Regeneron Pharmaceuticals, Gilead Sciences Shares Rise As Their Therapies Used To Treat President
MICHAEL KREY
04:28 PM ET 10/05/2020
The decision by President Donald Trump's doctors to treat his Covid-19 infection with drug therapies from Regeneron Pharmaceuticals (REGN) and Gilead Sciences (GILD) gave the drug companies a weekend of heavy publicity. It also boosted REGN stock and GILD stock on Monday.
By early Saturday the White House medical team had said they were treating Trump with Regeneron's antibody cocktail, which the company still is developing. It does not yet have U.S. Food and Drug Administration approval, though at least one analyst says approval could be very near. Just last week Regeneron posted positive initial data on its treatment for SARS-CoV-2, the type of coronavirus that causes Covid-19.
Additionally, doctors are giving Trump a five-day course of Gilead's remdesivir. The investigational antiviral has been shown to shorten hospital stays for some patients seriously ill with Covid-19. It was the first drug to get FDA emergency use authorization, on May 1.
Regeneron's cocktail of monoclonal antibodies, known as REGN-COV2, are injected into the body to act as immune cells and engineered to fight the infection. Regeneron earlier had developed an antibody cocktail to treat seriously ill Ebola patients.
For its Covid-19 therapy, Regeneron is amid four separate Phase 2/3 clinical trials with both hospitalized and non-hospitalized patients. But the company has not said when it expects Phase 3, or final-phase data, nor when it might seek FDA emergency use authorization.
Regeneron Antibody Cocktail Near FDA Approval?
"It is hard to see that this emergency use is not a tacit endorsement by the Federal medical bureaucracy for REGN's medicine," SVB Leerink analyst Geoffrey Porges wrote in a note to clients Monday. "We expect an (emergency use authorization) for the treatment of Covid in a matter of days.
"There are certainly risks for Regeneron in providing their antibody to the (president) in such circumstances. But both the company and the White House's medical staff are likely to have had access to much more information about REGN-COV2 than the company has disclosed publicly so far."
Porges said the next seven to 10 days will be critical in assessing Trump's condition. The president is 74 years old and classified as obese, two factors against any quick recovery. By administering REGN-COV2, Porges said that implies that Trump had a "high viral load."
Regeneron Chief Executive Dr. Leonard Schleifer told CNBC on Monday that giving the president the treatment was "a very tough situation," since the drug therapy isn't approved yet. "We have tried to take a principled approach until there is a broader authorization," Schleifer told CNBC.
Similarly, Gilead's remdesivir has shown some success but only in treating seriously ill Covid-19 patients. And Porges wrote that there are no known studies of that drug and REGN-COV2 together in humans. So, that's another unknown in treating Trump.
REGN Stock Rated Highly, But GILD Stock Has Slumped
On Thursday, Gilead said it now is responsible for distributing remdesivir, under the brand name Veklury, in the U.S. It said it is meeting demand, after increasing manufacturing capacity over the past several months. It also it's donated 1.5 million vials of Veklury at no cost for evaluation as an investigational agent in clinical trials worldwide.
In any case, the White House medical staff's endorsement of the Regeneron and Gilead treatments sent both stocks up in the stock market today.
REGN stock surged 7.1% on Monday to 605.08. Earlier, shares jumped as much as 9.8% to a one-month high.
GILD stock rose 2.3% to 63.60, earlier gaining as much as 2.9%.
Shares of Regeneron have generally been boosted by its efforts to develop a Covid-19 treatment. Gilead shares have slumped the past couple of months despite its emergency use authorization for Remdesivir.
Last month, Gilead announced its biggest acquisition ever, a $21 billion deal to buy Immunomedics (IMMU). The size of that deal has weighed on GILD stock. On Sept. 24, GILD stock hit a one-year low of 61.65.
On the other hand, REGN stock touched a record high of 664.64 on July 20, buoyed by hopes for its Covid-19 treatment. REGN stock sports a high Composite Rating of 95, putting it among the top 5% of all stocks.