Top Stories for Week of March 30, 2020

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Trump signs massive $2 trillion coronavirus stimulus bill.

President Trump on Friday signed into law the largest economic stimulus package in modern American history, backing a $2-trillion measure designed to respond to the coronavirus pandemic. Under the law, the government will deliver direct payments and jobless benefits for individuals, money for states and a huge bailout fund for businesses battered by the crisis.

Trump signed the measure in the Oval Office hours after the House approved it by voice vote and less than two days after the Senate unanimously passed it. In brief remarks, Mr. Trump, flanked by Republican leaders in Congress, thanked “Democrats and Republicans for coming together and putting America first” and said it would help pave the road to economic recovery. “I think we are going to have a tremendous rebound,” he said.

The legislation will send direct payments of $1,200 to millions of Americans, including those earning up to $75,000, and an additional $500 per child. It will substantially expand jobless aid, providing an additional 13 weeks and a four-month enhancement of benefits, and for the first time will extend the payments to freelancers and gig workers.

The measure will also offer $377 billion in federally guaranteed loans to small businesses and establish a $500 billion government lending program for distressed companies reeling from the crisis, including allowing the administration the ability to take equity stakes in airlines that received aid to help compensate taxpayers. It will also send $100 billion to hospitals on the front lines of the pandemic.

The law was the product of days of talks between members of Mr. Trump’s administration and Democratic and Republican leaders in Congress. And even before Mr. Trump held a bill signing on Friday (March 27, 2020) afternoon, congressional leaders said they expected to negotiate more legislative responses to the pandemic in the coming months.

COVID-19 Addenda: US eclipses 115,000 confirmed coronavirus cases; Trump wants governors to be “appreciative” of White House efforts; NYU Med School offers early graduation with conditions.

Nearly 120,000 people in the United States have now been infected with the coronavirus, according to a New York Times database, a grim milestone that comes in the same week that the national death toll rose above 1,900 and that the country surpassed the case totals in China and Italy. The outbreak has been especially severe in a handful of states, including New York, New Jersey, Washington, Louisiana and California, where cases number in the thousands.

But all across the country, numbers are rising quickly as containment efforts falter, the virus spreads and testing ramps up. New York State, which has been especially aggressive in testing, announced thousands more cases on Saturday. That state accounts for more than one-third of the country’s known coronavirus cases. As of Saturday afternoon, at least 119,525 people across every state, plus Washington, DC, and four US territories, have tested positive for the virus, according to a New York Times database, and at least 1,989 patients with the virus have died.

But President Trump voiced his frustration with governors who haven’t been as complimentary toward him and his administration over its response to the coronavirus. Trump said he just wants governors to be “appreciative” of what the White House is doing to address the crisis.

“I don’t want them to say things that aren’t true,” he said. “I want them to be appreciative.”

And, New York University has decided to allow medical students the opportunity to graduate early. Such a move may end up being a model for other institutions that are seeking to increase staffing amid the coronavirus pandemic, a researcher said.

“It’s definitely a positive move,” said Patricia Pittman, PhD, a professor at George Washington University’s Milken Institute School of Public Health.

A website led by specialists in emergency medicine, Brief-19, first reported that NYU’s Grossman School of Medicine had offered early graduation for students who would agree to begin working in internal medicine and emergency departments starting in April, says Medscape. Medical schools across the nation have removed students from clinical duties to protect them and conserve resources, such as personal protective equipment.

Coronavirus deaths predicted to peak in three weeks; stimulus deal includes billions in hospital funding; British PM tests positive for COVID-19.

An epidemiologist at the University of Florida and partner to the CDC, Ira Longini, PhD, predicts that COVID-19 deaths will peak in the US within two to three weeks, according to news reports. The prediction is based on disease modeling, and President Trump and other leaders have stated that if the worst truly is over within the coming weeks, low-risk persons could go back to work within the month.

While there are disease specialists that agree with Longini’s predictions, others say that it’s a big risk to assume too early that we’re seeing the worst of the virus. Disease modelers have offered many predictions about how long the outbreak will last, and some say the peak impact of COVID-19 is months away. From the news reports, Longini’s prediction appears to be his educated guess, without a reference to a more complete analysis or peer-reviewed paper.

“While we appreciate the insights of some of the world’s leading experts and statisticians, we would want to see the methodology and understand its assumptions before we covered this particular projection,” said Medscape.

Separately, the Coronavirus Aid, Relief and Economic Security (CARES) Act will give $100 billion to hospitals and community health centers to promote economic stability as they ramp up efforts to address the COVID-19 outbreak. Hospitals and community health centers are among those slated to receive billions of dollars in funding from the historic $2 trillion coronavirus stimulus package. The stimulus package will provide more than $100 billion in hospital funding to provide emergency relief to hospitals struggling to stay afloat financially as the novel coronavirus rapidly spreads throughout the US.

“There is much more money for our hospitals, for our nurses and physicians, for our nursing homes, for our community health centers to do the job they need to do,” Senate Minority Leader Chuck Schumer (D-NY) said after reaching a bipartisan agreement earlier Wednesday morning.

Hospitals got what they asked for.

According to the stimulus package, Congress is willing to meet that $100 billion figure and more. The package will also include other key provisions to help hospitals respond to the novel coronavirus outbreak, including:

  • Increasing Medicare reimbursement rates for COVID-19 hospitalizations by 20% during the emergency period;
  • Suspending the 2% Medicare sequestration through Dec. 31, 2020;
  • Waiving face-to-face requirements for telehealth services during the emergency period;
  • Expanding the Medicare Hospital Accelerated Payment Program; and
  • Requiring payers to cover COVID-19 tests performed by hospitals and laboratories.

And British Prime Minister Boris Johnson has tested positive for the coronavirus and is self-isolating at his Downing Street residence but said he would still lead the government’s response to the accelerating outbreak. Johnson, 55, experienced mild symptoms on Thursday, a day after he answered questions at a weekly question-and-answer session in parliament’s House of Commons chamber. He received the positive test result at around midnight.

“I’ve taken a test. That has come out positive,” Johnson said on Friday in a video statement broadcast on Twitter. “I’ve developed mild symptoms of the coronavirus. That’s to say–a temperature and a persistent cough.”

Medical Stock Spotlight

Cannabis cultivator Tilray Inc. (Nasdaq:TLRY) led advancing issues, rocketing 149% over the week to $9.10. A DataTrek report suggested the negative impact from the coronavirus could accelerate legalization as states look for ways to recoup losses. The Nanaimo, Canada-based company’s stock has been under pressure as of late as the market adjusts to the impact of the coronavirus.

Although there is no main reason for the stock to trade so much higher last week, it could potentially be trading on a rebound as equities across many sectors traded higher after the stimulus package passed through the US Senate. DataTrek suggested the negative impact from the coronavirus could push legalization across America. Social distancing, closing businesses and imposing travel restrictions have cost states millions of unrecoverable dollars, but legalizing marijuana could make up some losses.

“The stock is just bouncing from very weak levels caused by a capital raise,” New Cannabis Ventures Founder Alan Brochstein told Benzinga.

Tilray shares have a 52-week high of $66.40 and a 52-week low of $2.43.

Elsewhere, BioSig Technologies Inc. (Nasdaq:BSGM) soared 74% to $5.15 after the maker of computers used by heart surgeons said one of its subsidiaries has acquired the rights to an antiviral product that is said to have potential as a coronavirus treatment. The Westport, CT-based company said in a statement that its NeuroClear Technologies unit has acquired the rights to Vicromax, described as an antiviral agent that has shown promise as a treatment for COVID-19, the Connecticut Post reported. The product was developed by Trek Therapeutics of Cambridge, MA.

“Stopping the COVID-19 pandemic and preventing similar viral threats in the future must be the number-one priority of all of us in the healthcare community,” BioSig Chairman and CEO Kenneth Londoner said in a statement. “This very promising anti-viral is the result of tireless efforts by an accomplished group of pharmaceutical industry veterans, and we are doing everything…to ensure it gets tested and brought to market as soon as possible.”

BioSig’s NeuroClear unit will conduct trials of the product under a new subsidiary, ViralClear Pharmaceuticals, the BioSig statement said.

And Aravive Inc. (Nasdaq:ARAV) shot up 61% to $5.86 after H.C. Wainwright analyst Joseph Pantginis maintained a Buy rating and set a price target of $15.00. Aravive has an analyst consensus of Strong Buy, with a price target consensus of $28.67. Based on Aravive’s latest earnings release for the quarter ending September 30, the company reported a quarterly GAAP net loss of $6.14 million. In comparison, last year the company had a GAAP net loss of $6.55 million.

Aravive is a clinical-stage biotechnology company which engages in developing new therapies that target important survival pathways for both advanced solid tumors as well as hematologic malignancies. Its product candidate, Aravive-S6, is a soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL which also promotes metastasis, cancer cell survival, resistance to treatments, and immune suppression. The company was founded on December 10, 2008 and is headquartered in Houston, TX.

But the dilution bug bit Baudax Bio Inc. (Nasdaq:BXRX), causing it to fall 38% to $2.65 after the company reported pricing of public offering of common stock and warrants. Baudax offered 7,692,308 common shares, Series A warrants and Series B warrants to purchase the same number of common stock, at an exercise price of $4.59 per share for Series A Warrants and at $3.25 per share for Series B Warrants. Each share of common stock is being sold together with one Series A warrant and one Series B warrant for a combined price of $3.25 per share and a gross offering size of $25 million.

Net proceeds will be used for the launch and the commercialization of ANJESO, pipeline development activities, and general corporate purposes. Malvern, PA-based Baudax Bio’s first commercial product, ANJESO, won approval by the FDA on February 20, 2020 for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. ANJESO is a once-daily IV NSAID with preferential Cox-2 activity.

IPO Sector: The 2020 IPO boom has hit a brick wall due to the coronavirus disaster and has now ended with the worst crash since the global financial crisis. Twenty Four IPOs raised $6.8 billion, with as many as 20 companies forced to shelve offerings when the IPO door slammed shut in early March, as the focus of investors and policy-makers shifted to a post-coronavirus paradigm.

IPOs produced strong first-day pops in January and February, averaging a 17% gain, but the sell-off resulted in a -4% average return with about one-third finishing the quarter positive. Healthcare was both the most active and best-performing sector, accounting for half of all IPOs and nearly half of all proceeds while averaging a 24% return. (Ref: Renaissance Capital)

Outside the US, while the coronavirus outbreak has put the global IPO market on ice, an Italian respirator mask maker is preparing to go public as global demand for its products soars. Bologna-based GVS SpA sells filtration products used for healthcare services, industrial equipment, automobiles, appliances, and personal respirators across 60 countries. The company is planning a Milan IPO that could come as early as April. Here are five other things you need to know about GVS:

  • Booked €231 million ($261 million) in sales in 2019, a 9% y/y increase;
  • Has sold more masks in 2020 so far than in all of 2019 ($17 million);
  • Plans to expand its production line and employee headcount to increase mask output;
  • Has production facilities in Italy (6% of sales), the US, UK, Brazil, China, and Romania; and
  • Tests its masks with an active virus.

Founded in 1979, GVS, which tests its masks with a live virus, has hired Goldman Sachs Group Inc. and Mediobanco SpA to manage its IPO in April.

A series of novel biomarker signatures may help identify veterans exposed to battlefield explosions who will go on to develop behavioral, cognitive and/or memory complaints, new research shows. Conducted in humans and animals, the study uncovered an association between exposure to detonation of improvised explosive devices and an accumulation of tau protein in the brain, which may explain its presence in chronic traumatic encephalopathy (CTE).

The findings may open the door to more sensitive and objective estimation of brain degeneration among soldiers exposed to battlefield explosions and explain ensuing neuropsychiatric symptoms.

“We found that animals exhibited some sort of tauopathy after being exposed to repetitive blasts. In humans, on the other hand, imaging studies have shown there’s a reason to be concerned that there may be some signal there as well,” co-senior author Gregory Elder, MD, chief of neurology at the James J. Peters VA Medical Center in New York City, said.

The study was published online February 25, 2020 in Molecular Psychiatry.

Repetitive mild traumatic brain injury (mTBI) is a significant risk factor for subsequent development of neurodegenerative disease, including CTE. Following repetitive mTBI, CTE often presents as deterioration in behavior, cognition, and/or memory. Perhaps not surprisingly, there is concern regarding the role of TBI in the chronic cognitive and behavioral symptoms that often develop during or after military service. Research shows that as many as one in five veterans returning from service in Iraq and Afghanistan experience sustained mTBI after blast exposure, a rate that is likely even higher given that many blast-related injuries go undocumented.

“Over the years we’ve begun to see veterans coming back from conflicts in Iraq and Afghanistan who had a lot of postconcussive symptoms that we thought were related to blast-related mild traumatic brain injuries,” said Elder.

To date, there have been several reports of pathologically confirmed cases of CTE among military veterans. Although previous research has described some of these pathologies, the prevalence of distinct pathological subtypes in veterans with chronic cognitive/behavioral syndromes following blast-related TBI has yet to be determined.

Given this knowledge gap, the researchers used a rat model of blast-induced mild traumatic brain injury to study the clinicopathology of tauopathy, while simultaneously investigating clinical biomarkers in human veterans exposed to blasts who subsequently suffered behavioral, cognitive, and/or memory problems. In the animal portion of the study, rats exposed to the experimental blast protocol exhibited a range of anxiety and behavioral traits that resembled posttraumatic stress disorder (PTSD).

On the human side, the researchers used PET scans and the [18F]AV1451 (flortaucipir) tau ligand, a molecule that produces a signal by binding to a site on the tau protein. They found that five of the 10 veterans exhibited excessive retention of [18F]AV1451 at the white/gray matter junction in frontal, parietal, and temporal brain regions. This, they explained, matches the anatomical distribution of tauopathy previously observed in postmortem studies of individuals with CTE.

These findings not only demonstrate the existence of a relationship between blast injuries and clinical neuropsychiatric syndromes in both rats and humans, but also identified biomarker signatures that characterize such disorders, said Elder.

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