Inovio shares surge 229% as FDA approves first commercial product

INOVIO (INO) surged 245% after FDA accelerated approval for VOCERYQ. IDEXX (IDXX) rose 20% on strong Q3 earnings and raised guidance. Tempus AI (TEM) gained 12% with Q3 revenue up 23% and narrowed losses. VOCERYQ targets HPV-related RRP, with commercial launch planned for Q1 2027.

Inovio Pharmaceuticals (INO) surged 200% after-hours following FDA approval of its treatment, Voceryq. The stock had dropped 22% during regular trading. Biotech sector gains were driven by FDA innovations and AI-assisted drug discovery. Other biotech stocks like Genmab (GMAB), Prime Medicine (PRME), Replimune (REPL), and Glaukos (GKOS) also saw significant gains. The article highlights potential investment opportunities in biotech with upcoming regulatory milestones.

INOVIO (NASDAQ: INO) surged 213.75% to $1.89 on Monday, leading Nasdaq gainers. The FDA granted accelerated approval for VOCERYQ, a treatment for RRP, based on study data showing 27% of patients required no surgery after 12 months. INOVIO anticipates making VOCERYQ available in 60 days, with full deployment in Q1 2027.

The FDA approved Inovio's Voceryq, a plasmid DNA-based immunotherapy, for treating recurrent respiratory papillomatosis (RRP) in adults. The treatment aims to reduce surgical interventions. The approval was based on a study showing 27% of patients required no surgery after 12 months. Inovio must conduct post-approval trials to confirm clinical benefits. According to the company, the treatment targets HPV-infected cells, offering a new option for RRP patients.

INOVIO (INO) received FDA accelerated approval for VOCERYQ, a DNA-based immunotherapy for recurrent respiratory papillomatosis (RRP). The approval is based on Phase 1/2 trial results showing 27% of patients had no surgery needed for 12 months. VOCERYQ is expected to launch commercially in Q1 2027, with continued approval contingent on confirmatory study results.

Inovio Pharmaceuticals (INO) received FDA approval for VOCERYQ, its first commercial product, for treating recurrent respiratory papillomatosis (RRP). The approval was based on a study where 27% of patients achieved a complete response. The company plans to price the therapy at $460,000 for the full regimen and expects commercial launch in early 2027. Inovio also anticipates insurer coverage for 80% of U.S. patients within nine months.