On July 22, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported original data in the New England Journal of Medicine independently validating recent findings on tumor-infiltrating clonal hematopoiesis (TI-CH), and further reinforcing its leadership in precision oncology (Press release, Caris Life Sciences, JUL 22, 2025, View Source [SID1234654473]).

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As a champion of scientific collaboration, Caris appreciated the opportunity to validate a recent study published in the New England Journal of Medicine, which brought attention to the clinical challenge of TI-CH—blood-derived mutations that infiltrate tumor tissue and are often misinterpreted as tumor-specific mutations. These misinterpretations can lead to inappropriate treatment decisions and poorer patient outcomes.

"The ability to validate important studies shows how collaboration between Caris scientists and a Caris Precision Oncology Alliance member can quickly respond to and confirm new discoveries, enhancing clinically meaningful insights for oncologists and their patients," said David Spetzler, MS, PhD, MBA, President of Caris. "This precision ensures that treatment decisions are based on true tumor biology, ultimately leading to better outcomes for patients."

Caris built on the findings from the study and analyzed 3,255 matched tumor–blood NGS samples from its extensive real-world clinico-genomic database of over 500,000 samples. The study focused on patients with late-stage cancer and confirmed TI-CH is prevalent across solid tumors, with the highest incidence in non-small cell lung cancer (NSCLC) – approximately 1 in every 4 patients (23%). Patients with TI-CH have worse outcomes, with a 30% higher risk of death compared to patients without TI-CH.

"Clonal hematopoietic mutations play a critical role in the precision oncology puzzle," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. "Understanding their role in treatment response will lead to improved patient outcomes."

On July 22, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, reported the publication of an abstract for an oral presentation on IDE849 (SHR-4849) at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (WCLC), taking place September 6-9, 2025 in Barcelona, Spain (Press release, Ideaya Biosciences, JUL 22, 2025, View Source [SID1234654472]). The presentation will cover efficacy and safety results in SCLC from the Phase 1 trial Hengrui is conducting in China for IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topoisomerase-1 (TOP1) payload antibody drug conjugate (ADC). DLL3 is upregulated across multiple solid tumor types where significant unmet need remains, including SCLC, neuroendocrine tumors (NETs), non-small cell lung cancer (NSCLC) and melanoma.

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IDEAYA will also have a poster presentation with data from a second published abstract providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, the company’s proprietary, potentially first-in-class PARG inhibitor. This combination has the potential to enhance the durability of TOP1-payload based ADCs, including IDE849 and IDE034, IDEAYA’s B7H3/PTK7 bispecific TOP1 ADC, and aligns with the company’s clinical development strategy of evaluating rational combinations, where appropriate, to drive improved clinical outcomes for patients with cancer.

"We are excited to have the first-in-human Phase 1 clinical efficacy and safety data presented by our partner Hengrui for IDE849 (SHR-4849) in SCLC patients at the WCLC 2025, as IDEAYA rapidly advances the global development of IDE849," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "IDE849 represents a potential first-in-class DLL3-TOP1 ADC, and we look forward to evaluating its clinical potential as both a monotherapy agent in SCLC and NET patients, as well as in combination with immunotherapy and our Phase 1 PARG inhibitor, IDE161," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Details of the oral presentation are as follows:

Title: A first-in-human Phase 1 study of SHR-4849 (IDE849), a DLL3-directed antibody drug conjugate (ADC) in relapsed SCLC

Date and time: Sunday, September 7th, 4:45-6:00 PM (CET)

Session: OA6 – Novel ADCs in SCLC

Details of the poster presentation are as follows:

Control #: 2165

Title: Dual PARG-TOP1 Inhibition Exacerbates DNA-Protein Crosslinks and Replication Stress: A Promising Strategy for Enhancing TOP1i-ADC Efficacy

Presenter: Reeja Maskey, Ph.D.

Date and time: Monday September 8th, 10:30 AM – 12:00 PM (CET)

Session: P2.10 – Metastatic Non-small Cell Lung Cancer – Antibody-Drug Conjugate and Cytotoxic Therapy

The oral presentation and poster will be available online at View Source following the presentation.

On July 22, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that it has entered into a collaboration with the U.S. Food and Drug Administration (FDA) to develop reference materials to improve regulatory standards and enhance analytical methods for ADC drug development (Press release, Sutro Biopharma, JUL 22, 2025, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-announces-research-collaboration-with-the-fda-to-advance-regulatory-standards-for-antibody-drug-conjugates [SID1234654471]). The collaboration will leverage Sutro’s cell-free XpressCF technology to precisely engineer ADCs with predefined attributes, as well as FDA’s cutting-edge analytical capabilities to fully characterize these materials.

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"ADCs represent one of the most promising and fast-growing modalities for new biopharmaceuticals. We’re honored to be among a select group collaborating with the FDA to help shape regulatory standards for ADC development and quality control," said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. "This collaboration underscores the precision and flexibility of our cell-free XpressCF platform in advancing next-generation ADCs, and we look forward to the impact of this work across the industry, with regulators, and for the patient community. We thank the FDA for the opportunity to help define the future of ADC innovation."

As part of the collaboration, Sutro and the Office of Pharmaceutical Quality (OPQ) within the FDA Center for Drug Evaluation and Research (CDER) will jointly lead the study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved ADCs and those in development. The results will be published upon completion, and the insights gained from this collaboration are expected to enhance OPQ’s ongoing research efforts aimed at bolstering the FDA’s capacity for the analytical characterization of ADCs to enhance ADC quality assessments.

On July 22, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma (Press release, Replimune, JUL 22, 2025, View Source [SID1234654470]).

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The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised.

The Company will request a Type A meeting and expects it will be granted within 30 days. Replimune plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1 without which the development of RP1 for advanced cancer patients with limited options will not be viable.

"We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data," said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. "The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews. Additionally, we had also aligned on the design of the confirmatory study. We strongly believe that RP1 in combination with nivolumab can bring substantial benefit to advanced melanoma patients."

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On July 22, 2025 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2025 (Press release, Quest Diagnostics, JUL 22, 2025, View Source [SID1234654469]).

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"Through continued execution of our strategy, we delivered a strong second quarter, with revenues growing 15.2% which includes 5.2% from organic revenues, as well as adjusted EPS growth of 11.5%," said Jim Davis, Chairman, CEO and President. "Demand for our innovative clinical solutions and expanded business from enterprise accounts complemented growth from acquisitions. We also realized productivity gains as we continued to deploy automation and digital technologies across our operations. Given our performance in the quarter and continued utilization trends, we are raising our full year 2025 guidance."

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

Change

2025

2024

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,761

$ 2,397

15.2 %

$ 5,413

$ 4,763

13.7 %

Diagnostic Information Services revenues

$ 2,699

$ 2,333

15.7 %

$ 5,288

$ 4,631

14.2 %

Revenue per requisition

(0.4) %

— %

Requisition volume

16.3 %

14.3 %

Organic requisition volume

2.1 %

0.6 %

Operating income (a)

$ 438

$ 355

23.3 %

$ 784

$ 655

19.7 %

Operating income as a percentage of net revenues (a)

15.9 %

14.8 %

1.1 %

14.5 %

13.7 %

0.8 %

Net income attributable to Quest Diagnostics (a)

$ 282

$ 229

23.1 %

$ 502

$ 423

18.6 %

Diluted EPS (a)

$ 2.47

$ 2.03

21.7 %

$ 4.41

$ 3.75

17.6 %

Cash provided by operations

$ 544

$ 360

51.5 %

$ 858

$ 514

67.1 %

Capital expenditures

$ 108

$ 92

17.3 %

$ 225

$ 196

14.4 %

Adjusted (a):

Operating income

$ 466

$ 398

17.3 %

$ 872

$ 747

16.8 %

Operating income as a percentage of net revenues

16.9 %

16.6 %

0.3 %

16.1 %

15.7 %

0.4 %

Net income attributable to Quest Diagnostics

$ 298

$ 266

12.3 %

$ 549

$ 496

10.7 %

Diluted EPS

$ 2.62

$ 2.35

11.5 %

$ 4.83

$ 4.39

10.0 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2025

The company updates its full year 2025 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$10.80 billion

$10.92 billion

$10.70 billion

$10.85 billion

Net revenues increase

9.4 %

10.6 %

8.4 %

9.9 %

Reported diluted EPS

$8.60

$8.80

$8.62

$8.87

Adjusted diluted EPS

$9.63

$9.83

$9.55

$9.80

Cash provided by operations

Approximately $1.55 billion

Approximately $1.5 billion

Capital expenditures

Approximately $500 million

Approximately $500 million

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, gains and losses associated with changes in the carrying value of our strategic investments, impairment charges and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on July 22, 2025 until midnight Eastern Time on August 5, 2025, by phone at 866-388-5361 for domestic callers or 203-369-0416 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.