On July 22, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported it has completed the acquisition of Memo Therapeutics AG, a late-stage biotech company focused on potravitug, an anti-BK polyomavirus monoclonal antibody.

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About potravitug
Potravitug is a first-in-class monoclonal antibody targeting BK polyomavirus (BKPyV) reactivation in kidney transplant recipients. It has shown promising results in clinical trials, demonstrating a significant anti-viral response and resolution of BKPyV associated nephropathy. These findings are based on the Phase II SAFE KIDNEY II trial, the largest placebo-controlled study conducted in this patient population, with additional analyses presented at leading international renal and transplant congresses further supporting its clinical profile and the next stages of clinical development.

About BK polyomavirus
BK polyomavirus (BKPyV) is a common virus that most people are exposed to in childhood and usually remains inactive in the body.i However, in people with a weakened immune system, including kidney transplant recipients taking anti-rejection medication, the virus can reactivate and multiply. Around 90% of kidney transplant recipients are positive for BKPyV serotype,ii and high levels of BKPyV in the blood affect approximately 30% of patients within the first year after transplant indicating reactivation of the virus.iii BK polyomavirus reactivation and associated nephropathy (BKVAN) can have serious consequences, including an increased risk of graft loss and the need for dialysis or re-transplantation. There are currently no approved targeted therapies for BKPyV and clinical management is focused on balancing graft protection with BKPyV control through reducing the immunosuppression.iv,v Over 100,000 kidney transplants are performed each year worldwide, and in the U.S. >28,000 are performed each year, with a further >90,000 patients on the waiting list for a transplant.

(Press release, Ipsen, JUL 22, 2026, View Source [SID1234669385])

On July 22, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the first patient has been dosed in the TARGET-D 202 Phase 2 registration-directed trial evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, in patients with previously treated KRAS G12D-mutated advanced non-small cell lung cancer (NSCLC). The initiation of TARGET-D 202 marks the second registration-directed Phase 2 clinical trial now underway for VS-7375, following first-patient dosing in the TARGET-D 201 metastatic pancreatic cancer study announced last month.

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"Despite advances in RAS-targeted therapies, there are no FDA-approved therapies specifically designed to target KRAS G12D-mutated tumors. Among the many challenges facing patients with KRAS G12D-mutated lung cancer, they continue to experience some of the poorest outcomes with progression-free survival of approximately 11 months – shorter than those with other common KRAS mutations," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "We’re making significant progress with the TARGET-D clinical trial programs, and once the first patient is dosed in the TARGET-D 203 Phase 2 study for advanced metastatic colorectal cancer, we will have registration-directed trials underway across the three most common KRAS G12D-driven tumor types. We believe we are well positioned to advance the broad clinical development of VS-7375 across multiple tumor types to selectively target KRAS G12D to maximize efficacy, allow for tolerable combinations, and avoid toxicities problematic with non-specific pan-RAS inhibitors."

TARGET-D 202 (NCT07659782) is a global, open-label, Phase 2 registration-directed trial evaluating VS-7375 monotherapy at the recommended Phase 2 dose (RP2D) of 900 mg daily (QD) in patients with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC whose disease has progressed following prior treatment with platinum-based chemotherapy and an anti-PD-(1) therapy. The trial is designed to evaluate the efficacy and safety of VS-7375 and support a potential registration strategy in this patient population. A cohort in the study will also evaluate VS-7375 in non-small cell lung cancer patients with asymptomatic untreated brain metastases.

In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), NSCLC, and other solid tumor cancers. In a recent update, the Company shared that VS-7375 demonstrated encouraging anti-tumor activity across multiple KRAS G12D-driven tumor types, including mPDAC, mCRC, and advanced NSCLC, with evidence of dose-dependent activity, favorable PK supporting target exposure, and a favorable and manageable safety and tolerability profile. Patient follow-up continues to mature across monotherapy and combination cohorts, and the Company expects to share an update in the second half of 2026.

About Non-Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer-related death worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 80–85% of all lung cancer diagnoses. Approximately 10,000 patients with NSCLC harbor a KRAS G12D mutation in the U.S. annually. Compared with other KRAS mutation variants, metastatic KRAS G12D NSCLC is associated with the shortest progression-free survival and has been linked to immune suppression and resistance to anti-PD-(L)1 therapies. KRAS G12D is the most common KRAS mutation among never-smokers, while also occurring in many patients with a history of smoking. Additionally, brain metastases remain a significant clinical challenge in metastatic NSCLC, affecting approximately 10–20% of patients at diagnosis and up to 40% during the course of disease. Despite these challenges and the significant unmet medical need, there are currently no approved therapies specifically targeting KRAS G12D-mutated NSCLC.

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. When the KRAS gene is mutated, it can promote cancer development and growth. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. The KRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical Program

VS-7375 is a potential best-in-class, potent, and selective investigational oral KRAS G12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), advanced non-small cell lung cancer (NSCLC), and other solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559) in second-line advanced or metastatic PDAC, TARGET-D 202 (NCT07659782) in second/third-line advanced or metastatic NSCLC, and TARGET-D 203 (NCT07659795) in metastatic CRC. In June 2026, the company announced the first patient was dosed in the TARGET-D 201 trial.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy. In June 2026, the FDA also granted FTD to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUL 22, 2026, View Source [SID1234669370])

On July 22, 2026 argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, reported its half year 2026 results and provided a second quarter business update.

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"Our strong second quarter performance reflects continued execution of our Vision 2030 strategy and our commitment to accelerate immunology innovation," said Karen Massey, Chief Executive Officer. "During the quarter, we further strengthened our leadership in FcRn with the launch of the expanded label for VYVGART and VYVGART Hytrulo to now include all gMG serotypes, providing physicians with a single treatment option for the broadest adult gMG patient population. With important registrational study readouts in the second half, as well as continued progress with our early-stage pipeline, we are advancing the next wave of innovation, reinforcing our ambition to build a leading multi-asset immunology company."

Vision 2030
argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030.

Expanding global VYVGART opportunity and shaping the long-term future of FcRn
VYVGART (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all serotypes of adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. As the leading targeted biologic in MG and CIDP, argenx is progressing multiple label expansions while building the future of FcRn by advancing novel FcRn pipeline candidates and new delivery modalities.

Generated $1.5 billion in global product net sales in the second quarter of 2026, representing 17% quarter-over-quarter growth, and a year-over-year increase of 60% or $0.6 billion
Launched expanded label for VYVGART and VYVGART Hytrulo in the U.S., which now includes all gMG serotypes (anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative)
On track with plans to expand VYVGART into ocular myasthenia gravis (oMG) following positive ADAPT OCULUS results
Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026
Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027
Topline results from registrational UNITY study (Sjogren’s disease) expected in second half of 2027
Registrational study in Graves’ disease (GD) ongoing, expanding development into thyroid-driven autoimmunity
VYVGART SC autoinjector positioned to launch in 2027 for all approved indications
Progressing two future FcRn molecules: ARGX-213, designed for monthly dosing, is Phase 3 ready, and ARGX-124 is expected to complete Phase 1 evaluation by end of 2026

Advancing empasiprubart, argenx’s second pipeline-in-a-product opportunity
Empasiprubart (anti-C2) is argenx’s second pipeline-in-a-product opportunity and is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG.

Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026
Topline results from registrational EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
Data from Phase 2 VARVARA study (delayed graft function, DGF) support further evaluation of empasiprubart in transplant setting based on signal at 52 weeks
Advancing ADAPT-Forward combination study, evaluating empasiprubart as a potential add-on therapy to efgartigimod in gMG
Delivering next wave of immunology innovation
By the end of 2026, argenx expects to have ten molecules in clinical development across its immunology pipeline, including adimanebart (MuSK agonist), ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6) and additional candidates emerging from the Immunology Innovation Program. Together, these programs support argenx’s goal of building a durable pipeline of differentiated medicines.

Phase 2 study of adimanebart in spinal muscular atrophy (SMA) ongoing; registrational study in congenital myasthenic syndromes (CMS) expected to begin in 2026
Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
First-in-human Phase 1 study of TSP-101 (Fn14 inhibitor) is ongoing
ARGX-118 (Galectin-10 inhibitor) and ARGX-125 (first-in-class bispecific antibody against an undisclosed target) are on track to enter Phase 1 studies in 2026
SECOND QUARTER 2026 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $ except per share data) 2026 2025 2026 2025
Product net sales $ 1,516 $ 949 $ 2,813 $ 1,739
Other operating income 26 19 41 36
Total operating income $ 1,542 $ 967 $ 2,854 $ 1,775

Cost of sales $ (145) $ (111) $ (266) $ (192)
Research and development expenses* (486) (330) (929) (642)
Selling, general and administrative expenses (417) (325) (772) (601)
Total operating expenses $ (1,048) $ (766) $ (1,967) $ (1,435)

Operating profit $ 494 $ 201 $ 887 $ 340

Financial income $ 48 $ 38 $ 92 $ 76
Financial expense (1) (1) (2) (2)
Exchange (losses)/gains (8) 49 (19) 76

Profit for the period before taxes $ 532 $ 287 $ 958 $ 489
Income tax expense $ (59) $ (42) $ (119) $ (74)
Profit for the period $ 472 $ 245 $ 838 $ 415
Profit for the period attributable to:
Owners of the parent $ 472 $ 245 $ 838 $ 415
Weighted average number of shares used for basic profit per share 62,312,606 61,084,250 62,185,445 61,034,202
Basic profit per share (in $) 7.58 4.02 13.47 6.80
Weighted average number of shares used for diluted profit per share 64,524,979 65,639,446 64,409,488 65,653,007
Diluted profit per share (in $) 7.32 3.74 13.00 6.32
*Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of research and development expenses and loss from investment in a joint venture.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and six months ended June 30, 2026, was $1.5 billion and $2.9 billion, respectively, compared to $1.0 billion and $1.8 billion, respectively, for the same periods in 2025, and mainly consists of:

Product net sales of VYVGART for the three and six months ended June 30, 2026, were $1.5 billion and $2.8 billion, respectively, compared to $0.9 billion and $1.7 billion, respectively, for the same periods in 2025.

Other operating income for the three and six months ended June 30, 2026, was $26 million and $41 million, respectively, compared to $19 million and $36 million, respectively, for the same periods in 2025. The other operating income for the three and six months ended June 30, 2026 and 2025, primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and six months ended June 30, 2026 were $1.0 billion and $2.0 billion, respectively, compared to $0.8 billion and $1.4 billion, respectively, for the same periods in 2025, and mainly consist of:

Cost of sales for the three and six months ended June 30, 2026, was $145 million and $266 million, respectively, compared to $111 million and $192 million for the same periods in 2025, respectively. The cost of sales was related to the sale of VYVGART.
Research and development expenses for the three and six months ended June 30, 2026, were $0.5 billion and $0.9 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The research and development expenses mainly relate to advancing efgartigimod, empasiprubart, and adimanebart across multiple registrational studies, plus early-stage pipeline and preclinical programs.
Selling, general and administrative expenses for the three and six months ended June 30, 2026, were $0.4 billion and $0.8 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three and six months ended June 30, 2026, was $48 million and $92 million, respectively, compared to $38 million and $76 million, respectively, for the same periods in 2025.

Income tax for the three and six months ended June 30, 2026 and 2025 is detailed below:

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $) 2026 2025 2026 2025
Current tax expense $ (128) $ (41) $ (230) $ (70)
Deferred tax benefit/(expense) 68 (1) 110 (4)
Income tax expense $ (59) $ (42) $ (119) $ (74)
Profit for the three and six-month periods ended June 30, 2026, was $0.5 billion and $0.8 billion, respectively, compared to a profit of $0.2 billion and a loss of $0.4 billion, respectively, for the same periods in 2025. The basic profit per share was $7.58 for the three months ended June 30, 2026, compared to a basic profit per share of $4.02 for the same period in 2025. The basic profit per share was $13.47 for the six months ended June 30, 2026, compared to a basic loss per share of $6.80 for the same period in 2025.

Cash flow from operating activities for the six months ended June 30, 2026 was $0.7 billion compared to a cash flow used in operating activities for the same period in 2025 of $0.4 billion.

Cash, cash equivalents and current financial assets1 consisted of $3.6 billion in cash, cash equivalents and $1.6 billion in current financial assets which totaled $5.2 billion as of June 30, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

EXPECTED FINANCIAL CALENDAR

October 22, 2026: Third Quarter 2026 Financial Results and Business Update
February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update
CONFERENCE CALL DETAILS
The half-year 2026 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors.

Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below:

Belgium 32 2290 4635
France 33 172 001717
Netherlands 31 20 795 2683
United Kingdom 44 203 393 1560
Japan 81 3 4520 9761
Switzerland 41 43 210 51 68

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

A replay of the webcast will be available on the argenx website.

About VYVGART
VYVGART (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

(Press release, argenx, JUL 22, 2026, View Source [SID1234669371])

On July 22, 2026 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Sapu Nano reported the publication of a comprehensive peer-reviewed study in Biomedicines describing the preclinical translational package supporting Sapu003, the Company’s intravenous Deciparticle formulation of everolimus. The publication provides a complete evaluation of the formulation’s absorption, distribution, metabolism, excretion (ADME), pharmacokinetics (PK), tissue distribution, GLP toxicology, and cGMP manufacturing, representing one of the most comprehensive nonclinical evaluations reported for an intravenous formulation of everolimus.

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The study demonstrates that Deciparticle technology successfully transforms everolimus from an oral therapy with well-recognized pharmacokinetic limitations into a clinically manufacturable intravenous formulation while preserving the drug’s intrinsic metabolic characteristics. The findings support the ongoing Phase 1 clinical evaluation of Sapu003 in patients with advanced solid tumors.

The publication integrates multiple components required for clinical translation, including:

Complete ADME characterization
Pharmacokinetic and tissue-distribution studies
Metabolic pathway analysis
Excretion studies
GLP repeat-dose toxicology
cGMP manufacturing and release testing
Product stability and quality characterization

Reduced Gastrointestinal Drug Exposure

Compared with oral everolimus, intravenous Sapu003 produced broad systemic distribution without the marked gastrointestinal accumulation characteristic of oral administration. Repeat-dose GLP toxicology studies demonstrated no treatment-related gastric pathology following intravenous dosing, supporting the potential for improved tolerability.

Clinical-Grade Manufacturing Successfully Demonstrated

The publication also describes the successful development of a reproducible cGMP manufacturing process for Sapu003. These manufacturing studies establish that Deciparticle technology is suitable for clinical production under current Good Manufacturing Practice (cGMP) conditions.

"This publication represents a significant milestone in the clinical translation of the Deciparticle platform," said Vuong Trieu, Ph.D., Chief Executive Officer of Oncotelic Therapeutics. "Rather than describing only a formulation or a pharmacokinetic study, this work brings together the complete scientific package-from cGMP manufacturing and quality control to ADME, pharmacokinetics, tissue distribution, metabolism, and GLP toxicology-that supports the ongoing clinical development of Sapu003."

"Our objective has always been to build a platform capable of transforming challenging hydrophobic therapeutics into clinically practical intravenous medicines. The successful demonstration of reproducible manufacturing together with favorable pharmacokinetic and safety characteristics provides strong validation of the Deciparticle technology."

About the Publication

The manuscript, titled "IV-EVE: EVE for Injection-ADME, Pharmacokinetic and Toxicological Evaluation for Novel Deciparticle EVE Formulation," was published in Biomedicines on July 14, 2026. View Source

Clinical Trial Information

Study Title: SP-03-B101: A Phase 1b Study of Sapu003 (Intravenous Everolimus) in Patients with Advanced mTOR-Sensitive Solid Tumors

ClinicalTrials.gov Identifier: NCT07369505

About Sapu003

Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Nano’s proprietary Deciparticle nanoparticle platform. Sapu003 is designed to overcome the formulation limitations associated with oral everolimus by enabling intravenous administration with a scalable cGMP manufacturing process. The program is currently being evaluated in the Phase 1b SP-03-B101 clinical trial in patients with advanced mTOR-sensitive solid tumors.

About Deciparticle

Deciparticle is Sapu Nano’s proprietary nanomedicine platform designed to formulate poorly water-soluble therapeutic compounds into stable intravenous formulations. The platform combines amphiphilic polymer technology with scalable cGMP manufacturing to enable the clinical development of challenging hydrophobic therapeutics. In addition to Sapu003, the platform has demonstrated compatibility with multiple classes of hydrophobic molecules, supporting future pipeline expansion and potential strategic collaborations.

(Press release, Oncotelic, JUL 22, 2026, View Source [SID1234669372])

On July 21, 2026 Vas Narasimhan, CEO of Novartis, reporting on Q2 2026 results, said:

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"Novartis delivered a solid second quarter, returning to sales growth driven by continued momentum from Kisqali, Kesimpta, Scemblix and Pluvicto. We are encouraged by the early trajectory of our recent launches, Rhapsido in CSU and Itvisma. We also made meaningful pipeline progress, highlighted by updated Kisqali overall survival data in early breast cancer and the FDA accelerated approval submission for del-zota in DMD. We are on track for multiple important readouts ahead in the second half, and remain on track to deliver our full-year guidance and mid-term outlook."

Key figures
Q2 2026 Q2 2025 % change H1 2026 H1 2025 % change
USD m3 USD m3 USD cc USD m3 USD m3 USD cc
Net sales 14 408 14 054 3 1 27 521 27 287 1 -2
Operating income 4 750 4 864 -2 -3 8 985 9 527 -6 -7
Net income 3 257 4 024 -19 -19 6 413 7 633 -16 -17
EPS (USD) 1.71 2.07 -17 -18 3.37 3.91 -14 -15
Free cash flow 5 561 6 333 -12 8 891 9 724 -9
Core operating income 5 940 5 925 0 0 10 837 11 500 -6 -7
Core net income 4 578 4 710 -3 -4 8 372 9 192 -9 -10
Core EPS (USD) 2.41 2.42 0 -1 4.39 4.69 -6 -8

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. 3. USD millions unless indicated otherwise.

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

Second quarter

Net sales were USD 14.4 billion (+3%, +1% cc), with volume growth contributing 18 percentage points, offset by 14 percentage points from generic competition. Pricing had a negative impact of 3 percentage points, and currency had a positive impact of 2 percentage points.

Operating income was USD 4.8 billion (-2%, -3% cc), declining mainly due to lower gross profit, partly offset by lower SG&A expenses.

Net income was USD 3.3 billion (-19%, -19% cc), impacted by higher income taxes and higher interest expense. EPS was USD 1.71 (-17%, -18% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 5.9 billion (0%, 0% cc), in line with the prior-year quarter. Core operating income margin was 41.2% of net sales, decreasing 1.0 percentage point (0.7 percentage points in cc).

Core net income was USD 4.6 billion (-3%, -4% cc), mainly due to higher interest expense. Core EPS was USD 2.41 (0%, -1% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 5.6 billion (-12%), due to lower net cash flows from operating activities.

First half

Net sales were USD 27.5 billion (+1%, -2% cc), with volume growth contributing 15 percentage points, offset by 14 percentage points from generic competition. Pricing had a negative impact of 3 percentage points, and currency had a positive impact of 3 percentage points.

Operating income was USD 9.0 billion (-6%, -7% cc), declining mainly due to lower gross profit, partly offset by lower legal related costs and lower SG&A expenses.

Net income was USD 6.4 billion (-16%, -17% cc), mainly due to lower operating income, higher income taxes and higher interest expense. EPS was USD 3.37 (-14%, -15% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 10.8 billion (-6%, -7% cc), declining mainly due to lower gross profit. Core operating income margin was 39.4% of net sales, decreasing 2.7 percentage points (2.3 percentage points in cc).

Core net income was USD 8.4 billion (-9%, -10% cc), mainly due to lower core operating income and higher interest expense. Core EPS was USD 4.39 (-6%, -8% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 8.9 billion (-9%), due to lower net cash flows from operating activities.

Q2 priority brands

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q2 growth) including:

Kisqali (USD 1 695 million, +43% cc) sales grew strongly across all regions, with continued market share growth in the early breast cancer indication as well as leadership in metastatic breast cancer.
Kesimpta (USD 1 424 million, +32% cc) sales grew across all regions, driven by increased demand and strong access.
Scemblix (USD 562 million, +89% cc) sales grew across all regions, with continued strong momentum from the newly diagnosed patients-line indication in the US, Japan and Germany.
Pluvicto (USD 651 million, +43% cc) sales showed continued strong demand in the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) setting in the US, and access expansion ex-US.
Cosentyx (USD 1 824 million, +10% cc) sales grew driven by US performance including growth in HS and IV. Ex-US, growth in Europe and most emerging markets was partly offset by a decline in China.
Leqvio (USD 480 million, +59% cc) sales grew across all regions, with continued uptake in China following NRDL inclusion.
Fabhalta (USD 225 million, +88% cc) sales grew, reflecting continued expansion in PNH and renal indications.
Zolgensma Group (USD 365 million, +20% cc) sales grew driven by continued launch momentum from Itvisma in the US and UAE.
Rhapsido (USD 64 million) continued to show strong early uptake in the US, supported by increasing coverage and a free drug program facilitating patient access. Ex-US sales were driven by early launch uptake in China.

Net sales of the top 20 brands in the second quarter and first half

Q2 2026 % change H1 2026 % change
USD m USD cc USD m USD cc
Cosentyx 1 824 12 10 3 390 7 5
Kisqali 1 695 44 43 3 211 51 48
Kesimpta 1 424 32 32 2 588 31 29
Entresto 1 181 -50 -51 2 486 -46 -48
Pluvicto 651 43 43 1 293 57 55
Jakavi 576 10 8 1 133 12 6
Tafinlar + Mekinist 581 1 0 1 074 -5 -7
Ilaris 550 15 15 1 025 14 13
Scemblix 562 89 89 995 86 85
Leqvio 480 61 59 932 68 64
Xolair 342 -23 -25 730 -19 -22
Zolgensma Group 365 23 20 667 7 3
Sandostatin Group 302 0 -1 589 -5 -7
Lutathera 225 9 8 436 9 8
Exforge Group 191 0 -3 394 6 2
Fabhalta 225 88 88 394 96 94
Promacta/Revolade 179 -64 -65 363 -65 -66
Diovan Group 160 4 2 310 2 -2
Tasigna 142 -57 -58 297 -58 -59
Lucentis 126 -27 -30 230 -36 -40
Top 20 brands total 11 781 2 1 22 537 1 -2

R&D update – key developments from the second quarter

New approvals

Rhapsido
(remibrutinib) EC and Japan’s MHLW approved Rhapsido as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) with inadequate response to H1-antihistamine treatment. It is the first approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU.
Itvisma
(onasemnogene abeparvovec) EC approved Itvisma for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. It is the first and only gene replacement therapy available for this broad population.
Fabhalta
(iptacopan) In July, FDA granted traditional approval of Fabhalta as the first and only complement inhibitor to significantly slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

Regulatory updates

Kisqali
(ribociclib) FDA granted Kisqali pediatric exclusivity, adding a 6-month period of exclusivity to all existing patents listed in the Orange Book.
KPE179
(del-zota) A Biologics License Application (BLA) was submitted to the FDA for accelerated approval of del-zota in people living with Duchenne muscular dystrophy (DMD) who have a genetic variant that may be amenable to exon 44 skipping (DMD44). Del-zota previously received FDA Breakthrough Therapy designation.
Vanrafia
(atrasentan) Regulatory submissions for traditional approval of Vanrafia in adults with IgAN were completed in the US and EU.
Coartem
(artemether and lumefantrine) The World Health Organization prequalified Coartem Baby, the first antimalarial developed specifically for newborns and young infants between 2-5 kg, a key step towards enabling widespread access through public sector procurement.

Results from ongoing trials and other highlights

Rhapsido
(remibrutinib) In the Phase III RemIND study, Rhapsido met its primary endpoint across the three most common chronic inducible urticaria (CIndU) subtypes, with higher rates of complete responses at Week 12, and responses seen as early as Week 2 in two subtypes. Twice as many patients achieved symptom control compared with placebo. The safety profile was favorable with no liver safety concerns. Data supports its potential as a first targeted therapy for CIndU. Data were presented at EAACI.

The Phase IIIb REMIXED extension study in CSU demonstrated that patients continuing remibrutinib treatment had a 72% lower risk of relapse and maintained higher rates of disease control compared with those switched to placebo for up to 18 months. The safety profile remained favorable. Data were presented at EAACI. The extension study will continue with follow-up for 3 years.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Subgroup analyses from the Phase III PSMAddition study of Pluvicto plus standard of care (SoC) (ARPI + ADT) in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC)1 demonstrated consistent improvement in radiographic progression-free survival (rPFS) versus SoC alone, regardless of disease volume or presentation (de novo or recurrent). The benefit was comparable with the previously reported primary endpoint showing a 28% reduction in the risk of progression or death, with a consistent safety profile. Data were presented at ASCO (Free ASCO Whitepaper).

Further PSMAddition data showed Pluvicto plus SoC achieved a higher frequency and depth of PSA response versus SoC alone in PSMA+ mHSPC, with a 58% reduction in the risk of PSA progression. Data were presented at AUA.
Cosentyx
(secukinumab) In the Phase III REPLENISH study, Cosentyx demonstrated statistically significant sustained remission versus placebo at Week 52 in patients with polymyalgia rheumatica (PMR), doubling remission rates, while also reducing cumulative glucocorticoid exposure, with a safety profile consistent with Cosentyx. Data were published at the New England Journal of Medicine and presented at EULAR. Data have been submitted for health authority review in the US, EU and Japan.
VAY736
(ianalumab) In the Phase III NEPTUNUS-1 and -2 studies in adult patients with Sjögren’s Disease, ianalumab demonstrated consistent improvement across most ESSDAI domains, including key lymphadenopathy, PNS, muscular and pulmonary domains. In the NEPTUNUS extension study, deepening control of disease activity was observed, with continued reductions in ESSDAI at Week 108 and a favorable safety profile. Data were presented at EULAR. Data have been submitted for health authority review in the US, EU and Japan.
Vanrafia
(atrasentan) Final 30-month results from the Phase III ALIGN study showed Vanrafia achieved a clinically meaningful slowing of kidney function decline in adults with IgAN together with sustained proteinuria reductions. The benefits were consistent across kidney function measures and in patient groups receiving SGLT2 inhibitors. The safety profile was consistent with prior studies. Results were published in The Lancet and presented at ERA.
DWH213
(del-brax) The biomarker cohort of the FORTITUDE Phase I/II study of del-brax in patients with facioscapulohumeral muscular dystrophy (FSHD) met its primary and key secondary endpoints, with reductions in KHDC1L (cDUX) and creatine kinase biomarker levels, indicating both strong target engagement and reduction in muscle damage. The safety profile was consistent with previous findings.
Scemblix
(asciminib) Week 144 data from the pivotal Phase III ASC4FIRST study of Scemblix in adults with newly diagnosed Ph+ CML-CP demonstrated superior major molecular response (MMR) compared with all SoC tyrosine kinase inhibitors (TKIs), including a 15.2% higher MMR rate versus 2G TKIs. Scemblix showed fewer grade ≥3 AEs and less than half the discontinuation rate due to AEs. Data were presented at ASCO (Free ASCO Whitepaper).
Kisqali
(ribociclib) The NATALEE six-year follow up study showed clinically meaningful overall survival (OS) in the broadest at risk early breast cancer (eBC) population. Data will be presented at an upcoming medical congress.

In the largest CDK4/6i biomarker analysis in HR+/HER2- eBC, NATALEE showed Kisqali plus non-steroidal aromatase inhibitor (NSAI) demonstrated consistent invasive disease-free survival (iDFS) benefit versus NSAI alone across all PAM50 intrinsic subtypes, with greater benefit trends in patients with higher genomic risk or proliferation signature scores, including high-risk node-negative (N0) disease. Data were presented at ASCO (Free ASCO Whitepaper).
HTT227
(Votoplam) In the 24-month interim analysis of the Phase II PIVOT-HD long-term extension study, votoplam 10 mg dose demonstrated sustained mHTT lowering in early stage Huntington’s disease (HD) patients with a favorable safety profile. The Phase III INVEST-HD study is actively enrolling.
FUB523
(zigakibart) Long-term data from the Phase I/II study of zigakibart showed durable reductions in disease-relevant biomarkers, including Gd-IgA1 and IgA through Week 124, alongside clinically meaningful reductions in proteinuria and stabilization of eGFR, with no new safety signals. Data were presented at ERA.

Zigakibart is currently being evaluated in the Phase III BEYOND study in adults with IgAN, with readout anticipated in H1 2027.
YTB323
(rap-cel) Preliminary data from the Phase II AUTOGRAPH studies of rap-cel showed early, clinically meaningful improvements in patients with severe, refractory idiopathic inflammatory myopathies (IIM) and diffuse cutaneous systemic sclerosis (dcSSc), alongside rapid and deep B-cell depletion, with a manageable safety profile.
225Ac-PSMA-617

Phase I data from the AcTION study of the actinium-based RLT Ac225‑PSMA‑617 showed antitumor activity, with PSA declines and radiographic responses in patients with PSMA+ metastatic castration‑resistant prostate cancer2. The safety profile was manageable. Data were presented at ASCO (Free ASCO Whitepaper).
Selected transactions In July, Novartis entered into an agreement to acquire Myricx Bio, a biotechnology company developing a new class of antibody-drug conjugates (ADCs). The acquisition strengthens the Novartis oncology pipeline with two lead ADC assets targeting B7-H3 and HER2 and a broader payload platform with potential impact across multiple solid tumor settings. The transaction is expected to close in H2 2026, subject to customary closing conditions.

Novartis successfully completed the acquisition of Pikavation Therapeutics, Inc and SNV4818, strengthening its early-stage breast cancer pipeline.

Novartis successfully completed the acquisition of Excellergy including Exl-111, building on deep Novartis expertise in IgE biology and allergic disease.

1 Also known as prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer.
2 Also known as prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer.

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 half of 2026, Novartis repurchased 18.2 million shares for USD 2.8 billion on the SIX Swiss Exchange second trading line. These repurchases included 13.8 million shares (USD 2.1 billion) under the up-to USD 10 billion share buyback announced in July 2025 (with up to USD 5.6 billion still to be executed). In addition, 4.4 million shares (USD 0.7 billion) were repurchased to mitigate the anticipated full-year dilution related to participation plans of associates, with the remainder of repurchases for this purpose to be executed in H2 2026. A further 2.0 million shares (USD 0.3 billion) were repurchased from employees. During the same period, USD 0.6 billion equity-based compensation plans expenses were recognized to equity and 12.7 million shares were delivered to employees related to equity-based compensation plans from prior years. As a result, the total number of shares outstanding decreased by 7.5 million compared to December 31, 2025. These treasury share transactions resulted in an equity decrease of USD 2.4 billion and cash outflows of USD 3.1 billion.

Net debt increased to USD 39.4 billion at June 30, 2026, compared to USD 21.9 billion at December 31, 2025. The increase was mainly due to the free cash flow of USD 8.9 billion being more than offset by the net cash outflow for M&A, intangible asset transactions and other acquisitions of USD 15.3 billion, the USD 9.1 billion annual dividend payment and cash outflows for treasury share transactions of USD 3.1 billion.

As of Q2 2026, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2026 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow low single-digit
Core operating income Expected to decline low single-digit

Foreign exchange impact

If mid-July exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 1 percentage point on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1

Q2 2026 Q2 2025 % change H1 2026 H1 2025 % change
USD m2 USD m2 USD cc USD m2 USD m2 USD cc
Net sales 14 408 14 054 3 1 27 521 27 287 1 -2
Operating income 4 750 4 864 -2 -3 8 985 9 527 -6 -7
As a % of sales 33.0 34.6 32.6 34.9
Net income 3 257 4 024 -19 -19 6 413 7 633 -16 -17
EPS (USD) 1.71 2.07 -17 -18 3.37 3.91 -14 -15
Net cash flows from
operating activities 5 882 6 664 -12 9 558 10 309 -7
Non-IFRS measures
Free cash flow 5 561 6 333 -12 8 891 9 724 -9
Core operating income 5 940 5 925 0 0 10 837 11 500 -6 -7
As a % of sales 41.2 42.2 39.4 42.1
Core net income 4 578 4 710 -3 -4 8 372 9 192 -9 -10
Core EPS (USD) 2.41 2.42 0 -1 4.39 4.69 -6 -8

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. USD millions unless indicated otherwise.

(Press release, Novartis, JUL 21, 2026, View Source [SID1234669325])