Shares of Regeneron are ripping higher Thursday in premarket trading, building on its gains from Wednesday evening, after the company submitted its COVID-19 antibody cocktail to the FDA for emergency-use approval.
The news follows President Trump’s full-throated endorsement of the therapy, which the president credited for his speedy recovery, calling the treatment a “cure” for COVID-19.
Trump last night declared that he wants everyone who needs the treatment to get it, and added that the White House wants to “make it free for everyone.”
Of course, Regeneron isn’t the first drugmaker to file for an EUA from the FDA: Eli Lilly asked for approval for its antibody treatment, which it said had been found to reduce viral load, symptoms and hospitalizations in patients (per its extensive trial data).
As far as the prospects for approval for the cocktails submitted by Eli Lilly and Regeneron go, Bloomberg Intelligence analyst Sam Fazeli said in a note published Thursday that the FDA “should think hard” about approving Lilly’s single-antibody COVID-19 therapy and should only consider approval of its combination therapies given “the LY-CoV555 antibody alone – though also effective – is associated with development of resistant virus.”
He also noted that while comparison of data from Lilly and Regeneron’s combination antibody therapies may at first suggest Lilly’s is superior, this may be explained by “substantial differences” between the trials.
Regeneron and Eli Lilly aren’t the only drugmakers developing therapeutics tied to antibodies: Other companies testing antibody treatments include AstraZeneca, as well as GlaxoSmithKline and its partner Vir Biotechnology.
Lilly’s drug was derived from antibodies culled from a blood sample belonging to one of the earliest COVID-19 survivors in the US. Antibody treatments and cocktails are part of a new class of drugs that not only can help effectively treat people infected with the virus, but can also act as a short-term prophylactic for people – health care workers, immunocompromised patients – providing temporary immunity. Eli Lilly is also working on a cocktail of two ifferent antibodies, for which it expects to approach regulators next month.
Owen and DeAnna watch Trump’s bombshell statement on coronavirus therapeutics.