The Food and Drug Administration is moving at “lightning speed” to review data on Gilead Sciences Inc.’s experimental COVID-19 treatment remdesivir, Commissioner Stephen Hahn said, after encouraging results emerged from a key U.S. trial.

“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” Hahn said in an interview. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, shared early trial results Wednesday that showed remdesivir had a significant effect in treating the virus. Patients who received the drug recovered from their illness in 11 days, on average, while those who got a placebo recovered in 15 days, Fauci said.

Fauci told NBC’s Today Show on Thursday that a decision on emergency authorization for remdesivir is going to happen “really quickly.” Fauci said he spoke with Hahn Wednesday night and that the FDA hasn’t made a final determination, though he expects one soon.

Hahn declined to offer a timeline for allowing remdesivir to reach the market and said the agency has “several different pathways” through which it could allow access. In addition to emergency authorization, the FDA can speedily approve a medication and then ask for more study while it’s being used by patients.

Shares of Gilead (GILD) gained 1% to $84 Thursday in New York.

The FDA has only issued one emergency authorization for a drug to be used against COVID-19. Last month, the agency allowed for use of the malaria drugs hydroxychloroquine and chloroquine in hospitalized patients. Since then, some analyses have shown the pills don’t help and may harm COVID-19 patients. The FDA issued a warning about heart risks associated with those drugs last week.

Hahn said he’s still comfortable with the emergency authorization for hydroxychloroquine and chloroquine and is awaiting data from clinical trials. The decision “was based upon the published data and science available,” he said. “Just as in everything we’ve done in this pandemic, we’ll be flexible and we’ll adapt as data becomes available.”

The FDA has also aimed to be flexible on serology tests that tell people whether they have positive antibodies for the novel coronavirus. The agency has allowed the tests to come to market without its approval, though eight have gained emergency authorization. The National Institutes of Health’s National Cancer Institute is working to ensure the rest work properly and the FDA is reviewing that data as it comes in.

Given that some serology tests may not work as they claim and that some companies that make them haven’t handed over tests for government researchers to evaluate, FDA could consider revising its policy, he said.

After the market closed, Gilead posted stronger-than-forecast results, but the drugmaker said there is significant uncertainty about how COVID-19 will affect its business even though its experimental treatment for the disease appears headed toward a swift U.S. authorization.

The biotechnology company reported adjusted earnings per share of $1.68, topping analysts’ estimates of $1.57. Total revenue of $5.55 billion was higher than the $5.46 billion that Wall Street expected.

Key Insights

• There is ample enthusiasm for remdesivir, Gilead Sciences’ experimental medicine for COVID-19 that the Food and Drug Administration is rushing toward allowing on to the U.S. market after early clinical trials. But more broadly, Covid-19 could cause fewer patients to access treatments for conditions such as HIV, the company said.
• There is pressure on Gilead to reinvigorate its drug pipeline to offset slipping sales of its hepatitis C franchise, which turned the company into a pharmaceutical giant. The drugs brought in $729 million in the quarter, better than analyst estimates of $610 million. Gilead announced a $4.9 billion deal for the company Forty Seven in March, a pact that could help bolster the company’s pipeline.
• HIV sales continue to be a bright spot. Biktarvy, perhaps Gilead’s next big hit medicine, brought in $1.7 billion. Analyst estimates for the drug were $1.55 billion. The company’s HIV portfolio brought in $4.1 billion overall.