Precigen, Inc. ( PGEN ) shares are trading higher on Monday after the company completed the rolling submission for a biologics license application to the FDA for PRGN-2012 (zopapogene imadenovec) to treat adult patients with recurrent respiratory papillomatosis.

PRGN-2012 is an investigational AdenoVerse gene therapy targeting HPV 6 and HPV 11 infections. It has received Breakthrough Therapy and Orphan Drug Designations from the FDA, and Orphan Drug Designation from the European Commission.

PRGN-2012 could become the first FDA-approved treatment for recurrent respiratory papillomatosis, a rare, life-threatening condition with no cure.

Current treatment involves repeated surgeries, which don’t address the root cause and lead to recurring disease.

The submission is now under the FDA’s initial 60-day review period, during which the agency will determine whether to accept the application for further review and establish the Prescription Drug User Fee Act action date.

The biologics license application includes a request for priority review, which, if granted, would shorten the review timeline from 10 months to 6 months.

The BLA for PRGN-2012 is backed by a Phase 1/2 study (NCT04724980) in 38 RRP patients. The primary safety and efficacy endpoints were met, as reported in the results from the pivotal study presented at the 2024 ASCO annual meeting.

Helen Sabzevari, PhD, President and CEO of Precigen ( PGEN ), said, “There is currently no approved therapy for RRP patients and the submission of our BLA is an extremely important step in bringing the first therapy to fight this devastating disease.” 

“We look forward to working closely with the FDA on next steps now that we have completed the BLA submission and we are excited by the potential to bring PRGN-2012 to RRP patients as quickly as possible.”

“With our most recent financial transactions announced last week to enhance our balance sheet, we have extended our cash runway into 2026, well beyond potential commercial launch in the second half of 2025.” 

Price Action: PGEN shares are up 23.9% at $0.9000 at the last check Monday.

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