NicOx escapes a requirement for major trial
France's NicOx saw its shares make their way to a record high after the company announced that it would not need to conduct another large clinical trial for the anti-inflammatory drug naproxcinod. HCT 3012 is in a late-stage trial now as a treatment for the symptoms of osteoarthritis, and the FDA's feedback leaves the French biotech on track to gain marketing clearance in early 2009. European regulators have also indicated that they won't require a lengthy cardiovascular trial. That's been a particular concern for NicOx, which has had to face concerns over cardiovascular risks. A big trial on cardiovascular outcomes would have cost NicOx tens of millions of dollars and thrown it well off its timetable.
- see the release on the clinical trial situation
Related Articles:
NicOx launches Phase III trial of osteoarthritis drug. Report
NicOx stock soars on $385M development pact. Report
NicOx inks $351M licensing deal with Merck. Report
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