Inovio Shares Rise 8% After FDA Feedback for INO-3107
By Chris Wack
Inovio shares were up 8% to 39 cents after the company received feedback from the U.S. Food and Drug Administration that data from its completed Phase 1/2 trial of INO-3107 for the treatment of recurrent respiratory papillomatosis could support Inovio's submission of a biological license application for review under the FDA's accelerated approval program.
The FDA also advised that the company's previously planned Phase 3 randomized, placebo-controlled trial wouldn't be required to support this submission.
Inovio will be required to initiate a confirmatory trial prior to BLA submission for accelerated approval and satisfy all other FDA filing requirements. The design of the confirmatory trial hasn't been finalized yet.
If approved, INO-3107 would be the first DNA medicine in the U.S. and the first Inovio candidate to receive regulatory approval.
INO-3107 is Inovio's lead candidate and one of three clinical-stage DNA medicine candidates targeting HPV-related disease.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 10, 2023 10:36 ET (14:36 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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