Inovio Pharmaceuticals Inc INO shares are trading higher again on Wednesday after surging more than 40% on Tuesday after the FDA said it can use data from the completed Phase 1/2 trial of INO-3107 to submit a Biological License Application (BLA) for accelerated approval.
What Happened: Inovio received feedback from the FDA that data from a recent trial can be used to make a submission for the FDA's accelerated approval program. The FDA said the planned Phase 3 trial of INO-3107 would not be required to support the submission.
Inovio will need to initiate a confirmatory trial prior to the submission. If approved, INO-3107 would be the first DNA medicine in the U.S. and the first Inovio candidate to be approved.
"We're now focused on streamlining our development plan to support submission of a BLA for accelerated approval," said Jacqueline Shea, president and CEO of Inovio.
Inovio noted that the changes to the development plan for INO-3107 could impact prior cash runway guidance. The company plans to provide an update when it reports third-quarter financial results in November.
Inovio is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer and infectious diseases.
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INO Price Action: Inovio shares closed Tuesday up 41%. The stock was up another 8.67% at 55 cents Wednesday morning, per Benzinga Pro.
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