Enterome Phase 2 data show EO2463-induced CD8 T-cell expansion correlates with progression-free survival in patients with indolent non-Hodgkin lymphoma in the watch-and-wait setting

On July 21, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies, reported new positive interim data from the ongoing open-label Phase 1/2 SIDNEY trial of OncoMimics EO2463 to treat indolent Non-Hodgkin Lymphoma (iNHL). The data show EO2463 continues to have an effect, now showing a statistically significant correlation with progression-free survival (PFS) as a monotherapy in the watch-and-wait setting, and an additive effect, associated with complete response rates, when used in a triple combination, together with the standard of care, lenalidomide and rituximab (R2).

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These new findings confirm previous data suggesting specific CD8 T cell expansion caused by EO2463 could be developed as a predictive biomarker and represent a compelling rationale for further study to confirm that EO2463 increases PFS in patients with iNHL.

Enterome presented the data today at the Pan Pacific Lymphoma Conference (PPLC) at the Fairmont Orchid, Kohala Coast (Big Island) in Hawaii. Copy of the poster is available here.

"The correlation between the robust CD8 T cell expansion induced by EO2463 and PFS is a landmark finding that creates an imperative for further study and offers new hope for patients suffering from iNHL. It suggests that EO2463, which has been well-tolerated to date, may effectively extend PFS as a standalone therapy without hurting quality of life in this generally older and fragile patient population. We want to prioritize patients classified for watch-and-wait, an observational protocol, because they currently receive no active treatment, despite having to live with the grave psychological impact of their cancer diagnosis," said Pierre Belichard, Chief Executive Officer of Enterome. "Based on these and other data, we believe EO2463 is ready to start the final stage of registrational clinical development as a first-in-class therapeutic for patients with iNHL in a watch-and-wait setting. We are in active discussions with potential investors and partners to find the best way to bring this product to patients."

SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R2. Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies.

More recently, as SIDNEY progresses, data have begun to show the impact of EO2463 on clinical efficacy. Enterome reported at ASH (Free ASH Whitepaper) in late 2025 that EO2463 caused a higher-than-expected complete recovery (CR) rate with the triple combination therapy, EO2463 and R2, compared to the combination of only lenalidomide and rituximab (or "R2"). Data reported at ASH (Free ASH Whitepaper) in late 2024 showed that EO2463 monotherapy generated a 46% objective response rate in watch-and-wait patients.

Last month, at EHA (Free EHA Whitepaper) 2026, Enterome presented data showing that EO2463-induced CD8 T cell expansions were significantly associated with clinical outcomes in each of the monotherapy, rituximab ("R1"), and R2 cohorts, suggesting that EO2463-induced CD8 T-cell expansion can be used as a predictive biomarker. Today, Enterome announced that new analyses extend this finding to progression-free survival in the monotherapy cohort.

Key data presented at PPLC:

In the EO2463 monotherapy cohort (Cohort 2, watch-and-wait), higher CD8 T cell expansion was significantly associated with longer progression-free survival (HR=0.18, 95% CI 0.03–0.82; log-rank p=0.020).
In the EO2463 plus lenalidomide/rituximab combination cohort (Cohort 1+4, relapsed/refractory disease), higher CD8 T cell expansion was significantly associated with complete response (p=0.0073)
EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand pre-existing memory CD8 T cells, selectively target malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma.

Upcoming presentation at ESMO (Free ESMO Whitepaper) Congress 2026

Enterome will also present data on its solid-tumor OncoMimics candidate EO4010 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place 23–27 October 2026 in Madrid, Spain.

Title: EO4010 (EO) multi-target peptide immunotherapy: tumor directed CD8 T cell expansion kinetics and association to survival in patients (pts) with treated mismatch repair proficient (pMMR) metastatic colorectal carcinoma (mCRC)
Presentation number: 859P

Presentation time: Sun, October 25, 2026 – Time: 12:00 – 12:45

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention.

(Press release, Enterome, JUL 21, 2026, View Source [SID1234669338])

Alpha Tau Reports Positive Data Demonstrating 100% Objective Response Rate and 18.2-Month Median Overall Survival with Alpha DaRT® in Combination with Pembrolizumab in Locally Advanced or Metastatic Head and Neck Cancer, Surpassing the Study’s Pre-Specified Threshold for Success

On July 21, 2026 Alpha Tau Medical Ltd. ("Alpha Tau" or the "Company") (Nasdaq: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported positive results from a clinical study evaluating Alpha DaRT in combination with pembrolizumab (Keytruda) in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), in which the combination produced a 100% objective response rate and a median overall survival of 18.2 months among evaluable patients. The results are being presented in a podium presentation at the American Head and Neck Society ("AHNS") 12th International Conference on Head and Neck Cancer, held July 18-22, 2026, in Boston, Massachusetts.

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Head and neck cancer is among the most common cancers worldwide, with an estimated 890,000 new cases diagnosed globally each year, and with more than 60,000 new cases of HNSCC estimated in the United States in 2026 across the oral cavity, pharynx, and larynx. Despite treatment with curative intent, roughly half of patients with HNSCC will experience recurrence, and distant spread, when it occurs, most often involves the lung.

Since the Keytruda KEYNOTE-048 trial, pembrolizumab, with or without chemotherapy, has been the first-line standard of care for recurrent or metastatic HNSCC; however, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score, or CPS, ≥1), pembrolizumab was observed in the KEYNOTE-048 trial to produce a median overall survival of 12.3 months and an objective response rate of approximately 19%, leaving considerable room for improvement, particularly for elderly and frail patients who may not tolerate the addition of chemotherapy.

Alpha Tau’s study is a single-center, prospective, open-label, single-arm study evaluating Alpha DaRT in combination with pembrolizumab in up to 48 patients with recurrent unresectable or metastatic HNSCC and PD-L1 CPS ≥1, using a Simon two-stage adaptive design. Patients received a lead-in dose of pembrolizumab, followed by insertion of Alpha DaRT sources into a target lesion; the sources were removed ~14 days later, and patients continued on pembrolizumab per standard dosing. Tumor response was assessed systemically, i.e., in all tumors, both treated and untreated by Alpha DaRT, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and safety was graded using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Eleven patients (four female, seven male) were recruited in total, with a mean age of 72 years (range 52-96). Two patients died prior to response evaluation, leaving nine patients evaluable for response; one died before Alpha DaRT treatment, and the other died shortly after treatment from an unrelated cardiovascular issue. With every evaluable patient responding, the trial reached the efficacy threshold built into its two-stage adaptive design, under which the study was permitted to stop for success once more than six patients responded, and enrollment was concluded on that basis.

Efficacy Results

Note: Caution should be exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other relevant factors.

Response Rate

Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate (i.e., systemic complete response plus partial response) of 100%, including four complete responses and five partial responses, for a complete response rate of 44%. By comparison, pembrolizumab monotherapy in the PD-L1 CPS ≥1 population of KEYNOTE-048 produced an objective response rate of approximately 19%.

Survival Data

Median overall survival was 18.2 months, and median progression-free survival was 5.4 months, with four patients remaining alive at the time of this analysis. By comparison, pembrolizumab monotherapy in a similar population in the KEYNOTE-048 trial achieved a median overall survival of 12.3 months and a median progression-free survival of approximately 3.2 months.

Safety Results

No Alpha DaRT-related serious adverse events were observed. Only two Alpha DaRT-related adverse events were reported across the treated cohort, both Grade 1 in severity.

Uzi Sofer, CEO of Alpha Tau, stated: "These results reinforce two priorities at the heart of our strategy: establishing Alpha DaRT in localized, unresectable disease, and building the combination evidence to compete in the metastatic setting alongside blockbuster checkpoint inhibitors. Our interim data had already shown us that response rates with Alpha DaRT plus pembrolizumab were exceptionally high; what we were waiting for was the survival follow-up to confirm those responses would translate into real, lasting benefit. Now that the data have matured, the picture is even stronger. Combination trials like this one are central to how we intend to grow the platform. Showing that Alpha DaRT can be added to a systemic backbone safely, and with results like these, is exactly the kind of evidence we hope will define its role across our pipeline. And we won’t stop here: We are exploring, in ongoing discussion with the FDA, the possibility of a similar but larger study in the U.S."

Prof. Aron Popovtzer, MD, Director of the Sharett Institute of Oncology at Hadassah University Medical Center and the lead Principal Investigator in this clinical study at Hadassah, commented: "Elderly patients with recurrent or metastatic head and neck squamous cell carcinoma are among the most difficult we treat. Since KEYNOTE-048, pembrolizumab has been our first-line standard of care, but as a single agent it produces a response in fewer than one in five patients, and many are too frail to add chemotherapy. That unmet need is what led us to design the first study to combine Alpha DaRT with checkpoint inhibition, adding a localized, immune-activating alpha-emitting radiotherapy to the systemic treatment these patients are already receiving. After years of work, it is deeply gratifying to see the effort was worth it – the results are genuinely encouraging, and they exceeded our expectations. Every evaluable patient responded, including several complete responses, with improvements in both overall and progression-free survival relative to historic data on pembrolizumab alone and a safety profile that let patients stay on their standard treatment. To my knowledge, no other combination study with pembrolizumab has shown results like these in this patient population, and it is a real achievement to see a therapy add this much value on top of a checkpoint inhibitor. These are early data, and larger controlled studies are needed to confirm the benefit, but they make a compelling case for continuing to investigate Alpha DaRT with immunotherapy, both in head and neck cancer and across other solid tumors."

Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "It’s worth reading these results against the bigger picture of where our global clinical trial pipeline is heading. We have strong preclinical data suggesting that Alpha DaRT may prime a systemic anti-tumor immune response, and we have clinical experience, including multiple studies in head and neck and skin cancer, showing that Alpha DaRT monotherapy carries a favorable safety profile in this population. What this study suggests is that combining Alpha DaRT with pembrolizumab can translate that immune-priming effect into a clinical survival benefit for patients with recurrent or metastatic head and neck cancer. These results reinforce our plan to validate the clinical benefit of Alpha DaRT in this patient population in larger studies, and they add another key data point to a pipeline that now spans head and neck, skin, pancreatic, prostate, and brain cancers, among others."

About the Study

The study builds on Alpha Tau’s foundation of Alpha DaRT monotherapy data in head and neck and skin cancer, including a first-in-human study in which Alpha DaRT achieved an objective response rate of 100% and a complete response rate of 78.6% among evaluable SCC lesions in a population that skewed toward elderly, heavily pre-treated and radioresistant patients. The current study pairs Alpha DaRT with pembrolizumab, the current first-line standard of care for CPS ≥1 recurrent or metastatic HNSCC, to evaluate whether adding a localized, immune-activating radiotherapeutic to systemic checkpoint inhibition can improve outcomes without the added toxicity associated with chemotherapy. The study was conducted at Hadassah University Medical Center in Jerusalem, Israel. For more information, please see View Source

(Press release, Alpha Tau Medical, JUL 21, 2026, View Source [SID1234669337])

Akari Therapeutics Enters Strategic Research Collaboration with Whitehawk Therapeutics

On July 21, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported a strategic research collaboration with Whitehawk Therapeutics, a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved ADC cancer treatments. Under the collaboration, the companies will conduct a series of focused preclinical studies evaluating Akari’s proprietary PH1 spliceosome-modulating payload technology in combination with Whitehawk’s topoisomerase I inhibitor (TOP1i) ADC platform.

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Akari will lead the design, execution and evaluation of the research activities. The initial collaboration will include multiple preclinical workstreams designed to assess dual payload compatibility and synergies, while generating data intended to guide future development decisions and potential broader collaboration opportunities between the companies.

"This collaboration marks an important first step in exploring the broader potential of our PH1 payload technology to combine in unique ways with current classes of ADC payloads across the field to advance ADC innovation and impact," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "Whitehawk brings a differentiated ADC platform and strong expertise in evaluating novel ADC technologies. We believe the planned studies will provide further validation of PH1’s differentiated mechanism and support development of a dual payload technology that will be first-in-class for novel ADCs to attack cancer."

"Beyond our existing portfolio, we see dual-payload approaches as a potential next opportunity to expand the therapeutic potential of our ADC platform," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "We are pleased to enter this collaboration with Akari to understand whether combining these differentiated mechanisms has the potential to support future development."

The collaboration is expected to commence immediately, with interim data updates anticipated as studies progress. Both companies will jointly review resulting data and determine whether findings support broader development discussions.

(Press release, Akari Therapeutics, JUL 21, 2026, View Source [SID1234669336])

Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed

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])

Eikon Therapeutics Announces Seven Abstracts Accepted for Presentation at the 2026 European Society of Medical Oncology (ESMO) Congress

On July 20, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported the acceptance of seven abstracts covering progress across its lead programs at the 2026 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Madrid, Spain.

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"We are pleased to have these abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) this year. The presentations will cover both the progress of our pipeline and the growing body of evidence supporting differentiation of our lead programs," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. "At Eikon, we are driven by a desire to bring new medicines to patients with the ultimate goal of providing meaningful benefit to people living with cancer."

ESMO Abstract Titles:

EIK1001

Title: TeLuRide-005: Phase 2 study of EIK1001 (TLR7/8 dual agonist) plus pembrolizumab and chemotherapy in patients with stage IV NSCLC: results from the squamous cohort and updated pooled results.

Title: A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (NSCLC) [TeLuRide-008]

EIK1003

Title: Phase 1/2 study of a PARP1-selective inhibitor, EIK1003, in combination with abiraterone in patients with metastatic prostate cancer (mPC)

Title: Phase 1/2 study of a PARP1-selective inhibitor, EIK1003, as monotherapy and in combination with paclitaxel (PTX) in advanced solid tumors

EIK1004

Title: A first-in-human Phase 1/2 study of EIK1004, a PARP1-selective CNS-penetrant
inhibitor, in patients with advanced solid tumors with HRR mutations

EIK1005

Title: Phase 1/2 Study of the Novel Werner Helicase Inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, Including MSI-H or dMMR Tumors

Title: Analysis of the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor

(Press release, Eikon Therapeutics, JUL 20, 2026, View Source [SID1234669335])