FDA grants INOVIO accelerated approval for VOCERYQ in adult RRP

what happened

The U.S. Food and Drug Administration has granted INOVIO Pharmaceuticals (INO) accelerated approval for VOCERYQ. The drug is indicated to reduce how often adults with recurrent respiratory papillomatosis need surgical papilloma removal. TradingView reports this, citing INOVIO's press release distributed by PR Newswire.

The decision rests on complete response data, with 7 of 26 patients (27%) reaching that outcome at 12 months. Continued approval may depend on results from a confirmatory study the company still has to complete.

The company expects to launch the product in about 60 days. According to the release, the U.S. prevalence of RRP is at least 25,000 people.

why it matters

For INOVIO this is its first U.S. approval and the start of a commercial path in a narrow disease area. Investors will watch the launch, payer coverage decisions and the outcome of the confirmatory trial, which determines whether the approval stays in place.

market impact

INOVIO shares: first U.S. approval opens a path to revenue, but depends on a confirmatory study

• ▲INOVIO shares (INO) pressure up — first U.S. approval opens a path to commercial sales

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