Precigen (PGEN) transitioned to a commercial stage with the FDA approval of PAPZIMEOS, generating $3.4 million in revenue in Q4 2025. The therapy's demand is expected to increase following the assignment of a J-code, and its European regulatory approval is under review, positioning PGEN for stronger market presence and revenue growth.
FDA approves Precigen's Papzimeos for recurrent respiratory papillomatosis (RRP). Papzimeos is the first FDA-approved treatment for adults with RRP. 51% of patients achieved complete response, lasting over 12 months. Precigen will start promoting Papzimeos immediately following the approval. PGEN stock rose 44.32% to $2.67 in premarket trading.
- Precigen, Inc. (PGEN) reported a quarterly loss of $0.10 per share, missing estimates. - Company's revenue of $1.07 million for March 2024 missed Zacks' estimate by 30.84%. - Precigen shares have underperformed S&P 500, showing a 0.8% increase since the year began. Price Impact Rating: Bearish Impact Horizon Rating: Short-term Type: Earnings