Precigen Wins FDA Orphan Drug Exclusivity for Airway Disease Treatment

MT Newswires Live06-15 19:36

Precigen (PGEN) said Monday the US Food and Drug Administration granted orphan drug exclusivity for its recurrent respiratory papillomatosis treatment called papzimeos.

The regulatory designation prevents the approval of competing similar medications for a seven-year duration until August 2032, the company said.

Long-term clinical trial data revealed that 83% of complete responders maintained their status for a minimum of 36 months without requiring further surgeries or therapeutic interventions.

The therapy uses a modified adenovirus to stimulate the immune system against specific proteins linked to the respiratory tract disease, the company said.

Shares of Precigen rose more than 1% in recent Monday premarket activity.

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