FDA Breakthrough and Orphan Drug Designations
PRGN-2012 received a breakthrough designation and an accelerated path from the FDA in June 2023, along with orphan drug designation from both the FDA and EMA.
Strong Clinical Trial Results for PRGN-2012
In Phase I and II trials, 51% of patients achieved complete response and 86% exhibited reduced surgeries, marking unprecedented results in the treatment of Recurrent Respiratory Papillomatosis.
Commercial Readiness and Strategic Partnerships
Phil Tennant joined as Chief Commercial Officer, leading efforts towards a potential 2025 launch for PRGN-2012, with preparations for global commercialization.
Successful Equity Issuance
The company raised $31.4 million through equity issuance, extending the financial runway into early 2025, and plans to explore additional financing options.