Sangamo surges as FDA says no additional study required for gene therapy accelerated approval
22/10/2024 16:19
(Updates)
** Shares of genomic medicine company Sangamo Therapeutics
SGMO.O rise 33.6% to an over 8-month high of $1.22
** Co says the U.S. FDA has agreed that data from ongoing
early-mid-stage study can serve as the primary basis for
accelerated approval of its experimental gene therapy to treat
Fabry disease
** The FDA feedback is indicative of the agency's
"regulatory flexibility as it seeks to advance gene therapies
broadly," according to Guggenheim analysts
** Fabry disease is an inherited disorder caused by the
buildup of a type of fat in the body's cells
** No additional registrational study is required to support
accelerated approval for the gene therapy, isaralgagene
civaparvovec - SGMO
** SGMO says complete dataset from the study will be
available in H1 2025 with a filing expected in H2 2025
** Including session gains, stock more than doubled YTD
(Reporting by Mariam Sunny in Bengaluru)
((Mariam.ESunny@thomsonreuters.com;))