Precigen's immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for the condition, which typically requires frequent surgeries, sending the company's shares soaring 83% on Friday.

Shares of Precigen (NASDAQ:PGEN) added ~34% in the premarket on Friday after the U.S. Food and Drug Administration (FDA) approved its immunotherapy candidate Papzimeos (zopapogene imadenovec-drba) for a tumor condition called recurrent respiratory papillomatosis (RRP).

Precigen has won approval in the US for a first-in-class immunotherapy for recurrent respiratory papillomatosis (RRP), a rare, benign tumour that can cause significant health challenges.