Seth Lederman, Tonix Pharmaceuticals CEO

Small, strug­gling biotech winds up with a 3X los­er as an­oth­er PhI­II of its lead drug col­laps­es

Lit­tle Tonix Phar­ma­ceu­ti­cals has run in­to an­oth­er brick wall as its lead drug — a re­for­mu­lat­ed mus­cle re­lax­ant orig­i­nal­ly ap­proved 44 years ago — has failed an­oth­er Phase III study, send­ing shares back in­to pen­ny stock ter­ri­to­ry.

Three years af­ter go­ing down in their first Phase III tri­al of TNX-102 SL (cy­cloben­za­prine HCl sub­lin­gual tablets) for symp­toms of PTSD, the biotech — which had been en­cour­aged by a break­through des­ig­na­tion at the FDA — re­port­ed late Fri­day the drug al­so failed its sec­ond late-stage chal­lenge for pain as­so­ci­at­ed with fi­bromyal­gia. Out­side da­ta mon­i­tors rec­om­mend­ed the Phase III tri­al be halt­ed for fu­til­i­ty af­ter de­cid­ing in­ter­im da­ta made it un­like­ly the drug would pass muster.

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