Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Catalyst Will Try To Salvage Rare Disease Drug from Failed Phase III Trial

Executive Summary

Despite a Phase III study that found no statistically significant outcomes for its endpoints for Firdapse, Catalyst will seek FDA approval for treating a subgroup of patients who showed improvement

You may also be interested in...



Keeping Track: Intercept Submits OCA For NASH; Zogenix’ Fintepla Returns; US FDA Approves Bavarian Nordic Vaccine

The latest drug development news and highlights from our US FDA Performance Tracker

Catalyst Alleges US FDA 'Facilitating' Off-Label Use With Jacobus' Ruzurgi Approval

Lawsuit seeking invalidation of rare disease treatment's approval in Lambert-Eaton myasthenic syndrome encompasses policy trifecta of exclusivity, drug pricing, and expanded access issues.

Catalyst Collapses On FDA Firdapse Refusal

Investors hit Catalyst Pharmaceuticals Inc. hard on Feb. 17, driving shares down 50%, after the company disclosed the FDA refused to file (RTF) the Florida firm's new drug application (NDA) for Firdapse (amifampridine phosphate), a 3,4-diaminopyridine phosphate, as a symptomatic treatment for two very rare neuromuscular diseases – Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134409

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel