What occurred

Shares of the non-viral liver illness specialist Intercept Prescribed drugs (ICPT -12.49%) are beneath heavy stress as we speak. Particularly, the drugmaker’s inventory was down by 9.7% on exceptionally excessive quantity as of three:02 p.m. ET Thursday afternoon. 

The large loss got here in response to weaker-than-expected 2023 first-quarter gross sales of Intercept’s main biliary cholangitis (PBC) remedy, Ocaliva (obeticholic acid). Intercept reported Q1 Ocaliva internet gross sales of $68 million. Wall Road’s consensus gross sales goal, in contrast, stood at roughly $72.7 million for the three-month interval previous to as we speak’s earnings launch. 

So what 

This comparatively modest income miss most likely is not the explanation Intercept’s shares are falling as we speak. As an alternative, buyers look like shifting to the sidelines forward of the upcoming advisory committee assembly to be held on Could 19, 2023 for obeticholic acid as a therapy for pre-cirrhotic fibrosis because of nonalcoholic steatohepatitis (NASH).

The Meals and Drug Administration’s (FDA) goal motion date on the drug’s NASH submitting is presently set for June 22, 2023. If accredited, Intercept would sport the first-ever drug accredited for this more and more widespread, non-viral liver illness.  

What’s spooking buyers? FDA overview panels are inherently unpredictable. In consequence, some shareholders do not look like prepared to carry the biotech’s inventory heading into this risk-laden regulatory occasion. 

Now what

Is Intercept’s inventory a purchase on this dip? It relies on your consolation stage with danger. This upcoming regulatory overview may very well be a significant catalyst for the inventory. A destructive consequence, nonetheless, would doubtless spark one other sell-off. Sadly, FDA drug evaluations are hardly ever a simple occasion. In consequence, this biotech inventory is arguably solely suited to aggressive buyers at this vital level in its life cycle.