- Size:
- —
- Delta:
- No change (89.3% → 89.3%)
No cash available to trade. High approval probability already priced in at 89% for this rare disease sNDA.
No cash available to trade. High approval probability already priced in at 89% for this rare disease sNDA.
Recent Phase 3 data (March 1, 2026) confirmed robust 18. 8% BMI reduction, strongly supporting approval.
Phase 3 data was highly positive, showing a significant BMI reduction. The FDA's extension was for data analysis, not new safety or manufacturing concerns, suggesting the core data is strong. Steady-state cap reduced request to $1000.00.
89% YES fair for rare disease sNDA expansion with prior IMCIVREE approval; low rejection risk but no edge to add position pre-PDUFA.
Label expansion lowers safety risk, but acquired HO efficacy/benefit uncertainty makes 89% look rich. Approval is mostly priced in; a CRL would likely hit RYTM hard—trim YES. Steady-state cap reduced request to $1000.00.