Inovio Stock Drops 24.5% After FDA Reclassifies BLA to Standard Review
Inovio announced on December 29, 2025 that the FDA classified its BLA under a standard review timeline, not the expected accelerated pathway. Shares plunged 24.45%, falling $0.56 to close at $1.73, and investors have filed a class action alleging misrepresentation of regulatory eligibility.
1. FDA Reclassifies BLA to Standard Review
On December 29, 2025, the FDA informed Inovio that its biologics license application would proceed under a standard review timeline after determining the company’s submissions lacked sufficient data for accelerated approval eligibility. This unexpected shift removed the priority pathway from the regulatory process.
2. Shares Plunge 24.45% to $1.73
The reclassification triggered a one-day 24.45% drop in Inovio shares, erasing $0.56 per share and closing at $1.73. The steep decline reflected investor surprise and a reassessment of the company’s near-term regulatory prospects.
3. Investor Class Action Filed
Investors who purchased Inovio securities between October 10, 2023 and December 26, 2025 have filed a class action accusing the company of misrepresenting its eligibility for accelerated FDA review. Plaintiffs must seek lead plaintiff status by April 7, 2026 to pursue damages linked to the share price collapse.
4. Analyst Price Target Cuts
H.C. Wainwright flagged the dispute over the accelerated review pathway, while Jefferies cited an “AA overhang” on BLA acceptance contributing to nearly 20% stock decline post-disclosure. Multiple analysts subsequently lowered their price targets for the company.