Phase III Data Support Catalyst's NDA Resubmission For Firdapse
Catalyst executives note that the company has completed everything the FDA requested to support resubmission of Firdapse for its first two rare disease indications – a second Phase III study in LEMS and abuse liability studies.
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Public Company Edition: IGM raised $175m to advance its IgM antibodies and Henlius brought in $410m for its novel drug and biosimilar platforms. Also, Acadia follow-on brings in $250m, PTC sells $350m worth of stock and debt, and Karyopharm royalty deal totals $150m.
If companies meet their publicly stated NDA filing targets, at least four breakthrough-designated therapies will arrive at US FDA in March.
Keeping Track: FDA Approves Novel HIV Treatment, New Dosing Regimen For Opdivo; Another Rare Pediatric Disease Designation For Prometic
The latest drug development news and highlights from our US FDA Performance Tracker.