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January 6, 2014
08:15 EDTCPRXCatalyst reports successful completion of Type B therapy meeting with FDA
Catalyst Pharmaceutical announced the successful completion of a Type B meeting with the FDA about Firdapse tablets, its lead product being evaluated for the treatment of Lambert Eaton Myasthenic Syndrome, or LEMS. Catalyst provided FDA with an update on the development program for Firdapse, which received Breakthrough Therapy designation from the FDA in August 2013. The company also confirmed with FDA the clinical, nonclinical, and chemistry and manufacturing controls requirements that FDA will require to approve a New Drug Application for Firdapse. This Type B meeting with the FDA was Catalyst's first meeting as the sponsor of the IND for Firdapse. Catalyst will file rolling submissions of the NDA modules as completed in anticipation of receiving a priority review of its NDA for Firdapse. The Company provided a briefing package to the FDA that described all completed, in-progress, and planned preclinical studies, clinical studies, and drug manufacturing activities. This package included summaries of 54 preclinical studies, six clinical studies, and information related to drug manufacturing. The FDA concurred that the Company's completed, in-progress, and planned development activities represented a nearly complete package of information that would be needed for a complete NDA.
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September 16, 2014
09:00 EDTCPRXCatalyst Pharmaceutical price target raised to $5 from $3.50 at Roth Capital
Roth Capital increased its price target on Catalyst to reflect what it sees as greater pricing power opportunities for Firdapse and the re-entry of CPP-115 into the clinic. Evaluating the potential outcome of a Phase 3 trial of Firdapse expected at the end of this month, the firm says the decision by all patients enrolled to continue treatment in the 2-year open label part of the trial is positive. However, Roth warns that the data poses a binary risk to the stock. It keeps a Buy rating on the shares. .
September 15, 2014
08:32 EDTCPRXCatalyst Pharmaceutical price target raised to $13 from $5 at H.C. Wainwright
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