On October 28, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, inflammatory and autoimmune diseases, reported financial results for the third quarter ended September 30, 2025, and provided a pipeline update on its clinical-stage investigational molecules and discovery programs.

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"Data from the ARC-20 study demonstrate that casdatifan has a best-in-class profile, based on a meaningfully higher response rate and longer PFS relative to data for the only marketed HIF-2a inhibitor," said Terry Rosen, Ph.D., chief executive officer of Arcus. "With our global Phase 3 PEAK-1 study now enrolling, and based on the encouraging, emerging data from cohorts evaluating casdatifan-based regimens in early-line settings, we are extremely excited about the potential for casdatifan to be a transformative therapy in clear cell renal cell carcinoma (ccRCC). We remain well capitalized and funded through readout of multiple Phase 3 trials, and we are looking forward to a steady cadence of key data events in 2026 and beyond."
Corporate Update

•In October, Taiho exercised its option for an exclusive license to casdatifan in Japan and certain territories in Asia; in exchange, Taiho will make an option payment to Arcus along with milestone payments upon achievement of clinical, regulatory and commercialization milestones, and additionally make royalty payments on net sales.
Casdatifan (HIF-2a inhibitor)

Casdatifan Development Program:

•PEAK-1, a global Phase 3 study evaluating casdatifan + cabozantinib versus cabozantinib in immunotherapy (IO)-experienced metastatic ccRCC is enrolling and, with a primary endpoint of PFS, represents an opportunity for a rapid path to approval.

•The company is pursuing a multi-pronged strategy for the development of casdatifan in early-line ccRCC, likely in combination with standard-of-care mechanisms, with the goal of initiating a Phase 3 study in early-line ccRCC in the second half of 2026. This study will be informed by emerging data from eVOLVE-RCC02 and ARC-20.
▪eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan + volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line (1L), metastatic ccRCC, was initiated in mid-2025.
•The Phase 1b portion of the study has recruited rapidly, and in the context of this rapid enrollment, following observations of potential immune-mediated adverse events (AEs), none of which exceeded Grade 3, a decision was made to temporarily pause recruitment, while continuing to treat participants already enrolled in the study. No Grade 4 or 5 events were observed, and the majority of AEs were Grade 1 or 2.
•Arcus and AstraZeneca will continue to monitor these participants to further characterize the safety profile of the combination with longer follow-up. These data, along with any discussions with health authorities, will inform next steps for the study.
▪ARC-20 includes three cohorts evaluating casdatifan in earlier-line settings: casdatifan plus zimberelimab in 1L ccRCC, casdatifan monotherapy in favorable risk ccRCC and casdatifan monotherapy in immunotherapy-experienced, TKI-naive ccRCC.
◦Arcus expects to complete enrollment for these cohorts by the end of 2025 and to report data for one or more of these cohorts in the second half of 2026.

Recent Data Update:

•Data, including overall response rate (ORR) and PFS data, from the four monotherapy cohorts of the Phase 1/1b ARC-20 study in late-line ccRCC were presented at an investor event in October.
▪Casdatifan performed better on every efficacy measure evaluated, for each individual cohort and across all four monotherapy cohorts (n=121), relative to published data from studies with the only marketed HIF-2a inhibitor.
▪At the time of data cutoff (DCO, August 15, 2025), mPFS was 12.2 months, and 18-month landmark PFS was 43% in the pooled analysis of all four monotherapy cohorts.
▪In the 100mg once-daily cohort (the Phase 3 PEAK-1 dose and formulation), confirmed ORR was 35%, with two responses (including one that occurred after the DCO) pending confirmation, and mPFS had not been reached with greater than 12 months median follow-up.
▪Seventy-four percent (28 of the 38) of confirmed responders across all four cohorts remained on treatment.
▪No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses.

Planned Data Readouts:

•1H 2026: Additional analyses from the ARC-20 cohorts evaluating casdatifan monotherapy in late-line ccRCC.
•Mid-2026: More mature data from the ARC-20 cohort evaluating casdatifan plus cabozantinib in the IO-experienced setting. This is the same setting and combination being evaluated in the ongoing Phase 3 PEAK-1 study.
•2H 2026: Initial data from one or more ARC-20 cohorts evaluating casdatifan in early-line settings.
•2H 2026: Data from the Phase 1b portion and a go-no-go decision on the Phase 3 portion of eVOLVE-RCC02.

Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Recent Data Presentation:

•OS data from Arm A1 of the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, were presented in an oral session at the 2025 ESMO (Free ESMO Whitepaper) Congress in October. This is the same regimen and patient population being evaluated in the ongoing Phase 3 study, STAR-221.
◦Domvanalimab plus zimberelimab and chemotherapy showed 26.7 months of median OS, well beyond what would be required to demonstrate clinically meaningful benefit over standard of care in this setting.
◦The regimen was generally well tolerated and had a safety profile that is consistent with that of anti-PD-1 and chemotherapy.

Planned Data Readout:

•Data from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab and chemotherapy in PD-L1 all-comer 1L unresectable or metastatic upper GI adenocarcinomas are expected in 2026.

Quemliclustat (small-molecule CD73 inhibitor)

•Enrollment has been completed for PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in 1L metastatic pancreatic ductal adenocarcinoma, within 12 months of study initiation.

Emerging I&I Portfolio

•In October, Arcus disclosed five new research and preclinical programs addressing targets for inflammatory and autoimmune diseases. Potential new drug candidates include:
◦MRGPRX2 small-molecule inhibitor, a potential treatment for atopic dermatitis and chronic spontaneous urticaria
◦TNF-a (TNFR1) small-molecule inhibitor, a potential treatment for rheumatoid arthritis (RA), psoriasis and inflammatory bowel disease (such as ulcerative colitis)
◦CCR6 small-molecule inhibitor, a potential treatment for psoriasis
◦CD89 monoclonal antibody, a potential treatment for RA
◦CD40L small-molecule inhibitor, a potential treatment for multiple sclerosis and systemic lupus erythematosus
•Arcus expects to select development candidates for at least three of these programs within the next 12 months. The first of these, a small molecule directed against MRGPRX2, is expected to enter the clinic in 2026.

Financial Results for Third Quarter 2025:

•Cash, Cash Equivalents and Marketable Securities were $841 million as of September 30, 2025, compared to $992 million as of December 31, 2024. The decrease during the period is primarily due to the use of cash in our research and development activities partially offset by the net proceeds from our underwritten offering in February 2025 and the additional $50 million draw down under our term loan facility in June 2025. We believe our cash, cash equivalents and marketable securities, together with available facilities, will be sufficient to fund operations through the initial pivotal readouts for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.

•Revenues were $26 million for the third quarter 2025, compared to $48 million for the same period in 2024. The decrease in revenue was primarily driven by the prior year license revenue of $15 million as a result of Taiho’s exercise of its option for quemliclustat and lower revenues from the Gilead collaboration. Arcus expects to recognize GAAP revenue of between $225 million and $235 million for the full year 2025.

•Research and Development (R&D) Expenses were $141 million for the third quarter 2025, compared to $123 million for the same period in 2024. The net increase of $18 million was primarily due to costs incurred for our late-stage programs, resulting from increased enrollment and start-up activities for PRISM-1 and PEAK-1 and partially offset by lower costs from STAR-221. Non-cash stock-based compensation expense was $7 million for the third quarter 2025, compared to $9 million for the same period in 2024. For the third quarters 2025 and 2024, Arcus recognized gross reimbursements of $28 million and $37 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. Arcus expects R&D expenses to decline commencing in the fourth quarter 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly.
•General and Administrative (G&A) Expenses were $27 million for the third quarter 2025, compared to $30 million for the same period in 2024. The decrease was primarily driven by a decrease in compensation and personnel costs driven by lower stock-based compensation, partially offset by an increase in expenses shared under the Gilead collaboration. Non-cash stock-based compensation expense was $7 million for the third quarter 2025, compared to $10 million for the same period in 2024.

•Net Loss was $135 million for the third quarter 2025, compared to $92 million for the same period in 2024.

(Press release, Arcus Biosciences, OCT 28, 2025, View Source [SID1234657060])

On October 28, 2025 Alkermes plc (Nasdaq: ALKS) reported financial results for the third quarter of 2025.

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"Alkermes delivered another successful quarter, achieving strong revenue growth and robust profitability, fueled by focused execution and underlying demand across our commercial portfolio. We ended the quarter in a strong financial position and have raised our financial outlook for 2025, underscoring the momentum of the business. Our proposed acquisition of Avadel Pharmaceuticals announced last week represents another potential growth driver for our business and an important element of our strategic plan as we seek to become a leader in the treatment of central disorders of hypersomnolence," said Richard Pops, Chief Executive Officer of Alkermes. "During the quarter, we also advanced our development pipeline, with notable progress in our orexin 2 receptor agonist program. We recently presented positive data from Vibrance-1, our phase 2 study of alixorexton in patients with narcolepsy type 1, and expect to report topline results from Vibrance-2, in narcolepsy type 2, next month. As we prepare to initiate our phase 3 clinical program in early 2026, we believe alixorexton represents a compelling opportunity to create value and deliver meaningful innovation to patients."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

Total Revenues

$

394.2

$

378.1

$

1,091.4

$

1,127.6

Total Proprietary Net Sales

$

317.4

$

273.0

$

869.2

$

775.8

VIVITROL

$

121.1

$

113.7

$

343.8

$

323.2

ARISTADAi

$

98.1

$

84.7

$

272.8

$

249.6

LYBALVI

$

98.2

$

74.7

$

252.6

$

203.1

Profitability

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

GAAP Net Income From Continuing Operations

$

82.8

$

92.8

$

192.3

$

226.4

GAAP Net Income (Loss) From Discontinued Operations

$

—

$

(0.4)

$

—

$

(5.8)

GAAP Net Income

$

82.8

$

92.4

$

192.3

$

220.6

EBITDA From Continuing Operations

$

96.9

$

112.3

$

221.2

$

282.4

EBITDA From Discontinued Operations

$

—

$

(0.5)

$

—

$

(6.9)

EBITDA

$

96.9

$

111.8

$

221.2

$

275.5

Adjusted EBITDA

$

121.5

$

134.3

$

293.7

$

351.4

Revenue Highlights

LYBALVI

Revenues for the quarter were $98.2 million.
Revenues and total prescriptions for the quarter grew 32% and 25%, respectively, compared to the third quarter of 2024.
ARISTADAi

Revenues for the quarter were $98.1 million.
Revenues for the quarter grew 16% compared to the third quarter of 2024.
During the quarter, the company recorded ARISTADA revenue of approximately $5.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL

Revenues for the quarter were $121.1 million.
Revenues for the quarter grew 7% compared to the third quarter of 2024.
During the quarter, the company recorded VIVITROL revenue of approximately $8.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues

VUMERITY manufacturing and royalty revenues for the quarter were $35.6 million.
Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $30.2 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,

2025

2024

2025

2024

R&D Expense – Continuing Operations

$

81.7

$

59.9

$

230.9

$

187.2

R&D Expense – Discontinued Operations

$

—

$

0.5

$

—

$

6.9

SG&A Expense – Continuing Operations

$

171.8

$

150.4

$

514.3

$

498.2

SG&A Expense – Discontinued Operations

$

—

$

—

$

—

$

—

Balance Sheet
At Sept. 30, 2025, the company recorded cash, cash equivalents and total investments of $1.14 billion, compared to $1.05 billion at June 30, 2025.

Financial Expectations for 2025
Today, Alkermes raised its financial expectations for 2025, as set forth below. All line items are according to GAAP, except as otherwise noted.

In millions

Previous 2025 Expectations

(provided Feb. 12, 2025)

Updated 2025 Expectations

(provided Oct. 28, 2025)

Total Revenues

$1,340 – $1,430

$1,430 – $1,490

VIVITROL Net Sales

$440 – $460

$460 – $470

ARISTADAi Net Sales

$335 – $355

$360 – $370

LYBALVI Net Sales

$320 – $340

$340 – $350

Cost of Goods Sold

$185 – $205

$195 – $205

R&D Expense

$305 – $335

$315 – $325

SG&A Expense

$655 – $685

$675 – $705

GAAP Net Income a

$175 – $205

$230 – $250

EBITDA b

$215 – $245

$270 – $290

Adjusted EBITDA b

$310 – $340

$365 – $385

Effective Tax Rate

~17%

~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding

b Non-GAAP measure

Notes and Explanations
1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and nine months ended Sept. 30, 2024.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (12:00 p.m. GMT) on Tuesday, Oct. 28, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

(Press release, Alkermes, OCT 28, 2025, View Source [SID1234657059])

On October 28, 2025 Novartis CEO Vas Narasimhan, reported on Q3 2025 results and said;

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"Novartis delivered solid financial performance in Q3, more than offsetting the impact of increasing generic erosion in the US. Our key growth drivers performed well, including Kisqali, Kesimpta, Pluvicto and Scemblix. Importantly, we achieved FDA approval for Rhapsido in CSU and positive Phase III readouts for ianalumab in Sjogren’s disease – two assets with pipeline-in-a-pill potential that could underpin our growth through 2030 and beyond. In addition, we completed several deals in the quarter to further strengthen our pipeline in core therapeutic areas. We remain well on track to achieve our guidance for 2025 and over the mid-term."

Key figures
Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 909 12 823 8 7 41 196 37 164 11 11
Operating income 4 501 3 627 24 27 14 028 11 014 27 31
Net income 3 930 3 185 23 25 11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31 5.94 4.50 32 35
Free cash flow 6 217 5 965 4 15 941 12 618 26
Core operating income 5 460 5 145 6 7 16 960 14 635 16 18
Core net income 4 330 4 133 5 6 13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10 6.94 5.83 19 21
Strategy

Our focus

Novartis is a "pure-play" innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities

Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.

Financials

Third quarter

Net sales were USD 13.9 billion (+8%, +7% cc), with volume contributing 16 percentage points to growth. Generic competition had a negative impact of 7 percentage points, driven by Promacta, Tasigna and Entresto generics in the US. Pricing had a negative impact of 2 percentage points, driven by revenue deduction adjustments mainly in the US. Currency had a positive impact of 1 percentage point.

Operating income was USD 4.5 billion (+24%, +27% cc), mainly driven by higher net sales and lower impairments, partly offset by higher R&D investments.

Net income was USD 3.9 billion (+23%, +25% cc), mainly driven by higher operating income. EPS was USD 2.04 (+29%, +31% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 5.5 billion (+6%, +7% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.3% of net sales (-0.8 percentage points, stable in cc).

Core net income was USD 4.3 billion (+5%, +6% cc), mainly due to higher core operating income, partly offset by other core financial income and expense. Core EPS was USD 2.25 (+9%, +10% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 6.2 billion (+4% USD), compared with USD 6.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities.

Nine months

Net sales were USD 41.2 billion (+11%, +11% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 3 percentage points, while pricing and currency had no impact.

Operating income was USD 14.0 billion (+27%, +31% cc), mainly driven by higher net sales and lower impairments, partly offset by higher investments behind priority brands and launches.

Net income was USD 11.6 billion (+27%, +29% cc), mainly driven by higher operating income. EPS was USD 5.94 (+32%, +35% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 17.0 billion (+16%, +18% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 41.2% of net sales, increasing 1.8 percentage points (2.5 percentage points cc).

Core net income was USD 13.5 billion (+14%, +17% cc), mainly due to higher core operating income. Core EPS was USD 6.94 (+19%, +21% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 15.9 billion (+26% USD), compared with USD 12.6 billion in the prior-year period, driven by higher net cash flows from operating activities.

Q3 priority brands

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including:

Kisqali (USD 1 329 million, +68% cc) sales grew strongly across all regions, including +91% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancer.
Kesimpta (USD 1 222 million, +44% cc) sales grew across all regions driven by increased demand and strong access.
Pluvicto (USD 564 million, +45% cc) showed sustained demand growth in the US following the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) approval, as well as continued access expansion ex-US in the post-taxane mCRPC setting, with 25 countries now approved including Japan.
Scemblix (USD 358 million, +95% cc) sales grew across all regions, demonstrating the continued high unmet need in CML, with strong momentum from the early-line indication in the US and Japan.
Leqvio (USD 308 million, +54% cc) continued steady growth across all regions, with a focus on increasing account and patient adoption, and continuing medical education.
Fabhalta (USD 149 million, +236% cc) sales grew, reflecting market share gains in PNH globally and continued launch progress in IgAN and C3G in the US.
Lutathera (USD 213 million, +11% cc) sales grew mainly in the US, Japan and Europe due to increased demand and earlier-line adoption.
Cosentyx (USD 1 698 million, -1% cc) sales were broadly stable, as strong volume growth in the US was partially offset by higher revenue deductions, and ex-US declined due to a one-time price effect in the prior year. Novartis remains confident in Cosentyx USD 8 billion+ peak sales guidance.
Zolgensma (USD 301 million, -5% cc) sales declined reflecting a lower incidence of SMA compared to prior year.

Net sales of the top 20 brands in the third quarter and nine months

Q3 2025 % change 9M 2025 % change
USD m USD cc USD m USD cc
Entresto 1 877 1 -1 6 495 15 15
Cosentyx
– excl. revenue deduction adjust.* 1 698

0
5 -1
4 4 861

7
9 7
9
Kisqali 1 329 69 68 3 462 62 63
Kesimpta 1 222 46 44 3 198 41 40
Tafinlar + Mekinist 550 3 1 1 675 9 9
Jakavi 539 8 4 1 555 7 6
Promacta/Revolade 362 -36 -38 1 410 -14 -14
Pluvicto 564 46 45 1 389 33 33
Ilaris 473 27 26 1 369 25 24
Xolair 440 5 3 1 339 8 8
Tasigna 221 -47 -48 925 -27 -26
Zolgensma 301 -2 -5 925 -3 -4
SandostatinGroup 302 -1 -1 922 -5 -5
Scemblix 358 97 95 894 85 84
Leqvio 308 56 54 863 63 61
Lutathera 213 12 11 613 15 14
ExforgeGroup 176 1 0 546 0 2
Lucentis 148 -40 -42 510 -39 -39
DiovanGroup 143 -5 -5 447 -1 0
GalvusGroup 126 -21 -20 373 -19 -16
Top 20 brands total 11 350 10 9 33 771 14 14
*Sales growth impacted by a one-time revenue deduction adjustment in the US

R&D update – key developments from the third quarter

New approvals

Rhapsido
(remibrutinib) Rhapsido was approved by the FDA as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Remibrutinib is also in Phase III development for chronic inducible urticaria, hidradenitis suppurativa and food allergy, as well as multiple sclerosis and myasthenia gravis.
Regulatory updates

Scemblix (asciminib) The CHMP of the EMA adopted a positive opinion and recommended granting marketing authorization for Scemblix for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.

Results from ongoing trials and other highlights

Ianalumab
(VAY736) The Phase III NEPTUNUS-1 and -2 trials evaluating ianalumab in adults with active Sjögren’s disease met their primary endpoint, showing statistically significant improvements in disease activity as measured by a reduction in ESSDAI compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile, supporting its potential to become the first targeted treatment for this chronic autoimmune disease. Novartis plans to submit ianalumab to health authorities globally and was granted Fast Track Designation by the FDA.

In the Phase III VAYHIT2 trial, ianalumab plus eltrombopag significantly extended the time to treatment failure compared to placebo plus eltrombopag in adult patients with primary immune thrombocytopenia (ITP), previously treated with corticosteroids. The safety profile was consistent with previous studies. Data will be presented at an upcoming medical meeting and included in regulatory submissions in 2027.

Ianalumab is also in Phase III development for systemic lupus erythematosus, lupus nephritis and warm autoimmune hemolytic anemia.
Pluvicto
(lutetium Lu177
vipivotide
tetraxetan) In the Phase III PSMAddition trial, Pluvicto plus standard-of-care (SoC) reduced risk of progression or death by 28% versus SoC alone, with a positive trend in overall survival in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Safety remained consistent with PSMAfore and VISION trials. Data presented at ESMO (Free ESMO Whitepaper).
Kisqali
(ribociclib) The five-year analysis of the pivotal Phase III NATALEE trial in the broadest population of high-risk stage II and III HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy (ET) reduced the risk of recurrence by 28.4% compared to ET alone. Data also showed a 29.1% risk reduction in distant disease-free survival, a positive trend in overall survival, and no new safety signals. Data presented at ESMO (Free ESMO Whitepaper).
Cosentyx
(secukinumab) The Phase III REPLENISH study met its primary endpoint, with Cosentyx demonstrating statistically significant and clinically meaningful sustained remission compared to placebo at week 52 in adults with relapsing polymyalgia rheumatica (PMR). Full data will be presented at an upcoming medical congress and submitted to health authorities in 2026.
Fabhalta
(iptacopan) In the Phase III APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years. Full data will be presented at future medical meetings and included in regulatory submissions in 2026.
Leqvio
(Inclisiran) In the Phase IV V-DIFFERENCE study, 85% of patients with hypercholesterolemia who had not reached guideline-recommended LDL-C targets despite optimized lipid-lowering therapy (LLT) achieved their goals with Leqvio plus LLT, versus 31% with placebo plus LLT, with benefits evident in as early as 30 days. Leqvio also reduced LDL-C by 59% over 360 days, outperforming placebo plus LLT by 35%. Data presented at ESC.
Entresto
(sacubitril/ valsartan) Data from the Phase IV PARACHUTE-HF study in patients with heart failure with reduced ejection fraction due to chronic Chagas disease showed that Entresto outperformed enalapril on a composite endpoint of cardiovascular death, heart failure hospitalization or NT-proBNP change. Entresto was well tolerated, with no new safety signals identified. Data presented at ESC.
Kesimpta
(ofatumumab) In the ARTIOS Phase IIIb study, patients with RMS who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies showed a substantial reduction in disease activity. This was reflected in a low annualized relapse rate (ARR of 0.06 over 96 weeks), near-complete suppression of MRI activity, and over 90% of participants achieving no evidence of disease activity (NEDA-3). No new safety concerns were identified, regardless of prior disease-modifying treatment.

In the separate ALITHIOS open-label extension study, more than 90% of naïve patients receiving Kesimpta showed no evidence of disease activity (NEDA-3) at 7 years, with no new safety concerns, reinforcing the benefit of introducing Kesimpta early. Data from both studies presented at ECTRIMS.
Selected transactions Novartis entered into an agreement to acquire Tourmaline Bio, a clinical-stage biopharmaceutical company developing pacibekitug, a Phase III-ready anti-IL-6 monoclonal antibody for atherosclerotic cardiovascular disease (ASCVD). In Phase II, pacibekitug reduced median high-sensitivity C-reactive protein (hsCRP) levels by up to 86% compared to placebo, with similar incidence rates of adverse events and serious adverse events. The transaction is expected to close on October 28, 2025.

Novartis entered a second collaboration with Monte Rosa Therapeutics, in addition to the existing license agreement for VAV1 degraders, announced in October 2024. Under the new agreement, Novartis receives an exclusive license to an undisclosed discovery target and options to license two programs from Monte Rosa’s preclinical immunology portfolio.

Novartis continued its collaboration with Argo Biopharma, adding two new agreements: an exclusive license to an siRNA candidate currently in IND-enabling studies and expected to enter Phase I in 2026, and an option to exclusively license two second-generation siRNA molecules currently in development, with a right of first negotiation to the Phase II ANGPTL3 program.

Novartis entered into a global licensing and collaboration agreement with Arrowhead Pharmaceuticals for ARO-SNCA, a preclinical-stage siRNA therapy targeting alpha-synuclein for the treatment of synucleinopathies such as Parkinson’s disease. The agreement also includes additional collaboration targets leveraging Arrowhead’s proprietary Targeted RNAi Molecule (TRiM) platform.
Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

During the first nine months of 2025, Novartis repurchased a total of 66.4 million shares for USD 7.5 billion on the SIX Swiss Exchange second trading line. These repurchases included 49.1 million shares (USD 5.4 billion) under the USD 15 billion share buyback (announced in July 2023 and completed in July 2025) and 6.6 million shares (USD 0.8 billion) under the new up-to USD 10 billion share buyback announced in July 2025. In addition, 10.7 million shares (USD 1.3 billion) were repurchased to mitigate anticipated full-year dilution related to the equity-based compensation plans of associates. Further, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from associates. In the same period, 11.7 million shares (equity value of USD 0.9 billion) were delivered to associates related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 56.3 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 6.8 billion and a net cash outflow of USD 7.7 billion.

Net debt increased to USD 20.4 billion at September 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 15.9 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 7.7 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.7 billion.

As of Q3 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2025 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow high single-digit
Core operating income Expected to grow low-teens
Foreign exchange impact

If late-October exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be neutral to positive 1 percentage point on net sales and negative 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1

Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 909 12 823 8 7 41 196 37 164 11 11
Operating income 4 501 3 627 24 27 14 028 11 014 27 31
As a % of sales 32.4 28.3 34.1 29.6
Net income 3 930 3 185 23 25 11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31 5.94 4.50 32 35
Net cash flows from
operating activities 6 571 6 286 5 16 880 13 426 26
Non-IFRS measures
Free cash flow 6 217 5 965 4 15 941 12 618 26
Core operating income 5 460 5 145 6 7 16 960 14 635 16 18
As a % of sales 39.3 40.1 41.2 39.4
Core net income 4 330 4 133 5 6 13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10 6.94 5.83 19 21

(Press release, Novartis, OCT 28, 2025, View Source [SID1234657040])

On October 27, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).

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Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG.

"Receiving Rare Pediatric Disease Designation for iopofosine I 131 underscores its potential to address one of the most devastating cancers affecting children and young adults. Combined with the encouraging interim results from our CLOVER-2 pHGG study, which showed meaningful improvements in progression-free and overall survival, this designation further validates the promise of our targeted radiotherapeutic approach," stated James Caruso, president and CEO of Cellectar. "We believe iopofosine I 131 represents a compelling opportunity for strategic collaboration to accelerate development and bring a potentially first-in-class therapy to patients who urgently need new options."

The FDA’s Rare Pediatric Disease Designation program is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for iopofosine I 131 is approved, upon reauthorization of the program Cellectar may be eligible to receive a Priority Review Voucher (PRV), which can significantly expedite the review process for future New Drug Applications or Biologic License Applications, may be redeemed to receive priority review for another marketing application or may be sold or transferred.

Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively.

Interim data from CLOVER-2, the company’s ongoing Phase 1b trial of iopofosine I 131 in children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada, were highlighted in an oral presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pediatric Cancer that took place in late September 2025.

The company’s chief operating officer, Jarrod Longcor, delivered the update, "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment," which showed that all patients receiving a minimum of 55 mCi total administered dose (n=6) experienced an average of 5.4 months of PFS and 8.6 months of OS, ongoing. All patients experienced disease control, which according to the committee for the Response Assessment in Pediatric Neuro-Oncology (RAPNO) does correlate with survival benefit. Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response (ORR).

Two case studies were highlighted in the oral presentation. Case Study 1 showed a 25-year-old male with diffuse hemispheric glioma with the H3 G34R/V mutation who had three prior therapies and who received a total administered dose of 126.6mCi of iopofosine I 131 over four doses (40mCi/m2/dose) had his target lesion reduced by more than 50% approximately eight months post screening. This patient had PFS of 10.9 months and survival is ongoing at greater than 18 months as of July 25, 2025.

Case Study 2 showed a 15-year-old female with ependymoma who had eight prior therapies and who received a total administered dose of 58.9mCi of iopofosine I 131 over four doses (20mCi/m2/dose) had her target lesion reduced from 252mm2 to approximately 141mm2. This patient had PFS of 11.2 months and her ongoing survival was greater than 17 months as of July 22, 2025.

Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the company’s previously reported safety data. Importantly, patients on iopofosine I 131 did not experience any cardiovascular, renal, or liver toxicities, and no peripheral neuropathy or significant bleeding. The safety profile was consistent with selective targeting of tumor sites with clinically negligible off-target effect outside the hematologic system. The most frequently reported treatment emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable. No treatment-related deaths were reported.

The complete presentation can be accessed on the company’s website here.

About Pediatric High-Grade Gliomas
Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. The patients enrolled in CLOVER-2 with pHGG (n=14) were diagnosed with diffuse midline gliomas (DMG), ependymomas, diffuse intrinsic pontine gliomas (DIPG), diffuse hemispheric gliomas (DHG) and anaplastic ependymomas. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival.

About the CLOVER-2 Trial
The Phase 1b trial of iopofosine I 131 consists of children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada. The study is designed to evaluate the safety and tolerability of iopofosine I 131 in two dosing cohorts, one cohort receiving two doses at 20mCi/m2 each separated by 14 days for two cycles with a third optional cycle. Patients in the second cohort will receive 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle. The study will also determine therapeutic activity defined as progression free survival (PFS) and overall survival, antitumor activity defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of iopofosine I 131 in children, adolescents and young adults with r/r pHGG.

(Press release, Cellectar Biosciences, OCT 27, 2025, View Source [SID1234661196])

On October 27, 2025 Adaptam Therapeutics (‘Adaptam’), a biotech company pioneering cancer immunotherapies specifically targeting immunosuppressive myeloid cells, reported the successful completion of a €3 million (~$3.5 million) pre-seed financing round led by Criteria Bio Ventures.

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This financing round will enable Adaptam to further develop its programs and enter the preclinical phase in multiple oncology indications. As part of the round, Salvatore Cappadona, PhD, and Pablo Cironi, PhD, both from Criteria Bio Ventures, joined the board of directors.

Adaptam is developing first-in-class antibody-based therapeutic programs, including ADCs and bispecific antibodies, that target novel glyco-immune checkpoints, selectively expressed in immunosuppressive myeloid cells.

"Immunosuppressive myeloid cells within tumors present one of the toughest challenges in immunotherapy today. Our goal is to neutralize this obstacle by developing therapies that specifically target these cells, offering patients new hope where traditional approaches have failed," said Asis Palazon, PhD, founder, CEO and CSO of Adaptam. "The support from Criteria Bio Ventures enables us to take a step forward in achieving our mission. We are now actively planning our next funding round to support IND-enabling studies."

Immunotherapy has transformed cancer treatment, offering new solutions to patients worldwide. However, a significant number still fail to respond to these therapies or develop resistance over time. This lack of efficacy is primarily due to the immunosuppressive nature of the tumor microenvironment (TME), which hampers the immune system’s ability to effectively target and destroy cancer cells. Among the main contributors to this immunosuppression are myeloid cells, particularly TAMs, which play a crucial role in inhibiting T-cell responses. This challenge is particularly pronounced in patients with solid tumors, where these myeloid cells create an environment that prevents immune cells from mounting an effective anti-tumoral response.

"We are thrilled to support Adaptam in its mission to transform cancer treatment by targeting the immunosuppressive cells within the TME. The scientific breakthroughs achieved by Prof. Asis Palazon and his team have laid the groundwork for potentially life-changing therapies," said Pablo Cironi, PhD, chairman of the Adaptam board. "With this strong foundation, we believe Adaptam is well-positioned to deliver new, effective treatments for patients with solid tumors, addressing critical gaps in current immunotherapy options."

"Adaptam’s differentiated approach at the intersection of myeloid-mediated immunosuppression and glycobiology represents a one-of-a-kind vision uniquely positioned to unlock the next frontier in cancer immunotherapy. We are proud to have partnered with Asis Palazon to build this exciting new venture and support its next phase of development. We are confident that Adaptam’s emerging pipeline offers a game-changing opportunity to transform cancer treatment for many patients," said Salvatore Cappadona, PhD, board member of Adaptam.

Adaptam originated from research conducted by Prof. Asis Palazon and his team at CIC bioGUNE in Bilbao, Spain, with expert insights from Criteria Bio Ventures on the ideation, corporate strategy and operational setup of the company. Asis Palazon also received a Caixa Research Health grant from "la Caixa" Foundation in 2021. Some of the core structural and mechanistic discoveries of immune-modulating glycan-binding proteins and their interactions with immune cells were previously published in Nature Communications.

"CIC bioGUNE’s long-standing leadership in glycobiology provided the scientific foundation for Adaptam and we have supported the company from its earliest steps through to today’s preclinical maturation," said Prof. Jesús Jiménez-Barbero, scientific director of CIC bioGUNE.

(Press release, Adaptam Therapeutics, OCT 27, 2025, View Source [SID1234657099])