Drug Profile

Zopapogene imadenovec - Precigen Inc

Alternative Names: PRGN-2012

Latest Information Update: 07 Mar 2025

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At a glance

Originator Precigen Inc
Class Antineoplastics; Cancer vaccines; DNA vaccines; Immunotherapies; Synthetic vaccines; Vaccines
Mechanism of Action Immunostimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Recurrent respiratory papillomatosis
New Molecular Entity No

Highest Development Phases

Preregistration Recurrent respiratory papillomatosis

Most Recent Events

25 Feb 2025 FDA assigns PDUFA action date of (27/08/2025) for zopapogene imadenovec for Recurrent respiratory papillomatosis
25 Feb 2025 US FDA accepts sBLA for Zopapogene imadenovec for Recurrent respiratory papillomatosis for review
13 Jan 2025 Precigen annuounces intention to submit the BLA application to other regulatory authorities

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