Inovio shares jump 286% after FDA clears first product
The agency approved Voceryq for recurrent respiratory papillomatosis, a rare condition that causes airway growths and often requires repeated surgeries.
By Nathaniel Hayes ·
Inovio Pharmaceuticals shares climbed 286 percent in after-hours trading on Friday following the US Food and Drug Administration's approval of the company's first product. The FDA cleared the therapy, known as Voceryq, for use in patients with recurrent respiratory papillomatosis. This rare disease causes wart-like growths in the throat and airways that frequently return after treatment.
The condition is typically linked to human papillomavirus types 6 and 11. These growths are not cancerous but can impair a patient's ability to speak and breathe. Standard medical care involves surgical removal of the tissue. Many patients require multiple procedures each year because the growths often come back. Voceryq provides a new therapeutic option for adults managing this recurring condition.
The FDA noted that the most common adverse reactions to the injection include site reactions, headache, fatigue, high blood pressure, nausea, and dizziness. The approval was based on data from an early- to mid-stage clinical study. That trial involved adults who had undergone at least two surgical procedures for the condition in the year prior to treatment.
This is the second US approval for a medicine targeting recurrent respiratory papillomatosis. Last year, the FDA cleared Precigen's Papzimeos for adults with the disease. Innovio CEO Jacqueline Shea told Reuters that the two treatments work through different mechanisms. Precigen's drug uses a modified virus to trigger an immune response. Voceryq is a DNA-based immunotherapy. Both are designed to generate an immune response against HPV types 6 and 11.
Shea emphasized that physicians seek therapies that reduce the frequency of surgical interventions. Every operation carries a risk of permanent damage to the vocal cords. The company plans to handle the commercialization of Voceryq in the United States independently. Innovio is working with Syneos Health to support the launch of the new therapy.
The approval marks the first time the FDA has signed off on an Inovio product. The company had previously focused on developing candidates for other conditions. With Voceryq, Inovio now holds a marketed drug for a specific respiratory disorder. The stock market reaction reflects the financial weight of the company's first successful launch.
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