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US FDA Approval of PAPZIMEOS

Precigen (PAPZ) | August 18, 2025

By Laura Young

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Precigen announces the US FDA approval of PAPZIMEOS for the treatment of recurrent respiratory papillomatosis (RRP) in adults.

PAPZIMEOS is the first and only FDA-approved therapy for adults with RRP, marking a significant milestone in the treatment of this rare HPV-driven disease.

The approval of PAPZIMEOS opens up new possibilities and treatment options for patients suffering from RRP.

First FDA Approval

PAPZIMEOS is the first FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis.

Treatment Paradigm Shift

PAPZIMEOS has the potential to define a new treatment paradigm for adults with RRP, offering strong efficacy and durability of response.

Prescribing Information

PAPZIMEOS has received full approval with no requirement for a confirmatory clinical trial, providing broad eligibility for adults with RRP.

  • The approval of PAPZIMEOS is a significant advancement in the treatment of RRP, offering a non-replicating adenoviral vector-based immunotherapy with promising efficacy and safety profiles.
  • With the potential to become the standard-of-care for adults with RRP, PAPZIMEOS represents a breakthrough in addressing the challenges associated with this debilitating disease.

In conclusion, the US FDA approval of PAPZIMEOS marks a crucial moment in the medical landscape, providing new hope and effective treatment options for patients with recurrent respiratory papillomatosis. Precigen's dedication to innovation and addressing unmet medical needs is evident in the development of PAPZIMEOS.