Catalyst Pharma down 13% on adverse ruling in FDA lawsuit

Jul. 31, 2020 12:04 PM ETCatalyst Pharmaceuticals, Inc. (CPRX)CPRXBy: Douglas W. House, SA News Editor
  • Catalyst Pharmaceuticals (CPRX -12.7%) is under pressure on 77% higher volume in reaction to an adverse development in its lawsuit against the FDA related to Firdapse (amifampridine phosphate), approved in the U.S. in November 2018 for adults with an autoimmune disorder called Lambert-Eaton syndrome (LEMS), an Orphan Drug-tagged indication which is supposed to provide a seven-year period of market exclusivity.
  • The company sued the agency in June 2019 after it approved privately held Jacobus Pharmaceutical Company's Ruzurgi (amifampridine) for children with LEMS, enabling physicians to prescribe it "off label" for adults which, according to the company, undercuts the value of Orphan Drug status.
  • Today, a magistrate judge recommended to the district court judge that she grant FDA and Jacobus motions for summary judgement and deny the company's.
  • Unsurprisingly, Catalyst takes a dim view of the recommendation and intends to "continue to aggressively take all steps necessary" to protect the exclusivity of Firdapse for adults under the Orphan Drug Act.

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