Covid-19 roundup: Trump says he's been taking hydroxychloroquine for days; Moderna raises $1.3B on the heels of groundbreaking data
A couple of months after he started touting hydroxychloroquine as a potential treatment for Covid-19 on thin evidence, President Donald Trump revealed that he’s been taking the anti-malaria drug for a little over a week.
Trump’s public promotion of the drug — as well as his aides’ behind-the-scenes work to push for wider use — has been the center of a whistleblower complaint in which Rick Bright, the former chief of BARDA, alleged he was ousted for resisting the pressure to endorse the unproven therapy and chloroquine, a similar compound.
The FDA provided the emergency use authorization that paved the way for wider use in late March but limited the mandate to the hospital setting. Within a month, it also issued a safety warning within a month, advising physicians to closely screen and monitor patients to help mitigate the risks of heart rhythm problems.
At a press conference on Monday, Trump attacked Bright, saying “there’s a lot of bad things coming out about him” and pointing out that he had signed the application for the EUA, before pivoting to praising hydroxy.
The president said he’s taking hydroxychloroquine as a prophylactic, a use that’s being investigated among frontline healthcare workers and others at high risk of getting exposed to the virus.
“I happen to be taking it. I happen to be taking it. I’m taking it, hydroxychloroquine. Right now, yeah. A couple weeks ago I started taking it. Because I think it’s good, I heard a lot of good stories … I take a pill every day,” he said, adding: “I think people should be allowed to.”
When pressed, he cited “a lot of positive calls about it” as the source of his confidence that the drug would have a preventative effect, even though he maintains he’s not been exposed. Calling the negative VA study a “very unscientific report,” he reiterated the previous line: “What have you got to lose?” — Amber Tong
Bolstered by PhI update, Moderna quickly snags $1.35B raise
The frontrunner status in the race to develop a vaccine against Covid-19 is proving lucrative for Moderna, which has raised $1.34 billion in a public offering.
The Cambridge, MA-based biotech proposed to sell and then quickly priced 17,600,000 shares at $76 a pop. While that would have marked a 15% premium on the stock price Monday morning, the release of preliminary results from the ongoing Phase I trial of its mRNA SARS-CoV-2 vaccine boosted it well beyond that into the $80 territory.
From the proposal to the pricing, Moderna took merely hours to complete the exercise, illustrating the demand for its shares.
It’s not just investors who are betting on Moderna. BARDA has injected $483 million into the clinical and manufacturing ops, in the hopes of getting the production capacity in place for a large-scale rollout. — Amber Tong
Ahead of pricing strategy unveiling, Gilead reportedly donates more doses of remdesivir
As analysts’ anticipation continues to build regarding how Gilead would price remdesivir, the company has pledged to donate more doses of the antiviral.
The new donation would bring the total vials for the federal government from 607,000 to 940,000, STAT reported citing the HHS. That means 30,000 to 55,000 more patients could be treated, depending on how long their course of treatment is.
But Gilead won’t be offering the drug — the only treatment to have shown clinical benefit in a placebo-controlled study and one that’s been authorized for emergency use — for free forever. SVB Leerink analyst Geoffrey Porges, who hosted a virtual fireside chat with Gilead CFO Andrew Dickinson and SVP of HIV & emerging infections Diana Brainard, had this to report:
The initial donated supply of remdesivir to the US and foreign governments is expected to be depleted in June or July, and Gilead anticipates unveiling a pricing strategy before that occurs. The company intends to pivot to a commercial model, and stated that investors should expect remdesivir product sales in H2.
— Amber Tong
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