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DOD Biological Threat Reduction Program Should Be Part of a New Interagency Mechanism to Coordinate Efforts to Prevent Biological Threats, Including Natural Disease Outbreaks - Report Offers Five-Year Strategy for BTRP

Over the next five years, the U.S. Department of Defense’s Biological Threat Reduction Program (BTRP) should encourage and be among co-leaders in the federal government’s development of an enduring interagency mechanism to address an array of biological threats – including natural disease outbreaks, accidental releases, and intentional attacks -- to deployed U.S. forces and to the nation itself, says a new report from the National Academies of Sciences, Engineering, and Medicine




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Child Sexual Abuse Reports Are On The Rise Amid Lockdown Orders

; Credit: Fanatic Studio/Gary Waters/Science Photo Library/Getty Images

Anya Kamenetz | NPR

There has been a rise in the number of minors contacting the National Sexual Assault Hotline to report abuse. That's according to RAINN, the Rape, Abuse and Incest National Network, which runs the hotline.

By the end of March, with much of the country under lockdown, there was a 22% increase in monthly calls from people younger than 18, and half of all incoming contacts were from minors. That's a first in RAINN's history, Camille Cooper, the organization's vice president of public policy, tells NPR.

Of those young people who contacted the hotline in March, 67% identified their perpetrator as a family member and 79% said they were currently living with that perpetrator. In 1 out of 5 cases where the minor was living with their abuser, RAINN assisted the minor in immediately contacting police.

"As a result of looking at the information that we had from those sessions, it was clear that the abuse was escalating in both frequency and severity," Cooper says. "So a lot of the kids that were coming to the hotline were feeling pretty vulnerable and traumatized. And it was a direct result of COVID-19, because they were quarantined with their abuser. The abuser was now abusing them on a daily basis."

Lockdown orders are first and foremost public health and safety measures. But statistically speaking, home is not the safest place for every young person. RAINN reports that about 34% of child sexual abusers are family members. Closing schools and canceling youth activities like sports removes children from the watchful eyes of "mandatory reporters" — those trusted adults, like teachers, nurses and child care providers, who are required by law in most states to report suspicions of child abuse or neglect.

However, Cooper says her organization has confirmed with authorities around the country that the child welfare system is still operating during the pandemic. That is, an official report of current and ongoing abuse will still trigger an investigation, and, if necessary, a child will be removed from the home.

"[Child welfare workers] will be coming to the home in person and proceeding with a formal investigation and a child forensic interview and things like that," she says. If the abuse is farther in the past and the child is not quarantined with the accused, Cooper says, the interview may take place over video chat.

In the meantime, RAINN and other child welfare organizations are lobbying to make it easier for children to report abuse. Cooper says, "One of the solutions we came up with that we are now currently working directly with the leadership in Congress on is to get all of the online learning platforms that children are interacting with to have a reporting function on that platform in plain sight for children."

Copyright 2020 NPR. To see more, visit https://www.npr.org.

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




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Checklist devised to diagnose seafloor health

Scientists have produced a list of seafloor characteristics to determine the health status of the ecosystem it supports. These indicators could improve the quality and consistency of marine conservation efforts across Europe, particularly where the impact of human activities is high.




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In Belarus, World War II Victory Parade Will Go On Despite Rise In COVID-19 Cases

World War II veterans Pyotr Vorobyev (left), 90, and Pavel Yeroshenko, 94, attend a performance in Minsk by the 120th Rogachev Guards Mechanized Brigade of the Belarusian Armed Forces ahead of the 75th anniversary of the victory in World War II. Belarus is raising eyebrows — and concerns — by going ahead with a mass military parade marking the anniversary on Saturday.; Credit: Natalia Fedosenko/TASS

Charles Maynes | NPR

With the coronavirus forcing much of Europe to tone down public celebrations this week marking the 75th anniversary of the end of World War II, the small nation of Belarus is raising eyebrows — and concerns — by going ahead with a mass military parade in the capital Minsk on Saturday.

The move reflects the business-as-usual approach of the country's longtime president, Alexander Lukashenko — a former Soviet collective farm director leading what the U.S. once dubbed the last dictatorship in Europe.

As the coronavirus has raced across the globe, Lukashenko has dismissed the pandemic as mass "psychosis" — a disease easily cured with a bit of vodka, a hot sauna or time spent playing hockey or doing farm work on one of country's legendary Soviet-designed tractors.

The country's soccer league still competes. Belarus' schools opened after a short delay. And annual Victory Day celebrations will go on.

The government "simply cannot cancel the parade," the Belarusian leader said in a Cabinet meeting this week. "It's an emotional, deeply ideological event."

In a rare concession to at least some social distancing measures, Lukashenko has urged Belarusian men to spend time with their families, rather than their mistresses. But behind the theatrics sits a wily politician who plays to his base in the country's towns and villages, analysts say.

"Lukashenko prioritizes combating panic rather than combating the pandemic," Artyom Shraibman, a Minsk-based political analyst with Sense Analytics, tells NPR. "He downplays the threat, and of course he's very concerned about [the] state of [the] economy."

Shraibman notes similar echoes coming out of the Trump White House.

Belarus has reported over 21,000 suspected coronavirus cases and more than 120 deaths — comparatively low in the global count, but one of the fastest-growing infection rates in Europe, the World Health Organization says.

Amid the growing crisis, Belarusian civil society is rallying to fix what Lukashenko will not. With many Belarusians now self-isolating by choice, even the country's health ministry has endorsed some public distancing measures over Lukashenko's advice.

Volunteers have raised money to buy personal protective gear for hospitals. Restaurants have donated food. Hotels provide rooms pro bono to medical workers. Private businesses have raised funds.

"People who normally don't talk to each other are working together to help," says Andrej Stryzhak of #ByCovid19, a group of volunteer activists leading crowdfunded efforts to equip health workers across the country. "It's been magical and I don't use that word lightly."

Stryzhak says many are bracing for the aftershocks of Saturday's Victory parade, where attendance isn't required but there are reports of pay bonuses given to those who show up.

"We believe in statistics. And the experts and doctors tell us that if there's a crowd, then expect a new spike in cases a week or two later," says Stryzhak. "Belarus isn't Mars," he adds, noting that the country is as susceptible to the virus as any other.

Meanwhile, Lukashenko's contrarian approach has also fueled a rift with Belarus' big brother to the east. Russia has embraced lockdowns amid its own soaring coronavirus infection rates.

This week, the Belarusian leader ordered the expulsion of a journalist from Russia's Channel 1 state television network after it aired a report criticizing Lukashenko for risking lives and ignoring the pandemic.

"Leave us alone and don't count your chickens before they hatch," said Lukashenko. "Later we'll sit and find out who was right."

Copyright 2020 NPR. To see more, visit https://www.npr.org.

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




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Is Skyharbour Resources Poised to Move Higher?

With the recent 22% rise in the price of uranium, Peter Epstein of Epstein Research considers the upside for Skyharbour's holdings in the Athabasca Basin.




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When human expertise improves the work of machines

Full Text:

Machine learning algorithms can sometimes do a great job with a little help from human expertise, at least in the field of materials science. In many specialized areas of science, engineering and medicine, researchers are turning to machine learning algorithms to analyze data sets that have grown too large for humans to understand. In materials science, success with this effort could accelerate the design of next-generation advanced functional materials, where development now usually depends on old-fashioned trial and error. By themselves, however, data analytics techniques borrowed from other research areas often fail to provide the insights needed to help materials scientists and engineers choose which of many variables to adjust -- and the techniques can't account for dramatic changes such as the introduction of a new chemical compound into the process. In a new study, researchers explain a technique known as dimensional stacking, which shows that human experience still has a role to play in the age of machine intelligence. The machines gain an edge at solving a challenge when the data to be analyzed are intelligently organized based on human knowledge of what factors are likely to be important and related. "When your machine accepts strings of data, it really does matter how you are putting those strings together," said Nazanin Bassiri-Gharb, the paper's corresponding author and a scientist at the Georgia Institute of Technology. "We must be mindful that the organization of data before it goes to the algorithm makes a difference. If you don't plug the information in correctly, you will get a result that isn't necessarily correlated with the reality of the physics and chemistry that govern the materials."

Image credit: Rob Felt/Georgia Tech




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West Pharma Services' Shares Rise 10% on Q1 Sales Growth and Raised FY Earnings Guidance

Source: Streetwise Reports   04/23/2020

Shares of West Pharmaceutical Services traded higher and established a new 52-week high price after the firm reported Q1/20 earnings that included a 10.8% increase in YoY revenues.

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%).

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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, )




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Avadel Shares Rise and Shine on Positive Phase 3 Narcolepsy Study Findings

Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals' shares traded 25% higher reaching a new 52-week high price after the company reported positive topline results from its Pivotal Phase 3 REST-ON trial of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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: AVDL:NASDAQ, )




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Chimerix Shares Rise 50% as FDA Gives 'Go Ahead' for Phase 2/3 ALI Study in COVID-19 Patients

Source: Streetwise Reports   04/29/2020

Shares of Chimerix Inc. traded higher after the company reported it has received U.S. FDA clearance to initiate a Phase 2/3 Study of dociparstat sodium in acute lung injury for patients afflicted with severe COVID-19.

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%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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, )




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Horizon Therapeutics Shares Rise 15% on Strong Q1 Results and Raised F/Y Sales Guidance

Source: Streetwise Reports   05/06/2020

Shares of Horizon Therapeutics traded higher setting a new 52-week high price after the company reported a 27% y-o-y increase in net sales for Q1/20 and raised FY/20 net sales guidance.

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%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

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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Is Skyharbour Resources Poised to Move Higher?

With the recent 22% rise in the price of uranium, Peter Epstein of Epstein Research considers the upside for Skyharbour's holdings in the Athabasca Basin.




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Kraton Share's Rise on Positive Q1/20 Earnings Report

Shares of Kraton Corp. traded 24% higher after the specialty polymers and high-value biobased products maker reported that net income in Q1/20 increased to $209.0 million, compared to $13.6 million in Q1/19.




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ION Geophysical Shares Trade 70% Higher after Reporting 53% Rise in Q1 Sales

Shares of ION Geophysical traded higher after the company reported Q1/20 financial results that included a 53% year-over-year increase in revenue.




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Mapping helps visualise complex environmental risk assessment

Scientists involved in a pan-European project to develop better methods of risk assessment say maps that show such cumulative risks geographically are easy to interpret and should be considered as practical tools for conveying risk information to decision makers and the general public.




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Tourist cruise ships increase atmospheric pollution in the Arctic

Levels of air pollution significantly increase on the island of Svalbard in the Norwegian Arctic when tourist cruise ships are present, according to a recent study. With shipping levels rising in the region, the researchers recommend that stricter emissions regulations are introduced in order to limit the impact of pollution on the Arctic environment.




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Road traffic noise increases risk of diabetes

Increasing noise levels are a global environmental concern, and have been linked to important health issues, such as heart disease and cognitive development. New Danish research has now shown that it is also associated with an increased risk of diabetes.




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Urban greening reduces noise pollution

Green roofs have the potential to significantly reduce road traffic noise in the urban environment, according to a new study. The results suggest that greening of roofs and walls with materials suitable for growing plants softens the urban environment keeping sound levels low, whereas hard, manmade structures tend to amplify traffic noise.




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North Korean hackers infect real 2FA app to compromise Macs

Hackers have hidden malware in a legitimate two-factor authentication (2FA) app for macOS to distribute Dacls, a remote access trojan associated with the North Korean Lazarus group. [...]




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Sea level rise and the impact of salinity on soil invertebrates

Sea level rise may cause soils in coastal regions to become more saline. In a recent study, reproduction in soil invertebrates was impaired in soils containing salt levels below the threshold used currently to define saline soils. The authors recommend community-level studies to further investigate the salt concentrations that are harmful to soil organisms.




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New tool to compare and prioritise brownfield sites for redevelopment

Researchers have proposed a new indexing scheme to help decision-makers prioritise brownfield sites for redevelopment. The scheme scores potential sites according to socio-economic, smart growth and environmental dimensions. By giving users the flexibility to emphasise some aspects of development as more important than others, it can be adapted for use in different contexts.




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CRUISER: An open-source alternative to Google Maps...




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Flood-risk communications should be specific, tailored, and utilise social networks

Effective flood-risk communications should include specific information on how householders can protect themselves and their property against flooding, a recent Dutch study concludes. The researchers’ evaluation of communication strategies also highlights an important role for social media in spreading messages about flood risk and protection.




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Mediterranean diet associated with lower risk of death in cardiovascular disease patients

28 Aug 2016: The Mediterranean diet is associated with a reduced risk of death in patients with a history of cardiovascular disease, according to results from the observational Moli-sani study presented at ESC Congress 2016 today.1

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  • Health & Medicine

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Historical analysis examines sugar industry role in heart disease research

Using archival documents, a new report published online by JAMA Internal Medicine examines the sugar industry's role in coronary heart disease research and suggests the industry sponsored research to influence the scientific debate to cast doubt on the hazards of sugar and to promote dietary fat as the culprit in heart disease.

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  • Health & Medicine

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Comparing N2O emissions from organic and mineral fertilisers

A recent study compares the effects of organic, ‘natural’ fertilisers, such as compost, with mineral, synthetic fertilisers, such as urea, on N2O emissions from Mediterranean soil. It suggests that there is little difference between the fertilisers, but that pig slurry offers the best overall balance in terms of emissions and crop yield.




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Fertiliser resource limitations: recycling for food security

Global population growth since 1850 has been largely enabled by commercial phosphorus and nitrogen fertilisers. The availability of these nutrients for food production relies upon steadily diminishing resources of natural gas and phosphorus rock. A recent study suggests that to secure a long-term affordable food supply, policy intervention is needed to conserve these essential resources.




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Target the crop not the soil - to reduce fertiliser use

'Feed the crop not the soil' is the message of a new review into sustainable phosphorus use. Currently, phosphorus fertiliser is applied to the soil, and plants then take it up through the roots. However, more precise nutrient management is needed on farms, the researchers say, so that the phosphorus is targeted at the crop just as it needs it.




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Managing infectious disease under climate change

Health experts have called for a proactive, joined-up approach to public health in Europe under a changing climate. A recent study has examined the evidence for the influence of the climate on infectious disease and proposes a new integrated network for environmental and health data.




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Mapping helps visualise complex environmental risk assessment

Scientists involved in a pan-European project to develop better methods of risk assessment say maps that show such cumulative risks geographically are easy to interpret and should be considered as practical tools for conveying risk information to decision makers and the general public.




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Carbon emissions linked to rise in hay fever and asthma in Europe

Pollen allergy is a common cause of allergic respiratory diseases such as hay fever and asthma. A recent continent-wide study suggests that rising carbon dioxide (CO2) emissions over the last 30 years may be increasing pollen counts especially in European cities, which could have serious consequences for public health.




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Housing type has an influence on traffic noise annoyance

A recent pan-European study has reviewed the factors which influence how annoyed a person feels about road traffic and aircraft noise. Among its findings, residents in terraced housing or apartments were less annoyed by road traffic noise than residents in semi-detached or detached housing.




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Road traffic noise increases risk of diabetes

Increasing noise levels are a global environmental concern, and have been linked to important health issues, such as heart disease and cognitive development. New Danish research has now shown that it is also associated with an increased risk of diabetes.




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Antibiotic resistance in struvite fertiliser from waste water could enter the food chain

The application to crops of struvite (magnesium ammonium phosphate) recovered from waste water may cause antibiotic resistance genes (ARGs) present in this fertiliser to enter the food chain. Chinese researchers who conducted this study on Brassica plants suggest that ARGs in struvite pass from the soil into the roots of the plant, and from the roots to the leaves, via the bacterial community already present. The results of this research highlight the need for struvite production methods and agricultural practices that minimise the risk of antibiotic-resistance transmission from struvite to humans or animals via the environment.




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Environmental Noise

Noise pollution is among the most common complaints regarding environmental issues in Europe, especially in densely populated and residential areas near major roads, railways and airports. But noise - unwanted sound - is more than a mere annoyance, even at levels below ear damaging volumes. The EU's Environmental Noise Directive (END) has initiated action plans in Member States to reduce environmental noise exposure and its effects. This Thematic Issue reports on recent research to help guide effective noise action plans throughout Europe.




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Noise impacts on health – January 2015

Exposure to excessive noise is recognised as a major environmental health concern. This Thematic Issue examines the impact of noise on human health and outlines how policy initiatives may limit health effects from noise annoyance - and improve wellbeing.




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Noise pollution: separate regulations needed for construction

In a new study, Spanish researchers describe a method specifically designed for measuring and characterising noise from building sites. They claim the method could help shape future policy related to noise pollution caused by the construction industry and provide important information to help reduce construction noise.




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New method to accurately estimate levels of urban noise

New research has identified 25 variables that influence noise in urban areas. By combining these into an equation, the study produced an accurate tool to describe urban sound environments that could be useful in urban planning.




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Implementation of Noise Directive needs harmonising

New research has analysed some of the issues around the implementation of the EU's Environmental Noise Directive (END) by Member States. It demonstrated large differences in the way noise levels are calculated and geographically mapped between countries and called for more standardised and clearer guidelines.




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WHO recommends setting night noise limits at 40 decibels

The World Health Organisation (WHO) has set the European target limit of outdoor night noise levels at annual average of 40 decibels (dB) in its new guidelines. This would protect the public, including the most vulnerable, such as children and the elderly.




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Implementing the Noise Directive - lessons from Ireland

New research has reviewed the Irish implementation of the first phase of the EU Noise Directive. So far 31 different organisations have been involved and this will increase throughout the second phase of the Directive's implementation. More standardisation is needed to harmonise activities, perhaps by establishing a national expert steering group.




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Traffic noise causes loss of over one million healthy life years

A new World Health Organisation (WHO) study has estimated that the health impact of environmental noise in western Europe could be up to 1.6 million healthy life years lost annually through ill health, disability or early death.




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Cognitive impairment caused by aircraft noise: school versus home

A recent study suggests that exposure to aircraft noise during the day has a greater impact on cognitive ability in children than sleep-disruption caused by exposure to aircraft noise during the night. Protective policy is therefore likely to be most effective if focused at the school level.




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Noise maps suggest too many people exposed to damaging noise levels

Nearly 85% of residents in central Dublin, Ireland, could be exposed to damaging levels of night-time traffic noise, according to a recent study. The researchers explain how they assessed population exposure to noise and calculate the impacts of several noise reduction measures, providing information that could help EU Member States meet the Environmental Noise Directive’s requirements.