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Precigen Inc Receives FDA Approval for Papsius, Launches in US Amid Challenges
ByAinvest
Friday, Nov 14, 2025 12:06 am ET1min read
Precigen Inc (PGEN) received full FDA approval for Papsius, a treatment for recurrent respiratory papillomatosis (RRP), with a 51% complete response rate and favorable safety profile. The company has successfully launched Papsius in the US and submitted a marketing authorization application with the EMA for geographic expansion. However, the company is not providing specific revenue guidance, and reimbursement hurdles and competition in the RRP treatment space may impact market share.
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