Catalyst boosted as 'breakthrough' PhIII drug clears safety hurdle

Shares of Catalyst Pharmaceutical Partners ($CPRX) got a boost from the news that its late-stage drug Firdapse had passed a cardio safety test. BioMarin ($BMRN), which won a European approval for Firdapse and licensed out U.S. rights to Catalyst, conducted the study. Firdapse won the FDA's coveted "breakthrough" designation last year and is being developed as a treatment for rare cases of Lambert-Eaton myasthenic syndrome, which is characterized by muscle weakness. Coral Gables, FL-based Catalyst is small by any standard, but its market cap has doubled based on the prospects of Firdapse. Release

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.