U.S. loan to Kodak will not proceed unless allegations cleared: White House

The U.S. government will not proceed with a $765 million loan to Eastman Kodak Co (KODK.N) to make drugs at its U.S. factories unless the company is cleared of alleged wrongdoing in circumstances surrounding the announcement of the loan, the White House said on Monday.

White House Press Secretary Kayleigh McEnany made the remarks to reporters after U.S. President Trump said last week the federal government would quickly investigate the issue.

The U.S. International Development Finance Corp on Friday said the loan, aimed at helping the photographic equipment maker shift to making ingredients for pharmaceuticals, was on hold due to “recent allegations of wrongdoing.”

McEnany said the president took the allegations seriously but declined to say if the loan could be canceled outright.

“We will not proceed any further unless these allegations are cleared,” she said at a regular briefing, adding that the investigation was still underway.

She said the case had not shaken the president’s faith in using the Defense Production Act to increase U.S. stockpiles of ventilators and other equipment to respond to the pandemic.

News of the investigation and a halt in the loan weighed heavily on Kodak shares, which were trading down 28% at $10.70 on the New York Stock Exchange on Monday afternoon.

Initial news of the loan had driven the shares 1,000% higher, generating a windfall for executives, some of whom had received options one day earlier.

Senior Democratic lawmakers last week asked federal regulators to investigate securities transactions made by the company and its executives around the time it learned it could receive the government loan.

Lawmakers said they had “serious concerns” about the transactions and asked the Securities and Exchange Commission to investigate the circumstances surrounding the matter. They cited growing concerns about insider trading.

The company said it had appointed a special committee of independent directors of its board to conduct an internal review.

https://www.reuters.com/article/us-trump-eastman-kodak-insidertrading/u-s-loan-to-kodak-will-not-proceed-unless-allegations-cleared-white-house-idUSKCN2562CA

Salesforce, CVS to Collaborate on Covid-19 Workplace Programs

Salesforce.com Inc. and CVS Health Corp. said Monday they will collaborate on services to help workplaces and campuses return to in-person operations following coronavirus-related closures.

The programs will combine CVS-led Covid-19 testing with Salesforce.com data-management tools to help institutions implement health protocols. Under the partnership, management tools from Salesforce.com’s Work.com website will be integrated with CVS’s Covid-19 testing protocols, called Return Ready.

The program will manage Covid-19 testing for people associated with customer institutions, and enable reporting and contact-tracing for people who test positive for the viral disease.

https://www.marketscreener.com/CVS-HEALTH-CORPORATION-12230/news/CVS-Health-Salesforce-CVS-to-Collaborate-on-Covid-19-Workplace-Programs-31091207/

Gilead Sciences files U.S. application for remdesivir for COVID-19

Gilead Sciences (GILD -1.7%) has completed its rolling marketing application to the FDA seeking full approval of Veklury (remdesivir) for the treatment of severely ill hospitalized COVID-19 patients. It initiated the process on April 8.

The FDA approved the emergency use of the antiviral for these patients on May 1. It remains the only medicine to receive the nod in the U.S. to date. It is also available in Europe, Japan, India, Australia and Canada.

https://seekingalpha.com/news/3603499-gilead-sciences-files-u-s-application-for-remdesivir-for-covidminus-19

Omeros’ COVID-19 treatment shows promise

Omeros Corp said on Monday its experimental treatment helped six patients, with acute respiratory distress syndrome caused by COVID-19, recover and get discharged from the hospital, sending the drug developer’s shares up 60%.

The company said it was in talks with the U.S. government for potential funding to speed up large-scale manufacturing for broader availability of the treatment, narsoplimab.

All six patients had underlying conditions and needed mechanical ventilation before treatment, Omeros said.

Acute respiratory distress syndrome, or ARDS, causes fluid to collect in the lungs, depriving organs of oxygen. COVID-19 patients with ARDS often require intensive care.

The small study was done in Italy’s Bergamo, the initial epicenter of COVID-19 in Europe, under a compassionate use program following requests from doctors at the Papa Giovanni XXIII hospital.

Narsoplimab is a human monoclonal antibody that targets damage to endothelial cells, which serves as a general marker of both COVID-19 and recovery.

The therapy has already been studied in a pivotal trial for a stem cell transplant-related complication and in late-stage studies for two kidney conditions. Narsoplimab was also granted U.S. FDA’s breakthrough tag for these indications, but the agency has not yet approved the drug for any use.

The U.S. government, under its “Operation Warp Speed” initiative aimed at accelerating access to vaccines and treatments to fight COVID-19, has so far agreed to invest more than $7 billion in vaccines and has funded more than 30 projects, including those for diagnostics and treatments.

https://www.reuters.com/article/us-health-coronavirus-omeros/omeros-covid-19-treatment-shows-promise-shares-jump-idUSKCN2561DT

Humanigen on go with COVID-19 study in Brazil

Brazil’s Anvisa regulatory agency has signed off on a Phase 3 clinical trial evaluating Humanigen’s (OTCQB:HGEN +2.4%) lead drug lenzilumab in hospitalized severely ill and critically ill COVID-19 patients at high risk of disease progression.

The study will be conducted by CRO Clinical Trial & Consulting. The protocol will be the same as the ongoing trial in the U.S.

Lenzilumab is a monoclonal antibody that neutralizes (binds to) a pro-inflammatory protein called granulocyte-macrophage colony stimulating factor (GM-CSF) that is over-expressed in COVID-19 patients. The company is developing it for the potential treatment of CAR-T toxicity, graft versus host disease, certain blood cancers and eosinophilic asthma.

https://seekingalpha.com/news/3603458-humanigen-on-go-covidminus-19-study-in-brazil

AnaptysBio’s lead drug fails to beat placebo in sinus inflammation study

Thinly traded micro cap AnaptysBio (ANAB -5.2%) is down, albeit on modest turnover of 42K shares, in reaction to preliminary results from a Phase 2 clinical, ECLIPSE, evaluating lead candidate etokimab in patients with chronic rhinosinusitis with nasal polyps.

At the week 8 time point, treatment with etokimab failed to show a significant treatment effect versus placebo as measured by bilateral nasal polyps score and sino-nasal outcome test, the primary endpoints.

The company will determine next steps for the program after reviewing 16-week data by year-end.

It is also developing the IL-33 inhibitor for the treatment of eosinophilic asthma.

https://seekingalpha.com/news/3603471-anaptysbios-lead-drug-fails-to-beat-placebo-in-sinus-inflammation-study

White House willing to spend more on virus aid – Mnuchin

The Trump administration is open to resuming talks with Democrats and may be willing to add boost its coronavirus aid package if they can reach a compromise, U.S. Treasury Secretary Steven Mnuchin told CNBC in an interview.

“The president is determined to spend what we need to spend… We’re prepared to put more money on the table,” he said.

He didn’t say when he and White House Chief of Staff Mark Meadows would restart talks with Senate Minority Leader Chuck Schumer and House Speaker Nancy Pelosi, which came to a standstill on Friday. “If we can get a fair deal we’re willing to do it this week,” Mnuchin added.

He said the administration and Democrats do agree on two areas — more funding for the Paycheck Protection Program for small businesses and another round of direct payments for up to $1,200 for individuals.

The two sides stand far apart on the size of their aid packages. Democrats have proposed a package that will cost at least $3T, while Republicans have said they don’t want to spend any more than $1T.

The Democrats want to continue the supplemental $600 per week of unemployment benefits, while Republicans put forth a plan to cut that supplemental benefit to $200 per week for a specified period of time than transition to paying 70% of what the unemployed person received before they lost their job.

https://seekingalpha.com/news/3603445-white-house-is-willing-to-spend-on-virus-aid-mnuchin-says