Pharming falls as leniolisib's review loses accelerated tag in Europe

Hanall Biopharma

16/02/2023 15:38

** U.S.-listed shares of dutch biopharma co Pharming Group
NV  PHAR.O  down 13.3% at $11.39 
    ** Says European Medicines Agency (EMA) has decided to shift
assessment of marketing application for co's investigational
drug, leniolisib, to a standard review timetable from its prior
status of accelerated assessment
    ** EMA asks co to submit updated data from the ongoing
long-term extension study
    ** Leniolisib is being tested to treat a rare primary
immunodeficiency called activated PI3K-delta syndrome, which can
lead to permanent lung damage and lymphoma in long term
    ** EMA committee expected to issue opinion in 2H 2023,
delayed from prior expectation of marketing approval in H1 - Co
    ** Adds U.S. FDA's priority review for the drug remains on
track with a target action date of March 29 
    ** Stock rose 45% in last 12 months
 (Reporting by Aditya Samal)
 ((Aditya.Samal@thomsonreuters.com;))