Tonix jumps on re­jigged phase III for PTSD drug; MeiraGTx scores an­oth­er NIH deal; Op­Gen, Qi­a­gen join hands to de­tect su­per­bugs

→ Af­ter a Phase III tri­al test­ing its PTSD drug, Ton­mya, in­volv­ing pa­tients that suf­fered trau­ma dur­ing mil­i­tary ser­vice since 2001, was pre­ma­ture­ly halt­ed fol­low­ing a fu­til­i­ty analy­sis, Tonix Phar­ma $TXNP went to the FDA armed with a sub­group analy­sis that showed pa­tients with fresh­er trau­ma had ben­e­fit­ted from the drug. On Wednes­day, the com­pa­ny said it had con­vinced the US health reg­u­la­tor to give it an­oth­er shot with a new late-stage study in this cat­e­go­ry of pa­tients, as well as those that have ex­pe­ri­enced civil­ian trau­ma. Tonix has al­so changed the tri­al’s goal­posts, say­ing it will de­ter­mine whether the pri­ma­ry end­point has been met at week 4, ver­sus week 12. Shares of tiny Tonix, whose break­through ther­a­py Ton­mya has en­dured mul­ti­ple tri­al set­backs, jumped about 22% on the an­nounce­ment. CEO Seth Le­d­er­man re­mains bull­ish about drug’s prospects, but told End­points News that he will need to raise more cap­i­tal to take the drug to the fin­ish line.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER