Good News for Catalyst Pharma - Analyst Blog

By
A A A

The independent Data Monitoring Committee (DMC) has recommended the continuation of Catalyst Pharmaceutical Partners, Inc. 's ( CPRX ) phase III study (n=36) on Firdapse. The randomized, double-blind, placebo-controlled, discontinuation study is evaluating Firdapse for the treatment of patients suffering from Lambert-Eaton myasthenic syndrome (LEMS).

The committee's recommendation comes after reviewing the safety and clinical data from the study. Catalyst Pharma acquired the marketing rights to Firdapse from BioMarin Pharmaceutical Inc. ( BMRN ) in Oct 2012 in the U.S., as per which the former is responsible for the above-mentioned phase III study.

In 2013, the U.S. Food and Drug Administration (FDA) granted 'Breakthrough Therapy' designation to Firdapse for the LEMS indication. The designation should help to speed up the development and review process of the candidate. Catalyst Pharma is leaving no stone unturned to ensure the successful completion of this phase III study.

Catalyst Pharma expects to complete enrolling patients for the study shortly. Top-line data from the study's double-blind portion is anticipated in the third quarter of 2014. The company expects to seek FDA approval for Firdapse in the LEMS indication next year. We expect investor focus to remain on updates relating to the Firdapse development program.

Catalyst Pharma mentioned in its press release that Firdapse is the first and only approved drug in the EU for symptomatic treatment in adults suffering from LEMS. The drug is available in the EU since 2010 and is marketed there by BioMarin. Apart from Firdapse, Catalyst Pharma also has CPP-115 in its pipeline, being developed for multiple indications including infantile spasms and epilepsy.

Catalyst Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector include Questcor Pharmaceuticals ( QCOR ) and Shire ( SHPG ). Both stocks hold a Zacks Rank #1 (Strong Buy).



BIOMARIN PHARMA (BMRN): Free Stock Analysis Report

CATALYST PHARMA (CPRX): Free Stock Analysis Report

QUESTCOR PHARMA (QCOR): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research




The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: BMRN , CPRX , QCOR , SHPG

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

100,376,898
  • $17.62 ▲ 0.51%
83,231,837
  • $25.62 ▲ 1.91%
75,739,329
  • $111.78 ▼ 0.77%
65,297,937
  • $36.37 ▼ 1.76%
59,053,093
  • $47.66 ▲ 0.29%
53,482,350
  • $2.59 ▼ 0.38%
51,504,284
  • $7.34 ▲ 2.37%
51,434,656
  • $8.14 ▲ 6.96%
As of 12/19/2014, 04:15 PM


Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com