Catalyst (CPRX) Eyes Firdapse Label Expansion Amid Competition


We issued an updated research report on Catalyst Pharmaceuticals Inc. CPRX on Sep 7, 2020. Catalyst’s share price has declined 17.9% compared with the industry’s decline of 9% in the year so far.

The company’s lead drug Firdapse is approved for the treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) in adults. During the second quarter, the company saw an improvement in new LEMS patient enrolments. The company remains optimistic about this and expects the trend to continue and Firdapse sales to rise.

The company estimates approximately 3,000 LEMS patients in the United States. The market therefore represents potential. Currently, drugs and treatments like steroids, azathioprine, other immune suppressants and intravenous immunoglobulin are currently used for this ultra-rare disease.

The company is also working on developing Firdapse for additional indications. Catalyst initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG in February 2016. The company reported top-line results from the phase III study on Firdapse in anti-MuSK antibody positive myasthenia gravis patients in August 2020. The company plans to complete the full analysis of data and findings of the study and meet its neuromuscular advisors to decide the path forward for the MuSK-MG indication.

Firdapse is also being evaluated in a proof-of-concept study for the treatment of spinal muscular atrophy (SMA) type 3 patients. Top-line results from this study are expected before the end of 2020.Investigator studies for two additional neuromuscular indications are expected to commence later in 2020.

Catalyst is working on a generic version of Lundbeck’s Sabril (vigabatrin), CPP-109, which is marketed for the treatment of infantile spasms and complex partial seizures.

However, Catalyst has a limited number of candidates in its pipeline. The company is highly dependent on its only approved drug, Firdapse for growth, which is a concern. Also, Jacobus Pharmaceutical Co's drug, Ruzurgi, is approved by the FDA for the treatment of LEMS in pediatric patients (aged six to below 17 years) and this is a threat to the company’s drug Firdapse.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Bio Techne Corp TECH and Alimera Sciences Inc. ALIM. While Emergent and Bio Techne sport a Zacks Rank #1 (Strong Buy), Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $3.45 to $6.32 for 2020 and from $4.31 to $7.01 for 2021 over the past 60 days. Shares of the company have increased 94.2% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.58 for 2020 and from $6.41 to $6.45 for 2021 over the past 60 days. Shares of the company have increased 12.1% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 24.1% year to date.

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