Catalyst (CPRX) Up On New Drug Application For Firdapse
Zacks Investment Research | Apr 05, 2018 03:36AM ET
Shares of Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) have moved up 10.1% in the past one week, against the ’s decline of 0.4%. The rise in share price is due to the filling of a new drug application (“NDA”) by the company for itslead pipeline candidate Firdapse. Shares of the company rose 16.4% yesterday.
Firdapse has been developed for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (“LEMS”). The NDA submission addressed the two issues raised in the 2016 Refusal to File letter during the previous Firdapse NDA submission and included all additional information requested by the FDA.
Firdapse is currently approved in the EU for the symptomatic treatment of LEMS in adults. However, the drug is not yet approved in the United States. In January 2017, it held a Type C meeting with the FDA wherein Catalyst was advised, based on the briefing documents, that the company’s proposed NDA should be sufficient for resubmission. In November 2017, the company announced positive top-line results from its second phase III study of Firdapse in patients with LEMS.
Catalyst also announced its decision not to include in this FDA submission those limited types of congenital myasthenic syndromes (“CMS”) that are considered mechanistically similar to LEMS. Catalyst decided not to overcomplicate the review of its NDA submission for LEMS with this second indication.
The company is currently conducting a phase III study evaluating Firdapse for the treatment of CMS and expects to complete enrollment before the end of 2018 and report top-line results from this study in the first quarter of 2019. If the results of the trial are successful, the company plans to add the CMS indication to its labeling for Firdapse.
Shares of the company have been moving up the chart after this data readout.
Catalyst had in-licensed rights to Firdapse from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) in 2012 for the development and commercialization of the product in the United States. Also, Firdapse enjoys Orphan Drug and Breakthrough Therapy status in the United States for the treatment of LEMS. Firdapse received Orphan Drug status in the United States for the treatment of congenital myasthenic syndromes (“CMS”) and myasthenia gravis (“MG”).
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LEMS is an ultra-rare disease and though several drugs and treatments therapies like steroids, azathioprine, other immunosuppressants and intravenous immunoglobulin are currently in use. Guanidine HCl tablets are approved for the treatment of LEMS. However, due to significant side effects, the drug is not viewed as an effective treatment. This, in turn, has created ample space for introducing new therapies for LEMS.
Therefore, approval of Firdapse in these indications will be a huge boost for the company given its commercial potential in the target markets.
Stocks That Warrant a Look
Catalyst Pharma cararies a Zacks Rank #3 (Hold).
A few stocks from the same space worth looking at are Regeneron Pharmaceuticals (NASDAQ:REGN) , and Ligand Pharmaceuticals (NASDAQ:LGND) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see .
Regeneron’s earnings per share estimates have moved up from $18.67 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 53.6% over a year.
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