IndustryCompany release

Precigen's Papzimeos sales reach $72.9M in Q3 as FDA recognises AdenoVerse platform

🇺🇸 Precigen, Inc. (PGEN) · Thu 05 Nov 2026

The gene therapy company reported net income of $35.8 million and positive cash flow, with an EMA marketing application for Papzimeos under review.

Precigen reported third-quarter 2026 results on 4 November, with net revenue from Papzimeos (zopapogene imadenovec-drba) reaching $72.9 million. The product is indicated for adults with recurrent respiratory papillomatosis. The company's headline for the results put the sales increase at 37%.

Precigen posted net income of $35.8 million for the quarter and reported positive cash flow. The summary of the release does not give further detail on costs, guidance or the comparison period behind the 37% figure.

On the regulatory side, the release notes that the US Food and Drug Administration has granted Platform Technology Designation to Precigen's AdenoVerse platform. As general context, the FDA's platform technology designation programme is intended to let the agency draw on data from a designated platform when assessing later products built on the same technology, although the benefit depends on the specifics of each application.

The release also points to a permanent HCPCS J-code, J3404, effective April 2026. Separately, a marketing authorisation application for Papzimeos is under review at the European Medicines Agency. No timeline for an EMA opinion was available in the material reviewed.

What it means for your team

  • Market-access teams should note that a permanent J-code (J3404) has applied in the US since April 2026, which standardises how the product is identified for billing.
  • Regulatory teams working on viral-vector or gene therapy products may want to follow how the FDA applies the AdenoVerse platform designation in practice.
  • The pending EMA application means a possible European decision to track, though no timing has been disclosed.
  • Pharmacovigilance teams should expect growing real-world exposure to Papzimeos as sales increase.

Company's press release (SEC filing): Precigen, Inc. ↗

Article written by VigiEye from the official source (Precigen, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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