Regado Biosciences Trial Put on Clinical Hold by FDA

By Dow Jones Business News, 
A A A


By TESS STYNES

Regado Biosciences Inc. ( RGDO ) said it was notified that the U.S. Food and Drug Administration placed a clinical hold on a phase III trial of its Revolixys system.

Shares dropped nearly 3% to $2.62 in recent after-hours trading.

Regado said the FDA move follows its voluntary pause of the trial last week and aims to formalize the FDA's involvement in any decision to re-initiate enrollment and dosing in the trial.

Regado Biosciences shares plunged last week after the phase III trial of its Revolixys system for controlling antithrombotic drugs was "paused" for an unplanned safety check. The safety review, by an independent board, was to focus on serious adverse effects related to allergic reactions.

The system was being tested in patients undergoing a hospital procedure to treat a serious unstable heart condition.

Write to Tess Stynes at tess.stynes@wsj.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires


  (END) Dow Jones Newswires
  07-09-141715ET
  Copyright (c) 2014 Dow Jones & Company, Inc.


This article appears in: News Headlines

Referenced Stocks: RGDO

Dow Jones Business News


More from Dow Jones Business News:

Related Videos

Cheap Ways to Sleep Better
Cheap Ways to Sleep Better          

Stocks

Referenced

100%

Most Active by Volume

105,679,298
  • $16.13 ▼ 0.19%
43,130,824
  • $101.32 ▲ 0.74%
24,108,376
  • $59.80 ▲ 7.34%
22,524,427
  • $26.15 ▼ 1.06%
22,194,114
  • $24.65 ▼ 0.96%
21,835,360
  • $99.05 ▲ 0.15%
20,872,575
  • $34.94 ▼ 0.60%
20,561,803
    $74.57 unch
As of 8/22/2014, 04:02 PM