SteadyMed shares slammed as FDA toss­es its NDA for PAH drug-de­vice

When SteadyMed $STDY out­lined its IPO plans in ear­ly 2015, the biotech as­sured would-be in­vestors that it could be ready to file an ap­pli­ca­tion for its drug-de­vice ther­a­peu­tic Trevyent a year lat­er.

Things haven’t worked out as planned for the biotech, though. The NDA ar­rived at the agency in June of this year, and has now been hand­ed back as in­com­plete.

This morn­ing the biotech re­port­ed that the FDA has is­sued a refuse-to-file let­ter on Trevyent — the FDA’s sec­ond RTF this week — which us­es a pump to de­liv­er a re­for­mu­lat­ed ver­sion of Unit­ed Ther­a­peu­tics’ main­stay drug Re­mod­ulin for pul­monary ar­te­r­i­al hy­per­ten­sion.

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