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Fly News Breaks for June 12, 2019
CPRX
Jun 12, 2019 | 11:28 EDT
Piper Jaffray analyst Joseph Catanzaro maintained an Overweight rating and $7.50 price target on Catalyst Pharmaceuticals after the company filed a lawsuit against the FDA in relation to the approval of Jacobus' Ruzurgi for the treatment of pediatric LEMS. In a research note to investors, Catanzaro says the suit calls out Ruzurgi's labeling, specifically highlighting that all efficacy data supporting the drug's pediatric approval appears to have been generated in adult patients, and accuses the FDA of "playing favorites" because of pricing considerations. The analyst tells investors that he thinks establishing a precedent that finds Ruzurgi's approval acceptable could nullify many of the incentives in the orphan drug act to develop drugs for orphan indications with unmet need.
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