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Tuesday, March 3, 2020

Trump to prioritize infrastructure in any coronavirus stimulus package: Mnuchin

Treasury Secretary Steven Mnuchin said Tuesday that infrastructure spending would be a “priority” for President Trump if the economy requires stimulus to power through a slowdown caused by a coronavirus outbreak.
Mnuchin said at a House Ways and Means Committee hearing that while the U.S. benefits from a “very resilient economy,” the president and administration could turn to a long-sought bipartisan infrastructure package to boost growth.
“If there’s a need to stimulate the economy as a result of the coronavirus, I am sure that infrastructure is a priority for the president,” Mnuchin said.
Trump and congressional Democrats have long struggled to cement a bipartisan deal to pour billions of dollars into rebuilding U.S. roads, bridges, railroads and waterways. Hopes of a breakthrough have dwindled with just eight months until the 2020 election, but fears of a coronavirus-driven economic slowdown have revived talk of a potential deal.
Mnuchin’s comments on infrastructure came in response to a question from House Ways and Means Committee Chairman Richard Neal (D-Mass.). Infrastructure has long been a priority for Neal, and he and Mnuchin had been having conversations about the issue even before the coronavirus outbreak dominated the headlines.
Trump said in a tweet late Monday that he thinks House Democrats should propose a one-year payroll tax cut, saying that such a move would be “great for the middle class.”
But Neal said in his opening statement that he thinks that the administration should prioritize infrastructure as a way to stimulate the economy over short-term tax cuts.
“Before the administration begins to entertain any proposals for temporary tax cuts, the most important way that we can proceed in my judgment … if we were to develop a stimulus package, the soundest way to do that is clearly to proceed with a major infrastructure initiative,” Neal said.
A major obstacle to enactment on an infrastructure package is figuring out how to pay for it. House Democrats released a $760 billion infrastructure package in February but did not include pay-fors. Neal said at the time that Democrats wouldn’t be proposing a revenue stream unless they have an agreement with the administration.
Rep. Earl Blumenauer (D-Ore.), a supporter of increasing the gas tax, noted at Tuesday’s hearing that many states have worked on a bipartisan basis on infrastructure funding in recent years. He said that he hoped that Congress and the administration could look at what has been done in those states.
https://thehill.com/policy/finance/485659-mnuchin-trump-to-prioritize-infrastructure-in-any-coronavirus-stimulus-package

Fed slashes interest rates 50 bp to combat damage from virus

The Federal Reserve on Tuesday cut a key U.S. interest rate by 1/2-point point just hours after the G-7 nations pledged to “use all appropriate policy tools” to safeguard the global economy against further damage. The Group of Seven is composed of the U.S., U.K., Canada, France, Germany, Italy and Japan.
Stocks DJIA, -0.20%  surged on Monday after the G-7 announced plans to meet, with equities turning positive in Tuesday action after the rate reduction. U.S. Treasury Secretary Steven Mnuchin and Federal Reserve Chairman Jerome Powell took part in the call before the U.S. stock market opened.
https://www.marketwatch.com/story/covid-19-and-the-economy-fed-rate-cut-calls-grow-as-coronavirus-spreads-globally-2020-02-28?siteid=rss&rss=1

AbbVie Buy of Allergan Passes Muster in Europe, But U.S. Review Continues

AbbVie Inc. and Allergan PLC on Tuesday said they cleared the final European regulatory hurdle for their $63 billion union, but that the U.S. review of the deal will push the closing beyond the current quarter.
The companies said the European Commission has approved the sale of brazikumab to AstraZeneca PLC, which was a condition of the EC’s January blessing of AbbVie’s pending acquisition of Allergan.
AbbVie had previously said it expected to complete the Allergan acquisition in the first quarter, but the companies Tuesday said the U.S. Federal Trade Commission is still reviewing the transaction.
The companies said they have entered into a timing agreement with FTC staff that would likely result in a decision early in the second quarter, adding that they plan to close the transaction at the earliest possible date.

https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Buy-of-Allergan-Passes-Muster-in-Europe-But-U-S-Review-Continues-30101245/

Imara Sets IPO at 4.45 Million Shares, Sees Pricing at $16-$18 Each

Biopharmaceutical company Imara Inc. on Tuesday said it expects to sell 4.45 million shares at between $16 and $18 apiece in its planned initial public offering.
At the $17 midpoint of that range, the Boston company said it expects net proceeds of about $66.4 million, or roughly $76.9 million if the underwriters exercise their option to buy an additional 667,500 shares.
Imara said it will use proceeds from the offering to fund research and development costs, adding that it expects the proceeds, coupled with existing resources, will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2022.
In a filing with the Securities and Exchange Commission, Imara said it will have about 17 million shares outstanding after the IPO, assuming exercise of the overallotment option, for a valuation of about $288.9 million at the $17-a-share midpoint.
Imara’s principal shareholders include entities affiliated with New Enterprise Associates 14 L.P., Lundbeckfond Invest A/S, Pfizer Ventures (US) LLC and OrbiMed Private Investments VII LP are among its principal stockholders.
The company said it has applied to list its shares on the Nasdaq Global Market under the symbol IMRA.

https://www.marketscreener.com/PFIZER-INC-23365019/news/Pfizer-Imara-Sets-IPO-at-4-45-Million-Shares-Sees-Pricing-at-16-18-Each-30100521/

Hospitals, Companies Race to Develop Tests to Spot Coronavirus-Linked Illness

Testing for the new coronavirus in the U.S. may ramp up quickly after the Food and Drug Administration said it would speed approval of tests from hospital and public-health laboratories to augment the limited supply from the federal government.
At a White House briefing Monday evening, FDA Commissioner Stephen Hahn said he expects the U.S. to have capacity for close to one million tests by the end of this week, from both public-health labs and private suppliers.
“We’ve heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests, this week, next week and throughout the month,” he said.
Certain hospitals and health agencies around the country are working on their own diagnostics in addition to those in development from companies including Abbott Laboratories, Qiagen NV, Co-Diagnostics Inc. and bioMérieux SA.
Efforts to expand testing come as the illness caused by the virus spreads in the U.S., with new infections identified in people who hadn’t traveled outside the country. More testing will be important to help allocate resources to the right patients, health officials say. Some other countries have already tested thousands of people but as of Saturday, about 470 people had been tested in the U.S. since Jan. 21, according to the Centers for Disease Control and Prevention’s website, not including people who returned to the country on State Department- chartered flights.
A quick expansion of testing could produce a sharp increase in the case count in the U.S., though that wouldn’t necessarily indicate the virus is spreading at the same rate, experts say.
“When you start giving diagnostic tests to people who never had them before you will almost certainly see an increase in declared cases,” said Mark Miller, chief medical officer of French diagnostic-equipment maker bioMérieux. “Whether that’s a true increase or a detection bias, that has to be figured out on the local level.”
Initially developers of tests for coronavirus were required to obtain emergency FDA approval to ensure quality. The CDC test had been the only one approved for use in the U.S.
Some CDC test kits sent to state labs didn’t function properly, however, and many public health labs needed to wait for replacements. A handful of states had functioning CDC tests — sometimes providing results within hours — while others had to send their samples back to the CDC for results, a process that could take days.
The agency has since ramped up test production and, facing pressure to expand testing quickly, federal authorities allowed state and local health departments to drop the part of their test kits that weren’t working and move forward with the other components. Also, new test kits were manufactured and distributed. All positive diagnoses from the CDC-developed test, however, still need to be confirmed at the CDC’s lab in Atlanta.
The Department of Health and Human Services has said it launched an investigation into the manufacturing defect in the early CDC testing kits.
The FDA now is allowing certified laboratories to develop and begin using new coronavirus tests while it reviews applications for approval. The FDA says these labs also have to follow certain guidelines aimed at ensuring the tests are valid. The FDA has communicated with more than 70 developers and public health labs working on their own tests, the agency says.
Most tests for coronavirus world-wide use a technique called a real-time PCR, or polymerase chain reaction, a commonly used tool to look for pathogens by identifying unique parts of their genetic codes and amplifying them. The test can be used to diagnose a range of infections including influenza, and has been adapted to identify the genetic sequence of the new coronavirus. Specimens can be collected via swabs of nasal or pharyngeal fluids.
The New York State Department of Health is testing coronavirus samples and providing hospitals with instructions to replicate the test in their own labs with the goal of providing roughly 1,000 tests a day.
Hackensack Meridian Health, which operates 17 hospitals in northern New Jersey, began developing diagnostic assays several weeks ago, and now plans to make them available in the coming days, said David Perlin, chief scientific officer for Hackensack Meridian’s Center for Discovery and Innovation.
Hackensack Meridian’s test can provide results in about two hours, and if positive, health-care workers could start treating a patient with supportive care while the specimen is sent to a state lab for confirmation. The hospital system could handle tests for about 50 to 100 patients a day if needed, but that capacity could be increased, Mr. Perlin said.
Mr. Perlin said that if the virus spreads widely, experienced local labs will be needed — in tandem with government labs — to manage large-scale testing.
Several companies are seeking federal regulatory approval for their coronavirus tests as well.
BioMérieux is developing two diagnostic tests for the new coronavirus, one of which is being developed under contract with the U.S. Department of Defense. That test delivers results for a single specimen within an hour and can be used outside of a lab if needed, such as at a border crossing or airport, said Mr. Miller, bioMérieux’s medical chief. The second test can run hundreds of specimens at a time but takes about four to five hours for results.
The company expects to make the new tests available within the next several weeks, though regulatory approval could add to that timeline, Mr. Miller said.
Germany’s Qiagen is adding a test for the new virus to existing diagnostic equipment. It is being used in a handful of Chinese hospitals and the company is seeking to expand distribution to other countries.
“We are now at the point where we need a decentralized solution that we can use more or less anywhere,” Qiagen Chief Executive Thierry Bernard said in an interview.
Abbott Labs plans to make a coronavirus test available on its molecular diagnostic instruments, which are used in labs around the world, and on tests that can be given in doctor’s offices, a spokeswoman said.
Salt Lake City-based Co-Diagnostics Inc. and San Diego-based Mesa Biotech also are developing tests for the new coronavirus.
https://www.marketscreener.com/ABBOTT-LABORATORIES-11506/news/Hospitals-Companies-Race-to-Develop-Tests-to-Spot-Coronavirus-Linked-Illness-30101751/

Magenta Therapeutics EPS in-line

Magenta Therapeutics (NASDAQ:MGTA): Q4 GAAP EPS of -$0.59 in-line.
Cash, cash equivalents and marketable securities of $145.73M.
https://seekingalpha.com/news/3547951-magenta-therapeutics-eps-in-line

Novo Nordisk making inroads in obesity market

The Wall Street Journal reports that insulin king Novo Nordisk (NYSE:NVO) is making steady strides in the difficult-to-crack obesity market with Saxenda (liraglutide).
Several large employers now cover the drug in their customized medical plans despite the high cost (up to $1K/month).
Sales in the U.S. last year were almost $500M, well above the forecast of $250M by 2020 from analysts when the drug was approved by the FDA in 2014, making it the top seller in the space.
Roche’s (OTCQX:RHHBY) Xenical (orlistat) and Currax Pharmaceuticals LLC’s Contrave (naltrexone HCl/bupropion HCl) also compete.
One the main hurdles for drug makers is the prevailing opinion of doctors that lifestyle changes, diet and exercise, are better options. Nevertheless, the potential is huge. About 40% of adult Americans are considered obese, for example, while another ~32% are considered overweight.
https://seekingalpha.com/news/3547968-novo-making-inroads-in-obesity-market-wsj