The FDA granted accelerated approval to INOVIO Pharmaceuticals' Voceryq (INO-3107), the first U.S.-approved plasmid DNA-based immunotherapy, to reduce surgical interventions in adults with recurrent respiratory papillomatosis (RRP). The authorization was supported by an open-label multicenter trial of 32 adults, with 7 of 26 patients who had at least three prior surgeries requiring no surgery during the first year after treatment. The treatment is administered using the CELLECTRA 5PSP electroporation device, and INOVIO must conduct post-approval studies to verify clinical benefit.
FDA+1
Primary source: FDA announcement, October 30
Why it matters strategically
The approval creates a regulatory and commercial situation that deserves examination beyond the technological novelty.
INOVIO now has accelerated approval in a rare disease where another company, Precigen, already obtained full FDA approval for Papzimeos in August 2025.
Precigen reported that 18 of 35 pivotal-study participants (51%) achieved complete response without surgery for 12 months, and subsequently reported prolonged durability in many responders. Papzimeos also received seven-year orphan drug exclusivity extending to August 2032.
Precigen+1
These figures are not a valid head-to-head comparison. The trial populations, endpoint definitions, baseline disease severity, and statistical methods must be examined before comparing treatment effectiveness.
