- RBC Capital Markets writes that following the Advanz deal, Intercept Pharmaceuticals Inc (NASDAQ:ICPT) should be well-capitalized into make-or-break upcoming readouts for obeticholic acid (OCA) in NASH, with REGENERATE re-analyses on deck, REVERSE reading in the next quarter.
- The analysts say it remains challenging to get visibility on how the efficacy/safety analyses will look, how the FDA will interpret the benefit/risk profile from this data, and how effectively ICPT would be able to launch a first NASH agent, if approved.
- RBC increased the price target on ICPT to $18 from $16, with a Sector Perform rating.
- Related: Why Intercept Shares Are Rising Today.
- Raymond James maintains Outperform on ICPT following 1Q22 earnings and views that Ocaliva has a decent chance of approval in F2/F3 NASH (60% in the model).
- The Advanz Pharma deal that licenses OCA in PBC in ex-U.S. markets substantially impacts Raymond James DCF (since we modeled Ex-US risk-adjusted NASH revenues and the upfront doesn’t value NASH opportunity).
- ICPT is targeting June ‘22 for a pre-submission meeting with FDA to discuss an expanded NASH dataset.
- The analysts note three important catalysts for 2022, including REGENERATE re-analysis/pre-submission meeting with the FDA, NDA resubmission, and 3Q22 REVERSE readout in F4 patients, with potential to shift sentiment after ~2 NASH catalyst-free years.
- The analysts lowered the price target from $44 to $23.
- Price Action: ICPT shares are down 3.55% at $18.59 during the market session on the last check Monday.
