Intercept Slides As Analyst Calls CymaBay Drug ‘True Contender’ After Data

Shares of Intercept Pharmaceuticals (ICPT) are sliding after H.C. Wainwright analyst Ed Arce raised his price target for its competitor CymaBay Therapeutics (CBAY) following data from the company’s Phase 2 study of seladelpar in primary biliary cholangitis. The analyst argued that the latter’s results “are more robust” than Intercept’s Ocaliva.

STUDY RESULTS: CymaBay has announced interim results from its ongoing low-dose Phase 2 study of seladelpar in patients with primary biliary cholangitis, or PBC, a life-threatening and life-limiting chronic cholestatic liver disease. A planned interim analysis of the first 24 patients enrolled in the 5 mg or 10mg dose groups demonstrated after 12 weeks of treatment a significant alkaline phosphatase, or AP, reduction from baseline of 39% and 45%, respectively. On seladelpar, 45% of patients in the 5mg and 82% of patients in the 10 mg dose groups had AP values less than 1.67 times the upper limit of normal, or ULN. There were no serious adverse events and no safety transaminase signal was observed at either dose, said the company, which added that, consistent with prior studies, there was no signal for drug-induced pruritus. After sharing preliminary results from the study, the Food and Drug Administration has agreed to allow continuation of seladelpar treatment beyond six months for the 5 mg and 10 mg doses.

‘TRUE CONTENDER’ TO OCALIVA: In a research note this morning, H.C. Wainwright’s Arce raised his price target for CymaBay to $12 from $7 following the report of the 12-week Phase 2 results of its seladelpar, citing increased confidence in the drug’s approvability and market potential. The analyst noted that he views CymaBay’s results as “favorable” to those of Intercept Pharmaceutical’s Ocaliva 10mg and believes it likely that seladelpar’s efficacy grows stronger over time. Arce also added that he sees seladelpar as a “true contender” to Intercept’s Ocaliva as the former’s Phase 2 primary biliary cholangitis results “are most robust.” He reiterated a Buy rating on Cymabay.