Strug­gling Adap­ti­m­mune gets a boost from the FDA as T cell can­cer drug wins an in­side track at the agency

Adap­ti­m­mune has been strug­gling as of late, los­ing its R&D chief dur­ing a CEO tran­si­tion as its share price $ADAP steadi­ly drift­ed down to alarm­ing lows. But the strug­gling biotech got a much-need­ed boost to­day from the FDA, which put one of its top can­cer drugs on the in­side track re­served for drugs that qual­i­fy as a Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py.

RMAT — which ex­tends to cell ther­a­pies — hasn’t re­ceived near­ly as much at­ten­tion as the FDA’s much cool­er sound­ing break­through ther­a­py des­ig­na­tion, but it comes with much the same open-door in­vi­ta­tion from the agency, an op­por­tu­ni­ty to dis­cuss fast-track­ing sur­ro­gate end­points, and a chance to shoot ahead in gain­ing a mar­ket­ing de­ci­sion.

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