Precigen Inc

Precigen's sole marketed drug Papzimeos generated $74.6 million in revenues during the first six months of 2026, with second-quarter sales more than doubling sequentially. Papzimeos is the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis, and management said demand continued to grow as the third quarter progressed. The company's marketing authorization application for Papzimeos in Europe is under review, and the drug holds seven years of FDA market exclusivity through Aug. 14, 2032. Rival Inovio Pharmaceuticals is developing INO-3107 for RRP, with an FDA decision expected on Oct. 30, 2026. Precigen also plans to update on its AdenoVerse portfolio, including PRGN-2009 in a phase II study with Merck's Keytruda, by the end of 2026.

Precigen reported second-quarter 2026 financial results that exceeded analyst expectations. The company posted GAAP earnings per share of $0.05, beating estimates by $0.06. Revenue reached $54.98 million, surpassing forecasts by $27.15 million. The results were highlighted by accelerating momentum for Papzimeos.

Precigen Inc. shares surged 11.62 percent to close at $5.38 on Monday, extending a two-day rally as investors reacted to the FDA's grant of six-year orphan drug exclusivity for its recurrent respiratory papillomatosis therapy, Papzimeos. The exclusivity, which runs through August 14, 2032, covers a rare disease affecting fewer than 200,000 people in the United States. President and CEO Helen Sabzevari said the protection, combined with the company's patent portfolio, strengthens market protection and long-term revenue potential.