INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)
Key Highlights
- ➤FDA granted accelerated approval for VOCERYQ to reduce surgery frequency in adults with RRP
- ➤Seven of 26 efficacy patients achieved complete response after 12 months
- ➤INOVIO expects VOCERYQ ordering and shipping in approximately 60 days
- ➤Full commercial launch anticipated during the first quarter of 2027
- ➤Continued approval may depend on confirmatory-study verification of clinical benefit
Expert Statements
Dr. Jacqueline Shea, President and Chief Executive Officer of INOVIO
“With the approval of VOCERYQ, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option. VOCERYQ is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP”
Kim McClellan, President of the RRP Foundation
“This new FDA-approved therapy brings us an important step closer to ensuring every RRP patient has access to a non-surgical treatment option that works for them. In reaching this milestone, we have shown that patient voices matter in the drug development process”
Dr. Simon Best, Associate Professor of Otolaryngology at Johns Hopkins University and lead investigator for INOVIO's RRP-001 study
“The approval of VOCERYQ is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury. I believe it is in the best interest of RRP patients that the standard of care quickly transition away from surgical interventions to immunotherapy after RRP is diagnosed.”
INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) PR Newswire
* INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and debilitating disease that often requires surgery * VOCERYQ™ is a plasmid DNA-based immunotherapy that targets the root cause of RRP: HPV-6 and HPV-11 * INOVIO expects to make VOCERYQ available to order and ship in approximately 60 days, with full commercial launch in the first quarter of 2027 * VOCERYQ represents the first U.S. FDA approved DNA medicine, validating INOVIO's novel platform technology * INOVIO will host a conference call Monday, November 2, 2026 at 8:00 AM ET PLYMOUTH MEETING, Pa., Oct. 30, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107, to reduce the frequency of surgery in adults with RRP. This indication is approved 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. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory study(ies).
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