FDA Grants Accelerated Approval to Voceryq After 7 of 26 Patients Respond in Study
Key Facts
On October 30, 2026, the U.S. Food and Drug Administration granted accelerated approval to Inovio’s Voceryq to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis. The agency said the drug is the first plasmid DNA-based immunotherapy to receive approval in the United States. The decision was based on a study of 32 adults, in which 7 of 26 patients did not require surgical intervention during the first year after treatment. Those patients had undergone at least three surgeries before joining the study. The approval allows the treatment to be used for this purpose, subject to follow-up studies to verify and describe its clinical benefit.
The treatment targets a disease that causes wart-like growths in the airway, often near the larynx and vocal cords. Patients may need repeated procedures over many years because the virus can remain in tissue after the growths are removed. Voceryq is administered by intramuscular injection using the CELLECTRA 5PSP device and delivers two plasmids to the body. The first carries instructions for viral proteins, while the second carries the IL-12 molecule, which boosts the immune response. The treatment targets HPV-6 and HPV-11 in an effort to reduce the need for surgical removal of the growths.
The FDA said accelerated approval was based on a reduction in the frequency of surgical procedures, an intermediate clinical measure it considered likely to predict clinical benefit. The decision does not end the evaluation requirements: the company must conduct post-approval trials to verify and describe the drug’s clinical benefit. This follow-up is particularly important because the study’s reported result concerns the absence of a need for surgery during the first year among 7 patients in a group of 26. The multicenter, open-label study enrolled 32 adults in total. Subsequent verification remains part of the regulatory pathway’s requirements for the treatment.
Voceryq enters a field that includes Precigen’s PAPZIMEOS, which recorded sales of $74.7 million during the six months ended June 30, 2026. Precigen’s total revenue was $78.2 million over the same period, making the product the bulk of the company’s revenue in the first half. Both treatments target adults with the disease and focus on an immune response against HPV-6 and HPV-11. Their approaches differ, however: PAPZIMEOS uses a modified viral vector, while Voceryq relies on plasmid DNA. This comparison alone is not enough to determine the scale of commercial competition between the treatments.
In after-hours trading on October 30, Precigen shares fell 26.5% to $5.10, while Inovio shares rose 215% in extended trading, according to Benzinga and Reuters, as cited by WHBL. The source reporting Precigen’s decline did not attribute the move to a specific cause. Precigen shares had closed at $6.64 on October 29, before the approval was announced the following day, while Inovio shares closed at $0.7718 on the same date. These prices distinguish the previous session’s close from extended trading after the announcement. Inovio expected Voceryq to be available for ordering and shipment within approximately 60 days of the announcement, with a full commercial launch planned for the first quarter of 2027.
Inovio scheduled a conference call to discuss the approval on November 2, 2026, at 8 a.m. U.S. Eastern Time. The date follows the FDA announcement and precedes the availability and shipment period that the company said it expects to begin within approximately 60 days. The company also said a full commercial launch is targeted for the first quarter of 2027. The call will provide details on the decision and the company’s commercial plan, according to the date announced by Inovio. Follow-up clinical studies remain required to verify the treatment’s clinical benefit.