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Curis Announces Positive Emavusertib Update

(Very High)
(Very Positive)
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Curis (NASDAQ: CRIS) reported updated clinical data for emavusertib (CA-4948) in Primary CNS Lymphoma (PCNSL) from the TakeAim Lymphoma study and updated enrollment guidance for the TakeAim CLL Phase 2 study, and will host a webcast on July 22, 2026 at 8:30 a.m. ET.

In PCNSL as of July 1, 2026, BTK inhibitor (BTKi)-naïve patients showed a 100% objective response rate (ORR) in 5 of 5 evaluable patients and 86% ORR in all 7 patients, compared with 71% (5 of 7) in prior data as of May 1, 2025. BTKi-experienced patients demonstrated a 33% ORR in 10 of 30 evaluable patients and 26% ORR in all 39 patients, versus 27% (7 of 26) previously.

For TakeAim CLL, Curis disclosed that 10 patients have now been consented, with the first five expected to be dosed by the end of July 2026. The company increased its year-end 2026 data guidance from 5 patients to 5–10 patients.

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Positive

  • BTKi-naïve PCNSL ORR improved to 86% (6 of 7) from 71% (5 of 7)
  • BTKi-naïve evaluable PCNSL cohort achieved 100% ORR (5 of 5 patients)
  • BTKi-experienced PCNSL evaluable patients showed 33% ORR (10 of 30) as of July 1, 2026
  • BTKi-experienced PCNSL all patients recorded 26% ORR (10 of 39) versus 27% (7 of 26) previously
  • TakeAim CLL enrollment increased to 10 consented patients, up from 6 reported in early July 2026
  • Year-end 2026 CLL guidance raised from 5 patients to 5–10 patients with data expected in December 2026

Negative

  • None.

Market reaction: CRIS +21.05% on PCNSL clinical data

+21.05% $5.75
15m delay
+21.05% Since News
$5.75 Last Price
$4.49 $5.75 Day Range
+$2M Valuation Impact
$9.26M Market Cap
0.1x Rel. Volume

Following this news, CRIS has gained 21.05%, reflecting a significant positive market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $5.75. This price movement has added approximately $2M to the company's valuation.

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Market Context

An effective S-3 remains on file through Feb 13, 2029, registering 107,706,700 shares for investor r...
Analysis

An effective S-3 remains on file through Feb 13, 2029, registering 107,706,700 shares for investor resale rather than company proceeds. Low short positioning adds context; enrollment execution and December CLL data remain key items to watch.

Key Figures

BTK-naive cohort: 7 patients BTKi-experienced cohort: 39 patients BTK-naive ORR: 100% ORR (5 of 5) +5 more
8 metrics
BTK-naive cohort 7 patients PCNSL data as of July 1, 2026
BTKi-experienced cohort 39 patients PCNSL data as of July 1, 2026
BTK-naive ORR 100% ORR (5 of 5) Evaluable PCNSL patients
BTK-naive ORR 86% ORR (6 of 7) All BTK-naive PCNSL patients
BTKi-experienced ORR 33% ORR (10 of 30) Evaluable PCNSL patients
BTKi-experienced ORR 26% ORR (10 of 39) All BTKi-experienced PCNSL patients
CLL patients consented 10 patients TakeAim CLL study
Year-end CLL data guidance 5-10 patients December 2026, increased from 5 patients

Historical Context

5 past events · Latest: Jul 06 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 06 CLL enrollment milestone Positive -14.3% Six patients consented and eleven clinical sites opened for the CLL study.
Jun 26 CLL study update Positive +56.0% Eleven sites opened and stockholders approved a reverse stock split.
May 12 Quarterly business update Negative -9.2% First-quarter results included a $24.2M net loss and $15.0M cash balance.
May 05 Earnings scheduling notice Neutral +8.2% Curis scheduled its first-quarter results release and webcast for May 12.
Mar 19 Quarterly business update Positive +1.9% Curis reported Q4 net income and updated emavusertib clinical development.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

CRIS reactions to recent announcements varied, including a negative response to a prior CLL enrollment milestone despite the operational progress.

Key Terms

orr, irak4, flt3 inhibitor
3 terms
orr medical
"BTK-naïve | 100% ORR | 86% ORR | 71% ORR"
Objective Response Rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink or disappear by a predefined amount after treatment. For investors, ORR is a quick, measurable signal of a therapy’s effectiveness—like early sales numbers for a new product—and strong ORR data can boost a drug’s commercial prospects and company valuation, while weak ORR can temper expectations.
irak4 medical
"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 inhibitor medical
"small molecule IRAK4 and FLT3 inhibitor"
A FLT3 inhibitor is a drug that blocks the action of the FLT3 protein, which can send strong growth signals in certain blood cancers; when FLT3 is abnormal, it acts like a stuck accelerator pedal that makes cancer cells multiply. Investors watch FLT3 inhibitors because their success in clinical trials and approval can drive sales growth, affect company valuations and partnerships, and change the competitive landscape and regulatory risk in cancer treatment markets.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Updated Clinical Data in PCNSL

Increased Guidance on Year-End Data in CLL

Company to Host Webcast at 8:30 a.m. ET

LEXINGTON, Mass., July 22, 2026 /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, today announced that it will host a webcast on Wednesday, July 22 at 8:30 a.m. ET to discuss positive updated clinical data in the TakeAim Lymphoma study, its ongoing registrational study in Primary CNS Lymphoma (PCNSL), and provide updated guidance on year-end data in the TakeAim CLL study, its ongoing Phase 2 study in Chronic Lymphocytic Leukemia (CLL).

Participants may join the live audio webcast here or by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.

Take Aim Lymphoma

The PCNSL update includes data for 7 BTK-naïve patients and 39 BTKi-experienced patients:



                              (as of July 1, 2026)                        

            (as of May 1, 2025)          



Evaluable

 All

Previous Data



Patients*

Patients

All Patients




BTKi-naïve

100% ORR

86% ORR

71% ORR



(5 of 5)

 (6 of 7)

(5 of 7)




BTKi-experienced

33% ORR

26% ORR

 27% ORR



(10 of 30)

(10 of 39)

(7 of 26)




* excludes patients who did not complete



at least 1 cycle (~1 month) of treatment


TakeAim CLL

On June 26, 2026, Curis announced that eleven clinical sites had opened for enrollment in the TakeAim CLL study and on July 6, 2026, announced that it has consented the first six patients in that study. Today, the Company announced that the number of patients consented has increased to 10, with the first five expected to be dosed by the end of July. The company is also increasing its guidance for year-end CLL data from 5 patients to 5-10 patients in December 2026.

"We are very encouraged by the updated data from the PCNSL study and by the support of clinicians and regulators for this novel treatment for patients with PCNSL. We are especially excited by the results in the BTKi-experienced patients for whom there are no approved therapies, where emavusertib has shown it can reverse disease progression in patients currently progressing on a BTK inhibitor and enable them to achieve objective responses," said James Dentzer, Chief Executive Officer of Curis. "We are also encouraged by the strong interest among clinical sites and key opinion leaders in our TakeAim CLL study that has enabled us to exceed expectations for site activation and enrollment."

About PCNSL and CLL

In PCNSL and CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim Lymphoma and TakeAim CLL Studies is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTKi blocks the BCR pathway; emavusertib blocks the TLR pathway.

BTKi is an established standard of care in Relapsed/Refractory (R/R) PCNSL. For BTKi-naïve patients, response rates can be 40%-70% and are typically partial responses. For those patients who progress on BTKi, outcomes are generally poor, with many patients proceeding directly to hospice or best supportive care. Initial clinical data have shown that adding emavusertib to a BTKi regimen, directly after a patient progresses on BTKi monotherapy, can enable patients to reverse their disease progression and achieve an objective response.

BTKi is also standard of care in CLL, where outcomes are more favorable than in PCNSL. In the registrational study for the BTKi zanubrutinib in CLL, 93% of patients were able to achieve an objective response, though only 7% achieved complete response2. More recent clinical studies have shown that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD).

About the TakeAim Lymphoma Study

The TakeAim Lymphoma Study is a three-part study of emavusertib in combination with ibrutinib in patients with PCNSL (CA-4948-101, NCT03328078). Part A, the dose escalation part of the study, is complete. Part B is an ongoing single-arm study in BTKi-experienced patients. Part C is an ongoing randomized study in BTKi-naïve patients.

In 2025, Curis announced that it completed meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency's Committee for Medicinal Products for Human Use (EMA) to review initial clinical data from the Phase 1/2 single-arm study in PCNSL and received guidance that this ongoing study could support an application for accelerated approval in Relapsed/Refractory (R/R) PCNSL.

About the TakeAim CLL Study

The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months. Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL study by the end of July, with initial data in 5-10 patients expected in December 2026.

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) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company's monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. 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 the regulatory guidance on potential Conditional Marketing Authorization (CMA) from the EMA and potential NDA for Accelerated Approval from the FDA for emavusertib in the treatment of PCNSL, and Curis's expectations with respect to regulatory objectives; Curis's expectations with respect to enrollment of BTKi naïve and BTKi experienced populations in the TakeAim Lymphoma study; statements regarding updated PCNSL data and the timing of such data from the TakeAim Lymphoma study, the potential use thereof for regulatory submissions to support CMA and/or Accelerated Approval, and the therapeutic potential and tolerability of emavusertib in patients with PCNSL; expectations with respect to the number of patients consented in the TakeAim CLL study, the dosing of the first five patients and the timing thereof, the Company's increased guidance for year-end CLL data from five patients to five to ten patients, and the timing of and initial data from the TakeAim CLL study; statements concerning research, development, clinical trials and commercialization plans, timelines, anticipated results, use, safety, efficacy, rates and duration of responses, mutations or potential biomarkers, and potential benefits of emavusertib as a monotherapy and/or as a combination therapy. 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 or the CRADA with NCI will continue for their full terms, 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 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 of 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 recent Form 10-K, and the factors that are discussed in other filings that Curis periodically makes 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.

1 Bennett, Curr Opin Hematol. 2022
2 Zanubrutinib USPI

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/curis-announces-positive-emavusertib-update-302831553.html

SOURCE Curis, Inc.

FAQ

What new emavusertib data did Curis (CRIS) report on July 22, 2026?

Curis reported updated emavusertib data in Primary CNS Lymphoma from the TakeAim Lymphoma study, including improved response rates in BTKi-naïve patients. According to Curis, BTKi-naïve PCNSL patients reached 100% ORR in evaluable patients and 86% ORR in all patients as of July 1, 2026.

How strong were emavusertib response rates in BTKi-naïve PCNSL patients for Curis (CRIS)?

BTKi-naïve PCNSL patients showed a 100% objective response rate in 5 of 5 evaluable patients and 86% ORR in all 7 patients. According to Curis, this compares with 71% ORR (5 of 7) in the prior May 1, 2025 dataset.

What did Curis (CRIS) report for BTKi-experienced PCNSL patients treated with emavusertib?

Curis reported that BTKi-experienced PCNSL patients had a 33% ORR in 10 of 30 evaluable patients and 26% ORR in all 39 patients. According to Curis, prior data as of May 1, 2025 showed a 27% ORR (7 of 26 patients).

How is Curis progressing TakeAim CLL enrollment and guidance as of July 22, 2026?

Curis reported that 10 patients have been consented in the TakeAim CLL Phase 2 study, with five expected to be dosed by the end of July 2026. According to Curis, year-end 2026 data guidance increased from 5 patients to a range of 5–10.

When is the Curis (CRIS) webcast on the emavusertib updates scheduled?

The webcast discussing emavusertib clinical data and TakeAim CLL guidance is scheduled for July 22, 2026 at 8:30 a.m. ET. According to Curis, investors can access the live audio via its website, with a replay available afterward.

What studies are included in Curis’ emavusertib program mentioned on July 22, 2026?

Curis highlighted two ongoing emavusertib studies: the TakeAim Lymphoma trial, including a registrational PCNSL cohort, and the TakeAim CLL Phase 2 study in chronic lymphocytic leukemia. According to Curis, both programs are generating updated response and enrollment data in 2026.