Es­pe­ri­on shares surge as FDA waves off pan­el re­view; Adap­ti­m­mune buoyed by a pos­i­tive da­ta snap­shot

→ Es­pe­ri­on got a 15% bump on its stock price $ES­PR this morn­ing af­ter the biotech re­port­ed that the FDA had said it didn’t ex­pect to call an ad­vi­so­ry pan­el to­geth­er to re­view the new­ly ac­cept­ed NDAs for be­mpe­doic acid (BPA) and their be­mpe­doic acid/eze­tim­ibe com­bi­na­tion tablet. In­vestors saw that as a pos­i­tive sign for the LDL-low­er­ing ther­a­py. The PDU­FA date is Feb­ru­ary 21. The lack of an ad-com is an “im­por­tant, in­cre­men­tal pos­i­tive giv­en the in­vestor con­tro­ver­sies sur­round­ing BPA’s safe­ty and the as­sump­tion among most in­vestors that an ad­com was a fore­gone con­clu­sion; how­ev­er we would note, the FDA could still con­vene an ad­com if it feels one is need­ed at any point dur­ing the re­view process,” Stifel‘s Derek Archi­la wrote in a note.

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