Why Is Catalyst Pharmaceuticals' Stock Up 160% This Year?
Zacks Investment Research | Jun 27, 2017 10:18PM ET
Shares of Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) have soared 161% this year so far, massively outperforming the Zacks classified Medical Drugs industry’s gain of 8%. Here we analyze the factors that led to the rally.
Catalyst Pharma’s key drug Firdapse is currently approved in the EU for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS), in adults. However, the drug is not yet approved in the U.S. However, Catalyst Pharma has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for its second phase III study on Firdapse for the treatment of LEMS. Positive data would allow the company to resubmit the regulatory application for Firdapse in the second half of 2017.
In Mar 2017, the company announced positive top-line results from the study assessing Firdapse for another indication - myasthenia gravis patients who are MuSK antibody positive (MuSK-MG). Data from the study showed statistically significant results and showed a large clinical benefit to patients. Both of the co-primary efficacy endpoints of change from baseline (CFB) in total Quantitative Myasthenia Gravis (QMG) score (p=0.0003) and CFB in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score (p=0.0006) were statistically and clinically significant in the seven patient trial.
Shares of the company have been consistently rising 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 U.S.. Also, Firdapse enjoys Orphan Drug and Breakthrough Therapy status in the U.S. for the treatment of LEMS. Firdapse received Orphan Drug status in the U.S. for the treatment of congenital myasthenic syndromes (CMS) and for the treatment of myasthenia gravis (MG) as well.
Also, it expects top-line results from LEMS and congenital myasthenic syndromes (CMS) studies on Firdapse, and looks forward to submit the new drug application (NDA) for the same in the second half of this year.
It is to be noted that LEMS is an ultra-rare disease, and therefore its market represents significant potential even though drugs and treatments like steroids, azathioprine, other immunosuppressants and intravenous immunoglobulin are currently in use. Additionally, 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.
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Also, CMS is an ultra-rare disease with a prevalence of between 1,000 and 1,500 in the U.S. Moreover, approximately 5% to 8% of the MG patient population is estimated to be MuSK antibody-positive.
Therefore, approval of Firdapse in these indications will be a huge boost for the company given its commercial potential in the target markets.
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