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Kura Oncology to Report Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-02-26 12:30
SAN DIEGO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced it will report fourth quarter and full year 2025 financial results on Thursday, March 5, 2026, before the U.S. financial markets open. Kura’s management will host a conference call and webcast at 8:00 a.m. ET / 5:00 a.m. PT to discuss the financial results and provide a corporate update. The live we ...
Acrivon Therapeutics to Present at the TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-24 13:00
WATERTOWN, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, today announced the company’s president and chief executive officer, Peter Blume-Jensen, M.D., Ph.D., will parti ...
Kura Oncology Highlights Recent Accomplishments, Preliminary KOMZIFTI Revenue and Anticipated 2026 Milestones
Globenewswire· 2026-01-11 22:00
Core Insights - Kura Oncology has launched KOMZIFTI™ (ziftomenib), the first and only once-daily oral menin inhibitor approved for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML) [1][10] - The company reported $2.1 million in net product revenue from KOMZIFTI for the initial five-week period following its commercial sale [1][6] - Kura is positioned for significant advancements in 2026 with a robust pipeline of potentially transformative therapies [1][2] Financial Highlights - KOMZIFTI generated $2.1 million in net product revenue from November 21, 2025, to December 31, 2025 [6] - The company expects milestone payments of $195 million from a collaboration agreement with Kyowa Kirin in Q4 2025 [6] - Estimated collaboration revenue for Q4 2025 is between $15 million to $17 million [6] - Kura had $667.3 million in cash, cash equivalents, and short-term investments as of December 31, 2025 [6] Recent Program Highlights - KOMZIFTI received full FDA approval on November 13, 2025, for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation [6] - The drug was added to the NCCN Clinical Practice Guidelines as a Category 2A recommended treatment option for adults with R/R NPM1-m AML [6] - Positive data from the ongoing Phase 1a/1b KOMET-007 trial were presented at the ASH 2025 meeting, showing favorable safety and efficacy in combination with venetoclax and azacitidine [6] - The Phase 3 KOMET-017 trial began in September 2025, evaluating ziftomenib in combination with chemotherapy for newly diagnosed patients [6] Expected 2026 Key Milestones - Accelerate U.S. uptake of KOMZIFTI in R/R NPM1-m AML and drive quarter-over-quarter growth in net product revenue [12] - Present updated data from the KOMET-007 trial and publish combination data in the first half of 2026 [12] - Expand ziftomenib to non-AML indications and advance enrollment in various clinical trials throughout 2026 [12] - Anticipate non-cash collaboration revenue recognition of $45 million to $55 million in 2026 [12]
Acrivon Therapeutics to Announce Clinical Update on its Ongoing Phase 2b Studies and Planned Confirmatory Phase 3 Trial for ACR-368, Initial Clinical Data on ACR-2316, and Other AP3 Pipeline Updates via Webcast
Globenewswire· 2026-01-06 12:30
Core Viewpoint - Acrivon Therapeutics is set to provide clinical data for its lead programs ACR-368 and ACR-2316 on January 8, 2026, highlighting advancements in precision medicine through its proprietary platform [1][4][7] Group 1: Company Overview - Acrivon Therapeutics is a clinical stage biotechnology company focused on discovering and developing precision medicines using its Generative Phosphoproteomics AP3 platform [3] - The AP3 platform enables unbiased interpretation and quantification of drug-regulated pathway activity levels in intact cells, generating terabytes of data for actionable insights [3] - Acrivon aims to overcome traditional drug discovery limitations by rapidly designing differentiated compounds and advancing them into clinical development [3] Group 2: Clinical Programs - ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, is currently in a Phase 2b trial for endometrial cancer and has received Fast Track designation from the FDA [4] - The ACR-2316 program, a WEE1/PKMYT1 inhibitor, is in Phase 1 trials, with initial clinical activity and dose proportionality observed in early cohorts [5][7] - Upcoming updates will include interim clinical data from the ACR-368 study and initial data from the ACR-2316 study, along with a new preclinical development candidate [7]
UPDATE -- Acrivon Therapeutics to Announce Clinical Update on its Ongoing Phase 2b Studies and Planned Confirmatory Phase 3 Trial for ACR-368, Initial Clinical Data on ACR-2316, and Other AP3 Pipeline Updates via Webcast
Globenewswire· 2025-12-17 14:34
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon Therapeutics utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, allowing for unbiased interpretation of compound-specific pathway activity levels, generating terabytes of data for actionable insights [2] - The AP3 platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, which enhance drug discovery beyond traditional methods [2] Clinical Programs - Acrivon's lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-368 has also received Breakthrough Device designation for its OncoSignature assay to identify suitable patients for treatment [3] - The second clinical asset, ACR-2316, is a WEE1/PKMYT1 inhibitor showing promising early clinical activity and safety in a Phase 1 trial, with initial tumor shrinkage observed [4][6] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data through a conference call and webcast in January 2026, including interim data from the Phase 2b study and the Phase 1 study of ACR-2316 [1][6]
Acrivon Therapeutics to Announce Clinical Update on its Ongoing Phase 2b Studies and Planned Confirmatory Phase 3 Trial for ACR-368, Initial Clinical Data on ACR-2316, and Other AP3 Pipeline Updates
Globenewswire· 2025-12-17 12:30
Core Insights - Acrivon Therapeutics is a clinical stage biotechnology company focused on precision medicine through its proprietary Generative Phosphoproteomics AP3 platform, which enables the interpretation and quantification of drug-regulated effects in intact cells [2][3] Company Overview - Acrivon utilizes its Generative Phosphoproteomics AP3 platform to develop precision medicines, allowing for unbiased interpretation of compound-specific pathway activity levels, generating terabytes of data for actionable insights [2] - The platform includes tools such as the AP3 Data Portal, AP3 Kinase Substrate Relationship Predictor, and AP3 Interactome, which enhance drug discovery beyond traditional methods [2] Clinical Programs - Acrivon's lead program, ACR-368 (prexasertib), is a selective small molecule inhibitor targeting CHK1 and CHK2, currently in a Phase 2b trial for endometrial cancer, with Fast Track designation from the FDA [3] - ACR-2316, a second clinical stage asset, is a selective WEE1/PKMYT1 inhibitor showing promising preclinical results and is currently in a Phase 1 trial with initial clinical activity observed [4] Upcoming Updates - Acrivon plans to provide updates on ACR-368 and ACR-2316 clinical data in January 2026, including interim data from the Phase 2b study and initial results from the Phase 1 study of ACR-2316 [6]
Kura Oncology to Host Virtual Investor Event to Discuss Data Presented at ASH 2025 on Triplet Combination of Ziftomenib (KOMZIFTI®) with Venetoclax and Azacitidine in Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia
Globenewswire· 2025-12-03 13:32
Core Viewpoint - Kura Oncology is hosting a virtual analyst and investor event on December 8, 2025, to discuss data on the triplet combination of ziftomenib, venetoclax, and azacitidine for treating acute myeloid leukemia [1][2] Company Overview - Kura Oncology is a biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3] - The company has developed KOMZIFTI™, an FDA-approved oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia [3]
First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin
Globenewswire· 2025-12-02 13:02
Core Insights - Kura Oncology has completed its first U.S. commercial sale of KOMZIFTI™ (ziftomenib), marking a significant milestone for the company [1] - The sale triggers a $135 million milestone payment from Kyowa Kirin, expected to be received by Kura before year-end [1] - KOMZIFTI was approved by the U.S. FDA on November 13, 2025, for treating adults with relapsed or refractory NPM1-mutated acute myeloid leukemia [1][2] Company Overview - Kura Oncology is focused on precision medicines for cancer treatment, with a pipeline of small molecule drug candidates targeting cancer signaling pathways [2] - The company is commercializing KOMZIFTI™, a once-daily oral menin inhibitor, and is advancing research in menin inhibition and farnesyl transferase inhibition [2]
H.C. Wainwright Initiates Coverage on Acrivon Therapeutics (ACRV) With “Buy” Rating and $19 PT
Yahoo Finance· 2025-11-29 06:26
Core Viewpoint - Acrivon Therapeutics, Inc. (NASDAQ:ACRV) is highlighted as a promising investment opportunity due to its strong recent performance and significant upside potential, particularly driven by advancements in its clinical pipeline [1]. Group 1: Analyst Coverage and Price Target - H.C. Wainwright initiated coverage on Acrivon Therapeutics with a "Buy" rating and a price target of $19, reflecting a positive outlook based on the company's pipeline developments, especially the ACR-368 Phase 2b trial [2]. - The inclusion of a third cohort in the ACR-368 trial is expected to enhance enrollment and overall response rates, particularly for patients with less prior treatment, thereby improving market positioning [2]. Group 2: Financial Performance - In Q3 2025, Acrivon reported a net loss of $18.2 million, an improvement from a loss of $22.4 million in the same quarter the previous year [3]. - R&D expenses decreased from $18.9 million to $13.6 million, indicating a strategic focus on endometrial cancer [3]. - The company ended the quarter with cash reserves of $134.4 million, which is projected to fund operations into Q2 2027 [3]. Group 3: Company Overview - Acrivon Therapeutics is a clinical-stage biopharmaceutical company that develops precision medicines utilizing its Generative Phosphoproteomics AP3 platform to create targeted treatments [4].
KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)
Globenewswire· 2025-11-25 22:16
Core Insights - KOMZIFTI (ziftomenib) is the first and only once-daily oral menin inhibitor approved by the FDA for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, now commercially available in the U.S. [1][2] - The drug has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a Category 2A recommended treatment option for this patient population [1][3] Company Overview - Kura Oncology, Inc. is a biopharmaceutical company focused on precision medicines for cancer treatment, with KOMZIFTI being a key product in its pipeline [19] - Kyowa Kirin Co., Ltd. is a global specialty pharmaceutical company with a long history in drug discovery and biotechnology innovation, collaborating with Kura on the commercialization of KOMZIFTI [20] Clinical Data - KOMZIFTI received full FDA approval on November 13, 2025, based on the KOMET-001 clinical trial, which demonstrated a 21.4% complete response (CR) or complete response with partial hematologic recovery (CRh) rate and a median duration of response of 5 months [2] - The clinical trial involved 112 patients with R/R AML and NPM1 mutation, with differentiation syndrome (DS) occurring in 26% of patients [8][14] Treatment Guidelines - The inclusion of KOMZIFTI in the NCCN Guidelines highlights its potential impact on patients with R/R NPM1-mutated AML and reflects the commitment to patient access [3] - KOMZIFTI is also being developed for front-line treatment of AML with various mutations, indicating its potential to benefit a broader patient population [5] Safety Information - KOMZIFTI has a boxed warning for differentiation syndrome, which can be fatal, and requires monitoring and management protocols [6][7] - Adverse reactions reported in clinical trials include serious reactions in 79% of patients, with the most common being infections and differentiation syndrome [14][16]