FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Mol­e­c­u­lar Ther­a­peu­tics qui­et­ly tucked an FDA clin­i­cal hold on its Fab­ry gene ther­a­py in­to an SEC fil­ing.

Mean­while, the biotech is­sued a press re­lease the same day af­ter the clos­ing bell on Thurs­day tout­ing an IND for an­oth­er as­set, in di­a­bet­ic mac­u­lar ede­ma.

The Cal­i­for­nia biotech had paused en­roll­ment of pa­tients in its two tri­als of the Fab­ry gene ther­a­py (4D-310) last month af­ter three pa­tients ex­pe­ri­enced kid­ney is­sues, all of which were re­solved with­in four weeks. At the time, 4DMT said it would wait un­til the sec­ond half of this year to look at 12-month clin­i­cal da­ta on six pa­tients in the Phase I/II tri­als, one in the US and one in Tai­wan and Aus­tralia.

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