Catalyst Pharmaceuticals Announces Plans to Resubmit New Drug Application for Firdapse

Catalyst Pharmaceuticals (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the results of its recent Type C meeting with the U.S. Food and Drug Administration.

As quoted in the press release:

“We remain on track to resubmit our NDA for Firdapse in the first quarter of this year,” stated Patrick J. McEnany, President and CEO of Catalyst Pharmaceuticals. “Based on our discussions with the FDA, we believe that we have a clear regulatory pathway forward, and we will continue to work collaboratively with the FDA as we seek to bring FDA approved therapies forward for the treatment of LEMS and CMS.”

Click here to read the full press release.