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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