Precigen PGEN Soars 58.92% on $530M Trading Volume Surge as FDA Approves First RRP Therapy

Precigen (PGEN) surged 58.92% on August 15, 2025, with a trading volume of $0.53 billion, marking a 6,518.68% increase from the previous day. The rally followed the FDA’s full approval of PAPZIMEOS, the first and only therapy for recurrent respiratory papillomatosis (RRP), a rare disease caused by chronic HPV 6/11 infection. The approval eliminates the need for confirmatory trials, a strategic milestone for the biopharma firm.

PAPZIMEOS, a non-replicating adenoviral vector-based immunotherapy, targets the root cause of RRP by inducing immune responses against HPV 6/11 proteins. Clinical data showed 51% of patients achieved a complete response, with 18 out of 35 requiring no surgeries for 12 months post-treatment. The therapy demonstrated a favorable safety profile, with no dose-limiting toxicities and durable efficacy observed in long-term follow-ups.

Precigen’s CEO highlighted the approval as a validation of its AdenoVerse platform and a transformative moment for RRP patients, who previously relied on repeated surgeries. The company plans to launch a patient support program and host a conference call on August 18 to discuss commercialization strategies. Analysts note the approval strengthens Precigen’s pipeline in immuno-oncology and rare diseases, positioning it to capitalize on unmet medical needs.

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