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.

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

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

                  Schedule Your 30 min Free Demo!

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:

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

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

                  Schedule Your 30 min Free Demo!

"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.

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

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

                  Schedule Your 30 min Free Demo!

"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])

Telix Q2 Revenue US$247M, Strong Momentum and Pipeline Progress

On July 20, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported a market update on its commercial and operational performance for the quarter ended June 30, 2026 (Q2 2026).

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

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

                  Schedule Your 30 min Free Demo!

Q2 2026 Highlights1

Group revenue of US$247 million, up 7% quarter-over-quarter (QoQ) and up 21% year-over-year (YoY).
Precision Medicine continues to deliver strong growth, revenue of US$202 million, up 9% QoQ and up 30% YoY.
Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income received from Regeneron.
United States (U.S.) Food and Drug Administration (FDA) alignment on ProstACT Global Phase 3 study of TLX591-Tx in mCRPC2 to advance to Part 2 in the U.S.3
BiPASS, patient enrollment nearing completion for study of Illuccix and Gozellix for initial prostate cancer diagnosis in the pre-biopsy setting4.
Regeneron strategic collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies, initially focused on lung cancer.
FY 2026 research and development (R&D) expenditure guidance updated to US$230 million to US$270 million, enabled by the Company’s strong commercial performance and the non-refundable payment of US$40 million received from Regeneron.
Q2 2026 Revenue

Revenue (US$M) Q2 2026 Q2 2025 % Change Q1 2026 % Change
Group revenue 247 204 21% 230 7%
Precision Medicine revenue5 202 155 30% 186 9%
TMS revenue6 45 48 (6)%
44 2%

Executive Commentary

Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, "We delivered another quarter of growth with U.S. dose volumes increasing 7% during the quarter, driven by growing demand for Gozellix and continued strength across our PSMA7 imaging portfolio. This performance underscores the strength of our differentiated two-product PSMA imaging strategy and reinforces Telix’s market leadership, built on clinical differentiation, supply chain resilience and commercial execution. During the quarter, we achieved key regulatory, commercial and clinical milestones across both our Precision Medicine and Therapeutics businesses. We are tracking in line with the upper end of our FY 2026 revenue guidance and are investing further in R&D to accelerate a number of high-value programs that have the potential to create significant future growth and shareholder value."

Therapeutics Business Unit

Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q2 2026 highlights include:

TLX591-Tx (lutetium (177Lu) rosopatamab tetraxetan): Achieved key regulatory milestone for ProstACT Global Phase 3 trial, with the FDA confirming that the safety data from Part 1 of the study of Telix’s lead prostate cancer therapy candidate is sufficient to enable progression of Part 2 in the U.S. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment8. Part 2 continues to enroll strongly in regions where recruitment is open including Australia, New Zealand, Canada, Türkiye, the United Kingdom, Singapore and South Korea and has also received regulatory approval to commence in China.
TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA study evaluating TLX597-Tx for mCRPC has recently completed patient enrollment of 120 patients9. Building on initial findings of the OPTIMAL-PSMA study, the first patients have been dosed in the OPTIMAL-e Phase 2 study, evaluating TLX597-Tx for metastatic hormone sensitive prostate cancer10. TLX597-Tx is a next generation small molecule PSMA-targeting prostate cancer radioligand therapy (RLT) candidate designed to improve efficacy and quality of life in earlier-stage metastatic prostate cancer.
TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan): Dosed first patient in LUTEON11, a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC12. LUTEON will evaluate the efficacy of TLX250-Tx compared with investigator’s choice of monotherapy consistent with standard of care. LUTEON forms part of Telix’s global development program13 for TLX250-Tx, Part 1 is expected to enroll up to 40 patients.
TLX101-Tx (131I-iodofalan): Enrolled first patient cohort in Part 1 (assessing safety and dose optimization) of IPAX BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma14. The trial is open for enrollment in Australia, Austria, the Netherlands and Belgium, with approval being sought in additional jurisdictions. Completed patient enrollment in IPAX-215, a Phase 1 study evaluating TLX101-Tx in patients with newly diagnosed glioblastoma, with no dose-limiting toxicities observed to date16.
Precision Medicine Business Unit

PSMA imaging portfolio:

Telix’s Precision Medicine business continues to expand its commercial reach and support broader patient access to PSMA-PET/CT imaging17. Q2 2026 highlights include:

Rapid enrollment of 338 patients in BiPASS Phase 3 study of Illuccix and Gozellix for the initial diagnosis of prostate cancer, integrating non-invasive 68Ga-PSMA-11 PET imaging prior to biopsy. Building on the clinical foundation established by the PRIMARY18 and PRIMARY 219 studies, BiPASS is intended to support regulatory submissions in major markets, including the U.S., Europe and Australia.
Completed patient enrollment in Japan in Phase 3 registrational study of TLX591-Px (Illuccix)20. Telix is preparing a New Drug Application (NDA) for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix’s application for Conditional Approval is under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared.
TLX101-Px, (Floretyrosine F 18 or 18F-FET) for brain cancer imaging:

Submitted an IND application to the FDA for Pixclara, a Phase 3 registrational study for indication expansion for the diagnosis of brain metastases.
The FDA has accepted Telix’s resubmitted NDA for Pixclara21 and has granted a PDUFA22 goal date of September 11, 202623.
Telix’s Marketing Authorization Application (MAA) for Pixlumi21 in Europe has been validated and accepted for review24.
Zircaix21 (TLX250-Px, 89Zr-DFO-girentuximab) for kidney cancer imaging:

Telix continues to make good progress on its Biologics License Application (BLA) resubmission for Zircaix21 in the U.S. Final Chemistry, Manufacturing and Controls (CMC) documentation is nearing completion. Consistent with TLX250-Px’s Breakthrough Therapy designation, Telix has maintained regular consultation with the FDA and expects to resubmit the application shortly.
Telix Manufacturing Solutions (TMS): Expanded global operations

TMS continues to expand its global operations which are fundamental to Telix’s future growth, supporting supply chain resilience. Q2 2026 highlights include:

Opened TMS North Melbourne, in partnership with the Melbourne Theranostic Innovation Centre (MTIC)25. The purpose-built facility combines radiochemistry laboratories, clinical product manufacturing, patient dosing and imaging that aims to provide advanced clinical infrastructure and R&D capabilities to accelerate the development of targeted radiopharmaceuticals.
TMS Brussels South successfully completed its first Good Manufacturing Practice (GMP) production run of a lutetium-based therapeutic candidate, representing a significant operational milestone and further validating the facility’s capabilities to support the manufacture of Telix’s next-generation therapeutics.
Installed ARTMS’ QUANTM Irradiation System (QIS) at TMS Yokohama, expanding isotope production capabilities and enabling local Zirconium-89 (89Zr) manufacturing to support Telix’s portfolio. The installation represents further progress in scaling the ARTMS network and advancing toward the Company’s target of 50 QIS installations globally by the end of 2026.
Corporate Updates

Telix entered into a strategic collaboration with Regeneron to jointly develop and commercialize next-generation radiopharmaceutical therapies26. The strategic partnership combines Telix’s radiopharmaceutical development, manufacturing and supply chain capabilities with Regeneron’s leading antibody discovery and development platforms, creating a framework to advance multiple novel oncology programs and further strengthen Telix’s position in Precision Medicine. On execution of the agreement, Telix has received an initial non-refundable payment from Regeneron of US$40 million.

Telix also completed a refinancing of its existing convertible bond structure, issuing US$600 million of new convertible bonds due 2031 and repurchasing all outstanding 2029 convertible bonds27. The transaction extends debt maturities, enhances financial flexibility and further strengthens the Company’s capital structure, supporting the execution of Telix’s long-term growth strategy, including developing its late-stage therapeutics pipeline.

Three new Non-Executive Directors were appointed during the quarter as part of Telix’s Board expansion and succession planning. Effective May 11, 2026, David Gill, Maria Rivas, MD, and William Jellison28 joined the Board, further strengthening the Board’s clinical, commercial, financial and governance expertise, enhancing the Company’s capabilities as a dual-listed, commercial stage biopharmaceutical company.

FY 2026 guidance

Telix expects FY 2026 revenue and other income to be in excess of US$1 billion, with revenue tracking in line with the upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million non-refundable other income from Regeneron.
Revenue guidance reflects product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS.
Telix has updated FY 2026 R&D expenditure guidance to US$230 million to US$270 million, subject to achieving ongoing global clinical data outcomes and development milestones. The additional investment will support the advancement of high-value clinical programs beyond the Company’s original R&D forecast, including acceleration of the TLX597-Tx program and label expansion for Pixclara, and progression of the Regeneron strategic collaboration.

(Press release, Telix Pharmaceuticals, JUL 20, 2026, View Source [SID1234669334])

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors

On July 20, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the first patient has been dosed in the Phase 1, first-in-human trial of IM-3050, an investigational FAP-targeted radioligand therapy being evaluated in patients with FAP-expressing advanced solid tumors.

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

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

                  Schedule Your 30 min Free Demo!

"FAP is a high-potential target with expression in 75% of solid tumors," said Bob Lechleider, M.D., Chief Medical Officer of Immunome. "We believe an optimized radioligand therapy is well-suited to FAP’s intriguing biology. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, and we look forward to evaluating its potential in patients with advanced solid tumors."

The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of IM-3050 in participants with FAP-expressing advanced solid tumors. The dose escalation portion of the study will evaluate escalating repeated doses of IM-3050 to determine the maximum tolerated dose and/or recommended expansion dose; the expansion portion is designed to further evaluate safety and tolerability at the candidate recommended dose.

About IM-3050

IM-3050 is an investigational lutetium-177 radioligand therapy targeting fibroblast activation protein (FAP), which is broadly expressed on cancer-associated fibroblasts in the tumor microenvironment. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, where emitted beta particles may damage or kill nearby tumor cells through a bystander effect.

(Press release, Immunome, JUL 20, 2026, View Source [SID1234669333])