Summary
- Inovio Pharmaceuticals is highly dependent on the regulatory outcome for INO-3107, its DNA-based therapeutic for recurrent respiratory papillomatosis (RRP).
- The FDA accepted the BLA for INO-3107 but cited insufficient justification for accelerated approval, introducing significant regulatory risk ahead of the October 30 PDUFA date.
- INO-3107 demonstrated a 50-100% reduction in surgeries for 72% of trial participants, but e…
Summary
- Inovio Pharmaceuticals is highly dependent on the regulatory outcome for INO-3107, its DNA-based therapeutic for recurrent respiratory papillomatosis (RRP).
- The FDA accepted the BLA for INO-3107 but cited insufficient justification for accelerated approval, introducing significant regulatory risk ahead of the October 30 PDUFA date.
- INO-3107 demonstrated a 50-100% reduction in surgeries for 72% of trial participants, but evidence is limited to Phase 1/2 data, unlike its approved competitor.
- INO trades at elevated valuation multiples with only 5-7 months of cash runway, making dilution or spending cuts likely if approval is delayed.
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Thesis: Upside depends on INO-3107 outcome
As you probably heard, Inovio Pharmaceuticals (INO) previously announced that the FDA has accepted its BLA for INO-3107 in adults with recurrent respiratory papillomatosis [RRP]. It’s a decent regulatory
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