Im­muno­core's bis­pe­cif­ic lands speedy re­view with FDA, EMA; Low-pro­file gene ther­a­py play­er grabs $30M

UK TCR-fo­cused biotech Im­muno­core an­nounced that it scored a pri­or­i­ty re­view with the FDA for lead drug tebenta­fusp.

The bis­pe­cif­ic al­ready boasts a break­through ther­a­py des­ig­na­tion thanks to pos­i­tive Phase III da­ta. The pri­or­i­ty re­view shaves four months off the reg­u­lar 10-month process, lead­ing to an ex­pect­ed PDU­FA date of Feb. 23.

Across the At­lantic, the EMA agreed to ac­cel­er­ate its as­sess­ment of Im­muno­core’s mar­ket­ing au­tho­riza­tion ap­pli­ca­tion, which it has al­ready ac­cept­ed. That ac­cel­er­at­ed time­line re­duces the as­sess­ment process from up to 210 days to 150 days, ex­clud­ing clock stops.

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