Regulatory Update On Intercept Pharma's Obeticholic Acid For NASH Delayed Again

  • Intercept Pharmaceuticals Inc's ICPT pre-submission meeting to discuss the marketing application for obeticholic acid (OCA) in NASH has been moved to July (vs. June scheduling).
  • The update follows a recent request from the FDA that topline data from the REGENERATE reanalysis be provided to the agency for review before the meeting. 
  • SVB Leerink says that the move is in line with its view and expectation that the FDA would want to see REGENERATE data, despite ICPT comments during the 1Q22 earnings call that availability of these data was not a gating factor for the meeting.
  • Related: Analysts Expect Clarity Imminent On Intercept's NASH Story.
  • ICPT had previously guided to topline results from the REGENERATE reanalysis in 2Q22, though today's update confirms that these data are now expected to be available and made public in July. 
  • The analyst sees this as a minor delay from a timing standpoint. However, this announcement comes on the heels of the departure of Gail Cawkwell, SVP of Medical Affairs, Safety, and Pharmacovigilance, which SVB sees as suboptimal timing and likely to be interpreted as an incremental negative by some investors ahead of NASH data and regulatory updates.
  • Overall, SVB expects that the REGENERATE data and the REVERSE dataset expected in 3Q22 will provide long-awaited clarity on the potential viability for OCA in NASH.
  • Price Action: ICPT shares are down 10.60% at $14.64 during the market session on the last check Monday.

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