FDA gives Epizyme a green light on tri­al re­cruit­ment, but tazeme­to­stat isn’t com­plete­ly out of the woods yet

Epizyme is re­port­ing that the FDA has lift­ed the par­tial hold it im­posed on their clin­i­cal tri­al work for the lead drug tazeme­to­stat, but it has some work yet to do be­fore it gets all the stud­ies back on track.

The biotech $EPZM was hit hard when reg­u­la­tors in­sist­ed on sus­pend­ing en­roll­ment for the stud­ies af­ter a young pa­tient de­vel­oped sec­ondary T-cell lym­phoma.

“This al­lows us to turn our full at­ten­tion to our key pri­or­i­ties: prepar­ing for our first NDA sub­mis­sion for tazeme­to­stat in ep­ithe­lioid sar­co­ma and defin­ing our reg­is­tra­tion path in FL,” said Robert Baze­more, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Epizyme. “We, along with our in­ves­ti­ga­tors and the glob­al ex­perts we con­sult­ed to sup­port our com­plete re­sponse, con­tin­ue to be­lieve in the pos­i­tive ben­e­fit/risk of tazeme­to­stat as we move for­ward in our clin­i­cal de­vel­op­ment pro­gram.”

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER