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Inovio Wins FDA Approval for VOCERYQ, Its First Commercial Product

The accelerated approval is based on a complete response in 26 patients and could reduce repeated surgeries for a rare airway disease.

  • On Friday, the U.S. Food and Drug Administration granted accelerated approval to Inovio Pharmaceuticals' Voceryq, marking the first FDA-approved DNA medicine for treating recurrent respiratory papillomatosis .
  • Recurrent respiratory papillomatosis affects at least 25,000 patients in the United States, forcing repeated surgeries to remove papillomas that frequently regrow and threaten permanent vocal cord damage.
  • Clinical data showed 27% of patients achieved complete response with no surgical excision needed after 12 months, while treatment caused only transient grade 1 and 2 adverse reactions.
  • RRP Foundation President Kim McClellan said the therapy provides "a non-surgical treatment option," while Inovio President and Chief Executive Officer Dr. Jacqueline Shea called it a potential "paradigm shift."
  • The company expects to ship Voceryq in approximately 60 days with full commercial launch in early 2027, and will host a conference call Monday, November 2, 2026 for investor details.
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The Times of Northwest IndianaThe Times of Northwest Indiana
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INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)

INOVIO delivers a new nonsurgical treatment option with a broad indication for adults living with RRP, a rare and debilitating disease that often requires surgeryVOCERYQ™ is a plasmid DNA-based immunotherapy that targets the root cause of RRP: HPV-6 and HPV-11INOVIO…

·Munster, United States
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Reuters broke the news in London, United Kingdom on Friday, October 30, 2026.
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