On October 28, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the third quarter of 2025 and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Regeneron had a solid financial quarter and made progress across our late-stage portfolio by securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, receiving positive CHMP opinions for Libtayo and Dupixent, and sharing promising data across our oncology, obesity, allergy, and rare disease portfolios," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We were proud to receive one of the FDA’s first Commissioner’s National Priority Vouchers for DB-OTO for a rare form of congenital hearing loss. We also donated our Ebola treatment, Inmazeb, to countries most at risk of outbreaks, reflecting our commitment to ensuring patients in need are able to access our novel medicines."

Financial Highlights

($ in millions, except per share data) Q3 2025
Q3 2024
% Change
Total revenues $ 3,754 $ 3,721 1%
GAAP net income $ 1,460 $ 1,341 9%
GAAP net income per share – diluted $ 13.62 $ 11.54 18%
Non-GAAP net income(a) $ 1,287 $ 1,462 (12% )
Non-GAAP net income per share – diluted(a) $ 11.83 $ 12.46 (5% )

"We were pleased with our third quarter 2025 performance, which highlights the commercial strength of Dupixent, EYLEA HD, and Libtayo, and reinforces our momentum toward delivering solid financial performance for the year while advancing transformative therapies to patients around the world," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our disciplined approach to capital allocation fuels innovation through targeted investments, all while delivering value to shareholders. In the first nine months of 2025, we reaffirmed our commitment to advancing U.S. innovation and manufacturing by investing nearly $5 billion in R&D and capital expenditures, predominantly within the United States. We also returned over $3 billion to shareholders via share repurchases and dividends, underscoring our commitment to long-term value creation."

Business Highlights

Key Pipeline Progress
Regeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent (dupilumab)

In September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment. The European Commission (EC) is expected to announce a final decision in the coming months.
EYLEA HD (aflibercept) 8 mg

In October 2025, the Company was notified by Catalent Indiana, LLC (Catalent), the manufacturing filler in the EYLEA HD Biologics License Application (BLA), that they received an official action indicated (OAI) letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection (not specific to EYLEA HD).

Yesterday, the FDA issued a Complete Response Letter (CRL) for the pre-filled syringe supplemental BLA (sBLA). The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent. The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA.

There is also an sBLA under review by the FDA for EYLEA HD every-four-week dosing and for the treatment of macular edema following retinal vein occlusion (RVO), which has a target action date in late November 2025. In addition, the Company has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.
Libtayo (cemiplimab)

In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation, making Libtayo the first and only immunotherapy approved in this setting. The EMA’s CHMP also adopted a positive opinion for the adjuvant treatment of CSCC, and the EC is expected to announce a final decision in the coming months.
In September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Libtayo for an additional indication, as a monotherapy and in combination with chemotherapy for the treatment of adult patients with unresectable advanced or relapsed non-small cell lung cancer (NSCLC).
In September 2025, the Company announced five-year follow-up results on overall survival from a Phase 3 trial, which evaluated Libtayo plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic NSCLC. The data demonstrate a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone, and was presented at the IASLC 2025 World Conference on Lung Cancer.
Other Programs

In August 2025, the Company announced that the primary and key secondary endpoints were met in a Phase 3 trial of cemdisiran (siRNA therapy), as both a monotherapy and in combination with pozelimab (C5 antibody), in adults with generalized myasthenia gravis. Cemdisiran monotherapy was numerically better than the combination treatment across these endpoints, showing a statistically significant 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score. A U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA.
In October 2025, updated data from the pivotal trial of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were published in the New England Journal of Medicine and presented at the annual American Academy of Otolaryngology-Head and Neck Surgery meeting. These latest results from the CHORD trial show 11 out of 12 participants have experienced clinically meaningful hearing improvements. A U.S. regulatory submission for DB-OTO is planned for the fourth quarter of 2025.
In October 2025, the FDA selected DB-OTO to receive one of the Commissioner’s National Priority Vouchers, a pilot program intended to reduce the review time for certain drug and biologic applications to just one to two months.
In September 2025, the Company announced the primary endpoint was met in a Phase 3 trial of garetosmab in adults with FOP, showing a 90% or greater reduction in new bone lesions (heterotopic ossification, or HO lesions) compared to placebo at 56 weeks, and a greater than 99% reduction in the total volume of new HO lesions. A U.S. regulatory submission for garetosmab is planned for the fourth quarter of 2025.
In September 2025, the FDA approved Evkeeza (evinacumab) for the treatment of homozygous familial hypercholesterolemia (HoFH), extending the already approved indication to include children from age 1 to less than 5 years old.
In September 2025, the Company announced results from the Phase 3 trials evaluating its allergen-blocking antibodies in adults with moderate-to-severe cat allergies (REGN1908 and REGN1909) or birch allergies (REGN5713 and REGN5715). Both trials met their respective primary and key secondary endpoints, with single doses of the allergen-specific antibody blockers significantly reducing allergy symptoms compared to placebo at day 8. Additional Phase 3 development is planned to begin by the end of the year.
Corporate Updates

In September and October 2025, the Company reached resolution of its patent infringement litigation related to the Sandoz, Formycon, and Celltrion EYLEA (aflibercept) Injection 2 mg biosimilar products. The settlements preclude Sandoz, Formycon, and Celltrion from launching their biosimilar products in the United States until the fourth quarter of 2026. All intellectual property-related litigation with Sandoz, Formycon, and Celltrion in the United States has been dismissed.
Third Quarter 2025 Financial Results

Revenues

($ in millions) Q3 2025
Q3 2024
% Change
Net product sales:
EYLEA HD – U.S. $ 431 $ 392 10%
EYLEA – U.S. 681 1,145 (41% )
Total EYLEA HD and EYLEA – U.S. 1,112 1,537 (28% )
Libtayo – U.S. 219 195 12%
Libtayo – ROW* 146 94 55%
Total Libtayo – Global 365 289 26%
Praluent- U.S. 67 53 26%
Evkeeza – U.S. 43 32 34%
Other products – Global 1 35 (97% )
Total net product sales 1,588 1,946 (18% )

Collaboration revenue:
Sanofi 1,617 1,263 28%
Bayer 345 391 (12% )
Other 6 6 —%
Other revenue 198 114 74%
Total revenues $ 3,754 $ 3,720 1%

* Rest of world (ROW)

Net product sales of EYLEA HD increased in the third quarter of 2025, compared to the third quarter of 2024, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.

Net product sales of EYLEA in the third quarter of 2025, compared to the third quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Sanofi collaboration revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.46 billion and $1.09 billion in the third quarter of 2025 and 2024, respectively. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $165 million and $91 million for the third quarter of 2025 and 2024, respectively.

Operating Expenses

GAAP %
Non-GAAP(a) %
($ in millions) Q3 2025 Q3 2024 Change
Q3 2025 Q3 2024 Change
Research and development (R&D) $ 1,475 $ 1,272 16 % $ 1,350 $ 1,146 18 %
Acquired in-process research and development (IPR&D) $ 83 $ 56 48 % *
*
n/a
Selling, general, and administrative (SG&A) $ 658 $ 714 (8 %) $ 541 $ 613 (12 %)
Cost of goods sold (COGS) $ 281 $ 262 7 % $ 227 $ 217 5 %
Gross margin on net product sales(b) 82% 87% 86% 89%
Cost of collaboration and contract manufacturing (COCM)(c) $ 241 $ 229 5 % *
*
n/a
Other operating (income) expense, net $ (10 ) $ 8 ** *
$ — **

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful

GAAP and non-GAAP R&D expenses increased in the third quarter of 2025, compared to the third quarter of 2024, driven by the advancement of the Company’s late-stage clinical pipeline.
Acquired IPR&D expenses for the third quarter of 2025 included an $80 million up-front payment in connection with the Company’s license agreement with Hansoh Pharmaceuticals Group Company Limited. Acquired IPR&D expenses for the third quarter of 2024 included a $45 million development milestone in connection with the Company’s collaboration agreement with Sonoma Biotherapeutics, Inc.
GAAP and non-GAAP SG&A expenses decreased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.
GAAP and non-GAAP gross margin on net product sales decreased in the third quarter of 2025, compared to the third quarter of 2024, partly due to ongoing investments to support the Company’s manufacturing operations. In addition, GAAP gross margin on net product sales decreased due to higher amortization expense associated with the Company’s Libtayo intangible asset.
Other Financial Information

GAAP other income (expense), net included the recognition of net gains on marketable and other securities of $578 million in the third quarter of 2025, compared to $135 million in the third quarter of 2024.

In the third quarter of 2025, the Company’s GAAP effective tax rate (ETR) was 17.2%, compared to 10.2% in the third quarter of 2024. The GAAP ETR increased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to the impact of the enactment of the "One Big Beautiful Bill Act" or "OBBBA," including a $45 million charge related to the re-measurement of the Company’s U.S. net deferred tax assets, as well as lower tax benefits from less stock option exercises. In the third quarter of 2025, the non-GAAP ETR was 13.1%, compared to 10.7% in the third quarter of 2024.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Capital Allocation

During the third quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $663 million, as Treasury Stock. As of September 30, 2025, $2.156 billion remained available for share repurchases under the Company’s share repurchase programs.

In October 2025, the Company’s board of directors declared a cash dividend of $0.88 per share on the Company’s common stock and Class A stock, payable on December 5, 2025 to shareholders of record as of November 20, 2025.

2025 Financial Guidance*

The Company’s full year 2025 financial guidance consists of the following components:

2025 Guidance
Prior Updated
GAAP R&D $5.660–$5.790 billion $5.680–$5.750 billion
Non-GAAP R&D(a) $5.100–$5.200 billion $5.150–$5.200 billion
GAAP SG&A** $2.810–$2.940 billion $2.775–$2.845 billion
Non-GAAP SG&A(a)** $2.450–$2.550 billion $2.400–$2.450 billion
GAAP gross margin on net product sales Approximately 83% Approximately 82%
Non-GAAP gross margin on net product sales(a) Approximately 86% Unchanged
COCM*** $1.000–$1.050 billion $950 million–$1.000 billion
Capital expenditures*** $880–$950 million $850–$890 million
GAAP effective tax rate 11%–13% Approximately 14%
Non-GAAP effective tax rate(a) 11%–13% Approximately 12%

* The Company’s 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release
** The Company’s 2025 financial guidance includes potential matching program donations to Good Days, an independent national non-profit charitable organization, to support Good Days’ Retinal Vascular and Neovascular Disease Fund

(Press release, Regeneron, OCT 28, 2025, View Source [SID1234657073])

On October 28, 2025 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune disorders. The study is designed to evaluate the safety, tolerability, and biologic activity of MDX2004 as an immunotherapy for advanced cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MDX2004 is designed to stimulate T cells through three signaling pathways to enhance immune activation. This proprietary multispecific antibody engages CD3, CD28, and 4-1BB and is expected to activate T lymphocytes, including stem and memory T cells. Because stem T cells undergo self-renewal and give rise to mature T cells, the drug aims to recruit and replenish, or "rejuvenate," cellular immunity. Unlike previous 4-1BB antibody therapies, recognition of 4-1BB by this molecule does not involve antibody binding because it binds as a ligand to the natural receptor.

"Patients with advanced solid tumors may have limited options with existing treatments, facing challenging disease control rates and low long-term survival," said Giovanni Abbadessa, M.D., Ph.D., Chief Medical Officer of ModeX. "The MDX2004 multispecific antibody aims to rejuvenate T cells and sustain an expanded immune response in a broad range of tumors. We look forward to exploring further via this clinical trial."

"We are excited to bring MDX2004 to patients as a first-in-class trispecific antibody with a unique design aiming for a specific mechanism of action. By stimulating and sustaining immune function, this T cell rejuvenator has potential to treat diverse cancers and reverse immune impairment caused by chemotherapy, chronic diseases, infection and aging," said Phillip Frost, M.D., Chairman and CEO of OPKO Health and Gary Nabel, M.D., Ph.D., President and CEO of ModeX and Chief Innovation Officer of OPKO Health.

Preclinical proof-of-concept data as well as clinical dose selection analyses to support the MDX2004 development will be showcased in two poster presentations at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), National Harbor, MD, on November 5-9, 2025.

About MDX2004
MDX2004 is a novel trispecific antibody–fusion protein that targets CD3, CD28, and 4-1BB (CD137) on human T cells. It is designed to promote the expansion of stem and memory T cell populations, thereby rejuvenating immune function and enhancing anti-tumor immunity. This trifunctional approach aims to expand and sustain both stem and mature memory T cell subsets, which have been associated with favorable responses to immunotherapy. It may thus help restore immune function in subjects with underlying immune impairment from aging, chronic diseases such as diabetes, infections or chemotherapies.

Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)
Multispecific antibody therapeutics can help generate medicines of the future by targeting multiple disease pathways simultaneously. Many untreatable or complex conditions arise from multiple root causes; yet most medicines only act on a single target. ​​ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.

(Press release, Opko Health, OCT 28, 2025, View Source [SID1234657072])

On October 28, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported updated results from the single-arm squamous cell anal carcinoma (SCAC) cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq) in patients with ≥2L metastatic SCAC. Patients from this cohort continue to be followed, and additional efficacy data are expected to be reported.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The combination of pelareorep and atezolizumab achieved an objective response rate (ORR) of 30% (six among 20 evaluable patients). This represents a greater than 2x improvement over the historical benchmark of 13.8% ORR reported for the only FDA-approved immunotherapy for 2L SCAC.

Importantly, there have been two durable complete responses among the six responders, with one ongoing beyond two years, and the other lasting 15 months. In addition, another patient has an ongoing response at 64 weeks. The overall median duration of response for patients receiving pelareorep and atezolizumab is 15.5 months compared to 9.5 months for the current standard of care at this stage of treatment.

These updated results from this ongoing SCAC cohort reinforce the potential of pelareorep to drive durable immunologic tumor control in gastrointestinal tumors. The results also demonstrate the durability and depth of responses achievable with the combination of pelareorep and checkpoint inhibitors without chemotherapy.

"This is the most encouraging efficacy signal with a non-chemo regimen we have ever seen in anal cancer," said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "Achieving a 30% objective response rate — more than double the benchmark of the only approved immunotherapy — along with multiple responses lasting more than a year, including two complete responses, underscores pelareorep’s ability to unlock deep and durable immune responses. We believe the data represent our best chance to obtain an accelerated approval in a rare disease with virtually no options outside of chemotherapy."

The SCAC cohort is part of Oncolytics’ broader GOBLET study, a Phase 1/2 trial evaluating pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications, including pancreatic, colorectal, and anal cancers.

Based on these compelling data, Oncolytics intends to engage the U.S. Food and Drug Administration (FDA) to discuss a potential single-arm study designed for accelerated approval in second-line or later SCAC, with a potential launch date for such a study expected in the first half of 2026.

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

(Press release, Oncolytics Biotech, OCT 28, 2025, View Source [SID1234657071])

On October 28, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"KEYTRUDA monotherapy given in the adjuvant setting remains an important treatment choice for patients with renal cell carcinoma at an increased risk of recurrence following surgery and is the only approved option to have significantly improved disease-free survival and overall survival in this disease setting. Still, many of these patients do remain at risk of recurrence and continue to represent an unmet need," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. "These encouraging results of KEYTRUDA in combination with WELIREG from LITESPARK-022 demonstrate the potential to provide additional treatment options for those most in need."

The safety profiles of KEYTRUDA plus WELIREG in this trial were overall consistent with those observed in previously reported studies for the individual therapies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.

KEYTRUDA is approved for the adjuvant treatment of certain patients with RCC in the U.S., Canada, European Union (EU), Japan and other countries worldwide based on data from KEYNOTE-564.

WELIREG is approved in over 40 countries including the U.S., Canada, EU, and Japan for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

Merck has an industry-leading clinical development program in RCC, leveraging multiple approved therapeutic options across multiple settings, including adjuvant and advanced disease.

About LITESPARK-022
LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to KEYTRUDA plus placebo for the treatment of patients with clear cell RCC following nephrectomy. The primary endpoint is DFS; the key secondary endpoint is OS; other secondary endpoints include safety and quality of life outcomes. The trial enrolled 1,841 patients who were randomized to receive either:

WELIREG (120 mg orally once daily for approximately one year), plus KEYTRUDA (400 mg intravenously every six weeks for approximately one year) or;
KEYTRUDA plus oral placebo.
About renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnoses and approximately 156,000 deaths from the disease worldwide. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, OCT 28, 2025, View Source [SID1234657070])

On October 28, 2025 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported results for the third quarter ended September 30, 2025 and updated full-year guidance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Labcorp’s third-quarter performance reflects continued momentum in our Diagnostics and Central Laboratory businesses, resulting in strong revenue growth and margin improvement," said Adam Schechter, Chairman and CEO of Labcorp. "We advanced our strategy by forming new partnerships with health systems and regional laboratories, introducing innovative tests in key specialty areas and leveraging science and technology to improve customer experience and operational efficiency. Our performance led to double-digit adjusted EPS growth and strong cash flow in the quarter. We expect to finish the year strong as we remain focused on delivering value to our customers and shareholders."

Labcorp advanced its position as a partner of choice for health systems and regional/local laboratories. In the quarter, Labcorp:

Signed an agreement to acquire select assets of Empire City Laboratories, which serves the New York Tri-State area.
Signed an agreement to acquire select assets of Laboratory Alliance of Central New York, a pathology reference laboratory, and signed an agreement with Crouse Health to manage its inpatient labs.
Continued to progress the acquisition of select assets of the outreach business from Community Health Systems across 13 states.
Completed the acquisition of select oncology and clinical testing assets from BioReference Health, further solidifying Labcorp’s position as an industry leader in oncology.
The company also continued to incorporate the power of science, technology and innovation across the organization. In the quarter, Labcorp:

Expanded its leading oncology and genetic testing portfolio.
Labcorp expanded the use of OmniSeq INSIGHT, which now evaluates ovarian tumors for homologous recombination deficiency.
PGDx elio tissue complete became the first and remains the only tissue-based tumor profiling test with CE-marking under the European Union’s In Vitro Diagnostic Regulation.
Geneoscopy received FDA approval for a simplified at-home collection method for ColoSense, its RNA-based colorectal cancer screening test that Labcorp will make available to patients and providers.
The company expanded access to its Invitae genetic tests through Epic Aura, enabling streamlined ordering and results delivery for Epic customers.
Expanded its leadership in neurology with two new Alzheimer’s tests to be used in the specialty and primary care settings.
Demonstrated strong momentum in its consumer business with the introduction of several new tests through Labcorp OnDemand.
Accelerated growth, enhanced the customer experience and improved operational efficiency through the launch of Labcorp Test Finder and investments in digital and AI capabilities to enhance areas such as pathology, cytology and microbiology.
On October 8, 2025, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on December 11, 2025, to stockholders of record at the close of business on November 26, 2025. In the quarter, Labcorp repurchased $25 million of common stock.

(Press release, LabCorp, OCT 28, 2025, View Source [SID1234657069])