Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) reported a loss of 5 cents per share in the second quarter of 2017, narrower than both the Zacks Consensus Estimate as well as the year ago loss of 6 cents.
Being a development-stage company, Catalyst Pharma does not have any approved product in its portfolio yet. Hence, the company did not generate any revenues in the quarter.
The shares of the company increased 3.4% following the release. Catalyst Pharma’s share price has increased 183.8% year to date, compared with the Zacks classified industry’s loss of 1.8%.
Quarter in Detail
Research and development (R&D) expenses were $2.5 million, down 2.3% from the year-ago quarter. The decline was due to lower costs for regulatory consulting, drug product manufacturing and clinical and pre-clinical activities.
General and administrative expenses were $1.7 million, down 25%. The decline was primarily due to lower employee costs following a reduction in headcount, and a decrease in recruiting expenses as well as consulting costs for pre-commercialization activities.
At present, Catalyst Pharma has two candidates under development – Firdapse and CPP-115.
The company expects to report top-line results from its second phase III study of Firdapse for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in the second half of 2017 and resubmit a new drug application (NDA) before the end of 2017. Earlier in 2016, the company received a refusal to file letter from the FDA in connection with the NDA for Firdapse.
The agency had determined that the company’s NDA was insufficient after a preliminary review. Consequently, the company was required to conduct additional studies as per the agency’s requirements, in addition to the results of its previously submitted phase III data.
In Oct 2016, the company reached an agreement with the FDA under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in its second phase III study evaluating Firdapse.
Additionally, it expects to launch Firdapse in 2018, if it is successful in obtaining the FDA’s approval to commercialize the product. Also, Catalyst Pharma is developing Firdapse for other indications, including congenital myasthenic syndromes and MuSK antibody positive myasthenia gravis (MuSK-MG).
Furthermore, Catalyst Pharma is working on developing a generic version of Lundbeck Inc.’s Sabril (vigabatrin) which is used for the treatment of seizures. The company is also continuing its efforts to seek a partner for the development of CPP-115 and for the generic version of Sabril.
Zacks Rank & Stocks to Consider
Catalyst Pharma currently carries a Zacks Rank #3 (Hold). Better-ranked pharma stocks in the same space include Aduro BioTech, Inc. (ADRO - Free Report) , Enzo Biochem, Inc. and Sanofi (SNY - Free Report) sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 61.1% year to date.
Sanofi’s earnings per share estimates increased from $3.18 to $3.31 for 2017 and from $3.30 to $3.38 for 2018, over last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 18.1% year to date.
Aduro BioTech, Inc.’s loss per share estimates narrowed from $1.46 to $1.36 for 2017 and from $1.54 to $1.26 for 2018, over the last 30 days. The company pulled off positive earnings surprise in two of the trailing four quarters, with an average beat of 2.53%. The share price of the company has increased 6.5% year to date.
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