In a stunning setback for Celgene (CELG), the Food and Drug Administration has refused to review a drug that the biotech has been testing for multiple sclerosis because of “incomplete” pharmacology data. The move is deeply significant: Not only is the medicine the most important product in the Celgene pipeline, but the refusal is the latest in a series of shocks that has unnerved investors over the past few months.

Just last month, for instance, Celgene executives signaled that FDA approval for the drug, called orzanimod, was expected by the end of this year. Last October, the company unexpectedly halted development of another drug for combating Crohn’s disease, and then shortly afterward made deep cuts to its long-term financial guidance, moves that sent its shares plunging.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy