiff and other members of Congress who represent areas with large constituencies that work in the entertainment industry sent a letter to House leaders asking them to provide relief for both freelance and contract entertainment industry workers. “The unique freelance nature of work in film, television, theater, and live music means that a large number of the professionals who make these productions possible work only sporadically—often with extended periods between paying jobs—and count on income from each project to make ends meet,” the letter said in part. “As a result, many of them can’t qualify for traditional unemployment benefits or paid emergency leave, yet will now be unable to cover their basic expenses due to lost work.” 

Today on AirTalk, Congressman Schiff joins us to talk about what relief both freelance and contract entertainment industry professionals can expect if the House passes the stimulus package that would provide financial aid to Americans during the coronavirus pandemic. 

Guest: 

Adam Schiff, U.S. Congressman representing California’s 28th Congressional District, which includes Burbank, parts of Pasadena, and Glendale, and chairman of the House Intelligence Committee; he tweets @RepAdamSchiff

This content is from Southern California Public Radio. View the original story at SCPR.org.

Justin Timberlake and Anna Kendrick in Trolls World Tour.; Credit: Universal Pictures/Trolls World Tour (2020)

Larry Mantle and KPCC film critics Lael Loewenstein, Amy Nicholson and Charles Solomon review this weekend’s new movie releases and share some of their recommendations for movies and TV shows to discover, rediscover and binge-watch while you’re at home.

• "Trolls World Tour" on VOD (Vudu, FandangoNOW, AppleTV, Amazon Prime Video , Microsoft Store & more)

• "The Quarry" on VOD (FandangoNOW, Google Play, DirecTV On Demand)

• "A White, White Day" on The Frida Virtual Cinema

• "Away" on Laemmle's Virtual Cinema and Amazon Prime Video

• "Selah And The Spades" on Amazon Prime Video

• "The Booksellers" on VOD (Google Play) and virtual cinemas, including Laemmle's and The Virutal Frida Cinema

• "Endings, Beginnings" on VOD (iTunes and FandangoNOW)

• "Sergio" on Netflix

Want to see what our critics are watching and recommending you watch during stay at home? Click here to see a full list of our FilmWeek critics' favorite TV shows and films to binge-watch during COVID-19.

Guests:

Amy Nicholson, film critic for KPCC, film writer for The Guardian and host of the podcasts ‘Unspooled’ and the podcast miniseries “Zoom”; she tweets @TheAmyNicholson

Lael Loewenstein, KPCC film critic and film columnist for the Santa Monica Daily Press; she tweets @LAELLO

Charles Solomon, film critic for KPCC, Animation Scoop and Animation Magazine

This content is from Southern California Public Radio. View the original story at SCPR.org.

Circus of Books storefront.; Credit: Netflix/Circus Of Books (2020)

Rachel Mason had, to a certain extent, the normal upbringing you’d imagine a family of five with small business owner parents would have. But in her documentary, ‘Circus of Books’, she pulls the curtain on the double-life her parents led as modest business owners and pillars of the LGBTQ community.

Karen and Barry Mason established West Hollywood’s Circus of Books on Santa Monica Boulevard in the 1980s. What seemed like an unassuming bookstore was actually a gay porn shop that became an institution in the LGBTQ community during a time when homosexuality was still largely unaccepted. The store was far from being a “bookstore with a circus theme”. The Los Angeles-based shop was the central hub for gay pornography around the country, once one of the main distributors for adult films. 

While the store was becoming a home for gay culture and pride, the Masons largely kept their business a secret from colleagues, friends, family, even their own children. It’s a central conflict that Rachel Mason explores throughout the film as the daughter of two shop owners caught between the pressures of maintaining a traditional family image and making a living as gay pornography distributors.

Today on FilmWeek, we’re joined by ‘Circus of Books’ director Rachel Mason for a conversation on her documentary and the experience of creating a film with her parents and their secret as the subject.

‘Circus Of Books’ is currently streaming on Netflix. For more on the film from LAist’s Mike Roe, click here.

Guest:

Rachel Mason, director of the Netflix documentary ‘Circus of Books’ and daughter of Circus of Books owners Karen and Barry Mason; she tweets @RachelMasonArt

This content is from Southern California Public Radio. View the original story at SCPR.org.

New research has shed light on the factors needed to successfully implement pilot projects designed to reduce the dumping of unwanted fish by fishermen. The analysis of 15 European projects highlights the importance of involving the fishing industry in developing and implementing pilot projects.

Selective fishing aims to prevent the overexploitation of target fish species and to protect by-catch species, but recent research has indicated that it could be having the opposite effect by damaging biodiversity and sustainability. An alternative approach called 'balanced exploitation' works at the level of the ecosystem instead of selectively removing specific components from the ecosystem.

Between 10 and 50% of marine species and ecosystems are recovering from population declines and degradation, according to recent research, which identified five strategies for successful recoveries. Recoveries are often driven by a combination of factors, which include restricting exploitation, better protection of vulnerable habitats and greater political support and local involvement with conservation.

Some Marine and Coastal have been altered over long periods of time, resulting in a loss of knowledge of their true healthy state, new research suggests. In this UK study, researchers used historical records, samples of sediment and present-day diving surveys to reconstruct the true history of shellfish beds on the east coast of Scotland.

The National Science Foundation: Creating knowledge to transform our future

NFL Commissioner Roger Goodell talks during a press conference at the Hilton Hotel on Sept. 19, 2014 in New York City. Goodell spoke about the NFL's failure to address domestic violence, sexual assault and drug abuse in the league.; Credit: Elsa/Getty Images

Update 1:04 p.m. Goodell: 'Same mistakes can never be repeated'

Commissioner Roger Goodell says the NFL wants to implement new personal conduct policies by the Super Bowl. At a news conference Friday, Goodell made his first public statements in more than a week about the rash of NFL players involved in domestic violence. He did not announce any specific changes, but said he has not considered resigning.

"Unfortunately, over the past several weeks, we have seen all too much of the NFL doing wrong," he said. "That starts with me."

The league has faced increasing criticism that it has not acted quickly or emphatically enough concerning the domestic abuse cases.

The commissioner reiterated that he botched the handling of the Ray Rice case.

"The same mistakes can never be repeated," he said.

Goodell now oversees all personal conduct cases, deciding guilt and penalties.

He said he believes he has the support of the NFL's owners, his bosses.

"That has been clear to me," he said.

The Indianapolis Colts' Darius Butler was among those who tweeted criticism of the press conference:

Colts tweet 1

Colts tweet 2

The commissioner and some NFL teams have been heavily criticized for lenient or delayed punishment of Rice, Adrian Peterson and other players involved in recent domestic violence cases. Less than three weeks into the season, five such cases have made headlines, the others involving Greg Hardy, Ray McDonald and Jonathan Dwyer.

Vikings star running back Peterson, Carolina defensive end Hardy and Arizona running back Dwyer are on a special commissioner's exemption list and are being paid while they go through the legal process. McDonald, a defensive end for San Francisco, continues to practice and play while being investigated on suspicion of domestic violence.

As these cases have come to light, such groups as the National Organization of Women and league partners and sponsors have come down hard on the NFL to be more responsive in dealing with them. Congress also is watching to see how the NFL reacts.

In response to the criticism, the NFL announced it is partnering with a domestic violence hotline and a sexual violence resource center.

Goodell also said in a memo to the clubs late Thursday that within the next 30 days, all NFL and team personnel will participate in education sessions on domestic violence and sexual assault. The memo said the league will work with the union in providing the "information and tools to understand and recognize domestic violence and sexual assault."

The league will provide financial, operational and promotional support to the National Domestic Violence Hotline and the National Sexual Violence Resource Center.

12:07 p.m. Roger Goodell to break silence on domestic abuse and the NFL

Roger Goodell will make his first public statements in more than a week about the rash of NFL players involved in domestic violence when he holds a news conference Friday.

The NFL commissioner will address the league's personal conduct policy. The league has faced increasing criticism it has not acted quickly or emphatically enough concerning the domestic abuse cases.

His last public appearance was at a high school in North Carolina on Sept. 10.

The commissioner and some NFL teams have been heavily criticized for lenient or delayed punishment of Ray Rice, Adrian Peterson and other players involved in recent domestic violence cases. Less than three weeks into the season, five such cases have made headlines, the others involving Greg Hardy, Ray McDonald and Jonathan Dwyer.

Vikings star running back Peterson, Carolina defensive end Hardy and Arizona running back Dwyer are on a special commissioner's exemption list and are being paid while they go through the legal process. McDonald, a defensive end for San Francisco, continues to practice and play while being investigated on suspicion of domestic violence.

As these cases have come to light, such groups as the National Organization of Women and league partners and sponsors have come down hard on the NFL to be more responsive in dealing with them. Congress also is watching to see how the NFL reacts.

In response to the criticism, the NFL announced it is partnering with a domestic violence hotline and a sexual violence resource center.

Goodell also said in a memo to the clubs late Thursday that within the next 30 days, all NFL and team personnel will participate in education sessions on domestic violence and sexual assault. The memo said the league will work with the union in providing the "information and tools to understand and recognize domestic violence and sexual assault."

The league will provide financial, operational and promotional support to the National Domestic Violence Hotline and the National Sexual Violence Resource Center.

"These commitments will enable both the hotline and NSVRC to help more people affected by domestic violence and sexual assault," Goodell said in the memo.

The National Domestic Violence Hotline provides domestic violence victims and survivors access to a national network of resources and shelters. It is available 24 hours a day, seven days a week in 170 languages. Goodell noted that the hotline received 84 percent more calls from Sept. 8-15, and the organization said more than 50 percent of those calls went unanswered because of lack of staff.

"The hotline will add 25 full-time advocates over the next few weeks that will result in an additional 750 calls a day being answered," he said.

NSVRC supports sexual violence coalitions across the United States. The NFL's initial support will be directed toward state coalitions to provide additional resources to sexual assault hotlines.

This story has been updated.

The Trump administration asked the Supreme Court to block Congress from seeking the materials, saying, "The government will suffer irreparable harm absent a stay."; Credit: Andrew Harnik/AP

The Supreme Court has temporarily put on hold the release of redacted grand jury material from the Russia investigation to a House panel.

The Trump administration is trying to block the release.

Last October, a district court judge ruled the Justice Department had to turn over the materials, which were blacked out, from former special counsel Robert Mueller's report into Russian interference in the 2016 election.

An appeals court upheld the decision, but the Trump administration, hoping to keep the evidence secret, appealed to the Supreme Court.

Chief Justice John Roberts' order temporarily stops the process. Lawyers for the House Judiciary Committee have until May 18 to file their response to the Justice Department's attempts to keep the materials from the House panel.

The Justice Department had until Monday to turn over the material following the appeals court order. But on Thursday, the Trump administration asked the Supreme Court to block Congress from seeking it, saying, "The government will suffer irreparable harm absent a stay."

This content is from Southern California Public Radio. View the original story at SCPR.org.

Ron Struthers of Struthers' Resource Stock Report details the value proposition of Bam Bam Resources and its flagship prospect.

Full Text:

A National Science Foundation-funded study found that Charles Darwin's famous finches defy what has long been considered a key to evolutionary success: genetic diversity. The research on finches of the Galapagos Islands could change the way conservation biologists think about a species' potential for extinction in naturally fragmented populations. Researchers examined 212 tissue samples from museum specimens and living birds. Some of the museum specimens in the study were collected by Darwin himself in 1835. Only one of the extinct populations, a species called the vegetarian finch, had lower genetic diversity compared to modern survivors. Specifically, researchers believe a biological phenomenon called sink-source dynamics is at play in which larger populations of birds from other islands act as a "source" of immigrants to the island population that is naturally shrinking, the "sink." Without these immigrant individuals, the natural population on the island likely would continue to dwindle to local extinction. The immigrants have diverse genetics because they are coming from a variety of healthier islands, giving this struggling "sink" population inflated genetic diversity.

Image credit: Jose Barreiro

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The molecular mechanism used by many bacteria to kill neighboring cells has redundancy built into its genetic makeup, which could allow for the mechanism to be expressed in different environments, say researchers at Penn State and the University of Wisconsin-Madison. Their new study provides insights into the molecular mechanisms of competition among bacteria. "Many organisms, including humans, acquire bacteria from their environment," said Tim Miyashiro, a biochemist and molecular biologist at Penn State and the leader of the research team. "These bacteria can contribute to functions within the host organism, like how our gut bacteria help us digest food. We're interested in the interactions among bacteria cells, and between bacteria and their hosts, to better understand these mutually beneficial symbiotic relationships." Cells of the bioluminescent bacteria Vibrio fisheri take up residence in the light organ of newly hatched bobtail squid. At night, the bacteria produce a blue glow that researchers believe obscures a squid's silhouette and helps protect it from predators. The light organ has pockets, or crypts, in the squid's skin that provide nutrients and a safe environment for the bacteria. "When the squid hatches, it doesn't yet have any bacteria in its light organ," said Miyashiro. "But bacteria in the environment quickly colonize the squid's light organ." Some of these different bacteria strains can coexist, but others can't. "Microbial symbioses are essentially universal in animals, and are crucial to the health and development of both partners," says Irwin Forseth, a program director in the National Science Foundation's Division of Integrative Organismal Systems, which funded the research. "The results from this study highlight the role small genetic changes can play in microbe interactions. Increased understanding will allow us to better predict organisms' performance in changing environments."

Image credit: Andrew Cecere

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Scientists have recovered the first genetic data from an extinct bird in the Caribbean, thanks to the remarkably preserved bones of a Creighton's caracara in a flooded sinkhole on Great Abaco Island in the Bahamas. Studies of ancient DNA from tropical birds have faced two formidable obstacles. Organic material quickly degrades when exposed to heat, light and oxygen. And birds' lightweight, hollow bones break easily, accelerating the decay of the DNA within. But the dark, oxygen-free depths of a 100-foot blue hole known as Sawmill Sink provided ideal preservation conditions for the bones of Caracara creightoni, a species of large carrion-eating falcon that disappeared soon after humans arrived in the Bahamas about 1,000 years ago. Florida Museum of Natural History researcher Jessica Oswald and her colleagues extracted and sequenced genetic material from the 2,500-year-old C. creightoni femur. Because ancient DNA is often fragmented or missing, the team had modest expectations for what they would find –- maybe one or two genes. But instead, the bone yielded 98.7% of the bird's mitochondrial genome, the DNA most living things inherit from their mothers. The mitochondrial genome showed that C. creightoni is closely related to the two remaining caracara species alive today: the crested caracara and the southern caracara. The three species last shared a common ancestor between 1.2 and 0.4 million years ago. "This project enhanced our understanding of the ecological and evolutionary implications of extinction, forged strong international partnerships, and trained the next generation of researchers," says Jessica Robin, a program director in National Science Foundation's Office of International Science and Engineering, which funded the study.

Image credit: Florida Museum photo by Kristen Grace

The National Science Foundation: Creating knowledge to transform our future

Tradeshift, a supply...

Updates for the critical-rated vulnerabilities, which are being actively exploited in the wild, are still weeks away

The post Microsoft warns of two Windows zero‑day flaws appeared first on WeLiveSecurity

Even accounts belonging to banks and educational institutions were found on lists plastered across various hacker forums

The post Half a million Zoom accounts for sale on the dark web appeared first on WeLiveSecurity

The tool, which comes after a similar effort by Google, looks at how people’s traveling behavior has changed since the start of the pandemic

The post Apple releases mobility data to help combat COVID‑19 appeared first on WeLiveSecurity

…and why are they selling it to other security vendors and product testers?

The post Professional data leakage: How did that security vendor get my personal data? appeared first on WeLiveSecurity

As you rush to buy something for your mom, con artists will be trying to make a dent in your wallet. Here are some common types of fraud to look out for not only this Mother's Day.

The post Scams to watch out for not just this Mother’s Day appeared first on WeLiveSecurity

Coda Payments and Riot Games have announced that players...

Source: Streetwise Reports   04/22/2020

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from ROTH Capital Partners, Moderna Inc., Company Note, April 19, 2020

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Moderna, Inc.

ROTH makes a market in shares of Moderna, Inc. and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has managed or co-managed a public offering for Moderna, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   04/23/2020

Global healthcare packaging components manufacturer company West Pharmaceutical Services Inc. (WST:NYSE) today announced financial results for its first quarter ending March 31, 2020 and provided updated full-year 2020 financial guidance.

The company reported that net sales in Q1/20 increased to $491.5 million, a 10.8% increase from $443.5 million in Q1/19. During the same corresponding period, the firm stated that non-GAAP diluted earnings per share (EPS) increased by 36% to $0.99 and non-GAAP adjusted-diluted EPS increased by 36% to $1.01.

West Pharmaceutical Services advised that it is maintaining its FY/20 net sales guidance, which is expected to be in a range of $1.95-1.97 billion. The company stated that it is updating FY/20 adjusted-diluted EPS guidance to a new range of $3.52-3.62, compared to the prior estimated range of $3.45-3.55.

The company's President and CEO Eric M. Green commented, "During these unprecedented times, our priorities are focused on the well-being and safety of our team members as well as ensuring the supply of critical, high-quality components and solutions to our customers...I am extremely pleased that we delivered a strong performance in the first quarter given the challenging environment that the COVID-19 pandemic has had on our customers, our suppliers and our team members. In particular, we continued to deliver strong sales growth in high-value products, as demand trends from our worldwide customer base were similar to trends we saw last year. Our teams are partnering with a broad range of customers working to support efforts to develop solutions that address the global COVID-19 pandemic such as diagnostics, anti-viral therapeutics and vaccines."

The firm outlined sales in the most recent quarter by product line. The company reported that in Q1/20, net sales in its Proprietary Products segment grew by 9.7% to $373.5 million and that this segment "saw good demand for Westar^®, Daikyo^®, NovaPure^® and FluroTec^® components as well as for devices such as Daikyo Crystal Zenith^® syringes and cartridges and our self-injection platforms."

The firm noted that net sales from its Contract-Manufactured Products segment grew by 14.5% to $118.1 million led by sales of components for diagnostic devices and drug-injection delivery devices.

The company added that the Biologics market unit enjoyed double-digit organic sales growth, the Generics market unit achieved high-single digit organic sales growth and the Pharma market unit registered mid-single digit organic sales growth.

The firm additionally noted that during Q1/20 under its share repurchase program, it repurchased 761,500 shares for $115.5 million at an average share price of $151.65.

West Pharmaceutical Services is headquartered in Exton, Pa., roughly 35 miles west of Philadelphia, and is a designer and manufacturer of injectable pharmaceutical packaging and delivery systems.

West Pharmaceutical has market capitalization of around $13.5 billion with approximately 73.84 million shares outstanding. WST shares opened 5.25% higher today at $179.05 (+$8.93, +5.25%) over yesterday's $170.12 closing price and reached a new 52-week high price this morning of $190.27. The stock has traded today between $177.13 and $190.27 per share and is currently trading at $187.04 (+$17.17, +10.11%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: WST:NYSE, )

Source: Streetwise Reports   04/29/2020

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: CMRX:NASDAQ, )

Source: Streetwise Reports   05/06/2020

In a May 4 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Arcturus Therapeutics Holdings Inc. (ARCT:NASDAQ) formed a partnership with Catalent Inc. (CTLT:NYSE), which "raises the profile of LUNAR-COV19 as a leading vaccine candidate."

Arce reviewed Catalent's contribution to the partnership. The global contract development and manufacturing organization is to manufacture Arcturus' messenger RNA (mRNA) LUNAR-COV19 for protection against SARS-CoV-2 to be used first for human clinical trials and potentially, eventually commercially.

As for timing, Arce noted, San Diego, Calif.-based Arcturus intends to transfer its vaccine technology to Catalent this month and expects Catalent to manufacture the first batches of LUNAR-COV19 by June 2020. "Critically, Arcturus continues to anticipate initiation of Phase 1 testing of LUNAR-COV19 in the summer of 2020," Arce highlighted.

Catalent is to produce the vaccine at its biomanufacturing facility in Madison, Wisc. "This facility utilizes Catalent's flex-suite, a current good manufacturing practice manufacturing suite, that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process," explained Arce.

Obtaining the vaccine from one facility domestically versus multiple entities worldwide should result in several benefits, Arce continued. They include easy development and production, accelerated delivery and improved costs. Arcturus believes Catalent can produce millions of doses of LUNAR-COV19 mRNA in 2020 and, if need be, hundreds of millions of doses each year subsequently for use globally.

Arce pointed out that LUNAR-COV19 differentiates itself from other similar vaccine candidates in that the technology and delivery platform behind it deliver an "extraordinarily low dose (perhaps 2 micrograms)" in "a potential single shot."

H.C. Wainwright has a Buy rating and a $62 per share price target on Arcturus, the stock of which is currently trading at about $42.12 per share.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., First Take, May 4, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Arcturus Therapeutics Holdings Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Arcturus Therapeutics Holdings Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Arcturus Therapeutics Holdings Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Arcturus Therapeutics Holdings Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Arcturus Therapeutics Holdings Inc. during the past 12 months.

The Firm does not make a market in Arcturus Therapeutics Holdings Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: ARCT:NASDAQ, )

Source: Streetwise Reports   05/06/2020

Biopharmaceutical company Horizon Therapeutics Inc. (HZNP:NASDAQ), which focuses on developing and commercializing medicines for treatment of rare and rheumatic diseases, today announced its Q1/20 financial results for the period ending March 31, 2020. The firm began by advising that it is raising its FY/20 net sales guidance and revised its adjusted EBITDA guidance.

For Q1/20 the company reported that net sales increased by 27% to $355.9 million over Q1/19. The firm provided a breakdown of revenue by business unit and listed that in Q1/20 compared with Q1/19, its Orphan segment net sales increased 47% to $245.4 Million, KRYSTEXXA® net sales rose by 78% to $93.3 million and TEPEZZA (teprotumumab-trbw) net sales were $23.5 million, which exceeded expectations.

The firm advised that it is increasing FY/20 net sales guidance to $1.40-1.45 billion driven primarily by significantly higher TEPEZZA net sales and reflecting anticipated impacts from COVID-19. The company also presented revised FY/20 adjusted EBITDA guidance of $450-500 million, which reflects increased TEPEZZA program investment to support higher-than-expected demand.

The firm indicated that in Q1/20 it posted a GAAP net loss of $13.6 million with adjusted EBITDA of $107.2 million and non-GAAP net income of $83.2 million.

The company's Chairman, President and CEO Timothy Walbert commented, "We had a very strong start to 2020, highlighted by the early approval and rapid uptake of TEPEZZA, which significantly exceeded expectations, excellent KRYSTEXXA growth and our recent acquisition of HZN-825...We are increasing our full-year net sales guidance to account for significantly higher TEPEZZA net sales that more than offset the expected impact from COVID-19 this year, and we are widening both our net sales and adjusted EBITDA guidance ranges to account for future uncertainty. The fundamentals of our business are strong, including a robust cash position, and we continue to be very well positioned for the long term."

The company noted that it received FDA approval for TEPEZZA for the treatment of thyroid eye disease (TED) earlier this year in January. The firm described TED as "a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement." The company further s explained that "TEPEZZA, a fully human monoclonal antibody insulin-like growth factor-1 receptor (IGF-1R) inhibitor, is the first and only FDA-approved medicine for the treatment of TED."

Horizon Therapeutics is a biopharmaceutical company headquartered in Dublin, Ireland. The firm researches, develops and commercializes medicines for treatment of rare and rheumatic diseases.

Horizon has a market capitalization of around $7.1 billion with approximately 190.2 million shares outstanding and a short interest of about 4.9%. HZNP shares opened 10% higher today at $44.19 (+$3.81, +10.19%) over yesterday's $37.38 closing price and reached a new 52-week high price this morning of $43.57. The stock has traded today between $40.00 and $43.90 per share and is currently trading at $42.95 (+$5.57, +14.90%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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