Inovio stock rises 2.5-fold on plasmid DNA drug approval

Inovio Pharma's plasmid DNA-based immunotherapy Voceryq has been approved in the US for adults with recurrent respiratory papillomatosis (RRP) – a first for a drug of this type.

Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid) has been granted an accelerated approval by the FDA as a non-surgical treatment for RRP, a rare and debilitating disease caused by human papillomavirus (HPV) that leads to the growth of wart-like lesions in the airways.

The disease – generally caused by HPV 6 and HPV 11 infection – causes growths in the respiratory tract, most commonly the larynx, that can result in voice changes, breathing difficulties, and airway obstruction, and often requires repeated surgeries to remove the tumours. In some cases, RRP carries a risk of becoming cancerous over time.

Voceryq is designed to stimulate an immune response against the two HPV strains, and in clinical trials helped to reduce the frequency of surgical procedures.

Shares in the company, which had dipped ahead of the FDA decision date on the marketing application, surged 250% to more than $2.00 on the news, which gives Inovio its first approved therapy. It is administered intramuscularly using Inovio's Cellectra device, an electroporation system designed for the delivery of large molecules across cell membranes.

"Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it," commented Karim Mikhail, director of the FDA's Center for Biologics Evaluation and Research (CBER).

"Today's approval represents a meaningful scientific breakthrough: a plasmid DNA-based immunotherapy that harnesses the body's own immune system to fight the underlying cause of RRP," he added. "For patients, that could mean fewer surgeries, fewer disruptions, and more time living their lives on their own terms."

Inovio said it intends to start shipping Voceryq within 60 days, with a full commercial launch in the first quarter of 2027. The list price of the new therapy has not yet been announced, but more detail may be available on a company call later today.

Second non-surgical option

Voceryq is the second non-surgical therapy to be approved for RRP after Precigen's Papzimeos (zopapogene imadenovec), another immunotherapy that was cleared by the FDA in August 2025. Papzimeos is given as a series of subcutaneous injections to trigger a targeted T-cell immune response against HPV 6 and HPV 11.

There are around 1,000 new cases of RRP each year in the US, according to the FDA, while Precigen has estimated that around 27,000 adult Americans are living with the condition at any time.