Precigen rises as FDA confirms study for respiratory disease therapy

Precigen

09/08/2023 12:36

** Shares of gene therapy developer Precigen Inc  PGEN.O 
rise 5.2% to $1.22 premarket
    ** Co says U.S. FDA clears efficacy and safety goals for
ongoing early-mid stage study testing its experimental
immunotherapy to treat recurrent respiratory papillomatosis
(RRP)
    ** RRP is a disease in which non-cancerous tumors grow in
the air passages leading from the nose and mouth to the lungs
    ** FDA confirms goals will support filing for accelerated
approval pathway; confirms no additional randomized,
placebo-controlled trial needed for marketing application
    ** Co plans to initiate a confirmatory study prior to
submission of the application 
    ** Up to last close, stock down ~24% YTD 

 (Reporting by Mariam Sunny in Bengaluru)
 ((Mariam.ESunny@thomsonreuters.com;))