Inovio Pharmaceuticals, Inc. filed an 8-K on November 2, 2026, disclosing that the U.S. Food and Drug Administration granted accelerated approval on October 30, 2026, for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgery in adults with Recurrent Respiratory Papillomatosis.

Key Highlights

  • Accelerated approval granted: The FDA approved VOCERYQ (previously referred to as INO-3107) on October 30, 2026, for adults with Recurrent Respiratory Papillomatosis (RRP).
  • Approval basis: The indication was approved based on demonstrated complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population.
  • Confirmatory study required: Continued approval may be contingent on verification and description of clinical benefit in one or more confirmatory studies.
  • Protocol timeline: The FDA requires Inovio to submit a draft protocol for the confirmatory study by the end of 2026, with alignment on a final protocol expected by mid-2027.
  • Delivery device: VOCERYQ was approved in combination with CELLECTRA 5PSP, the company's proprietary DNA medicine delivery device.
  • Commercial availability: The company expects to make VOCERYQ available to order and ship in approximately 60 days, with full field deployment anticipated during the first quarter of 2027.

Inovio Discloses FDA Accelerated Approval of VOCERYQ for Recurrent Respiratory Papillomatosis

According to the filing, Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced via an 8-K current report that the FDA granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) on October 30, 2026. The therapy is indicated to reduce the frequency of surgery in adults with Recurrent Respiratory Papillomatosis. The filing notes that the approval was granted under the FDA's accelerated approval program, with the basis being a demonstrated complete response defined as "no requirement for surgical intervention in the 12 months after treatment in the efficacy population."

The company disclosed that continued approval for this indication "may be contingent on verification and description of clinical benefit in one or more confirmatory studies." To satisfy this requirement, the filing states that a confirmatory study is expected to be conducted. The FDA has required Inovio to submit a draft protocol by the end of 2026, with the expectation of aligning on a final protocol by mid-2027. VOCERYQ was approved for use in combination with CELLECTRA 5PSP, described in the filing as the company's proprietary DNA medicine delivery device.

On the commercial side, the filing states that the company expects to make VOCERYQ available to order and ship in approximately 60 days and anticipates full field deployment during the first quarter of 2027. The company also disclosed plans for a corporate presentation via teleconference on November 2, 2026, to discuss the approval, with slides posted to the company's website under "Investor Relations - Events and Presentations." The press release and presentation slides were furnished as Exhibit 99.1 and Exhibit 99.2 to the filing, respectively. The 8-K was signed by Peter Kies, Chief Financial Officer, on November 2, 2026.

What Was Disclosed

Inovio Pharmaceuticals filed an 8-K reporting the FDA's accelerated approval of VOCERYQ for adults with RRP, the basis for that approval, conditions for continued approval including a required confirmatory study, and the company's expected commercial timeline for the product.