We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Catalyst (CPRX) Up on New Drug Application for Firdapse
Read MoreHide Full Article
Shares of Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) have moved up 10.1% in the past one week, against theindustry’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. (BMRN - Free Report) 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”).
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.
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.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
Image: Bigstock
Catalyst (CPRX) Up on New Drug Application for Firdapse
Shares of Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) have moved up 10.1% in the past one week, against the industry’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. (BMRN - Free Report) 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”).
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.
Catalyst Pharmaceuticals, Inc. Price
Catalyst Pharmaceuticals, Inc. Price | Catalyst Pharmaceuticals, Inc. Quote
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 (REGN - Free Report) , and Ligand Pharmaceuticals (LGND - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>