real-time news and commentary for investors
Tuesday, Aug 20
RedHill Biopharma concludes scientific advice meetings with European regulators; says path is clear towards Phase III study with RHB-104
- RedHill Biopharma (RDHL +0.1%) says it recently concluded Scientific Advice Meetings with the UK Medicines and Healthcare Products Regulatory Agency and the Swedish Medical Products Agency, and believes there's a clear regulatory path towards a Phase III clinical study in Europe with RHB-104 to treat Crohn's disease.
- The company intends to file applications to begin the Phase III MAP Europe study in several European countries and, working with a leading international CRO, has already identified potential sites.
- It plans to commence a first Phase III double-blind placebo-controlled clinical study, enrolling 240 subjects in up to 50 sites in North America and Israel, in the coming weeks.