Last Thursday, analysts urged caution when reading into leaked data for Gilead’s COVID-19 hopeful remdesivir, stressing that the numbers came from a single site participating in a study with no control group. Now, a congressman is asking the Securities and Exchange Commission (SEC) to investigate.
The experimental drug swiftly relieved fever and respiratory symptoms in patients with severe COVID-19, said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital, in leaked video. She made her comments in a discussion of the results with other university faculty members that was recorded. Stat obtained a copy of the video and reported the results Thursday.
The leak was “so significant” at a time that the world is “so desperate to find a cure,” said Rep. Lloyd Doggett, a Texas Democrat who chairs the House Ways and Means Health Subcommittee, CNN reported on Friday.
Although the source of the leak is unclear, “providing information that’s designed to impact the stock market is not something that is permitted under federal securities law,” Doggett said.
“That’s why we need a thorough SEC investigation,” he said.
Remdesivir isn’t supposed be a moneymaker for Gilead, which “will work to ensure affordability and access so that remdesivir is available to patients with the greatest need,” according to an open letter penned by CEO Daniel O’Day last month. But the program did move the needle on the company’s stock, sending it up more than 15% in after-hours trading Thursday.
“We calculate remdesivir has already been responsible for ~$15bn in market cap to Gilead, and the move today and in the after-market increases that to a total value of ~$35bn,” wrote SVB Leerink analyst Geoffrey Porges in an investor note Thursday. “This seems a generous amount of credit for a product that the company has specifically stipulated will not be sold for a profit, but investors may be discounting that commentary, or simply looking to buy any positive COVID news.”
Gilead told CNN that the company was not involved in the leak.
The University of Chicago is participating in a study of remdesivir in patients who had severe disease but who were not sick enough to need a ventilator. The study is testing a five-day and a 10-day course of remdesivir in those patients but does not have a control arm. Of the 125 patients recruited by the hospital for two phase 3 studies, 113 had severe disease.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Mullane.
Gilead is sponsoring two phase 3 studies of remdesivir, including one in patients with moderate disease, as well as the trial in patients with severe disease. The former does have a control arm, testing a five- or 10-day course of remdesivir against standard of care. And since the studies kicked off in late February, the company has expanded the latter trial to include thousands more patients with severe disease, including those on ventilators. Gilead expects preliminary data from the “severe” study by the end of April and data from the “moderate” study in May.
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The company has also made the drug available to studies run by other sponsors, such as the National Institutes of Health, as well as to more than 1,700 people on a compassionate use basis. Last week, The New England Journal of Medicine published data from 53 patients with severe disease, but that data set also lacked a control group.