PGEN Precigen Inc

By Dean Seal

Precigen said the U.S. Food and Drug Administration has granted breakthrough therapy designation for PRGN-2012 AdenoVerse immunotherapy, its recurrent respiratory papillomatosis treatment.

Shares jumped 10.7% to $1.35 in premarket trading Tuesday.

The breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have preliminary clinical evidence showing substantial improvement at certain endpoints over currently available therapies.

Chief Executive Helen Sabzevari said the designation would allow Precigen to directly engage with the FDA's senior leadership about forging an efficient product development pathway.

"The potential of PRGN-2012 to reduce surgical interventions and improve outcomes for these patients makes us incredibly proud to receive the FDA's Breakthrough Therapy Designation," Sabzevari said.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

June 20, 2023 08:06 ET (12:06 GMT)

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