Catalyst Pharma Files Lawsuit Against FDA Approval Of Ruzurgi

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) has filed a suit against the FDA and several related parties, challenging the recent approval of Jacobus Pharmaceutical Co's drug, Ruzurgi, for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in pediatric patients.

According to the lawsuit, the approval of Ruzurgi, in May 2019, violated provisions of the FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). The lawsuit also alleges that the approval also violated Catalyst's rights to exclusivity for its drug, Firdapse. Among other remedies, the suit seeks an order vacating the FDA's approval of Ruzurgi.

Firdapse was approved by the FDA in November 2018 for the treatment of LEMS in adults. The drug was launched in the United States in January 2019.

Shares of Catalyst have surged 91.2% compared with the industry’s growth of 6.2%.

The company is also working on developing Firdapse for additional indications. Catalyst initiated an investigator-sponsored phase II/III study on the drugfor the symptomatic treatment of MuSK-antibody positive myasthenia gravis (MG) in February 2016. In April 2018, the company enrolled the first patient in its phase III study for the same indication. The company expects to announce top-line results in the second half of 2019.

In October 2015, the company initiated a small-blinded study on Firdapse for the treatment of certain types of congenital myasthenic syndromes (CMS) in the pediatric population (aged 2-17 years). The company expects to report top-line results in the second half of 2019. If the results are successful, the CMS indication will be added to Firdapse’s label.

Zacks Rank and Stocks to Consider

Catalyst currently has a Zacks Rank #2 (Buy).

Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. (NASDAQ:ANIK) , Applied Genetics Technologies Corp. (NASDAQ:AGTC) and Acorda Therapeutics Inc. (NASDAQ:ACOR) . All of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings per share estimates have moved up from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.

Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.

Acorda’s loss per share estimates have narrowed from $3.84 to $3.59 for 2019 and from $3.32 to $3.09 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 79.32%.

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