De­nied: FDA re­jects Ag­ile's con­tra­cep­tion patch for sec­ond time

Ag­ile Ther­a­peu­tics $AGRX is suf­fer­ing yet an­oth­er re­jec­tion from the FDA this morn­ing as reg­u­la­tors de­clined to ap­prove its con­tra­cep­tion patch for the sec­ond time. The com­pa­ny’s stock tanked on the news, falling 60% in pre-mar­ket trad­ing Fri­day.

The FDA said the New Jer­sey com­pa­ny need­ed to re­con­sid­er its ad­he­sion test meth­ods and re­solve some is­sues found dur­ing an in­spec­tion of a third-par­ty man­u­fac­tur­ing fa­cil­i­ty Cori­um In­ter­na­tion­al. Reg­u­la­tors al­so want­ed Ag­ile to ad­dress the im­pli­ca­tions of patch com­pli­ance dur­ing clin­i­cal tri­als and dropout rates.

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