1. Scrip
  2. >>Business
  3. >>Strategy

Intercept Commits To Resubmitting NASH NDA, But Analysts See Conflicting Signs

 
• By Joseph Haas

CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.

Back view image of young businessman standing against business sketch
Analysts wonder if Intercept is de-emphasizing NASH to focus on PBC

Market analysts have been trying to read the tea leaves regarding Intercept Pharmaceuticals, Inc.’s prospects for getting obeticholic acid (OCA) refiled for US approval in non-alcoholic steatohepatitis for months now, and while the firm’s fourth quarter/full-year 2020 earnings call on 25 February offered assurances about refiling the new drug application by year’s end, those same analysts don’t seem fully convinced.

New CEO Jerome Durso, promoted from chief operating officer on 1 January as long-time former CEO Mark Pruzanski retired and took a seat on the Intercept board, opened the investor...

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
Start Free Trial

Already a subscriber?

More from Strategy

More from Business

Challenging Environment For Biopharma Is A Tailwind For Royalty Pharma

 
• By Jessica Merrill

The royalty revenue stream acquirer has around 40 products in its portfolio and expects to generate roughly $3bn this year. Head of R&D and investments Marshall Urist talked about the investment strategy at the RBC Healthcare Conference.

Finance Watch: SV Closes Second Dementia Discovery Fund, Exceeding $250m Goal

 
• By Mandy Jackson

Private Company Edition: SV Health Investors revealed the final closing of its second Dementia Discovery Fund. Also, Eikon cut nearly 15% of its staff, Pathos AI raised $365m in series D venture capital and CellCentric completed a $120m series C round, among other financings.

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By Kevin Grogan

The French drugmaker is expanding its neurology activities with the $470m deal.