Needham Cuts Price Target On This NASH-Focused Stock As Its Awaits Visibility On Regulatory Path

Needham Cuts Price Target On This NASH-Focused Stock As Its Awaits Visibility On Regulatory Path
  • Yesterday, Intercept Pharmaceuticals Inc ICPT announced data from the new interim analysis of the Phase 3 REGENERATE trial evaluating obeticholic acid in nonalcoholic steatohepatitis (NASH).
  • Needham writes that the efficacy results were similar to the initial results announced in February 2019. 
  • Core cardiovascular and renal events were low and balanced across treatment arms, but hepatic events were higher. 
  • According to the management, these events were manageable, with the majority mild in severity. 
  • A pre-submission meeting with the FDA is planned this month, with resubmission anticipated.
  • The analyst says that concerns regarding the overall benefit/safety profile and how the FDA will view this new analysis remain in investors' minds.
  • Needham looks forward to visibility on the regulatory path. It lowered the price target from $25 to $22 (51% upside) but kept the Buy rating on the shares.
  • In the new analysis, 22% of patients achieved fibrosis improvement without NASH worsening in the 25mg group and 14.1% in the 10 mg arm compared to 9.6% on placebo.
  • The data is similar to the original analysis, which showed 23.% vs. 17.6% vs. 11.9%, respectively.
  • The placebo-adjusted treatment differences were similar: +11.2% original analysis vs. +12.8% new analysis.
  • The analyst thinks the data probably satisfies FDA's requirement for more consistency around the biopsy readings.
  • Price Action: ICPT shares are down 2.84% at $14.73 during the market session on the last check Friday.

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