Reg­u­lus or­dered to re­main in lim­bo as FDA re­fus­es to lift hold, de­mand­ing more da­ta on lead drug

Reg­u­lus is still in the FDA’s dog­house. Reg­u­la­tors have stiff armed the biotech, re­fus­ing to lift a clin­i­cal hold on the hep C drug RG-101 and blow­ing far past the com­pa­ny’s promise to get every­thing wrapped and hope­ful­ly back on track in Q4 of last year.

The agency put the drug on hold 6 months ago af­ter a sec­ond case of jaun­dice de­vel­oped among the pa­tients tak­ing the ther­a­py. And now it will have to wait un­til Q4 of this year to get more da­ta that the FDA wants to see from on­go­ing stud­ies – a hefty de­lay for a ques­tion­able lead ther­a­py.

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