earnings
confidence high
sentiment positive
materiality 0.75
Curis gains FDA & EMA support for accelerated approval of emavusertib in PCNSL
CURIS INC
2025-Q1 EPS reported
-$1.25
revenue$2,380,000
- FDA and EMA agree TakeAim Lymphoma study may support accelerated approval path for PCNSL.
- Emavusertib granted Orphan Drug Designation for PCNSL in both US and EU.
- In 20 BTKi-experienced PCNSL patients: 6 objective responses, 4 complete responses.
- Q4 2024 net loss $9.6M ($1.25/share); FY2024 net loss $43.4M ($6.88/share).
- Cash $20.0M at Dec 31, 2024; plus $10M from March 2025 offerings funds ops into Q4 2025.