Inovio Pharmaceuticals Inc on Monday said it expects the U.S. Food and Drug Administration to decide this month whether to allow an advanced trial of the company’s experimental COVID-19 vaccine to move forward.
The regulatory agency in September placed a hold on the mid- to late-stage trial, citing the need for more information on the device used to inject the vaccine. Inovio said it provided responses to the FDA’s questions in October.
Shares of Inovio, which closed down 19% at $8.50, were up 5% after hours.
Inovio’s vaccine, known as INO-4800, was designed using the company’s novel DNA medicine platform. It is administered through a device called Cellectra, which sends out an electrical pulse to open pores in a cell so DNA molecules can enter.
Inovio in June announced positive results from an initial trial of its vaccine in volunteers, but the company has lagged behind others in the race to develop vaccines against the new coronavirus.
Pfizer Inc and German partner BioNTech SE on Monday announced the first successful interim data from a large-scale COVID-19 vaccine trial and said they expected to seek U.S. emergency use authorization this month.
For the third quarter, Inovio reported net income of $19.2 million, or 11 cents per share, compared with a year-earlier net loss of $23.1 million, or 25 cents a share, due mainly to a change in value of the company’s convertible bonds and an investment gain.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.