INOVIO filed an 8-K on October 30, 2026, announcing that the U.S. Food and Drug Administration granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).

Key Highlights

  • Accelerated approval granted: The FDA approved VOCERYQ under the accelerated approval program based on demonstrated complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population.
  • Clinical data basis: In the RRP-001 study, 7 out of 26 patients in the efficacy population (27% [95% CI: 12; 48%]) demonstrated a complete response after 12 months of follow-up.
  • Study population: The efficacy population consisted of 26 adult patients who required 3 or more surgeries in the 12 months prior to treatment, with a median of 4.5 surgical excisions (range: 3 to 8).
  • First U.S. FDA approved DNA medicine: According to the filing, VOCERYQ represents the first U.S. FDA approved DNA medicine, validating INOVIO's platform technology.
  • Commercial timeline: INOVIO expects to make VOCERYQ available to order and ship in approximately 60 days, with full field deployment anticipated in the first quarter of 2027.
  • Confirmatory study required: The FDA requires INOVIO to submit a draft protocol for a confirmatory study by the end of 2026, with alignment on a final protocol expected by mid-2027.
  • Safety profile: The most common adverse reactions (incidence greater than 5%) included injection site reactions, headache, fatigue, hypertension, nausea, and dizziness; there were no grade 4 or 5 common adverse events, and all 32 patients completed the study.

INOVIO's VOCERYQ Approval: Key Details From the Announcement

According to the filing, the FDA's accelerated approval of VOCERYQ covers its use in adults with RRP, a rare disease caused primarily by HPV-6 and/or HPV-11 and characterized by wart-like papillomas in the respiratory tract. The current standard of care, per the filing, is surgery to remove papillomas, though papillomas often grow back. INOVIO disclosed that its market research, based on ongoing analysis of claims data, indicates a prevalent population of at least 25,000 patients with RRP in the United States.

The approval is supported by data from the RRP-001 study, which evaluated VOCERYQ in 32 adult patients. The efficacy evaluation focused on the 26 patients who had required 3 or more surgeries in the prior 12 months. The filing states that seven of those 26 patients (27% [95% CI: 12; 48%]) achieved a complete response, defined as requiring no surgical excision of papillomas after 12 months of follow-up, an outcome "not expected as part of the natural history of the disease when untreated," according to the filing. During the VOCERYQ dosing window, no additional papilloma surgical excisions were required in the protocol.

VOCERYQ is administered using INOVIO's proprietary CELLECTRA 5PSP device and was approved in combination with it. The filing notes that the FDA previously granted VOCERYQ both Orphan Drug and Breakthrough Therapy designations. INOVIO disclosed it has engaged Syneos Health to support recruitment and deployment of its medical and commercial field teams. INOVIO also disclosed that the FDA requires submission of a draft confirmatory study protocol by the end of 2026, with a final protocol expected by mid-2027. Continued approval for this indication, the filing states, "may be contingent on verification and description of clinical benefit in a confirmatory study(ies)."

What Was Disclosed

INOVIO (NASDAQ:INO) disclosed the FDA's accelerated approval of VOCERYQ for adults with RRP, supported by RRP-001 study data showing a 27% complete response rate in the efficacy population, with commercial availability expected in approximately 60 days and full launch in Q1 2027.