Intercept Pharmaceuticals Inc (ICPT) has been downgraded by Canaccord Genuity, lowering the price target from $26 to $12 with a Hold rating. The analyst believes that Ocaliva, used for PBC, is worth $16 per share, while OCA in NASH is costing $4 based on overhead allocation for the rest of 2023. The FDA has raised concerns about drug-induced liver injury (DILI) that could be fatal.
With 12 cases being presented at the AdCom, the FDA was clear on its concern over how this could be magnified given the size of the patient population being targeted by OCA in NASH. It also questions whether Intercept’s monitoring strategy is enough to catch all DILI cases, as the company’s expert has reportedly stated that monitoring only intends to identify signals of DILI early in treatment but not to prevent it.
Needham has also downgraded ICPT’s stocks from Buy to Hold citing the FDA’s negative tone throughout the meeting, which confirmed the agency’s considerable worries. Although the PBC program holds some value, Needham awaits more transparency into the long-term potential of this program given competitive landscape.
On yesterday’s last check, ICPT shares fell by 2.89% at $9.26.