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FDA approves of Catalyst’s phase III study protocol

Published: 00:57 14 Jun 2016 AEST

test tubes in a laboratory
Catalyst has agreed the design of the phase III trials for its Firdapse drug

Shares in Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) ticked higher on an agreement with the US Food and Drug Administration (FDA) for the framework of phase III trials for drug Firdapse.

Firdapse is a treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare disorder that causes muscle weakness.

“We are pleased to have the FDA’s agreement on the design of the protocol for our second phase III trial evaluating Firdapse for the treatment of LEMS,” said chief executive Patrick McEnany.

The company added that it had enough cash to get to an approved drug submission without the need for additional financing.

It is a change of fortune for the company that only a few months ago received a ‘Refusal to File’ letter from the FDA, after it said Catalyst had not sufficiently completed the original new drug application (NDA).

Shares were up 9c, or 14%, to US$0.71.

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