Precigen Inc. Reports Q3 2025 Earnings and Receives FDA‑Approved Product Launch
Precigen Inc. (NASDAQ: PGEN), a biotechnology company focused on gene and cell therapies for immuno‑oncology, autoimmune disorders and infections, released its third‑quarter 2025 financial results and business updates on November 13, 2025. The company’s share price remained largely flat in early trading on November 14, 2025, as analysts reaffirmed an $8 price target for the stock.
Earnings Snapshot
| Item | Q3 2025 | Analyst Expectation | Outcome |
|---|---|---|---|
| Net sales | $0.50 million | $0.50 million | Met expectations |
| Earnings per share | -$0.97 USD | –$0.09 USD | Missed by $0.88 USD |
| Revenue growth | – | – | – |
Precigen’s revenue of $0.5 million matched the consensus estimate of $0.5 million, a modest increase over the prior quarter. However, the company posted a loss per share of $0.97 USD, well below the expected loss of $0.09 USD, highlighting the high cost of research and development that the firm continues to incur.
FDA Approval of PAPZIMEOS
A key highlight of the earnings release was the announcement that the company’s first‑in‑class gene therapy, PAPZIMEOS (zopapogene imadenovec‑drba), received full approval from the U.S. Food and Drug Administration in August. PAPZIMEOS is the only FDA‑approved treatment for adults with Recurrent Respiratory Papillomatosis (RRP) and has been launched under a broad label in the United States.
- Patient Hub: To date, more than 100 patients have been registered in the PAPZIMEOS Patient Hub, underscoring early uptake by clinicians.
- Commercial Availability: The product is now shipping to prescribers, positioning Precigen to begin generating revenue from this therapy in the coming months.
The approval is a milestone for Precigen, validating its gene‑editing platform and providing a potential revenue stream that could offset its current operating losses.
Analyst Reactions
Following the earnings call, analysts from Citizens reiterated their $8 price target for PGEN, citing the firm’s strong pipeline and the recent FDA approval as positive catalysts. The company’s share price closed at $3.86 on November 12, 2025, well below its 52‑week high of $5.23 and above its 52‑week low of $0.65.
Despite the earnings miss, the market appeared to view the news favorably, as evidenced by the flat early‑trading movement and the absence of a sharp sell‑off. Precigen’s market capitalization remains at approximately $1.36 billion, reflecting investor confidence in its long‑term prospects.
Outlook
- Revenue Growth: Precigen anticipates incremental sales from PAPZIMEOS as the product gains traction in the U.S. market.
- Pipeline Development: The company continues to advance additional candidates in immuno‑oncology and autoimmune indications.
- Cost Management: Precigen remains focused on controlling R&D expenses while scaling its manufacturing capabilities.
The combination of a newly approved product, a steady pipeline, and a clear revenue path positions Precigen to potentially transition from a loss‑making entity to a revenue‑generating one in the near future. Investors will likely monitor the company’s ability to convert clinical approvals into commercial success while maintaining disciplined capital expenditure.
