1. Curis reported 62.5% of AML patients achieved undetectable MRD. 2. Emavusertib shows promise in triplet therapy against AML. 3. No change in safety profile after latest clinical evaluation. 4. CEO emphasized need for further evaluation of therapy regimens. 5. Curis requires substantial funding to continue drug development.
FAQ
Why Bullish?
The increase in patients achieving uMRD is a significant clinical advancement for CRIS. Similar past data presentations have positively influenced stock prices in biotech.
How important is it?
The study's positive outcomes directly affect CRIS's market potential and investor confidence. Historical performance shows investor reaction to clinical trial updates.
Why Short Term?
Immediate focus on clinical results may drive short-term investor interest, similar to other biotech announcements.
Curis (NASDAQ: CRIS) Updates Data from Frontline AML Triplet Study
Curis, Inc. (NASDAQ: CRIS), a leading biotechnology firm, announced updated clinical trial results from its ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104). The results were shared through a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, showcasing the potential of their drug emavusertib (CA-4948) in treating AML.
Details of the AML Triplet Study
The AML triplet study aims to assess the efficacy of emavusertib, an oral small molecule inhibitor of IRAK4 and FLT3, in combination with venetoclax and azacitidine (ven-aza) for AML patients. Specifically, the study includes patients who have achieved complete remission on ven-aza but remain measurable residual disease-positive (MRD+), with the primary objective of enabling these patients to attain undetectable MRD (uMRD).
In initial findings presented at ASH, data indicated that 4 out of 8 patients (50%) had reached the uMRD status as of July 2, 2025. Recent updates revealed that this figure has improved to 5 out of 8 patients (62.5%), with no significant changes to the safety profile noted as of October 12, 2025.
Implications of the Study Results
James Dentzer, CEO of Curis, commented, "These data are very promising and warrant further evaluation of additional triplet (ema/ven/aza) regimens to determine the optimal dose and schedule for safety and efficacy to improve patient outcomes in a difficult to treat population." The increased percentage of patients achieving uMRD underscores the potential of emavusertib as an effective treatment option in combination therapies for AML.
About Curis, Inc.
Curis is dedicated to advancing the development of emavusertib, which is currently being assessed in multiple clinical trials including the Phase 1/2 studies in both lymphoma and AML. Notably, emavusertib has received Orphan Drug Designation from the FDA for AML, as well as for high-risk myelodysplastic syndrome (hrMDS) and primary central nervous system lymphoma (PCNSL).
- Study Code: CA-4948-101 – Exploring emavusertib with ibrutinib in relapsed/refractory PCNSL.
- Study Code: CA-4948-102 – Evaluating emavusertib monotherapy in relapsed/refractory AML and hrMDS.
- Study Code: CA-4948-104 – Investigating the combination of emavusertib with venetoclax and azacitidine for MRD+ AML patients.
Cautionary Note on Forward-Looking Statements
This release includes forward-looking statements as defined by the U.S. Private Securities Litigation Reform Act of 1995, including predictions regarding the results of the AML triplet study. Such statements involve risks and uncertainties that could lead to actual results differing materially from those expressed.
Investors and stakeholders are encouraged to consider the potential challenges in drug development and the financial needs associated with advancing emavusertib. These include the necessity for additional funding and the possibility of delays in clinical trials, which may adversely affect the company's operations and market prospects.