Catalyst Focuses on Firdapse Label Expansion Amid Competition

We issued an updated report on Catalyst Pharmaceuticals Inc. CPRX on Nov 28.

In November 2018, the company’s Firdapse tablets obtained FDA approval for the treatment of LEMS in adults. Firdapse became the first FDA-approved treatment for LEMS. It is the first approved product for Catalyst, boosting the company’s growth prospects. The drug was launched in January and the uptake has been strong since launch.

Shares of the company have surged 133.3% year to date compared with the industry’s growth of 11.2%.

The company is also working on developing Firdapse for additional indications. Catalyst initiated an investigator-sponsored phase II/III study on the drug for the symptomatic treatment of MuSK-antibody positive MG in February 2016. In April 2018, the company enrolled the first patient in its phase III study for MuSK-antibody positive myasthenia gravis. The company expects to report top-line results from the study in the first half of 2020.

The company announced top-line results from the CMS-001 phase III study of Firdapse in CMS. It expects to meet the FDA before the end of 2019 to discuss the study outcome and the path forward.

Additionally, Catalyst’s efforts to develop the drug for other rare neuromuscular indications are impressive. The label expansion of the drug should boost sales for the company.

Catalyst has an early-stage candidate, CPP-115, in its pipeline. It is developing CPP-115 (a GABA aminotransferase inhibitor) for the treatment of epilepsy (initially infantile spasms) and the treatment of other selected neurological indications such as complex partial seizures and Tourette’s disorder.

However, Catalyst has a limited number of candidates in its pipeline and is highly dependent on its only-approved drug Firdapse for growth, which is a concern. The drug also faces competition from other companies.

Zacks Rank & Stocks to Consider

Catalyst currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks in the same space are Adherex Technologoes Inc. FENC Ironwood Pharmaceuticals Inc. IRWD and Jazz Pharmaceuticals Plc. JAZZ, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Adherex’s loss per share estimates have narrowed from 85 cents to 67 cents for 2019 in the past 60 days.

Ironwood’s earnings per share estimates have increased from 52 cents to 78 cents for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 135.01%, on average.

Jazz’s earnings per share estimates have increased from $14.99 to $15.81 for 2019 and from $17.03 to $17.51 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 16.49%, on average.

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