Benzinga Pro data showed Inovio Pharmaceuticals shares rising 192.07% to $1.75 at publication on Monday. Benzinga Pro recorded session trading volume of 8.969 million shares, against average volume of 4.604 million shares. The FDA granted Voceryq accelerated approval on Friday to reduce how often adults with Recurrent Respiratory Papillomatosis (RRP) need surgery. Voceryq contains doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd and was formerly called INO-3107.
RRP causes noncancerous, wart-like growths called papillomas within the respiratory tract. The rare disease also has the names laryngeal papillomatosis and squamous cell papillomatosis. Voceryq uses recombinant plasmid DNA to deliver two plasmids into cells. Plasmids are small DNA fragments originally obtained from bacteria. One plasmid encodes specific HPV proteins, while the other encodes IL-12, a molecule that strengthens the immune response. The immunotherapy aims to prompt immune attacks against cells infected with HPV types 6 and 11, which cause RRP.
Inovio's RRP-001 study provided the data supporting approval. The study enrolled 32 adults with RRP who had undergone at least two surgeries during the preceding year. The protocol did not require additional surgical removal of papillomas during the Voceryq dosing period. The efficacy evaluation included 26 patients who had undergone at least three papilloma-removal surgeries during the 12 months before treatment. The efficacy population had a median of 4.5 surgical excisions during the 12 months before the first dose. Seven of the 26 patients achieved a complete response, meaning no surgery to remove papillomas was needed after 12 months of follow-up. Such a response is not expected in the untreated course of RRP.
Continued approval for this use may depend on confirmatory research verifying and describing clinical benefit. A confirmatory study is expected to assess Voceryq's clinical benefit. The FDA requires Inovio to provide a draft study protocol by the end of 2026. Agreement on a final protocol is expected by mid-2027.
Inovio Stock Surges 192% After FDA Grants Accelerated Approval for RRP Treatment Voceryq
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Summary
Inovio Pharmaceuticals (NASDAQ: INO) shares jumped 192.07% to $1.75 on Monday, with trading volume hitting 8.969 million shares. The FDA granted accelerated approval for Voceryq, Inovio's treatment for RRP, to reduce surgical interventions in adults. The drug, previously INO-3107, uses DNA to target HPV-related RRP. The RRP-001 trial showed seven of 26 patients had no surgery after 12 months. Inovio must submit a study protocol by 2026 to confirm benefits. Altcoins to watch may gain attention as trading volume spikes in biotech and crypto markets.
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