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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
WATERTOWN, Mass., Jan. 06, 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 designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell which is deployed for rational drug design and predictive clinical development, ...
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
WATERTOWN, Mass., Dec. 17, 2025 (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 designed to interpret and quantify global compound-specific, drug-regulated effects in the intact cell which is deployed for rational drug design and predictive clinical development, ...
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
With strong three-month performance and significant upside potential, Acrivon Therapeutics, Inc. (NASDAQ:ACRV) secures a spot on our list of the 12 hot penny stocks to invest in right now. H.C. Wainwright Initiates Coverage on Acrivon Therapeutics (ACRV) With "Buy" Rating and $19 PT On November 25, 2025, Acrivon Therapeutics, Inc. (NASDAQ:ACRV) saw H.C. Wainwright’s Emily Bodnar initiate coverage with a “Buy” rating and a $19 price target. The analyst’s bullish rating reflected the company’s strong outlo ...
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]
Beacon Biosignals Announces Multi-Year Expansion of Strategic Collaboration with Takeda to Advance Narcolepsy Diagnosis and Neurobiomarker Discovery
Globenewswire· 2025-11-19 11:30
Core Insights - Beacon Biosignals has announced a multi-year expansion of its collaboration with Takeda, focusing on AI-driven neurodiagnostics and precision medicine for narcolepsy [1] - The partnership aims to utilize Beacon's technology to enhance the diagnosis of narcolepsy, particularly addressing the challenges faced by patients with Narcolepsy type 1 [2][3] - The agreement allows Beacon to receive up to $109 million in potential fees and milestones, indicating significant financial backing for the initiative [1] Company Overview - Beacon Biosignals is a leader in precision medicine, specializing in neurophysiology for clinical diagnostics and drug development [5] - The company offers an FDA-cleared at-home EEG headband that provides PSG-quality sleep staging, which is crucial for diagnosing sleep disorders [5] - Advanced AI and machine learning algorithms are employed to assist clinicians in diagnosing sleep disorders and evaluating treatment effects [5] Industry Context - Narcolepsy is a rare neurological disorder that affects sleep regulation, with a significant portion of patients, particularly those with Narcolepsy type 1, remaining undiagnosed [2] - The collaboration with Takeda aims to leverage real-world clinical data to identify sleep biomarkers, potentially leading to improved diagnostic pathways and therapeutic opportunities [3][4] - The partnership reflects a growing trend in the healthcare industry towards utilizing AI and real-world data to enhance patient outcomes and streamline diagnostic processes [4]
OnKure Therapeutics to Participate in Upcoming Investor Conferences
Globenewswire· 2025-11-04 21:05
Core Insights - OnKure Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel precision medicines targeting cancers that are underserved by existing therapies [2] - The company is utilizing a structure-based drug design platform to create a pipeline of tumor-agnostic candidates aimed at achieving optimal efficacy and tolerability [2] - OnKure's lead program is OKI-219, a selective PI3Kα inhibitor, with the goal of becoming a leader in targeting oncogenic or pathologically activated PI3Kα [2] Upcoming Events - The CEO, Nichoals Saccomano, will present at the Guggenheim Healthcare Innovation Conference on November 10, 2025, at 4:00 p.m. ET [4] - A corporate presentation will take place at the Stifel Healthcare Conference on November 12, 2025, at 4:00 p.m. ET [4] - A fireside chat is scheduled for the Evercore Healthcare Conference on December 3, 2025, at 12:30 p.m. ET [4]
Maze Therapeutics CEO Jason Coloma on how the new biotech is taking on Kidney disease
CNBC Television· 2025-10-28 20:27
Research firm BTI calls this company an emerging leader in a fight against specific types of kidney disease. Millions of people around the world could be candidates for maze therapeutics main drug candidate. Company expects data from its phase 2 trial in the first quarter of next year.They've got a variety though of different programs trying to solve some of these diseases. Jason Col is the CEO of Maze Therapeutics joining us now here in our San Francisco studio for another CNBC exclusive. Jason, good to ha ...