Precigen gains on FDA Breakthrough Therapy Designation

• Precigen (NASDAQ:PGEN) added ~7% pre-market Tuesday after announcing that the FDA granted Breakthrough Therapy Designation for its immunotherapy PRGN-2012 as a treatment for breathing disorder recurrent respiratory papillomatosis (RRP).
• It is the first FDA breakthrough therapy designation issued for the company’s AdenoVerse immunotherapy platform, Precigen (PGEN) CEO Helen Sabzevari noted.
• A rare neoplastic condition in the respiratory tract, RRP has no cure. It is caused by human papillomavirus infection with HPV 6 or HPV 11 types. The juvenile-onset and adult-onset RRP affect 4 and 2 – 3 per 100,000 individuals, respectively.
• FDA’s Breakthrough Therapy designation aims to speed up the development and review of treatments targeted at serious or life-threatening conditions.
• With full features of the designation, a breakthrough therapy developer can receive intensive regulatory guidance with potential eligibility for FDA’s priority review.

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