This section highlights FDA-related milestones and regulatory updates for drugs developed by Curis (CRIS).
Over the past two years, Curis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CA-4948 and Emavusertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CA-4948 - FDA Regulatory Timeline and Events
CA-4948 is a drug developed by Curis for the following indication: Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CA-4948
- Announced Date:
- March 31, 2025
- Indication:
- Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS)
Announcement
Curis, Inc. provided Business Update
AI Summary
Curis, Inc. provided a business update on its development efforts for emavusertib, an oral IRAK4 inhibitor, during a recent conference call. The company shared that it recently received supportive feedback from both the FDA and the European Medicines Agency regarding its plan to use data from the ongoing TakeAim Lymphoma study to support a potential accelerated approval path for primary central nervous system lymphoma (PCNSL).
CEO James Dentzer highlighted that with encouraging early responses in the trial, Curis is now focused on enrolling 30-40 additional patients over the next 12-18 months. This enrollment will help strengthen the case for regulatory filing for accelerated approval in the US and Europe, reinforcing the company’s commitment to rapidly advancing emavusertib for patients with this rare form of lymphoma.
Read Announcement
Emavusertib (CA-4948) BcM - FDA Regulatory Timeline and Events
Emavusertib (CA-4948) BcM is a drug developed by Curis for the following indication: B-cell malignancies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Emavusertib (CA-4948) BcM
- Announced Date:
- December 10, 2024
- Indication:
- B-cell malignancies
Announcement
Curis, Inc. presented data from the TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) at the 66th ASH annual meeting.
AI Summary
Curis, Inc. presented new data from its TakeAim Leukemia study at the 66th ASH Annual Meeting, focusing on patients with relapsed/refractory acute myeloid leukemia (AML). The study evaluated emavusertib (CA-4948), an orally available small molecule inhibitor that targets IRAK4, at a Recommended Phase 2 Dose of 300 mg taken twice daily. Among 21 patients with a FLT3 mutation who received fewer than three prior therapy lines, 19 were deemed evaluable for response. The results showed 10 objective responses, including six complete remissions, two cases of partial or incomplete hematological recovery, and two cases of morphologic leukemia-free state. Many patients experienced a rapid response, with most responses observed by the first assessment. These findings highlight the promise of emavusertib’s novel mechanism in addressing a major unmet need in relapsed/refractory AML treatment.
Read Announcement
Free CRIS Stock Alerts