other material
confidence high
sentiment positive
materiality 0.60
Mereo BioPharma: setrusumab Phase 3 Orbit 2nd interim analysis mid-2025; alvelestat gets positive EMA orphan opinion
Mereo BioPharma Group plc
- Phase 3 Orbit study of setrusumab in OI progressing to second interim analysis expected mid-2025; final analysis possible Q4 2025.
- Alvelestat receives positive EMA COMP opinion for Orphan Designation; European Commission final decision expected Q1 2025.
- Cash runway reaffirmed into 2027, funding through multiple key inflection points including setrusumab milestones.
- Cosmic study in OI patients aged 2 to <7 years continuing; data will be evaluated with Orbit analyses.