Year Of NASH Upheaval Means Incremental Data At AASLD

Firms Are Retrenching, But There Are Signs Of Progress

With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.

Urban Car Road Traffic Congestion Aerial View
Many paths to the first NASH drug therapy remain viable in a year of upheaval

This year began with the expectation of the first drug approval in non-alcoholic steatohepatitis, with a number of other Phase III programs right on the lead product’s heels. But instead, the year is closing out with uncertainty – and the datasets presented at the American Association for the Study of Liver Diseases’ 13-16 November virtual annual meeting reflected that.

Instead of approval for NASH, Intercept Pharmaceuticals, Inc.’s FXR agonist obeticholic acid (OCA) got a complete response letter from...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Cogent Peaks With Bezaclastinib SUMMIT Results

 

The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.

France’s AB Science Plots Pivotal Masitinib Trial In Prostate Cancer

 
• By 

Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

2025’s Biggest Launches – Half-Year Progress Report

 

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

More from R&D

2025’s Biggest Launches – Half-Year Progress Report

 

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Will AstraZeneca Reach Summit And Be A PD-1xVEGF Player?

 
• By 

Rumor mill suggests a $15bn licensing deal for ivonescimab is in the offing.

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.