Yahoo Finance Catalyst Pharmaceuticals (CPRX) Rallies 80.69% YTD: Here's Why
Catalyst Pharmaceuticals CPRX stock has skyrocketed 80.6% in the year-to-date period against the industry’s decline of 28.5%.
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The upside can be attributed to the stellar performance of its only approved drug, Firdapse.
The company recently received FDA approval for its supplemental new drug application (sNDA) for Catalyst (CPRX) price rallies on FDA approval of the sNDA of its lead drug, Firdapse, approved to treat LEMS in patients above six years of age. Firdapse (amifampridine) tablets in 10 mg dosage to include pediatric patients (six years and older) for treating Lambert-Eaton myasthenic syndrome (“LEMS”). Firdapse was previously approved in the United States for treating only adults with LEMS.
Firdapse is currently the only FDA-approved treatment option for LEMS in the United States. The drug is also approved for treating LEMS in Canada and the European Union.
LEMS is an extremely rare autoimmune disease characterized by muscle weakness of the limbs. Catalyst is presently well-positioned in the lead, with almost no competitors.
However, the limited target market can also become a concern for the company. To deal with the looming problem, Catalyst has been working consistently on expanding the global reach of Firdapse.
In June 2021, Catalyst entered into an agreement with DyDo Pharma to develop and commercialize Firdapse in Japan. DyDo initiated a phase III registrational study in Japan in December 2021 to evaluate the efficacy and safety of Firdapse 10 mg tablets for LEMS.
Catalyst also made substantial advancements to protect Firdapse’s exclusivity and commercial potential in the target market, which also boosted the company’s share prices
In this regard, we remind investors that Catalyst settled its long-term patent infringement dispute with Jacobus Pharmaceuticals and PANTHERx Rare in July 2022. The dispute has been going on since 2019 when the FDA approved Jacobus’ drug Ruzurgi (amifampridine) for treating pediatric LEMS patients. However, Catalyst contested this in a lawsuit claiming that the regulatory body’s approval for Ruzurgi violated the orphan drug status granted to Fridapse for LEMS.
Per the settlement, Catalyst obtained the rights to develop and commercialize Ruzurgi in the United States and Mexico along with other intellectual property rights. In return, the company dismissed all claims related to the litigation between the companies. Catalyst will make a cash payment to Jacobus. Jacobus is also eligible to receive low single-digit royalties on U.S. net sales of amifampridine.
In spite of all the positives, overdependence on Firdapse is a major concern for Catalyst. Catalyst also lacks any promising candidates in its pipeline, which might yet be another headwind.
Zacks Rank and Other Stocks to Consider
Catalyst currently has a Zacks Rank #2 (Buy).
Some similar-ranked stocks in the same sector are Acer Therapeutics ACER, Aerie Pharmaceuticals AERI and Soleno Therapeutics SLNO, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acer Therapeutics’ loss per share estimates for 2022 remained steady at $2.47 in the past 30 days. The same for 2023 has remained steady at $1.07 during the same time frame.
Earnings of Acer missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average negative earnings surprise for ACER is 106.16%.
Aerie Therapeutics’ loss per share estimates for 2022 remained steady at $1.82 over the past 30 days. The same for 2023 has remained steady at 96 cents over the same time frame.
Earnings of Aerie beat estimates in three of the trailing four quarters and missed the same in the remaining occasion. The average earnings surprise for AERI is 70.27%.
Soleno Therapeutics’ loss per share estimates for 2022 remained steady at $4.05 over the past 30 days. The same for 2023 has remained steady at $2.10 in the same time frame.
Earnings of Soleno missed estimates in three of the trailing four quarters and were in line on the remaining occasion. The average earnings surprise for SLNO is 11.40%.
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Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report
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