Incyte falls as FDA rejects extended-release version of lead drug

Fidia SpA

24/03/2023 14:31

(Updates)
    ** Shares of drugmaker Incyte Corp  INCY.O  down 4.6% at
$68.9 
    ** U.S. FDA declines to approve extended-release version of
co's blockbuster cancer drug Jakafi
    ** Jakafi, which is already approved to treat bone marrow
cancer, abnormally high RBC count in blood, and graft-vs-host
disease, is set to lose its market exclusivity in 2028
    ** Co had filed for marketing approval for a once-daily
dosed extended release version, based on a study that showed it
to be bio-equivalent to twice-daily dosed approved version of
Jakafi
    ** Cannot approve application in present form, identified
additional requirements for approval - FDA
    ** Co says it intends to meet with FDA to determine
appropriate next steps
    ** The setback casts doubt on the opportunity to extend
Jakafi's exclusivity to 2033, and expand patient reach by
reducing dosing burden - Brokerage BMO Capital Markets
    ** Brokerage adds setback likely temporary and addressable
    ** Stock down 12% in last 12 months

 (Reporting by Aditya Samal)
 ((Aditya.Samal@thomsonreuters.com;))