Precigen receives FDA platform designation

• Precigen (NASDAQ:PGEN) received FDA platform technology designation for its AdenoVerse immunotherapeutic platform.
• The designation may allow the company to use existing data and manufacturing knowledge across future programs.
• AdenoVerse supports PAPZIMEOS and ongoing clinical trials targeting HPV-associated cancers and recurrent respiratory papillomatosis.

Precigen (NASDAQ:PGEN) received U.S. FDA platform technology designation for its AdenoVerse immunotherapeutic platform, which supports the company’s first commercial product, PAPZIMEOS.

The FDA determined that AdenoVerse can be applied consistently across multiple products and may create efficiencies in development, manufacturing and regulatory review processes.

The designation allows Precigen to potentially use existing data, manufacturing information and preclinical knowledge from PAPZIMEOS to support future AdenoVerse-based programs, along with earlier FDA engagement and regulatory guidance.

AdenoVerse currently supports PAPZIMEOS, which was approved by the FDA in August 2025 for adults with recurrent respiratory papillomatosis, and ongoing Phase 2 studies of PRGN-2009 combined with pembrolizumab in HPV-associated cancers.

Precigen is also conducting an open-label PAPZIMEOS redosing study in recurrent respiratory papillomatosis as it continues development of AdenoVerse-based therapies.