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Catalyst (CPRX) Skyrockets 110% Over a Year: Here's Why
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Catalyst Pharmaceuticals’ (CPRX - Free Report) shares have surged 111.1% in the past year against the industry’s 31.1% decline.
Image Source: Zacks Investment Research
The stock price rise is primarily attributable to Firdapse, the first drug in CPRX’s portfolio to receive approval. The drug received FDA approval in November 2018 for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients.
Firdapse is currently the only approved treatment of LEMS in adults in the United States. Since its commercial launch in 2019, the drug has shown a rapid uptake in sales. The drug recorded sales of $102 million in the year of its launch. Since then, sales have been rising steadily year over year, driven by solid patient persistency and new patient enrollments. The company’s product sales from Firdapse rose 16% year over year to $141 million in 2020.
While the CPRX is scheduled to report fourth-quarter and full-year 2021 results on Mar 16, it announced preliminary total revenues of $141 million from Firdapse product sales for 2021, suggesting 18% year-over-year growth. For 2022, the company expects total revenues in the range of $195-$205 million, suggesting a 38-45% increase from 2021.
Firdapse enjoys a Breakthrough Therapy status and an Orphan Drug status from the FDA for the treatment of LEMS.
CPRX achieved a major milestone in September 2021, when it received a positive decision from the Appeals Court, which supported the orphan drug designation for Firdapse granted by the FDA for LEMS. The FDA had previously approved Jacobus Pharmaceutical Company's drug, Ruzurgi, to treat LEMS in pediatric patients violating the orphan drug designation granted to Firdapse. The Appeals Court has also denied Jacobus’ petition for rehearing its ruling and issued a mandate to the District Court to grant summary judgment in the company’s favor. The District Court granted summary judgment last month, thereby making the FDA’s approval to Ruzurgi in LEMS invalid.
Catalyst Pharmaceuticals is also pursuing label expansion studies for Firdapse. The company plans to file a supplemental new drug application for Firdapse to treat pediatric patients with LEMS in first-quarter 2022.
It has also been focused on gaining approvals for Firdapse in markets outside the United States. In June 2021, CPRX entered into an exclusive license and supply agreement with DyDo Pharma to develop/commercialize Firdapse for the treatment of LEMS in Japan. The drug has already received an Orphan Drug designation in the country for the said indication.
Presently, Catalyst is solely dependent on Firdapse for revenues. The company’s pipeline also lacks any other promising candidate, which is a woe. Nonetheless, CPRX is looking to expand its pipeline beyond Firdapse, either by acquisitions or by in-licensing rights of products or companies.
Catalyst Pharmaceuticals currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the overall healthcare sector include BioDelivery Sciences , Collegium Pharmaceutical (COLL - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Collegium Pharmaceutical sports a Zacks Rank #1 (Strong Buy), BioDelivery Sciences and Vertex Pharmaceuticals each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.76 in the past 30 days. The same for 2023 has risen from $4.79 to $7.96 in the past 30 days.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on a single occasion, with the average negative surprise being 57.6%.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 35 cents in the past 30 days. Shares of BDSI have surged 40.9% in the past year.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 33.7%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 11.2% in the past year.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, with the average being 10%.
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Catalyst (CPRX) Skyrockets 110% Over a Year: Here's Why
Catalyst Pharmaceuticals’ (CPRX - Free Report) shares have surged 111.1% in the past year against the industry’s 31.1% decline.
Image Source: Zacks Investment Research
The stock price rise is primarily attributable to Firdapse, the first drug in CPRX’s portfolio to receive approval. The drug received FDA approval in November 2018 for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients.
Firdapse is currently the only approved treatment of LEMS in adults in the United States. Since its commercial launch in 2019, the drug has shown a rapid uptake in sales. The drug recorded sales of $102 million in the year of its launch. Since then, sales have been rising steadily year over year, driven by solid patient persistency and new patient enrollments. The company’s product sales from Firdapse rose 16% year over year to $141 million in 2020.
While the CPRX is scheduled to report fourth-quarter and full-year 2021 results on Mar 16, it announced preliminary total revenues of $141 million from Firdapse product sales for 2021, suggesting 18% year-over-year growth. For 2022, the company expects total revenues in the range of $195-$205 million, suggesting a 38-45% increase from 2021.
Firdapse enjoys a Breakthrough Therapy status and an Orphan Drug status from the FDA for the treatment of LEMS.
CPRX achieved a major milestone in September 2021, when it received a positive decision from the Appeals Court, which supported the orphan drug designation for Firdapse granted by the FDA for LEMS. The FDA had previously approved Jacobus Pharmaceutical Company's drug, Ruzurgi, to treat LEMS in pediatric patients violating the orphan drug designation granted to Firdapse. The Appeals Court has also denied Jacobus’ petition for rehearing its ruling and issued a mandate to the District Court to grant summary judgment in the company’s favor. The District Court granted summary judgment last month, thereby making the FDA’s approval to Ruzurgi in LEMS invalid.
Catalyst Pharmaceuticals is also pursuing label expansion studies for Firdapse. The company plans to file a supplemental new drug application for Firdapse to treat pediatric patients with LEMS in first-quarter 2022.
It has also been focused on gaining approvals for Firdapse in markets outside the United States. In June 2021, CPRX entered into an exclusive license and supply agreement with DyDo Pharma to develop/commercialize Firdapse for the treatment of LEMS in Japan. The drug has already received an Orphan Drug designation in the country for the said indication.
Presently, Catalyst is solely dependent on Firdapse for revenues. The company’s pipeline also lacks any other promising candidate, which is a woe. Nonetheless, CPRX is looking to expand its pipeline beyond Firdapse, either by acquisitions or by in-licensing rights of products or companies.
Catalyst Pharmaceuticals, Inc. Price
Catalyst Pharmaceuticals, Inc. price | Catalyst Pharmaceuticals, Inc. Quote
Zacks Rank & Other Stocks to Consider
Catalyst Pharmaceuticals currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the overall healthcare sector include BioDelivery Sciences , Collegium Pharmaceutical (COLL - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Collegium Pharmaceutical sports a Zacks Rank #1 (Strong Buy), BioDelivery Sciences and Vertex Pharmaceuticals each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.76 in the past 30 days. The same for 2023 has risen from $4.79 to $7.96 in the past 30 days.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on a single occasion, with the average negative surprise being 57.6%.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 35 cents in the past 30 days. Shares of BDSI have surged 40.9% in the past year.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 33.7%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 11.2% in the past year.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, with the average being 10%.