Catalyst (CPRX) Reports Positive Phase III Data On Firdapse

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) announced positive top-line results from a second phase III study of Firdapse. As the lead pipeline candidate of the company, Firdapse is being developed for the treatment of Lambert-Eaton myasthenic syndrome (LEMS).

The study achieved statistical significance for both its co-primary endpoints — quantitative myasthenia gravis score (QMG) and subject global impression (SGI) — and secondary endpoint. For the QMG endpoint, the data showed a clinically significant difference of 6.4 points between the Firdapse and placebo groups

The top-line results showed that Firdapse has a significant magnitude of effect for treating the symptoms of LEMS. Additionally, it was well tolerated in the study and showed a similar safety profile as seen in the earlier studies.

The company presented detailed results from the first phase III trial of Firdapse last year. The study also met its co primary and secondary endpoints.

So far this year, Catalyst Pharma’s shares have outperformed the industry. The stock has surged 243.8% compared with the industry’s gain of 3.2%. The company’s shares were up more than 3% on Monday, November 27, following the announcement of positive data read out. It is however important for the investors to note that the shares of the company were down by about 8% in after-hours trading on Monday as the company announced a 11 million share offering.

The company remains on track to submit a new drug application (NDA) to the FDA in the first quarter of 2018.

Catalyst had inlicensed development and commercialization rights to Firdapse in the United States from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) . Currently, the candidate is approved in the EU for the symptomatic treatment of LEMS in adults. It also enjoys Orphan Drug and Breakthrough Therapy status in the United States for the treatment of LEMS.

Also, the company is working on the development of Firdapse for additional indications. It expects to initiate phase III study for the treatment of MuSK- myasthenia gravis (MG) in the first quarter of 2018.

Earlier, Catalyst had initiated a small blinded study on Firdapse for the treatment of certain types of congenital myasthenic syndromes (CMS)- an inherited neuromuscular disorderin both pediatric population(2-17 years) as well as in adults. Top-line data from the study are expected in the first half of 2018. Positive data would allow Catalyst to add the CMS indication to Firdapse’s label either as part of the NDA resubmission for Firdapse to treat LEMS or as a supplement to the resubmission.

The company’s efforts to develop Firdapse appear encouraging, given its significant commercial potential. An approval for the same is likely to be a huge growth driver for Catalyst.

Zacks Rank & Stocks to Consider

Catalyst carries a Zacks Rank #3 (Hold). Some better-ranked health care stocks in the same space are Sucampo Pharmaceuticals (NASDAQ:SCMP) and Ligand Pharmaceuticals (NASDAQ:LGND) . While Sucampo sports a Zacks Rank #1 (Strong Buy), Ligand holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have moved up from $1.01 to $1.12 for 2017 and from $1.06 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.

Ligand’s earnings per share estimates have climbed $3.68 to $3.70 for 2018 over the last 60 days. The company pulled off a positive earnings surprise in two of the trailing four quarters, with an average beat of 8.22%. The share price of the company has increased 28.1% year to date.

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