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Catalyst Pharma (CPRX): What???s in Store in Q4 Earnings?
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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) is expected to report fourth-quarter 2016 results this month. Last quarter, the company recorded a positive earnings surprise of 16.67%. The company beat expectations in all of the last four quarters with average positive earnings surprise of 10.42%.
Catalyst’s share price has increased 7.6% year to date, in line with the Zacks classified Medical Drugs industry gain.
Let’s see how things are shaping up for this announcement.
Factors to Consider
Given that Catalyst does not have any revenue-generating product in its portfolio yet, investor focus will remain on pipeline and regulatory updates. At present, Catalyst has three candidates under development – Firdapse, CPP-115 and CPP-109.
Its lead pipeline candidate Firdapse is being evaluated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). However, the company was handed a “refusal-to-file” letter from the FDA in Feb 2016 in connection with its New Drug Application (NDA) for the product. The agency determined that the company’s NDA was insufficient after a preliminary review.
In June, Catalyst reached an agreement with the FDA for a confirmatory phase III study protocol on Firdapse. In October, Catalyst received a Special Protocol Assessment (SPA) from the FDA on the protocol of the confirmatory phase III study. It was determined that the confirmatory study will have the same co-primary endpoints as Catalyst's first phase III trial evaluating Firdapse for the treatment of LEMS and not a cross-over design as management previously expected. Catalyst is also working on developing Firdapse for additional indications. The company is evaluating it for the treatment of certain types of congenital myasthenic syndromes (CMS) and for a specific type of myasthenia gravis (MG). The company initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG (MuSK-MG) in Feb 2016 and top-line results from this study are expected in first half of 2017. Positive data would allow the company to add the CMS indication to Firdapse’s label (either as part of the NDA resubmission for Firdapse for LEMS or as a supplement to the resubmission).
Apart from Firdapse, the company is looking to develop CPP-115 for the treatment of epilepsy (initially infantile spasms), and other selected neurological indications such as complex partial seizures and Tourette’s disorder. Catalyst is also working on a generic version of Sabril (vigabatrin), which is marketed by Lundbeck, for the treatment of infantile spasms and complex partial seizures.
Consequently, its R&D spending is expected to go up due to clinical development efforts taken toward Firdapse in the pediatric CMS population and MuSK-MG.
Earnings Whispers
Our proven model does not conclusively show that Catalystis likely to beat the Zacks Consensus Estimate this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) for this to happen. That is not the case here, as you will see below.
Zacks ESP: The Earnings ESP is 0.00% as both the Most Accurate estimate as well as the Zacks Consensus Estimate are pegged at a loss of 7 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Catalyst’s Zacks Rank #3 increases the predictive power of ESP. However, we need to have a positive ESP to be confident about an earnings beat.
We caution against Sell-rated stocks (Zacks Rank #4 or 5) going into the earnings announcement, especially when the company is seeing negative estimate revisions.
Stocks to Consider
Here are some companies to consider as our model shows that they have the right combination of elements to post an earnings beat in the upcoming quarter:
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017? Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>
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Catalyst Pharma (CPRX): What???s in Store in Q4 Earnings?
Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) is expected to report fourth-quarter 2016 results this month. Last quarter, the company recorded a positive earnings surprise of 16.67%. The company beat expectations in all of the last four quarters with average positive earnings surprise of 10.42%.
Catalyst’s share price has increased 7.6% year to date, in line with the Zacks classified Medical Drugs industry gain.
Let’s see how things are shaping up for this announcement.
Factors to Consider
Given that Catalyst does not have any revenue-generating product in its portfolio yet, investor focus will remain on pipeline and regulatory updates. At present, Catalyst has three candidates under development – Firdapse, CPP-115 and CPP-109.
Its lead pipeline candidate Firdapse is being evaluated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). However, the company was handed a “refusal-to-file” letter from the FDA in Feb 2016 in connection with its New Drug Application (NDA) for the product. The agency determined that the company’s NDA was insufficient after a preliminary review.
In June, Catalyst reached an agreement with the FDA for a confirmatory phase III study protocol on Firdapse. In October, Catalyst received a Special Protocol Assessment (SPA) from the FDA on the protocol of the confirmatory phase III study. It was determined that the confirmatory study will have the same co-primary endpoints as Catalyst's first phase III trial evaluating Firdapse for the treatment of LEMS and not a cross-over design as management previously expected. Catalyst is also working on developing Firdapse for additional indications. The company is evaluating it for the treatment of certain types of congenital myasthenic syndromes (CMS) and for a specific type of myasthenia gravis (MG). The company initiated an investigator-sponsored phase II/III study on Firdapse for the symptomatic treatment of MuSK-antibody positive MG (MuSK-MG) in Feb 2016 and top-line results from this study are expected in first half of 2017. Positive data would allow the company to add the CMS indication to Firdapse’s label (either as part of the NDA resubmission for Firdapse for LEMS or as a supplement to the resubmission).
Apart from Firdapse, the company is looking to develop CPP-115 for the treatment of epilepsy (initially infantile spasms), and other selected neurological indications such as complex partial seizures and Tourette’s disorder. Catalyst is also working on a generic version of Sabril (vigabatrin), which is marketed by Lundbeck, for the treatment of infantile spasms and complex partial seizures.
Consequently, its R&D spending is expected to go up due to clinical development efforts taken toward Firdapse in the pediatric CMS population and MuSK-MG.
Earnings Whispers
Our proven model does not conclusively show that Catalystis likely to beat the Zacks Consensus Estimate this quarter. That is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) for this to happen. That is not the case here, as you will see below.
Zacks ESP: The Earnings ESP is 0.00% as both the Most Accurate estimate as well as the Zacks Consensus Estimate are pegged at a loss of 7 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Catalyst’s Zacks Rank #3 increases the predictive power of ESP. However, we need to have a positive ESP to be confident about an earnings beat.
We caution against Sell-rated stocks (Zacks Rank #4 or 5) going into the earnings announcement, especially when the company is seeing negative estimate revisions.
Stocks to Consider
Here are some companies to consider as our model shows that they have the right combination of elements to post an earnings beat in the upcoming quarter:
Achillion Pharmaceuticals, Inc. has an Earnings ESP of +50% and a Zacks Rank #3. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
BioMarin Pharmaceutical Inc. (BMRN - Free Report) has an Earnings ESP of +3.13% and a Zacks Rank #3.
Bristol-Myers Squibb Company (BMY - Free Report) has an Earnings ESP of +5.41% and a Zacks Rank #3.
Catalyst Pharmaceuticals, Inc. Price and EPS Surprise
Catalyst Pharmaceuticals, Inc. Price and EPS Surprise | Catalyst Pharmaceuticals, Inc. Quote
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017? Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>