Tercica up on Increlex approval

TRCA gained $1.98 (21%) to $11.31 on Wednesday after FDA approved Increlex mecasermin to treat children with a severe form of primary insulin-like growth factor-1 deficiency (IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.

FDA also granted the recombinant human IGF-1 protein ( rhIGF-1) Orphan Drug status for severe primary IGFD. Prior to approval, Increlex had Orphan Drug designation for growth hormone insensitivity syndrome (GHIS). Company spokesperson Kathleen Reinhart said TRCA filed an amendment to change the Orphan Drug designation from GHIS to severe primary IGFD on Aug. 25 because IGFD "more accurately defined the population we were looking at." In a May SEC filing, TRCA said it believed GHIS is "substantially equivalent" to severe primary IGFD. ...