Lex­i­con gears up for an­oth­er shot in di­a­betes as path for­ward agreed with FDA

Lex­i­con Phar­ma­ceu­ti­cals is prepar­ing to re­sub­mit its type 1 di­a­betes drug can­di­date to the FDA af­ter its first at­tempt at ap­proval was met with a CRL back in 2019 amid safe­ty con­cerns. This comes af­ter sev­er­al years of Lex­i­con ar­gu­ing its case in an at­tempt to chal­lenge the agency’s de­ci­sion.

New fil­ing plans for so­tagliflozin, an SGLT1/2 in­hibitor, as an ad­junct to in­sulin in pa­tients with type 1 di­a­betes and chron­ic kid­ney dis­ease (CKD) fol­low re­cent feed­back from the FDA and are an­tic­i­pat­ed in mid-year, per a Lex­i­con re­lease. The com­pa­ny’s stock $LXRX rose by 16% Mon­day morn­ing to $2.52.

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