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Catalyst Pharmaceuticals Focuses on Development of Firdapse
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We issued an updated report on Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) on May 22.
Being a development-stage company, Catalyst Pharmaceuticals does not have any approved product in its portfolio yet. Firdapse is the company’s lead candidate and currently approved in the EU for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Catalyst’s shares are up 99.1% year to date, comparing favorably with an increase of 7.1% witnessed by the Zacks classified Medical - Drugs industry.
Catalyst started enrolling patients in a second phase III study (LMS-003) on Firdapse for LEMS in Dec 2016. In fact, the company reached an agreement with the FDA under a Special Protocol Assessment (SPA) for protocol design, clinical endpoints and statistical analysis in October. Top-line data from the study is anticipated in the second half of 2017. Consequently, positive outcome from the study would allow the company to resubmit the new drug application (NDA) for Firdapse for the treatment of LEMS in the same period.
Additionally, the company is working on developing Firdapse for additional indications. It had initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG in Feb 2016. In Mar 2017, Catalyst reported top-line data from the phase II/III trial. Catalyst’s efforts to develop Firdapse appear encouraging given the significant commercial potential in its target markets. We believe an approval would give a huge boost to the company.
LEMS is an ultra-rare disease and Catalyst estimates approximately 3,000 LEMS patients in the U.S. The market, therefore, represents significant potential even though drugs and treatments like steroids, azathioprine, other immunosuppressants and intravenous immunoglobulin are in use at present. 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 anymore. As a result, this has created ample space for introducing new therapies for LEMS.
Catalyst is exploring the possibility of developing CPP-115 (a GABA aminotransferase inhibitor) for the treatment of epilepsy (initially infantile spasms) and the treatment of other selected neurological indications such as complex partial seizures and Tourette’s disorder. Nevertheless, the company is highly dependent on Firdapse for growth with a limited number of candidates in its pipeline. Thus, Firdapse’s approval is critical to its success ahead.
Catalyst Pharmaceuticals, Inc. Price and Consensus
Catalyst currently holds a Zacks Rank #2 (Buy). Some other favorably placed stocks in the health care sector are VIVUS, Inc. , MEI Pharma, Inc. (MEIP - Free Report) and Aeglea BioTherapeutics . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates have narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all the four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates have turned around from loss per share of 1 cent to gain of 1 cent per share for 2017 over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.
Aeglea’s loss per share estimates have narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company pulled off positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
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Catalyst Pharmaceuticals Focuses on Development of Firdapse
We issued an updated report on Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) on May 22.
Being a development-stage company, Catalyst Pharmaceuticals does not have any approved product in its portfolio yet. Firdapse is the company’s lead candidate and currently approved in the EU for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Catalyst’s shares are up 99.1% year to date, comparing favorably with an increase of 7.1% witnessed by the Zacks classified Medical - Drugs industry.
Catalyst started enrolling patients in a second phase III study (LMS-003) on Firdapse for LEMS in Dec 2016. In fact, the company reached an agreement with the FDA under a Special Protocol Assessment (SPA) for protocol design, clinical endpoints and statistical analysis in October. Top-line data from the study is anticipated in the second half of 2017. Consequently, positive outcome from the study would allow the company to resubmit the new drug application (NDA) for Firdapse for the treatment of LEMS in the same period.
Additionally, the company is working on developing Firdapse for additional indications. It had initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG in Feb 2016. In Mar 2017, Catalyst reported top-line data from the phase II/III trial. Catalyst’s efforts to develop Firdapse appear encouraging given the significant commercial potential in its target markets. We believe an approval would give a huge boost to the company.
LEMS is an ultra-rare disease and Catalyst estimates approximately 3,000 LEMS patients in the U.S. The market, therefore, represents significant potential even though drugs and treatments like steroids, azathioprine, other immunosuppressants and intravenous immunoglobulin are in use at present. 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 anymore. As a result, this has created ample space for introducing new therapies for LEMS.
Catalyst is exploring the possibility of developing CPP-115 (a GABA aminotransferase inhibitor) for the treatment of epilepsy (initially infantile spasms) and the treatment of other selected neurological indications such as complex partial seizures and Tourette’s disorder. Nevertheless, the company is highly dependent on Firdapse for growth with a limited number of candidates in its pipeline. Thus, Firdapse’s approval is critical to its success ahead.
Catalyst Pharmaceuticals, Inc. Price and Consensus
Catalyst Pharmaceuticals, Inc. Price and Consensus | Catalyst Pharmaceuticals, Inc. Quote
Zacks Rank and Other Key Picks
Catalyst currently holds a Zacks Rank #2 (Buy). Some other favorably placed stocks in the health care sector are VIVUS, Inc. , MEI Pharma, Inc. (MEIP - Free Report) and Aeglea BioTherapeutics . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates have narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all the four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates have turned around from loss per share of 1 cent to gain of 1 cent per share for 2017 over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.
Aeglea’s loss per share estimates have narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company pulled off positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>