Regeneron said on Thursday it was working to address questions over how to target the most in-need patients for its antibody treatment for Covid-19, which US president Donald Trump said was a “cure” for the disease.
The treatment could be approved for emergency use in the “relatively near future”, Leonard Schleifer, Regeneron’s chief executive, told analysts in a discussion of its latest earnings.
The New York-based biotech said it will have 80,000 doses available by the end of the month, and 300,000 by the end of January.
But the number of Covid-19 patients who could benefit from the drug, if approved, is soaring, with 100,000 cases reported in the US in a single day on Wednesday for the first time.
The drug works best in patients that are failing to produce enough of their own antibodies. At first though it is likely to be given more widely — to those at most risk of complications from Covid-19, as it was to Mr Trump — because it is still a challenge to test patients’ antibody levels.
Dr Schleifer said Regeneron is working with its partner Roche, which has a large diagnostics business, to see if they could use their Covid-19 antibody tests to discover whether patients are struggling to produce their own.
A further complication is that the company is seeking emergency approval for use by patients who are not in hospital, even though the drug is an infusion, not a pill, which can be harder to administer at home.
“We don’t have all this buttoned down in this emergency situation, and it will probably evolve fairly quickly if we get an [emergency use authorisation],” Dr Schleifer told analysts.
Shares in Regeneron rose 1 per cent to $593.27, as the company beat expectations on both revenue and earnings per share in the third quarter. Revenue rose 32 per cent to $2.3bn. Net income was up 26 per cent to $842m.
The company’s shares fell last week when it paused enrolling seriously ill patients in the trial of its treatment, after an independent data-monitoring committee warned that the risks may outweigh the benefits for patients in hospital who are on high levels of oxygen.
Regeneron executives on Thursday held out the possibility that the pause will be reversed.
Although the company was still “blinded” and could not see the data on which the pause was based, Regeneron’s chief scientific officer George Yancopoulos said he saw no reason why there should be potential safety problems unique to any subset of patients.
“We do not know whether there really is any safety signal,” Dr Yancopoulos said. “Theoretically, there is not really a great deal of rationale why there might be.”
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