PRGN-2012 FDA Priority Review
PRGN-2012 received FDA priority review with a PDUFA date set for August 27, 2025, indicating a strong regulatory progress and potential market entry.
Significant Efficacy in PRGN-2012 Trials
PRGN-2012 demonstrated a 51% complete response rate, with responders remaining surgery-free for up to three years, showcasing significant efficacy and durability.
Manufacturing Readiness for PRGN-2012
The company has upgraded its GMP facility and completed process validations, ensuring readiness for the commercial launch of PRGN-2012.
Expansion of Commercial Team
Precigen completed the build-out of its commercial leadership team and partnered with EVERSANA to implement the US launch, indicating robust preparations for commercialization.
Increased Market Opportunity
Updated analysis suggests there are up to 27,000 adult RRP patients in the US, indicating a larger market opportunity than previously estimated.
Successful Fundraising
Precigen raised $79 million through a preferred stock issuance, strengthening its balance sheet and extending its financial runway into 2026.
Promising Developments in PRGN-2009 and UltraCAR-T
Phase 1 data for PRGN-2009 showed 30% objective responses in refractory patients, and UltraCAR-T platform developments indicate potential first-in-class treatments for AML and autoimmune diseases.