Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment

On March 30, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) has completed its filing review of the New Drug Application (NDA) for lirafugratinib, an investigational therapy, for the treatment of patients with cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements who have received prior therapy. The FDA determined that the NDA is sufficiently complete to permit a substantive review and granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2026.

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Priority Review designations are given to applications for medicines that, if approved, would lead to "significant improvements in the safety or effectiveness of the treatment" of a serious condition, according to the FDA. The Priority Review designation of the lirafugratinib NDA was supported by positive clinical data from the Phase 1/2 ReFocus trial (NCT04526106), which demonstrated a confirmed objective response rate (ORR) of 46.5% in the patients with the proposed indication. Its safety profile in the clinical data has been shown to be predictable and manageable through dose adjustments.

"Lirafugratinib has established a compelling clinical profile that differentiates it from existing treatment options," said Dong-Gun Kim, chief executive officer of Elevar. "We are very pleased with the FDA’s priority review designation and focused on advancing the review process efficiently to bring this therapy to patients as quickly as possible."

CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. diagnosed each year, according to the American Cancer Society.

Elevar Therapeutics continues to evaluate lirafugratinib in ongoing clinical development programs, including studies in other FGFR2-altered solid tumors. Any future indications will be subject to regulatory review and approval.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, MAR 30, 2026, View Source [SID1234664042])

Aktis Oncology Announces FDA Clearance of Investigational New Drug Applications for AKY-2519 and Provides Business Updates and Full Year 2025 Financial Results

On March 30, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. The Company also provided business updates and reported financial results for the year ended December 31, 2025.

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"Aktis was founded to improve outcomes for cancer patients by pioneering a new class of targeted radiopharmaceuticals for prevalent tumor types that have historically been beyond the reach of this modality," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "We continue to make significant progress on all fronts of our plan, including advancing the enrollment of our Phase 1b clinical trial of AKY-1189 in patients with Nectin-4 expressing tumors, which was granted FDA Fast Track designation in February, as well as the recent clearance of our IND applications for AKY-2519. We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026. This momentum, together with our proprietary miniprotein radioconjugate platform, supply chain infrastructure, and strong cash position, strengthens our leadership in targeted radiopharmaceuticals."

Dr. Roden continued, "AKY-1189 and AKY-2519 each represent significant patient impact opportunities, with the potential to address multiple indications across various tumor types. We are working urgently to generate the clinical data necessary to support registrational trials for both programs."

Business updates and anticipated key milestones

Pipeline
AKY-1189, a novel miniprotein radioconjugate designed to selectively deliver 225Ac to Nectin-4 expressing tumors, is in an ongoing Phase 1b clinical trial enrolling patients with locally advanced or metastatic urothelial cancer (mUC), breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.

In February 2026, the FDA granted Fast Track designation for AKY-1189 for the treatment of adult patients with locally advanced or mUC who have progressed on or after prior systemic therapies.

AKY-2519, a miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung and other solid tumors, is in an ongoing imaging and dosimetry clinical assessment of AKY-2519 to enable initial understanding of biodistribution and uptake in tumors and normal tissues.

In March 2026, the FDA cleared the IND applications for [64Cu]Cu-AKY-2519 (imaging) and [225Ac]Ac-AKY-2519 (therapeutic use) to proceed to a Phase 1b clinical trial.

Corporate
On January 8, 2026, the Company priced an initial public offering (IPO) of its common stock, raising $365.4M gross proceeds, before underwriting discounts and other offering-related expenses.

Anticipated key milestones for the next 12 months

AKY-1189: Preliminary data from Part 1 of the ongoing Phase 1b clinical trial are expected in the first quarter of 2027.
AKY-2519:
Results from clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026.
Phase 1b clinical trial is expected to commence in mid-2026. The Company plans to provide further details on the overall clinical development strategy of AKY-2519 at that time.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility is expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.
2025 financial results

Cash position: Cash, cash equivalents and marketable securities were $226.8 million as of December 31, 2025, compared to $297.2 million as of December 31, 2024. Subsequent to December 31, 2025, the Company completed its IPO, generating net proceeds of approximately $335.3 million, after underwriting discounts, commissions and offering-related expenses. As a result, the Company’s pro forma as adjusted cash position as of year-end 2025 was $562.1 million, reflecting cash, cash equivalents and marketable securities as of December 31, 2025, plus net proceeds from the January 2026 IPO. The Company believes that the pro forma as adjusted cash position will fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $6.5 million for the year ended December 31, 2025, compared to $1.5 million for the year ended December 31, 2024. The increase was attributable to revenue recognized under the Company’s collaboration with Eli Lilly and Company, which was entered into in May 2024. In 2024, revenue recognition began in the fourth quarter, whereas a full year of revenue was recognized in 2025.
R&D expenses: Research and development expenses were $67.5 million for the year ended December 31, 2025, compared to $41.0 million for the year ended December 31, 2024. The increase was primarily driven by higher headcount, and increased program expenses to support the advancement of AKY-1189 in a Phase 1b clinical trial and AKY-2519 IND-enabling studies and clinical imaging and dosimetry assessment.
G&A expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2025, compared to $12.6 million for the year ended December 31, 2024. The increase was primarily due to higher headcount to support the Company’s growing business.
Net loss: Net loss was $63.7 million for the year ended December 31, 2025, compared to $44.0 million for the year ended December 31, 2024. The increase in net loss was primarily driven by the increase in R&D expenses described above.

(Press release, Aktis Oncology, MAR 30, 2026, View Source [SID1234664041])

RenovoRx Reports Full Year 2025 Financial Results and Provides Business Update

On March 30, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the full year and fourth quarter ended December 31, 2025, and is providing a business update to shareholders.

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Shaun Bagai, Chief Executive Officer of RenovoRx, commented, "2025 marked a key year as it was our first full year of RenovoCath commercialization, generating over $1 million in revenue and reflecting strong initial physician adoption and demand in a handful of active commercial cancer centers. We also learned many valuable lessons to finalize our go-to-market strategy that we are implementing and building out a team to drive commercial growth in 2026 and beyond."

Mr. Bagai continued, "We entered 2025 having just taken our initial steps towards commercialization, with no dedicated sales team and limited approved commercial cancer centers. We exited the year with a strong understanding of the market and a clear strategy supported by a focused and agile sales and marketing team. Our network of active commercial cancer center clients continues to grow, resulting in meaningful revenue generation. While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential for RenovoCath as a stand-alone device. Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, and increasing procedural utilization. As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCath, and 21 additional centers are evaluating the device, have completed evaluation, or are preparing for activation. These 33 centers represent a tripling of our near-term pipeline compared to the first quarter of 2025."

"Importantly, we established our commercial infrastructure in the fourth quarter of 2025, positioning us to scale in 2026 with a targeted focus on high-volume cancer centers. On top of this, we have significantly strengthened our balance sheet with $10 million in gross proceeds (net proceeds of $9.2 million) from recent financing led by new and existing institutional investors including insider participation, giving us $13 million in cash on hand as of today. We strongly believe we now have the funding, business plan, leadership, and infrastructure to propel execution across all of our activities as we drive towards important milestones, including breakeven operations and trial data."

"Simultaneously, we are advancing our pivotal Phase III TIGeR-PaC trial, which remains on track for full enrollment in the near term and with final results anticipated next year. We recently announced the achievement of a milestone by randomizing our 100th patient in the trial. As of March 24, 2026, 104 patients have been randomized with 72 events (deaths) observed. Our target of full enrollment by the middle of this year would ensure a minimum of 114 patients will be randomized. Our study protocol requires us to advance a minimum of 114 patients to randomization, so we are really in the home stretch of this trial. Moreover, our goal is to transition the 17 cancer centers that have used RenovoCath as part of the TIGeR-PaC trial to commercial customers for RenovoCath in the second half of 2026 after completion of TIGeR-PaC enrollment. Select TIGeR-PaC cancer centers have already begun using the TAMP (Trans-Arterial Micro-Perfusion) therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors, giving us even more optimism for the expansion of our revenue potential," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx achieved key milestones in the commercial launch of RenovoCath in 2025, its first full year of generating revenue. For the year ending December 31, 2025, the Company generated $1.1 million in revenue from RenovoCath sales, driven by both new cancer centers adopting the device and repeat orders from existing customers. This early commercial traction reflects increasing physician interest in targeted intra-arterial drug-delivery and shows that RenovoCath is becoming widely used within clinical workflows at leading, high-volume cancer centers. The Company also learned valuable lessons about cycle trends, activation timelines, customer preferences, and other commercial data which it expects to apply as it seeks to grow RenovoCath revenues in 2026 and beyond.

Adoption continued to expand across the United States, with 12 cancer centers actively utilizing RenovoCath as of early 2026 and a growing pipeline of additional centers evaluating the device, having completed evaluation or are preparing for activation. The Company is also observing repeat ordering patterns and increased procedural utilization among early adopters, reinforcing confidence in physician satisfaction and the potential for recurring revenue. RenovoRx believes these trends support the long-term commercial opportunity for RenovoCath as both a stand-alone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, and ultimately a multi-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs Update

RenovoRx continues to advance its ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC). The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized.

During 2025, the TIGeR-PaC trial reached a key milestone with the completion of the second pre-planned interim analysis. Following its review, the independent Data Monitoring Committee for the trial recommended that the study continue without modification, which the Company believes is an expression of confidence in the potential for a positive outcome in the trial overall. TIGeR-PaC remains the cornerstone of RenovoRx’s clinical development strategy and is designed to evaluate overall survival benefit with the potential to support a future New Drug Application submission, if successful.

The Company also continues to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT studies achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath.

Fourth Quarter 2025 and Subsequent Key Highlights

During the fourth quarter of 2025, RenovoRx completed the initial buildout of its commercial infrastructure, including the launch of its sales and marketing team, and continued advancing its commercialization strategy.

RenovoRx strengthened its executive leadership team in February 2026 to support the commercial growth of RenovoCath with the appointment of Mark Voll as Chief Financial Officer. Mr. Voll brings more than 30 years of financial leadership experience with a proven track record of guiding high-growth public companies through periods of commercial buildout and strategic development. He has served as Chief Financial Officer for multiple publicly traded technology companies where he successfully led initiatives that scaled operations into high-growth businesses.

In February 2026, the Company established the RenovoCath Medical Advisory Board (MAB) to provide strategic clinical guidance in advancing the TAMP therapy platform across indications of high unmet medical needs. The MAB includes leading interventional oncology experts: Nadine Abi-Jaoudeh, MD of UCI Health, Mustafa Al-Roubaie, MD of Moffitt Cancer Center, Khashayar Farsad, MD, PhD of Oregon Health and Science University, Ripal Gandhi, MD of Baptist Health South Florida, Paula Marie Novelli, MD of University of Pittsburgh Medical Center and Jonathan Kessler, MD of City of Hope Comprehensive Cancer Center.

On March 20, 2026, RenovoRx closed on an oversubscribed private placement of common stock and revenue milestone warrants resulting in gross proceeds of $10 million to RenovoRx, before deducting placement agent fees and offering expenses with net proceeds of $9.2 million. The financing was led by new and existing high-quality institutional investors, and the Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The net proceeds of the private placement provide RenovoRx with a total of approximately $13 million cash and cash equivalents in hand to drive its business towards the expected achievement of important milestones in 2026 and 2027.

Financial Highlights for the Full Year Ended December 31, 2025

Revenue for the year ended December 31, 2025, was $1.1 million, compared to $43,000 for the year ended December 31, 2024. Fiscal year 2025 marked our first full year of revenue of RenovoCath and early customer adoption across U.S. cancer centers.

Cash and cash equivalents were approximately $7.0 million as of December 31, 2025. Subsequent to year end, on March 20, 2026, the Company strengthened its balance sheet and closed a private placement offering with gross proceeds of $10 million and net proceeds of $9.2 million.

Research and development expenses were approximately $6.3 million for the year ended December 31, 2025, compared to approximately $6.0 million for the same period last year. The increase was primarily attributable to continued investment in the Company’s ongoing Phase III TIGeR-PaC clinical trial, as well as development activities related to the next generation of the RenovoCath device.

Selling, general, and administrative expenses were approximately $7.0 million for the year ended December 31, 2025, compared to approximately $5.0 million for the year ended December 31, 2024. The increase was primarily driven by the buildout of the Company’s commercial infrastructure, including sales and marketing capabilities, as well as higher professional services and personnel-related costs.

Net loss for the year ended December 31, 2025, was approximately $11.2 million, compared to approximately $8.8 million for the prior year.

Shares of common stock outstanding as of March 23, 2026 was 45,052,706.

Conference Call Details

Event: RenovoRx Fourth Quarter & Full Year 2025 Financial Results and Business Highlights Call
Date: Monday, March 30, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until April 13, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13758677.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAR 30, 2026, View Source [SID1234664040])

Certis Oncology Unveils Oncology Intelligence® Platform Integrating Predictive and Agentic AI with Biological Validation

On March 30, 2026 Certis Oncology, an AI-enabled translational science company, reported the launch of Certis Oncology Intelligence, an integrated platform designed to generate data-driven insights into therapeutic response by combining predictive modeling, agentic AI-enabled biological data exploration, and functional validation in clinically relevant cancer models.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

"One of the central challenges in oncology drug development is that we generate enormous amounts of data, but struggle to translate that into reliable predictions of therapeutic response," said Peter Ellman, Certis President and CEO. "Certis Oncology Intelligence was built to close that gap—linking prediction, biological context, and experimental validation into a system that continuously learns and improves over time."

A Three-Layer Translational Intelligence System

Certis Oncology Intelligence is a secure, multi-tenant, closed loop system that integrates three data layers:

1.

Predictive Intelligence Layer— CertisAI

A patented, generalized drug-response foundation model trained to internalize relationships between chemical structure, tumor biology, and therapeutic response, CertisAI enables zero-shot prediction of how cancers are likely to respond to therapeutic agents, including novel compounds, even in the absence of prior experimental data.

This predictive layer can be fine-tuned using sponsor training data, producing powerful, custom computational models uniquely aware of each company’s novel chemical space.

2.

Exploration Layer — Agentic Biospecimen Management

Agentic biospecimen management enables researchers to dynamically query and analyze biological specimens together with their associated molecular and experimental datasets—offering a secure in silico environment in which to rapidly test hypotheses.

Within the Oncology Intelligence platform, licensors can integrate their own proprietary datasets—molecular profiles, drug-response screening results, target binding data, and other translational information accumulated across programs over many years.

By cross-referencing a company’s proprietary datasets with the platform’s foundational training data, the system can surface previously hidden relationships within each sponsor’s institutional knowledge base—generating new hypotheses, translational insights, and opportunities to advance or reprioritize therapeutic programs.

3.

Validation Layer—Functional Biological Evidence

A key differentiator of this platform is its ability to learn from continuous biological validation using experimental data generated either by Certis or by its collaborators. Validation data may include results from studies performed in human-concordant cancer models such as patient-derived xenografts (PDX), as well as in vitro assays, organoid models, or clinical trials.

Importantly, results from experimental studies are seamlessly fed back into the system as additional training data, continually improving predictive performance over time.

Unlocking the Value of Translational Data

The platform is designed to help pharmaceutical and biotechnology companies:

Integrate diverse datasets across programs and time
Identify biologically meaningful drivers of therapeutic response
Generate and test hypotheses more efficiently
Improve confidence in translational and clinical decision-making
By enabling organizations to extract new insights from existing data while continuously generating new evidence, Certis Oncology Intelligence offers a scalable foundation for more predictive and data-driven oncology development.

Availability

Certis Oncology Intelligence is available to pharmaceutical and biotechnology partners through licensing and collaborative engagements.

(Press release, Certis Oncology Solutions, MAR 30, 2026, View Source [SID1234664039])

IDEAYA Biosciences Announces First-Patient-In for Phase 1 Combination Study of IDE849, DLL3 TOP1 ADC, and IDE161, PARG Inhibitor, in DLL3 Upregulated Solid Tumor Indications, including SCLC, NETs, NECs, and Melanoma

On March 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported first-patient-in for a Phase 1 clinical trial combination study to evaluate IDE849, a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, and IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor. The Phase 1 combination study will be evaluated in DLL3 upregulated solid tumor indications, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.

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"We are excited about the progress in our Phase 1 IDE849 monotherapy study to determine the RP2D and to initiate a registrational study by year-end, and the advancement of our wholly owned first-in-class clinical combination of IDE849 and IDE161 in DLL3 upregulated solid tumor indications," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We are leveraging our deep scientific expertise in DNA damage repair to enable this rational combination with IDE161, with the goal of inducing accumulation of TOP1 lesions to enhance the clinical efficacy and durability of our proprietary TOP1-payload ADCs, including IDE849 and IDE034, a Phase 1 B7H3/PTK7 bispecific TOP1 ADC," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDEAYA is advancing a multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, NETs, and NECs, and melanoma (NCT07174583). The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating a 3.5 mg/kg IV dose once every 3-weeks (Q3W). Next, to determine the recommended Phase 2 dose (RP2D), IDEAYA is also enrolling patients in a IDE849 expansion cohort at the 2.4 mg/kg IV dose Q3W, where multiple partial responses (PRs) have been observed by RECIST 1.1, including 3 PRs out of 4 SCLC patients pre-treated with IMDELLTRA (tarlatamab-dlle). The preliminary safety and efficacy profile observed to date in the IDEAYA sponsored study is consistent with the clinical data presented by our China-region partner Jiangsu Hengrui Pharmaceuticals Co. Ltd., at the IASLC World Conference on Lung Cancer 2025 (WCLC 2025).

In addition, IDE849 is being evaluated in a clinical combination with IDEAYA’s potential first-in-class Phase 1 PARG inhibitor, IDE161. IDEAYA has presented preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at WCLC 2025. IDE161 prevents the removal of poly(ADP-ribose) chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA’s TOP1-payload based ADC pipeline, including IDE849 and IDE034 (Phase 1 B7H3/PTK7 Bispecific TOP1 ADC).

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NETs, NSCLC, melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.

(Press release, Ideaya Biosciences, MAR 30, 2026, View Source [SID1234664037])