Biotech Values

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Intercept analyst commentary at Leerink FDA could tilt toward black box warning for Intercept's Ocaliva, says Leerink.

Leerink analyst Joseph Schwartz noted the FDA issued a new warning letter about liver injury risk with Intercept's Ocaliva that echoes much of the same content as the last week's "Dear Doctor" letter, but includes a warning that pertains to a larger portion of PBC patients.

The FDA's mention of 19 deaths and worsening of PBC cases is "particularly concerning" and could tilt it toward a black box warning for the drug, added Schwartz.

The analyst, who thinks Ocaliva adoption in PBC patients could face headwinds from safety issues, keeps a Market Perform rating on Intercept shares, which are down about 9% near noon.