Inovio Pharmaceuticals Share Price Plunges 24.89% After FDA Assigns Standard Review, Delays Commercialization Hopes

The share price fell to its lowest level since this month, with an intraday decline of 24.89%.

The sharp selloff followed the U.S. Food and Drug Administration’s (FDA) decision to assign a standard review timeline to Inovio Pharmaceuticals’ Biologics License Application (BLA) for INO-3107, a potential treatment for recurrent respiratory papillomatosis (RRP). The PDUFA goal date of October 30, 2026, fell short of the accelerated approval pathway the company had sought, raising concerns over commercialization delays. While INO-3107 demonstrated durable clinical benefits in a Phase 1/2 trial and holds Orphan Drug and Breakthrough Therapy designations, the regulatory setback has dampened investor confidence. Inovio plans to address gaps in its BLA submission through a regulatory meeting, though the prolonged timeline increases competitive risks and revenue uncertainty.

Financial metrics highlight Inovio’s precarious position. Despite holding more cash than debt, the company faces significant cash burn, with analysts forecasting no near-term profitability. A recent $25 million public offering underscores liquidity needs, though such dilution often exacerbates stock volatility. The stock’s beta of 1.55 reflects heightened sensitivity to market swings, while a price-to-sales ratio of 309.18 suggests overvaluation relative to revenue. Institutional ownership at 38.78% indicates moderate stakeholder confidence, but the firm’s negative operating and net margins underscore operational challenges. With regulatory and financial risks persisting, investors remain cautious as Inovio navigates a critical juncture in its RRP pipeline’s development.