Curis Provides Updated Data from its Frontline AML Triplet Study

Rhea-AI Summary

Curis (NASDAQ: CRIS) posted updated clinical data from its frontline Acute Myeloid Leukemia triplet study (CA-4948-104) presented at the 67th ASH Annual Meeting on December 9, 2025. The study adds emavusertib (ema) to venetoclax plus azacitidine in AML patients who were in complete remission but remained MRD-positive.

As of October 12, 2025, 5 of 8 patients (62.5%) achieved undetectable MRD (uMRD), up from 4 of 8 (50%) reported as of July 2, 2025. The company reported no change in safety profile across the updated dataset. The first two cohorts tested ema dosing for 7 or 14 days per 28-day cycle.

Positive

• uMRD achieved in 5 of 8 patients (62.5%) as of Oct 12, 2025
• Improved uMRD rate from 50% to 62.5% versus July 2, 2025
• Reported no change in safety profile with addition of ema

Negative

• Small sample size: 8 patients limits statistical confidence
• Results limited to first two cohorts (ema dosing for 7 or 14 days)

Key Figures

uMRD rate (updated) 5 of 8 patients (62.5%) Frontline AML triplet study as of October 12, 2025

uMRD rate (initial) 4 of 8 patients (50%) Frontline AML triplet study as of July 2, 2025

Sample size 8 patients Frontline AML triplet MRD-positive cohort

Dosing duration cohort 1 7 days Emavusertib dosing within 28-day cycle plus venetoclax/azacitidine

Dosing duration cohort 2 14 days Emavusertib dosing within 28-day cycle plus venetoclax/azacitidine

Cycle length 28 days Frontline AML triplet regimen cycle duration

ASH meeting number 67th ASH Annual Meeting where updated AML triplet data were presented

Market Reality Check

$1.16 Last Close

Volume Volume 81,660 vs 20-day average 106,956 (relative volume 0.76) ahead of this update. normal

Technical Price 1.35 is trading below the 200-day MA of 1.86 and 70% under the 52-week high of 4.50.

Peers on Argus

Peers show mixed moves: ELEV -2.28%, FBLG +4.85%, GDTC +2.78%, QTTB +6.79%, while AKTX is flat. No consistent sector trend indicated for this AML data update.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 14	Scientific meeting update	Neutral	+17.7%	Announcement of SNO presentations featuring emavusertib clinical and preclinical data.
Nov 06	Earnings and pipeline	Neutral	+2.8%	Q3 2025 results and clinical progress update, including AML triplet MRD data.
Oct 30	Earnings call notice	Neutral	+0.0%	Scheduling notice for Q3 2025 financial results call and webcast.
Oct 03	Equity incentives	Neutral	+0.6%	Inducement stock option grants to new employees totaling 84,750 shares.
Sep 02	Conference appearances	Neutral	-1.8%	Announcements of September healthcare conference presentations by management.

Pattern Detected

Recent news (presentations, business updates, grants) has generally coincided with modest positive or flat price reactions, with one larger move on scientific meeting news.

Recent Company History

Over the last six months, Curis has reported several operational and scientific milestones. A Q3 2025 business update on Nov 6, 2025 highlighted net loss reduction, $3.2M revenue, and ongoing emavusertib trials, with a +2.82% price move. Scientific visibility increased with upcoming SNO presentations announced on Nov 14, 2025, which saw a larger +17.7% reaction. Other items, including inducement option grants and conference appearances, produced small or minimal moves. Today’s AML triplet data update fits into this pattern of clinically focused news around emavusertib.

Market Pulse Summary

This announcement reports improved undetectable MRD rates, with 5 of 8 AML patients achieving uMRD after adding emavusertib to venetoclax and azacitidine, up from 4 of 8 in July. It adds to a series of recent clinical and scientific updates around emavusertib. Investors may weigh these early efficacy signals against prior disclosures of operating losses and tight liquidity, monitoring future data from larger cohorts and subsequent regulatory or financing developments.

Key Terms

undetectable mrd (umrd) medical

"5 of 8 patients (62.5%) achieved Undetectable MRD (uMRD)"

Undetectable MRD (uMRD) means that highly sensitive laboratory tests cannot find remaining cancer cells after treatment. Think of it like inspecting a garden after weeding and not finding any roots left — it suggests a deeper response and lower short-term relapse risk. For investors, uMRD is important because it often predicts better patient outcomes, can be used by regulators and doctors to judge a therapy’s effectiveness, and may speed approval or broaden market use.

acute myeloid leukemia (aml) medical

"ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104)"

A fast‑growing cancer of the blood and bone marrow in which abnormal cells crowd out healthy blood cells, leading to infections, bleeding and fatigue; think of it as aggressive weeds rapidly taking over a garden. It matters to investors because the size, severity and unmet need of this condition drive demand for new drugs, influence clinical trial and regulatory outcomes, and determine revenue and risk for companies developing therapies.

irak4 medical

"an orally available, small molecule IRAK4 and FLT3 inhibitor"

IRAK4 is a protein in immune-system cells that acts like a control knob for inflammation signals, helping the body detect and respond to infections. Drugs that block IRAK4 can dial down excessive inflammation, so IRAK4 is an important target for developing treatments for autoimmune diseases and some cancers; progress or setbacks in IRAK4 drug programs can materially affect the prospects and valuation of companies working in those areas.

flt3 medical

"an orally available, small molecule IRAK4 and FLT3 inhibitor"

FLT3 is a gene that makes a protein acting like a growth switch for blood-forming stem cells; when that switch is faulty or overactive it can drive certain blood cancers, most notably acute myeloid leukemia. Investors care because drugs that target FLT3 mutations can become important therapies, influencing clinical trial outcomes, regulatory approvals and the future revenues and valuations of biotech companies—think of it as a key control knob whose position can determine a treatment’s market value.

venetoclax medical

"addition of emavusertib (ema) to the combination of venetoclax and azacitidine"

Venetoclax is an oral prescription medicine that blocks a protein cancer cells use to avoid death, causing those cells to self-destruct. Investors watch it because clinical trial results, regulatory approvals, pricing, and sales determine revenue potential and partnership value for companies that develop or sell the drug; think of trial readouts and approvals as gatekeepers that can rapidly change a company’s future cash flow and stock price.

azacitidine medical

"addition of emavusertib (ema) to the combination of venetoclax and azacitidine"

Azacitidine is a prescription cancer drug that helps restore normal control of cell growth by reactivating genes turned off in certain blood cancers and bone marrow disorders; think of it like a reset switch for a damaged cellular control system. It matters to investors because regulatory approvals, clinical trial results, dosing changes, or generic competition can materially affect a drug maker’s sales, future earnings and risk profile.

mrd-positive (mrd+) medical

"but remain MRD-positive (MRD+), with the goal of enabling patients to achieve uMRD"

MRD-positive (mrd+) means sensitive laboratory tests detect tiny numbers of disease cells remaining after treatment, even when standard exams show no visible illness. Like finding a few weeds after you thought a garden was cleared, MRD+ signals a higher risk the disease will return and often drives decisions about further therapy, regulatory review, and future sales or earnings potential for related treatments.

complete remission medical

"AML patients who have achieved complete remission on ven-aza but remain MRD-positive"

Complete remission means that medical tests and exams show no detectable signs or symptoms of a disease after treatment, though it does not guarantee the disease is permanently gone. Investors care because complete remission rates are a clear, measurable outcome used by regulators and doctors to judge a therapy’s effectiveness; like a fire appearing fully extinguished, it can boost a drug’s perceived value and commercial prospects while still requiring ongoing monitoring.

AI-generated analysis. Not financial advice.

5 of 8 patients (62.5%) achieved Undetectable MRD (uMRD)

LEXINGTON, Mass., Dec. 9, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, yesterday provided updated clinical data from the ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104) in a poster presentation at the 67th ASH Annual Meeting (ASH).

The AML triplet study is evaluating the addition of emavusertib (ema) to the combination of venetoclax and azacitidine (ven-aza) in AML patients who have achieved complete remission on ven-aza but remain MRD-positive (MRD+), with the goal of enabling patients to achieve uMRD. The first two cohorts in the study evaluate patients who received emavusertib for either 7 or 14 days in a 28-day cycle, in addition to their ven-aza treatment regimen.

In the ASH abstract, the company reported initial data showing 4 of 8 patients (50%) had achieved uMRD as of July 2, 2025. These data were updated in the poster presented at ASH with 5 of 8 patients (62.5%) achieving uMRD, with no change in safety profile, as of October 12, 2025.

"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," said James Dentzer, Curis's Chief Executive Officer.  

About Curis, Inc.
Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor ibrutinib in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL), in the TakeAim Leukemia Phase 1/2 study (CA-4948-102) of emavusertib monotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS), and in a Phase 1 study (CA-4948-104) that adds emavusertib to the combination with venetoclax and azacitidine (ema-ven-aza) in AML patients being treated with ven-aza in the frontline setting who have achieved CR but remain MRD-positive. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis's website at www.curis.com.

Cautionary Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning Curis's expectations with respect to statements regarding data from the AML triplet study.  Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "likelihood", "continue," "potential," "opportunity," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. Curis is dependent on the success of emavusertib and any delays in the development of emavusertib could have a material adverse effect on its business. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, or the CRADA with NCI will be extended, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. Curis will require substantial additional funding in the immediate term to fund the development of emavusertib through regulatory approval and commercialization, and to support its continued operations. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate the development emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA, EMA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control, including its ability to regain and maintain its listing on the Nasdaq Capital Market, could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most Form 10-Q and Form 10-K, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.

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SOURCE Curis, Inc.

FAQ

What update did Curis (CRIS) announce for the AML triplet study on December 9, 2025?

Curis reported that 5 of 8 patients (62.5%) achieved uMRD as of Oct 12, 2025, with no change in safety.

How did Curis's uMRD rate change between July 2 and Oct 12, 2025 in the CRIS study?

The uMRD rate increased from 4 of 8 (50%) on July 2, 2025 to 5 of 8 (62.5%) on Oct 12, 2025.

What emavusertib (ema) dosing schedules were evaluated in Curis's CA-4948-104 study?

The first two cohorts evaluated ema for either 7 days or 14 days in a 28-day cycle alongside ven-aza.

Does Curis report any new safety concerns with the ema/ven/aza triplet in the 2025 update?

No; the company reported no change in safety profile in the updated poster as of Oct 12, 2025.

How many patients were included in Curis's updated frontline AML triplet dataset (CRIS)?

The updated dataset included 8 patients, with results reported as of Oct 12, 2025.