Inovio Stock Soars Following FDA Approval for Rare Respiratory Disease Immunotherapy

Inovio Pharmaceuticals Inc. (NASDAQ:INO) stock is surging on Monday with a session volume of 8.969 million, compared to an average volume of 4.604 million, according to Benzinga Pro data.

On Friday, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously referred to as INO-3107, to reduce the frequency of surgery in adults with Recurrent Respiratory Papillomatosis (RRP).

Targeting Respiratory Tumors

RRP—also known as laryngeal papillomatosis or squamous cell papillomatosis—is a rare condition characterized by the growth of benign (noncancerous) wart-like tumors called papillomas in the respiratory tract.

Voceryq is a recombinant plasmid DNA-based immunotherapy that delivers two plasmids (small pieces of DNA originally derived from bacteria) into the body’s cells, one of which contains the genetic instructions for specific HPV proteins and the other an immune response-enhancing molecule called IL-12.

The therapy is designed to stimulate the immune system to respond to and attack cells infected by the specific types of HPV that cause RRP (types 6 and 11).

Clinical Trial Findings

Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory study(ies). 

The approval is supported by data from INOVIO’s RRP-001 study, which evaluated Voceryq in 32 adult patients with RRP who had two or more surgeries in the year prior to treatment.

During the Voceryq dosing window, no additional papilloma surgical excisions were required in the protocol. 

Of the 32 patients, 26 patients required 3 or more surgeries for papilloma excision in the 12 months prior to treatment and were included in the efficacy evaluation (median number of surgical excisions in the 12 months prior to the first dose in the efficacy population was 4.5.

Seven out of the 26 patients demonstrated a complete response, defined as requiring no surgical excision of papillomas, after 12 months of follow-up, which is not expected as part of the natural history of the disease when untreated.

Regulatory Next Steps

To verify the clinical benefit of Voceryq, a confirmatory study is expected to be conducted.

The FDA requires INOVIO to submit a draft protocol for the study by the end of 2026, with the expectation of aligning on a final protocol by mid-2027.

INO Price Action: Inovio Pharmaceuticals shares were up 192.07% at $1.75 at the time of publication on Monday, according to Benzinga Pro data.

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