INO-3107
Recurrent respiratory papillomatosis · Adults with recurrent respiratory papillomatosis
INO · Inovio Pharmaceuticals
Regulatory designations
Full timeline
6 milestonesFDA decision expected
FDA assigned an October 30, 2026 PDUFA goal date to the INO-3107 BLA under Standard Review.
INOVIO — BLA acceptance and PDUFA date↗FDA review remained active after the mid-cycle meeting
INOVIO said the BLA remained under active review and that it continued to address FDA's preliminary concern about eligibility for the accelerated approval pathway.
INOVIO — First-quarter 2026 regulatory update↗FDA accepted the BLA under Standard Review
FDA accepted the application, said it did not then plan an advisory committee meeting and identified accelerated-approval eligibility as a potential review issue.
INOVIO — BLA acceptance↗INOVIO completed the rolling BLA submission
INOVIO submitted the BLA seeking accelerated approval, supported by Phase 1/2 clinical data and durability follow-up.
INOVIO — Rolling BLA submission completed↗Related News
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Nov 27, 2018イノビオ社、3件の前臨床試験で同社のDNAコード化モノクローナル抗体 (dMAb™) プラットフォームの効力をさらに実証し、2019年初旬の初回臨床試験に向けて準備を進める
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Nov 27, 2018Inovio在三項臨床前試驗結果文獻中進一步顯示Inovio的DNA編碼單克隆抗體（dMAb™）平台的療效，並準備在2019年初進行首次臨床試驗