Days af­ter a CRL and damn­ing re­ports of tri­al mis­con­duct, a trou­bled biotech beats a hasty re­treat from Eu­rope

Two weeks af­ter lit­tle Sesen Bio popped its in­flat­ed stock price $SESN with news of an FDA re­jec­tion — and a week af­ter the re­main­ing mar­ket cap was tram­pled by a re­port of tri­al mis­con­duct — the ex­ec­u­tive team has now yanked its ap­pli­ca­tion at the EMA.

The biotech re­port­ed in an SEC fil­ing that it had de­cid­ed to pull the Eu­ro­pean pitch “giv­en that cer­tain com­po­nents in the EMA’s re­view are in­ter­re­lat­ed with el­e­ments of the US Food and Drug Ad­min­is­tra­tion’s de­ci­sion to is­sue a com­plete re­sponse let­ter re­gard­ing the Com­pa­ny’s Bi­o­log­ics Li­cense Ap­pli­ca­tion for Vicineum for the treat­ment of BCG-un­re­spon­sive NMIBC.”

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