We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Catalyst (CPRX) Settles Patent Dispute Over Sole Marketed Drug
Read MoreHide Full Article
Catalyst Pharmaceuticals (CPRX - Free Report) has reached a settlement with Jacobus Pharmaceutical Company, Inc. and PANTHERx Rare LLC, with regard to the ongoing patent infringement litigation over its sole-marketed drug, Firdapse (amifampridine), which is approved to treat Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients.
The settlement of this litigation marks the end of an ongoing dispute between Catalyst Pharmaceuticals and Jacobus ever since the FDA approved the latter’s drug, Ruzurgi (amifampridine), in 2019, for treating LEMS in pediatric patients. This was contested by CPRX in its lawsuit, which claimed that the regulatory body’s approval violated the orphan drug designation granted to Firdapse for the treatment of LEMS.
Per the terms of the settlement, CPRX will stop pursuing all claims related to patent litigation between the companies. In addition, Catalyst Pharmaceuticals will acquire certain intellectual property (IP) rights belonging to Jacobus, including the rights to develop and commercialize Ruzurgi in the United States and Mexico.
In return, CPRX will make an undisclosed cash payment to Jacobus, with the latter also being eligible to receive low single-digit royalties on net U.S. sales of amifampridine.
Following the settlement, Jacobus will dismiss its pending petition before the U.S. Supreme Court seeking to overturn the Appeal Court’s decision.
Shares of Catalyst Pharmaceuticals have risen 14.3% in the past year against the industry’s 20.7% decline.
Image Source: Zacks Investment Research
CPRX achieved a major milestone last September, when it received a positive decision from the U.S. Appeals Court. The positive decision supported the orphan drug designation for Firdapse, granted by the FDA for LEMS. 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 Catalyst’s favor. The District Court granted summary judgment this February, making the FDA’s approval to Ruzurgi in LEMS invalid.
Firdapse is the first and currently the only approved drug in Catalyst Pharmaceuticals’ portfolio. In fact, the drug is currently the only approved treatment for LEMS in adults in the United States. The company has multiple patents for Firdapse issued in the United States that strengthen the drug’s commercial durability through 2034.
Catalyst Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Jazz Pharmaceuticals (JAZZ - Free Report) , Merck (MRK - Free Report) and Spectrum Pharmaceuticals . While Jazz Pharmaceuticals and Spectrum Pharmaceuticals each sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Jazz Pharmaceuticals’ 2022 earnings have increased from $17.05 to $17.06 in the past 30 days. Shares of JAZZ have risen 21.3% in the year-to-date period.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.8%. In the last reported quarter, JAZZ delivered a negative earnings surprise of 0.5%.
Estimates for Spectrum Pharmaceuticals’ 2022 loss have narrowed from 55 cents to 52 cents in the past 30 days. The loss estimates for 2023 have also narrowed from 10 cents to 7 cents in the past 30 days. Shares of SPPI have fallen 36.2% in the year-to-date period.
Earnings of Spectrum Pharmaceuticals beat estimates in two of the last four quarters and missed the mark on the other two occasions, the average surprise being 5.7%. In the last reported quarter, SPPI delivered an earnings surprise of 50%.
Estimates for Merck’s 2022 earnings have increased from $7.28 to $7.31 in the past 30 days. Shares of MRK have risen 22.1% in the year-to-date period.
Earnings of Merck beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 13.4%. In the last reported quarter, MRK delivered an earnings surprise of 18.2%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Catalyst (CPRX) Settles Patent Dispute Over Sole Marketed Drug
Catalyst Pharmaceuticals (CPRX - Free Report) has reached a settlement with Jacobus Pharmaceutical Company, Inc. and PANTHERx Rare LLC, with regard to the ongoing patent infringement litigation over its sole-marketed drug, Firdapse (amifampridine), which is approved to treat Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients.
The settlement of this litigation marks the end of an ongoing dispute between Catalyst Pharmaceuticals and Jacobus ever since the FDA approved the latter’s drug, Ruzurgi (amifampridine), in 2019, for treating LEMS in pediatric patients. This was contested by CPRX in its lawsuit, which claimed that the regulatory body’s approval violated the orphan drug designation granted to Firdapse for the treatment of LEMS.
Per the terms of the settlement, CPRX will stop pursuing all claims related to patent litigation between the companies. In addition, Catalyst Pharmaceuticals will acquire certain intellectual property (IP) rights belonging to Jacobus, including the rights to develop and commercialize Ruzurgi in the United States and Mexico.
In return, CPRX will make an undisclosed cash payment to Jacobus, with the latter also being eligible to receive low single-digit royalties on net U.S. sales of amifampridine.
Following the settlement, Jacobus will dismiss its pending petition before the U.S. Supreme Court seeking to overturn the Appeal Court’s decision.
Shares of Catalyst Pharmaceuticals have risen 14.3% in the past year against the industry’s 20.7% decline.
Image Source: Zacks Investment Research
CPRX achieved a major milestone last September, when it received a positive decision from the U.S. Appeals Court. The positive decision supported the orphan drug designation for Firdapse, granted by the FDA for LEMS. 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 Catalyst’s favor. The District Court granted summary judgment this February, making the FDA’s approval to Ruzurgi in LEMS invalid.
Firdapse is the first and currently the only approved drug in Catalyst Pharmaceuticals’ portfolio. In fact, the drug is currently the only approved treatment for LEMS in adults in the United States. The company has multiple patents for Firdapse issued in the United States that strengthen the drug’s commercial durability through 2034.
Catalyst Pharmaceuticals, Inc. Price
Catalyst Pharmaceuticals, Inc. price | Catalyst Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Catalyst Pharmaceuticals currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Jazz Pharmaceuticals (JAZZ - Free Report) , Merck (MRK - Free Report) and Spectrum Pharmaceuticals . While Jazz Pharmaceuticals and Spectrum Pharmaceuticals each sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Jazz Pharmaceuticals’ 2022 earnings have increased from $17.05 to $17.06 in the past 30 days. Shares of JAZZ have risen 21.3% in the year-to-date period.
Earnings of Jazz Pharmaceuticals beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 12.8%. In the last reported quarter, JAZZ delivered a negative earnings surprise of 0.5%.
Estimates for Spectrum Pharmaceuticals’ 2022 loss have narrowed from 55 cents to 52 cents in the past 30 days. The loss estimates for 2023 have also narrowed from 10 cents to 7 cents in the past 30 days. Shares of SPPI have fallen 36.2% in the year-to-date period.
Earnings of Spectrum Pharmaceuticals beat estimates in two of the last four quarters and missed the mark on the other two occasions, the average surprise being 5.7%. In the last reported quarter, SPPI delivered an earnings surprise of 50%.
Estimates for Merck’s 2022 earnings have increased from $7.28 to $7.31 in the past 30 days. Shares of MRK have risen 22.1% in the year-to-date period.
Earnings of Merck beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 13.4%. In the last reported quarter, MRK delivered an earnings surprise of 18.2%.