Pen­ny stock biotech Syn­thet­ic Bi­o­log­ics sees its 'break­through' sta­tus pulled as FDA pon­ders safe­ty is­sues

A lit­tle un­der a year ago the pen­ny stock of Syn­thet­ic Bi­o­log­ics $SYN gy­rat­ed high­er on the news that its drug SYN-004 (rib­axa­m­ase) — de­signed to pro­tect the gut mi­cro­bio­me from the hav­oc caused by some an­tibi­otics and guard against Clostrid­i­um dif­fi­cile in­fec­tion — had won the FDA’s not-so-rare break­through ther­a­py des­ig­na­tion.

To­day, though, af­ter the biotech re­viewed plans for an up­com­ing Phase III pro­gram, they fol­lowed up with the rare news that the FDA is drop­ping the BTD af­ter reg­u­la­tors con­clud­ed that they couldn’t fig­ure out why the drug arm ex­pe­ri­enced a high­er rate of deaths in their Phase IIb tri­al.

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