By Sahil Pandey and Christy Santhosh
Oct 30 (Reuters) – The US Food and Drug Administration on Friday approved Inovio Pharmaceuticals’ treatment for a rare respiratory condition, marking the company’s first approved product.
Shares of Inovio were up 257% in extended trading.
Inovio’s therapy INO-3107, branded as Voceryq, gives a new treatment option for patients with recurrent respiratory papillomatosis, which causes growths in the airways and often requires repeated surgeries.
Recurrent respiratory papillomatosis is characterized by recurrent wart-like growths in the throat and airways.
The condition is usually caused by HPV types 6 and 11 and can affect a person’s ability to speak and breathe. Although the growths are not cancerous, they often return after treatment.
Doctors currently treat it by surgically removing the growths, but many patients require multiple procedures each year because the condition often recurs.
Inovio said it expects Voceryq to be available for order and shipment within about 60 days, with a full commercial launch planned for the first quarter of 2027.
The company’s application was supported by an early- to mid-stage study in adults who had undergone at least two or more surgeries in the previous year.
Last year, Precigen’s Papzimeos for adults with recurrent respiratory papillomatosis became the first medicine to get US approval for the disease.
Inovio CEO Jacqueline Shea told Reuters ahead of the FDA decision that, unlike Precigen’s Papzimeos, which uses a modified virus to trigger an immune response, Voceryq is a DNA-based immunotherapy. She said both therapies are designed to generate immune responses against HPV types 6 and 11, but do so through different mechanisms.
Shea said physicians are primarily looking for therapies that reduce the need for surgery, noting that every operation carries a risk of permanent vocal cord damage.
The approval was granted under the FDA’s accelerated approval pathway, and Inovio will be required to conduct a confirmatory study to verify Voceryq’s clinical benefit.
The company expects to submit a draft protocol by the end of 2026 and finalize the study design by mid-2027.
(Reporting by Sahil Pandey, Christy Santhosh and Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
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