Precigen's Papzimeos Receives Full FDA Approval, Stock Soars.

Precigen's shares have rallied after its gene and cell therapy, Papzimeos, received full FDA approval for recurrent respiratory papillomatosis. This is the first-ever approval for the indication.

Precigen, Inc. (NASDAQ: PGEN) has seen its shares rally significantly following the full FDA approval of its gene and cell therapy, Papzimeos, for recurrent respiratory papillomatosis (RRP). This approval, the first of its kind for the indication, has marked a pivotal moment for the company and its investors.

Papzimeos, which received full approval on August 14, 2025, is a significant advancement in the treatment of RRP. This rare and sometimes fatal disease affects the vocal cords, trachea, and lungs, often caused by infection from HPV6 and HPV11 strains. The therapy, administered subcutaneously over a 12-week period, has demonstrated a complete response rate of 51% and an 86% reduction in the need for surgeries at 52 weeks, significantly improving the quality of life for patients.

The approval of Papzimeos validates Precigen's AdenoVerse platform, which houses a library of adenovectors for efficient gene therapy transfer. The platform uses gorilla adenovectors, offering advantages such as repeat administration and the ability to deliver large payloads.

Precigen has priced Papzimeos at $115,000 per vial, equating to $460,000 per therapy course. The total addressable domestic market for RRP treatment is estimated at around $12.4 billion. The strong safety profile of Papzimeos allows for potential redosing, further expanding its market potential.

The company's financial position has also been bolstered by a $125 million credit facility agreement with Pharmakon Advisors, which was announced in early September. This infusion of capital will support the commercialization and global expansion of Papzimeos, as well as additional indications.

While Precigen's stock has seen substantial gains, analysts remain cautious about the company's profitability prospects. Precigen is not expected to achieve profitability until FY2027, with a projected earnings per share of 30 cents. However, the potential market opportunity for Papzimeos, combined with its first-mover advantage, suggests that there could be significant upside for investors.