Market Overview

Analyst: Intercept's NASH Drug Could Launch Sans Competition After Gilead Trial Failure

Share:
Analyst: Intercept's NASH Drug Could Launch Sans Competition After Gilead Trial Failure

With Gilead Sciences, Inc. (NASDAQ: GILD)'s NASH setback, Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT)'s Ocaliva, which is being evaluated in a late-stage study for NASH with fibrosis, is taking the spotlight. 

A clinical readout from the trial is expected this quarter.

The Analyst

Raymond James analyst Steven Seedhouse maintained a Strong Buy rating on Intercept Pharma. 

The Thesis

In an update on the REGENERATE Phase 3 study at clinicaltrials.gov, Intercept defined the study's secondary endpoints, Seedhouse said in a Tuesday note. 

Given that the trial data was blinded when the endpoints were defined, the analyst said the listed endpoints should not be overinterpreted as being suggestive of the actual trial results.

"The list of endpoints offers insight into what may ultimately frame the 'totality of the data' in support of Ocaliva's efficacy, assuming one or both primary endpoints also hit statistical significance," Seedhouse said.

Hepatocellular carcinoma, or HCC, was removed from the seven-year clinical efficacy outcomes, according to Raymond James. 

This may have to do with the FDA's stance of not considering HCC as part of the composite clinical outcome endpoints for confirmatory NASH studies, the analyst said. 

Seedhouse said he expects a statistically significant outcome on one or both primary endpoints, with benefit across secondaries likely to be the main driver of the stock after the data release. 

Following Gilead's failed STELLAR-4 study and the likelihood of STELLAR-3 study also failing, the analyst said he expects Ocaliva to launch in NASH unencumbered by competition.

"Therefore, safety/tolerability questions that we know will be apparent (lipid changes and pruritus) likely won't overshadow an efficacy win, especially in top-line data." 

The Price Action

Intercept Pharma shares were down 0.63 percent at $110.35 at the time of publication Wednesday. 

Related Links:

Johnson & Johnson Wins FDA Panel Backing For Nasal Spray Depression Drug; PDUFA Date Awaits

The Daily Biotech Pulse: Exelixis Q4 Results, FDA Panel Greenlights J&J's Depression Drug, MacroGenics Prices Offering

Latest Ratings for ICPT

DateFirmActionFromTo
Oct 2019MaintainsStrong Buy
Sep 2019UpgradesNeutralBuy
Aug 2019ReiteratesOverweight

View More Analyst Ratings for ICPT
View the Latest Analyst Ratings

Posted-In: NASH Raymond James Steven SeedhouseAnalyst Color Biotech Reiteration Analyst Ratings General Best of Benzinga

 

Related Articles (GILD + ICPT)

View Comments and Join the Discussion!

Latest Ratings

StockFirmActionPT
BKUDA DavidsonInitiates Coverage On39.0
JDVertical GroupInitiates Coverage On
WWells FargoMaintains123.0
TXRHWells FargoMaintains48.0
QSRWells FargoMaintains75.0
View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Trading Daily
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com

6 Stocks Moving In Wednesday's After-Hours Session

Cisco Shares Rise After Q2 Earnings Beat