The approval covers adults with recurrent respiratory papillomatosis, whose airway growths can require repeated surgery. Further trials must verify the treatment’s clinical benefit.
The US Food and Drug Administration (FDA) granted accelerated approval on 30 October 2026, to Voceryq for adults with recurrent respiratory papillomatosis, a rare, chronic disease that causes wart-like growths in the airways. The treatment combines doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd.
Human papillomavirus (HPV) types 6 and/or 11 cause these growths, most often around the voice box, particularly the vocal cords. Surgery removes the growths but does not cure the disease: the virus remains in the tissue, so patients often need repeated operations over many years.
The approval went to Inovio Pharmaceuticals, an American biotechnology company focused on synthetic DNA products for cancer and infectious diseases. The FDA described the decision as the first US approval of a plasmid DNA-based immunotherapy—a treatment designed to prompt an immune response.
The FDA says Voceryq delivers two plasmids—small pieces of DNA originally derived from bacteria—into the body’s cells. One carries genetic instructions for specific HPV proteins; the other carries instructions for IL-12, a molecule that enhances the immune response. The treatment is designed to stimulate the immune system to attack cells infected with the HPV types that cause the disease.
Voceryq is injected into muscle using the CELLECTRA 5PSP device. The FDA says the device delivers the dose and uses electroporation: brief electrical pulses temporarily and reversibly open pores in cell membranes, allowing the treatment to enter the cells.
The FDA lists injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness as the most commonly reported adverse reactions to Voceryq.
President Rodrigo Paz signed the decree on 31 October 2026, enabling resource mobilization and additional rescue-team deployments, with coordination among national and regional authorities, the armed forces and police.
The FDA said safety and effectiveness were evaluated in a trial involving 32 adults at multiple centers. The trial was open-label, meaning participants and researchers knew which treatment was given. Eligible patients had two or more operations to remove growths from the voice box or windpipe in the preceding 12 months, including a scheduled operation at trial entry.
Among 26 patients who had at least three baseline surgeries, seven—27%—needed no surgical intervention during the first year after treatment, the FDA said.
This is accelerated rather than traditional approval. The FDA based its decision on reduced surgical frequency, treating that result as an intermediate clinical endpoint—a measured outcome reasonably likely to predict clinical benefit. This pathway permits approval for serious or life-threatening conditions on that predictive basis.
Inovio must conduct post-approval clinical trials to verify and describe Voceryq’s clinical benefit.
2 min
Specific Flebogamma DIF, Yimmugo and Gamunex batches have already been withdrawn in certain EU member states after allergic-reaction clusters. EMA says the new review covers all human normal immunoglobulins to assess whether further safeguards are needed.
3 min
Researchers interpret the reduced yields as evidence of quark-gluon plasma, extending its energy-loss signature to smaller nuclei at lower collision energy.
3 min
