On July 23, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to elironrasib, the company’s RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor (Press release, Revolution Medicines, JUL 23, 2025, View Source [SID1234654483]).

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The Breakthrough Therapy Designation is based on data from the Phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with advanced KRAS G12C solid tumors. Results from the trial have demonstrated highly competitive antitumor activity, including differentiated safety and tolerability along with a compelling objective response rate and progression-free survival.

"There continues to be a need for new targeted therapies for patients with RAS-addicted cancers, and this Breakthrough Therapy Designation from the FDA highlights the therapeutic potential of elironrasib, a differentiated inhibitor, for patients with KRAS G12C lung cancer," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Coming shortly after daraxonrasib was granted a designation for patients with advanced RAS mutant pancreatic cancer, this designation for elironrasib further validates our innovative product engine as a source for novel potential treatment approaches for patients with RAS mutant cancers."

Elironrasib is an innovative inhibitor that binds selectively and covalently to the oncogenic RAS(ON) form of the RAS G12C variant that drives approximately 12% of cases of NSCLC. Revolution Medicines is exploring elironrasib monotherapy and combinations in various treatment settings and continues work to prioritize multiple options for advancing its development.

NSCLC accounts for 80%-85% of all lung cancers, and most patients have advanced or metastatic disease at initial diagnosis.1,2 KRAS mutations are found in nearly 30% of NSCLC cases, among which KRAS G12C is the most common. Currently there are no RAS-targeted inhibitors with full approval by the FDA to treat patients with KRAS G12C NSCLC.3

Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions and address significant unmet medical needs. Pursuant to FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates substantial improvement on a clinically significant endpoint over available medicines.

About Non-Small Cell Lung Cancer
More than 197,000 people are diagnosed with non-small cell lung cancer (NSCLC) in the U.S. each year.4 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies.

On July 22, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office (Press release, BioAffinity Technologies, JUL 22, 2025, View Source [SID1234654467]). This patent strengthens the international protection of the Company’s diagnostic platform that powers its flagship test, CyPath Lung.

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"As with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives," said Maria Zannes, President and CEO of bioAffinity Technologies.

Lung cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000 Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths were linked to smoking.

"We believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science," Ms. Zannes said. "Recent case studies highlight CyPath Lung’s ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada, according to government statistics."

The Canadian patent (Patent No. 3,136,245) – titled "System and Method for Determining Lung Health" – protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

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.

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 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.