Filgotinib falls at final hurdle in rheumatoid arthritis

19 August 2020
gilead-big

Shares in California’s Gilead Sciences (Nasdaq: GILD) fell 7% in pre-market trading on Wednesday morning, after the firm announced bad news from the US regulator on its rheumatoid arthritis (RA) candidate filgotinib.

Co-developer Galapagos (Euronext: GLPG), a Belgian company, lost a quarter of its share price after news of the Complete Response Letter (CRL) was announced.

The Food and Drug Administration has requested data from the MANTA and MANTA-RAy studies before completing its review of the submission. The agency also expressed concerns regarding the overall benefit/risk profile of the higher dose of filgotinib.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology