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Friday, May 1, 2020

3M sues vendors for offering to sell non-existent N95 respirators

3M (MMM -1.9%) says it is suing five vendors for allegedly attempting to target government officials with fraudulent offers to sell non-existent N95 respirators at inflated prices.
The company says one case claimed to have up to 5B respirators at inflated prices, falsely affiliating themselves with 3M.
N95 respirators, which are designed to filter 95% of airborne particles, are among personal protective gears most needed by medical professionals battling COVID-19.
3M says it filed a total of 10 lawsuits in April in its effort to combat fraud.
https://seekingalpha.com/news/3567702-3m-sues-vendors-for-offering-to-sell-non-existent-n95-respirators

Analyst action, May 1

Axcella Health (NASDAQ:AXLA) initiated with Buy rating and $10 (115% upside) price target at BTIG Research.
Viking Therapeutics (NASDAQ:VKTX) initiated with Buy rating and $9 (56% upside) price target at BTIG. Shares up 2% premarket.
Y-mAbs Therapeutics (NASDAQ:YMAB) initiated with Buy rating at Janney Montgomery.
Mirati Therapeutics (NASDAQ:MRTX) upgraded to Overweight with a $116 (36% upside) price target at JPMorgan.
ResMed (NYSE:RMD) upgraded to Outperform with a $200 (29% upside) price target at Oppenheimer. Shares up 2% premarket.
Seattle Genetics (NASDAQ:SGEN) upgraded to Buy with a $175 (28% upside) price target at Guggenheim.
Cerner (NASDAQ:CERN) downgraded to Hold with a $72 (4% upside) price target at SunTrust.
NovoCure (NASDAQ:NVCR) downgraded to Market Perform with a $78 price target at Oppenheimer. Shares down 2% premarket.
PRA Health (NASDAQ:PRAH) downgraded to Market Perform at William Blair.
PolarityTE (NASDAQ:PTE) downgraded to Market Perform at Oppenheimer.
https://seekingalpha.com/news/3567579-guggenheim-likes-seattle-genetics-in-premarket-analyst-action

AbbVie Lowers 2020 Earnings Outlook

AbbVie Inc. on Friday lowered its earnings outlook for 2020 as it reported higher profit and sales for the first quarter as customers stocked up amid the Covid-19 pandemic.
The biopharmaceutical company said it now expects per-share earnings of between $7.60 and $7.70, down from its prior guidance of $7.66 to $7.76.
The company backed its adjusted earnings guidance of between $9.61 and $9.71 a share.
Analysts polled by FactSet were expecting full-year adjusted earnings of $9.60 a share on sales of $35.34 billion.
The company said it will issue combined guidance following the close of its planned acquisition of Allergan PLC.
Shares rose 1.3% in premarket trading.
AbbVie also said it is collaborating with health authorities and institutions to determine the efficacy and safety of Kaletra/Aluvia, the company’s antiretroviral therapy for HIV treatment, against Covid-19.

https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Lowers-2020-Earnings-Outlook-30511368/

Vertex Gets Euro CHMP Positive Opinion for Kalydeco Expanded Pediatric Use

Vertex Pharmaceuticals Inc. on Friday said the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended expanded approval of Kalydeco to include the treatment of children and adolescents with the most common cystic fibrosis genetic mutation.
The European Commission, which generally follows the CHMP’s recommendations, will now review the positive opinion, which covers patients ages six months and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene, the Boston drug maker said.
Vertex said Kalydeco, if approved, will be the first and only medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation in the progressive, genetic disease that causes persistent lung infections.
Kalydeco is already approved in Europe for adults with the R117H mutation and for children with several other mutations.

https://www.marketscreener.com/VERTEX-PHARMACEUTICALS-11321/news/Vertex-Pharmaceuticals-Gets-European-CHMP-Positive-Opinion-for-Kalydeco-Expanded-Pediatric-Use-30510612/

For small business loan program, forgiveness may be the hardest part

The U.S. government’s $660 billion small business rescue program has stumbled on missing paperwork, technology failure, and the misdirection of funds to big corporations. Now, it is lurching toward another hurdle: forgiving those hastily arranged loans.
The second round of the Small Business Administration’s Paycheck Protection Program launched on Monday, allowing lenders to issue forgivable, government-guaranteed loans to small businesses shuttered by the novel coronavirus outbreak.
Smoothing the forgiveness process is critical for the program to succeed, but a lack of government guidance on the related calculations and necessary documentation could land borrowers and banks alike with billions in unexpected debts.
“Probably every PPP borrower expects their loan to be forgiven, but it is not that simple,” said Paul Merski, an executive at the Independent Community Bankers of America.
“There are rules and regulation to consider. So the borrower best have their information and paperwork in order.”
In principle, the forgiveness terms are straightforward: borrowers must spend 75% of the loan on payroll costs, such as salaries, tips, leave, severance pay and health insurance, within the first two months. The remaining 25% can be spent on other running costs, such as rent and utilities. Money spent on non-qualifying expenses must be repaid at an annual rate of 1% within two years.
But in reality, it is going to be very tricky calculating partial forgiveness sums for borrowers who have not met the 75% threshold, said bankers. They point to potential areas of confusion such as when employees must be rehired and what happens if borrowers do not use the funds as promised.
“I do think it could become a little bit complex, because with every answer there’s another question,” said Chris Giamo, head of the commercial bank at TD Bank in New York.
That has created uncertainty for borrowers like Josh Mason, founder of Maryland catering company Vittles Catering. He said his bank only gave him instructions on how to maximize his eligibility for forgiveness on April 24, two days after he received the funds. Those instructions warned clients that the forgiveness process was “not yet clear.”
While a 1% interest rate is very low, the two-year repayment term could see companies that fail to qualify for full forgiveness landed with chunky monthly payments.
“I have read all the guidelines, but I wouldn’t be able to say exactly how much will be forgiven and not forgiven. I think that ambiguity is going to create a little bit of a mess when all of this comes to a close,” said Mason.
Given the many potential calculation variables, banking groups are pushing the SBA and the Treasury Department to issue a standard forgiveness form for borrowers and to create a calculator so every bank gets the same outcome when using the same data, said executives at three bank groups.
They are also seeking clarity on which documents are necessary to prove borrowers’ expenditures, and how closely banks are expected to scrutinize that paperwork.
Spokespeople for the Treasury and SBA did not respond to requests for comment, but the agencies are aware of the issues said David Pommerehn, general counsel of the Consumer Bankers Association.
“From a banking perspective, we are really acting as a middleman here. We don’t want to carry these loans on our books,” he said. “We see this as potentially a bigger mess than the funding process.”
https://www.marketscreener.com/news/For-small-business-loan-program-forgiveness-may-be-the-hardest-part–30510947/?countview=0

Athersys advances MultiStem study in COVID-19

Athersys (NASDAQ:ATHX) and University Hospitals Cleveland Medical Center (UH Cleveland) announce that latter is now open as the first clinical site for the MACOVIA (MultiStem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome) trial.
UH Cleveland has commenced enrollment and is now screening COVID-19 induced ARDS patients for inclusion in the trial.
The MACOVIA trial aims to confirm the safety and efficacy of MultiStem therapy as a treatment for patients with moderate to severe ARDS due to COVID-19.
The primary efficacy endpoint will be number of ventilator-free days through day 28 as compared to placebo, and the secondary objectives are to evaluate time in the intensive care unit, pulmonary function, all-cause mortality and quality of life among survivors.
The study is designed to enroll ~400 subjects.
https://seekingalpha.com/news/3567504-athersys-advances-multistem-study-in-covidminus-19-shares-up-14-premarket

Co-Diagnostics up on COVID-19 test data

Co-Diagnostics (NASDAQ:CODX) perks up 10% premarket on light volume on the heels of performance data on its LogixSmart real-time PCR test that detects RNA from the SARS-CoV-2 virus in lower respiratory tract fluids.
Tests performed in Australia (n=207), India (n=45) and Mexico (n not provided) showed 100% sensitivity and 100% specificity with no cross-reactivity with other viruses.
It also says that the test detected more low-level positives than the CDC assay while testing at the Minnesota Department of Health showed 100% concordance with another (unnamed) assay.
https://seekingalpha.com/news/3567516-co-diagnostics-up-10-premarket-on-covidminus-19-test-data