Precigen gets EU orphan drug status for respiratory tract drug

Mlenny EU regulators have granted orphan drug designation to Precigen’s ( NASDAQ: PGEN ) drug candidate PRGN 2012 for the treatment of recurrent respiratory papillomatosis, a rare respiratory tract disease caused by HPV 6 or HPV 11. The product has already received orphan drug designation, breakthrough therapy designation and an accelerated approval pathway from the FDA for the illness.

A presentation of Phase 2 data for the product is expected in Q2 2024. The company anticipates filing for FDA approval under an accelerated pathway in the second half of the year, with a potential launch in 2025. More on Precigen Precigen: Big Ambitions But Outstanding Funding Concerns Seeking Alpha’s Quant Rating on Precigen Historical earnings data for Precigen Financial information for Precigen.