Accelerated Approval Pathway for Emavusertib
The discussions with EMA and FDA were productive, leading to the potential for accelerated approval in the U.S. and conditional marketing authorization in Europe for emavusertib in combination with ibrutinib in PCNSL.
Orphan Drug Designation for Emavusertib
Emavusertib has been granted Orphan Drug Designation for primary CNS lymphoma in both the U.S. and Europe.
Positive Clinical Data in NHL and AML
In the TakeAim Lymphoma study, 6 out of 13 BTKI experienced patients and 5 out of 6 BTKI naïve patients showed objective responses. In AML, a 38% composite CR rate was achieved in FLT3 mutation patients.
Financial Improvements
Net loss decreased to $9.6 million in Q4 2024 from $117 million in Q4 2023. R&D and G&A expenses were also reduced.
Extended Cash Runway
Two offerings have extended Curis's cash runway into the fourth quarter of 2025.