Catalyst Pharmaceuticals Announces First Quarter 2016 Financial Results And Provides Corporate Update
CORAL GABLES, Fla., May 10, 2016 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today reported financial results for the first quarter ended March 31, 2016.
“This past quarter has been very challenging, as we were very disappointed by the receipt of the refusal to file letter from the U.S. Food and Drug Administration (FDA) for the Firdapse® new drug application (NDA),” said Patrick J. McEnany, Chief Executive Officer of Catalyst. “While we are frustrated by the delay, our focus remains to provide the FDA with the additional studies required to file our NDA for review and to hopefully ensure that all LEMS patients have access to an FDA approved safe and effective therapy. We are currently engaged in dialogue with the FDA with regard to logistics required for our path forward and will provide an update once we have more clarity.”
“This past quarter has been very challenging, as we were very disappointed by the receipt of the refusal to file letter from the U.S. Food and Drug Administration (FDA) for the Firdapse® new drug application (NDA),” said Patrick J. McEnany, Chief Executive Officer of Catalyst. “While we are frustrated by the delay, our focus remains to provide the FDA with the additional studies required to file our NDA for review and to hopefully ensure that all LEMS patients have access to an FDA approved safe and effective therapy. We are currently engaged in dialogue with the FDA with regard to logistics required for our path forward and will provide an update once we have more clarity.”