Precigen brings first-ever treatment for HPV-linked respiratory disorder to market

The FDA has approved Precigen’s Papzimeos, the first treatment for recurrent respiratory papillomatosis (RRP), a rare HPV-driven disease that forces patients to undergo repeated surgeries to remove benign tumors in the airway.

Why it matters: For the first time, patients may avoid a lifetime of surgeries, sometimes more than a dozen per year, thanks to a therapy that targets the root cause of the disease. Analysts project Papzimeos could generate $1.1 billion in annual sales by 2033. Pricing information is coming soon and appears to be cause for excitement as Precigen stock soared 83% last Friday.

Backstory:

• RRP, caused by HPV types 6 and 11, has long lacked an approved treatment.

• Papzimeos is a non-replicating adenoviral vector-based immunotherapy. It works by delivering genetic material that triggers the body's immune system to recognize and destroy cells infected with HPV types 6 and 11.

• In trials, 51% of patients required no surgeries in the year after treatment; most maintained results for two years.

• The FDA granted full approval ahead of schedule, without requiring a confirmatory trial.

Big picture: Papzimeos marks a paradigm shift in how rare viral-driven diseases can be treated, validating new immunotherapy platforms and showing the FDA’s willingness to approve transformative therapies without large randomized trials. It also strengthens the case for broader HPV vaccination and immunotherapy innovation.