Curis Inc (CRIS)

Curis to Report First Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast on May 12, 2026May 5, 2026 5:11 PM
PR Newswire (US) LEXINGTON, Mass., May 5, 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 the Company will report its first quarter 2026 financial and operating results on Tuesday, May 12, 2026, at 4:00 p.m. ET. Management will host a conference call and simultaneous webcast on the same day at 4:30 p.m. ET. Participants may join by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or a live audio webcast can be accessed here or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.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. View original content to download multimedia:https://www.prnewswire.com/news-releases/curis-to-report-first-quarter-2026-financial-and-operating-results-and-host-conference-call-and-webcast-on-may-12-2026-302763278.htmlSOURCE Curis, Inc. Original: Curis to Report First Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast on May 12, 2026

Curis Provides Fourth Quarter 2025 Business UpdateMarch 19, 2026 4:00 PM
PR Newswire (US)

Management to host conference call today at 4:30 p.m. ETLEXINGTON, Mass., March 19, 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 reported its business update and financial results for the quarter ended December 31, 2025.







Operational HighlightsTakeAim LymphomaLakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute in Boston, presented a poster with updated clinical data in Primary CNS Lymphoma (PCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients, showed results for 24 patients who have received treatment with emavusertib and ibrutinib, a BTK inhibitor (BTKi), for at least 1 cycle (28 days):5 of 5 BTKi-naïve patients achieved objective response (100% ORR)7 of 19 BTKi-experienced patients achieved objective response (37% ORR)Median treatment duration for the 12 responders was 123 days (44 – 798 days)9 additional patients were unable to complete 1 cycle of treatment; reasons for discontinuing treatment included adverse events unrelated to treatment, disease progression, and transition to hospice care.Cecilia Merrigan, DNP, Mayo Clinic in Rochester, presented a poster with initial clinical data in Secondary CNS Lymphoma (SCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib, showed results for 2 patients who had previously progressed on a BTKi. Adding emavusertib to their ibrutinib treatment resulted in 1 complete response (CR) and 1 stable disease (SD) with a 38% reduction in disease burden.  Curis continues to enroll PCNSL patients in the Company's TakeAim Lymphoma study of emavusertib in combination with ibrutinib which, as a result of discussions with FDA and EMA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.TakeAim CLL Curis initiated an open label Phase 2 clinical study of emavusertib in combination with zanubrutinib, a BTKi, in patients with Chronic Lymphocytic Leukemia (CLL). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is BTKi, which blocks the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.AMLChristina Papayannidis, MD, IRCCS Azienda Ospedaliero Universitaria di Bologna, presented a poster with initial clinical data in frontline AML at the 67th ASH Annual Meeting in December. The AML triplet study (CA-4948-104) is evaluating the addition of emavusertib to the combination of azacitidine and venetoclax (aza-ven) in AML patients who have achieved complete remission on aza-ven but remain MRD-positive (MRD+). 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 aza-ven treatment. The poster, titled Preliminary Pharmacokinetic and MRD Results from AML Patients Treated with 7- and 14-Day Dosing Schedule of Emavusertib added to Combination Therapy with Azacitidine and Venetoclax, showed results for 4 patients in the 7-day cohort and 6 patients in the 14-day cohort:8 patients had central MRD samples5 of 8 patients (62.5%) achieved MRD conversion (MRD+ to undetectable).CorporateOn January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are currently exercisable at $0.75 per share and have the following termination conditions:Series A warrants terminate on January 8, 2031Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreementSeries C warrants terminate on January 8, 2027.Fourth Quarter 2025 Financial ResultsFor the year ended December 31, 2025, Curis reported a net loss of $7.6 million, or $0.58 per share on both a basic and diluted basis, as compared to a net loss of $43.4 million, or $6.88 per share on both a basic and diluted basis in 2024. For the fourth quarter of 2025, Curis reported net income of $19.4 million or $1.23 per share on both a basic and diluted basis as compared to a net loss of $9.6 million or $1.25 on both a basic and diluted basis for the same period in 2024.Revenues, net were $9.4 million and $10.9 million for the years ended December 31, 2025 and 2024, respectively. Revenues are comprised of royalty revenues related to Genentech and Roche's net sales of Erivedge®. Revenues were $1.1 million and $3.3 million for the fourth quarters of 2025 and 2024, respectively. As previously announced, on November 6, 2025, the Company sold to TPC Investments Royalty LLC, a limited liability company managed by Oberland, its interest in Curis Royalty LLC. The sale included the Erivedge intellectual property, other assets associated with Erivedge and the License Agreement with Genentech ("Erivedge"), in exchange for upfront consideration of $2.5 million and a release of the Company's liability related to sale of future royalties to Oberland. In connection with such transaction, the Company transferred to Curis Royalty all rights to Curis Technology, Inventions and Joint Patents (each as defined in the License Agreement) and assigned the Company's rights, duties and obligations under the License Agreement to Curis Royalty. Following the sale, the Company is no longer entitled to revenues under the License Agreement.Research and development expenses were $28.3 million and $38.6 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related, clinical, manufacturing and consulting costs. Research and development expenses were $5.8 million and $9.0 million for the fourth quarters of 2025 and 2024, respectively.General and administrative expenses were $14.0 million and $16.8 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $2.9 million and $3.4 million for the fourth quarters of 2025 and 2024, respectively.Gain on release of liability related to sale of future royalties associated with sale of assets was the result of the sale of Erivedge. In the fourth quarter 2025, the Company recognized a non-cash $27.2 million gain and the liability related to sale of future royalties was extinguished.Other expense, net was $1.9 million for the year ended December 31, 2025 and other income, net was $1.2 million for the year ended December 31, 2024. The increase was partially attributable to an increase in expense related to the sale of future royalties and a decrease in interest income. Other expense, net was $0.3 million and $0.6 million for the fourth quarters of 2025 and 2024, respectively.As of December 31, 2025, Curis's cash and cash equivalents totaled $5.1 million, and the Company had approximately 12.9 million shares of common stock outstanding.Cash Runway GuidanceCuris believes its cash and cash equivalents as of December 31, 2025, together with initial gross proceeds of $20.2 million received in January 2026 and expected gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company's planned operations into the second half of 2027.Conference Call Information Curis management will host a conference call today, March 19, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.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 Curis's cash runway or expectations with respect to the timing or exercise of the January 2026 PIPE Financing Series B Warrants; Curis's expectations with respect to the dosing of the fifth patient in the TakeAim CLL study, and the therapeutic potential of emavusertib in combination with zanubrutinib to improve treatment outcomes, achieve complete remissions and/or undetectable MRD, and/or reduce time on treatment for patients with CLL; 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, or the use of such data to support regulatory filings for approval of emavusertib in PCNSL, and the therapeutic potential and tolerability of emavusertib in patients with PCNSL.  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 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.CURIS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)(In thousands, except share and per share data) 
Three Months EndedDecember 31,
Twelve Months EndedDecember 31,
2025
2024
2025
2024Revenues, net$       1,138
$       3,345
$     9,443
$     10,908Operating expenses:






Cost of royalties-
17
45
98Research and development5,825
8,968
28,254
38,562General and administrative2,883
3,354
14,046
16,790Total operating expenses8,708
12,339
42,345
55,450Gain on release of liability related to sale of future royalties associated with sale of assets 27,189
-
27,189
-Income (loss) from operations19,619
(8,994)
(5,713)
(44,542)Total other income (expense)(263)
(624)
(1,869)
1,153Net income (loss)$     19,356
$     (9,618)
$    (7,582)
$   (43,389)Net loss per common share (basic and diluted)$         1.23
$       (1.25)
$      (0.58)
$       (6.88)Weighted average common shares (basic and diluted)15,747,068
7,671,226
13,164,032
6,306,284 CURIS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)(In thousands) 

December 31, 2025
December 31, 2024ASSETS



Cash and cash equivalents
$5,061

$                   19,997
Restricted cash
544

544
Accounts receivable
-

3,349
Prepaid expenses and other assets
3,427

4,999
Property and equipment, net
62

231
Operating lease right-of-use asset
1,890

3,163
Goodwill
8,982

8,982
Total assets
$19,966

$                   41,265





LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)Accounts payable and accrued liabilities
$12,886

$                   10,135
Operating lease liability
1,618

2,954
Liability related to the sale of future royalties, net
-

34,174
Total liabilities
14,504

47,263
Total stockholders' equity (deficit)
5,462

(5,998)
Total liabilities and stockholders' equity (deficit)
$19,966

$                   41,265
 



View original content to download multimedia:https://www.prnewswire.com/news-releases/curis-provides-fourth-quarter-2025-business-update-302719122.htmlSOURCE Curis, Inc.

Original: Curis Provides Fourth Quarter 2025 Business Update

Curis to Report Fourth Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on March 19, 2026March 12, 2026 4:27 PM
PR Newswire (US)

LEXINGTON, Mass., March 12, 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 the Company will report its fourth quarter 2025 financial and operating results on Thursday, March 19, 2026, at 4:00 p.m. ET. Management will host a conference call and simultaneous webcast on the same day at 4:30 p.m. ET.







Participants may join by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or a live audio webcast can be accessed here or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.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 has completed its monotherapy and combination studies in acute myeloid leukemia (AML), with additional funding we plan to continue development of emavusertib as a monotherapy and in combination with other agents 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.



View original content to download multimedia:https://www.prnewswire.com/news-releases/curis-to-report-fourth-quarter-2025-financial-and-operating-results-and-host-conference-call-and-webcast-on-march-19-2026-302712824.htmlSOURCE Curis, Inc.

Original: Curis to Report Fourth Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on March 19, 2026

time for this to bust out monksdream

CRIS under $2

CRIS 10 Q due Tuesday 5/6

CRIS, under $2

maybe moving up soon again

well i know im sitting here down a few bucks but i know im in....i aint gonna chase this when news hits

Why they halt it news coming or out 

BRO, thanks for that post, HUGE alert...expecting monster once they pr it...You're the man!

$4.47AH

once they pr it, I think they holding it back..jmho

That was very nice!😍

$4.14 lol

$3.90

Back to $5s soon at $3,80

new 5 year low today? coincidence? muahahahahaha!

It's boooooom time!

CRIS $3.45 + 12% about 8m float 

MACAU casino meca 

https://www.imdb.com/title/tt0041268/

VSME popped on news too



$VSME Late Webull news in AHs

VS Media Holdings Acquires MLINK Limited pic.twitter.com/echRSSZky9— BullishTrade (@Bullish_Trades) December 31, 2024

$CRIS Patent for treatment of Cancer! Huge!
heads-up no official PR yet!

definitely will swing this! pic.twitter.com/9ee1lpOaTa— TheBull (@TheBull_Stocks) December 31, 2024

Patent pending news 

Patent pending $CRIS Patent for treatment of Cancer! Huge!
heads-up no official PR yet!

What's the news

...

The Company is party to a collaboration agreement with Genentech Inc. (“Genentech”), a member of the Roche Group, under which Genentech and F. Hoffmann-La Roche Ltd (“Roche”) are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway antagonist. Erivedge is approved for the treatment of advanced basal cell carcinoma (“BCC”).
The Company is party to an exclusive collaboration agreement with Aurigene Discovery Technologies Limited (“Aurigene”) for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology, including emavusertib.

$CRIS ♥️ Expecting a gap up and run into intraday Thursday! https://t.co/JBxFQ4bg5t— TheBull (@TheBull_Stocks) December 31, 2024

I once had high hopes for this Company

Like $3.30s

CRIS CROSS CRIS CROSS lol

CRIS under $4

CRIS under $6

CRIS under $7

IS THIS STOCK A SCAM OR WHAT??? I WANT THE TRUTH!!!

CRIS under $10

BRUTAL DUMPING

RS is never good.

CRIS new 52 week low

CRIS new 52 weeklow

Nobody saw this because it was sent out along with a 2nd of 15 mil direct financing offering. Next update we RUN!
NEWS
FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID
LEXINGTON, Mass., July 6, 2023 /PRNewswire/ -- Curis, Inc., (Nasdaq: CRIS), a biotechnology company focused on the development of emavusertib, an orally available small molecule triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).


"We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 prior lines of treatment). We also plan to initiate a front-line combination study of emavusertib with azacitidine and venetoclax. We believe emavusertib has the potential to be the cornerstone agent in the treatment of hematological malignancies." said James Dentzer, President and Chief Executive Officer of Curis. "In 2024, we expect to have updated data from the TakeAim Leukemia monotherapy study, clarification of a monotherapy registrational study design, and initial data from an azacitidine and venetoclax combination study."

On April 4, 2022, the Company announced that the FDA placed a partial clinical hold on the TakeAim Leukemia study. On August 30, 2022, the Company announced that the FDA notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase of the TakeAim Leukemia study, so that the Company could enroll at least nine additional patients at the 200 mg BID dose level. On July 6, 2023, the Company announced the FDA had removed the partial clinical hold on the TakeAim Leukemia study and that the RP2D has been established at 300 mg BID.

In the TakeAim Leukemia study, as of the March 17, 2023 data cutoff for patients dosed prior to February 9, 2023, 84 patients received emavusertib monotherapy, ranging from doses of 200 mg to 500 mg BID. Significant blast count reductions have been observed across all patient groups, regardless of dose level, mutation status, or number of prior lines of treatment. Emerging from these data are two genetically-defined subpopulations of relapsed/refractory (R/R) patients who have demonstrated compelling responses in monotherapy: AML patients with FLT3 mutation and AML patients with spliceosome mutation (U2AF1 or SF3B1 mutation) who have received ≤ 2 prior lines of treatment. In these subpopulations of evaluable patients (patients whose disease has been determined to be evaluable for objective response with baseline and post-treatment marrow assessments) treated with 300 mg BID, 2 of 3 patients with a FLT3 mutation achieved a CR (Complete Response), and 2 of 3 patients with spliceosome mutation achieved a CR or CRh (Complete Response with Partial Hematologic Recovery). The duration of response for these patients ranged from 5.6 to 7.0 months.

"A significant unmet need remains for patients with AML and MDS with the majority of front-line patients relapsing with currently available treatment options," said Dr. Reinhard von Roemeling, Senior Vice President of Clinical Development of Curis. "Emavusertib has the potential to be uniquely positioned as an addition to frontline therapy in combination with standard of care and also as a monotherapy in targeted R/R patient populations."

About emavusertib (CA-4948)

Emavusertib is a triple target inhibitor (IRAK4, FLT3 and CLK). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax.

About TakeAim Studies

TakeAim Leukemia Study (NCT04278768) – study is open for enrollment.
TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment.

About Curis, Inc.

Tons of insider buying today at $0.75

Gotta get powerful news and or a serious PUMP. Will take either.

Grossly OVERSOLD!

Just bought 60k shares.88 which is the lowest I have gotten since I discovered this gem. Like taking candy from a baby with all the good news. Market manipulation at its best!

Picked up the 0.97 blocks. Can it get better than this?

FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study
August 30 2022 - 08:00AM
PR Newswire (US)
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Curis working with clinical sites to resume enrollment

Preliminary clinical data update expected in 2023

LEXINGTON, Mass., Aug. 30, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study.

(PRNewsfoto/Curis, Inc.)

Previously, Curis announced that the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April 2022. On August 18, 2022, Curis reported that the partial clinical hold on the TakeAim Lymphoma study was lifted. After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. The partial hold remains in place for the combination therapy phase (Phase 1b) and the expansion phase (Phase 2a) of the study until Phase 1a is complete and the FDA approves proceeding to the next phases of the study.

Before lifting the restriction on patient enrollment, the FDA reviewed additional data provided by the company related to the risk of rhabdomyolysis, a side effect also associated with statins, as well as with cancer medications such as Odomzo® and Cotellic®. The FDA also reviewed the company's strategy for utilizing objective laboratory measurements, similar to those used with Odomzo and Cotellic, to identify rhabdomyolysis, as well as the company's strategy for managing rhabdomyolysis, if it is detected.

"We are pleased to announce the results of the FDA's review and to have addressed potential concerns about the identification and management of rhabdomyolysis," said James Dentzer, President and Chief Executive Officer of Curis. "We are working with our clinical sites to quickly resume enrollment of additional patients."

Similar to the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from the TakeAim Leukemia study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib in leukemia, including alignment on optimal dose and development path, with the FDA's leukemia division.

About Emavusertib (CA-4948)

Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.

About TakeAim Leukemia

The TakeAim Leukemia study (NCT04278768) is a Phase 1/2 open-label dose

Got my GTC filled @ 0.99 this morning. A GIFT

Now that last week's pump is over and done it's time to buy in and accumulate for the next PUMP. Great Company for the long haul as well.

Looks ready for the next leg up. I’m in.