Precigen rallies on FDA approval of first rare disease therapy

Precigen Inc. (NASDAQ: PGEN) shares have jumped nearly 150% since the US biotechnology group secured Food and Drug Administration approval for Papzimeos, the first treatment for recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) that leads to benign growths in the respiratory tract. The drug also marks the company’s first FDA-approved therapy.

Analysts forecast Papzimeos to generate $14 million in sales in 2025, rising sharply to $117 million in 2026 as uptake accelerates in the US. The therapy is expected to account for 80% of the company’s total revenue in 2025. Overall company revenue is projected to grow from $17 million in 2025 to $120 million in 2026, positioning the drug as Precigen’s main growth driver.

Precigen is targeting Integrated Delivery Networks and community hospitals, which cover the bulk of prescribing physicians, as part of its US launch strategy. Analysts believe supply will be sufficient to meet near-term demand. Precigen also intends to secure an ex-US commercial partner to expand the drug’s reach.

While the approval marks a breakthrough, analysts caution that Precigen’s near-term growth hinge almost entirely on a single product, raising execution and pricing risks. The company has five other therapies in development, including PRGN-2009 for HPV-linked solid tumors (Phase 2) and PRGN-3006 for acute myeloid leukaemia and myelodysplastic syndromes, which has received Orphan Drug and Fast Track designations. Therapies for ovarian cancer, haematologic and solid tumours, and Type 1 diabetes are at earlier stages.

Papzimeos offers a near-term revenue inflection point, but pipeline execution will be key to sustaining longer-term growth and derisking reliance on a single rare disease franchise.

This article was published by Visible Alpha, part of S&P Global Market Intelligence and not by S&P Global Ratings, which is a separately managed division of S&P Global.