On July 31, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 30 June 2026 (Q4 FY26).

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EFTILAGIMOD ALFA SYSTEMATIC EVALUATION

In May 2026, Immutep announced results from a systematic evaluation of five clinical trials of eftilagimod alfa (efti) in combination with standard-of-care (SOC) therapies in cancer patients, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting1.

The analysis included 592 patients across five independent studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, and AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, metastatic breast cancer, and melanoma).

Treatment with 30 mg subcutaneous efti plus SOC in these trials resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, which was not seen with SOC alone.

Increased ALC was significantly associated with improved clinical outcomes, with ALC responders in the efti plus SOC group showing a clinically meaningful median overall survival (OS) improvement of 7.7 months compared to non-responders (p=0.0017). These effects were observed across tumour types and were independent of the combination partner.

The analysis did not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating efti in patients in 1st line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

In response to the IDMC’s recommendation, enrolment in TACTI-004 was halted and Immutep is continuing an orderly wind-down of the study, including appropriate patient follow-up and site close-out.

Immutep is also continuing its thorough review of available data to understand the factors behind the futility outcome, including manufacturing aspects. This root cause analysis is ongoing in Q3 CY 26, as it is dependent on data availability and logistics, and covers TACTI-004 database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a licensing partner for efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

Subsequent to quarter end, Immutep provided an update on aspects of the root cause analysis. In the interim futility analysis (N=173), the objective response rate was 42.9% in the efti arm compared with 55.1% in the control arm, with no superiority observed in any PD-L1 subgroup. Pending final analysis, no new safety signals have been observed. Preliminary immune-monitoring data indicated that patients treated with efti in TACTI-004 showed a different immune-activation profile, with lower circulating lymphocyte and monocyte counts, compared with prior efti studies. While no conclusive causal factor has been established to date, the ongoing analysis is expected to provide further insights, with additional results anticipated in Q3 CY26.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 Phase I trial, in which dosing is now complete, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels2.

Subsequent to the end of the quarter, Immutep announced mature overall survival (OS) results from INSIGHT-003 (data cut-off 27 March 2026). Median OS was 30.9 months in the overall population (N=51) and in patients with PD-L1 TPS <50% (N=47). Approximately 92% of patients had no or low PD-L1 expression (PD-L1 TPS <1 or PD-L1 TPS 1-49).

These single-arm Phase I results compare favourably with historical benchmarks.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary objective, with patients showing strong immune system activation in line with efti’s mode of action, including statistically significant increases in the expression of key cytokines and chemokines in peripheral blood. Patients are continuing to be followed up for disease-free survival.

In April 2026, Immutep announced that it had been granted orphan drug designation for efti in this setting from the FDA.

An abstract containing health-related quality of life (HRQoL) data from the EFTISARC-NEO trial has been accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in October 2026. Consistent with the congress’ embargo policy, the data will be made available by the investigator at the time of presentation.

BREAST CANCER

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

The AIPAC-003 Phase II trial, evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2 negative/low metastatic breast cancer that is resistant to endocrine-based therapy, as well as in metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy, has been completed. The last patient follow-up visit occurred during the quarter and the trial was accordingly closed effective 30 June 2026.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

As previously announced, a proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer remains on hold pending completion of the root cause analysis related to TACTI-004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In June 2026, Immutep presented positive interim data from its placebo-controlled, double-blind, randomized, first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody, at the EULAR 2026 Congress in London.

The single ascending dose part of the study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers, with IMP761 well tolerated across all dose levels tested.

The data also showed statistically significant pharmacodynamic activity, including reduced local inflammatory responses and attenuated T-cell activity compared to placebo, with the 7 mg/kg dose achieving a statistically significant inhibition in skin blood perfusion (p = 0.029).

The pharmacokinetic profile supports once-every-four-weeks dosing. These encouraging results support further clinical evaluation of IMP761 in autoimmune diseases driven by T-cell-mediated inflammation, such as rheumatoid arthritis, with additional trial updates expected in H2 CY26.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted seven patents.

Four patents were granted directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody. The patents were granted in China, Hong Kong, South Korea, and Canada. A new patent was also granted in Indonesia directed to IMP761.

New patents were also granted during the quarter in the United States and Israel directed to LAG525 (ieramilimab), jointly owned by Immutep S.A.S. and Novartis AG. Subsequent to quarter end, Novartis gave notice terminating the out-license agreement relating to ieramilimab after years of clinical inactivity, effective 9 August 2026. The license is not generating revenue for Immutep and no further milestone or royalty payments are anticipated. Under the terms of the agreement, following termination Novartis is required to assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S.

LEGAL PROCEEDINGS

Following the announcement on 13 March 2026 regarding the discontinuation of the TACTI-004 Phase III trial, one putative securities class action was filed in the United States but not served. After the Company sent a Rule 11 letter to the plaintiff, the suit was dismissed voluntarily.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with cash and cash equivalents, and term deposit balance as at 30 June 2026 of approximately A$68.87 million, which is A$29.2 million greater than the FY2026 budget.

The total balance consists of 1) a cash and cash equivalent balance of A$63.67 million and 2) bank term deposits totaling A$5.20 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q4 FY26, cash receipts from customers were A$13K, which is mainly due to research material sales. For the very first time the Company also received A$218K (EUR 133K) under Germany’s R&D tax incentive program (Forschungszulage) in relation to eligible R&D activities undertaken in FY22.

The Forschungszulage is Germany’s statutory research tax incentive under the Forschungszulagengesetz (FZulG). Under the current regime, eligible companies may claim a tax credit of up to 35% (25% before 28 March 2024) of qualifying internal R&D personnel costs. The timing of receipt of Forschungszulage payments may differ significantly from the period in which the related R&D expenditure is incurred due to the statutory application, assessment and review process. The FY2022 claim was the Company’s first claim under the program and was subject to a detailed review. The allowance is a non-dilutive source of funding for the Company’s German R&D operations (conducted through Immutep GmbH).

The net cash used in G&A activities in the quarter was A$1.5 million compared to A$0.9 million in Q3 FY26. In respect of the US$20 million upfront eftilagimod license fee received from Dr. Reddy’s in January 2026, US$2.7 million (A$4.1 million3) was recognised as revenue and US$17.3 million (A$25.8 million4) as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following discontinuation of TACTI-004, Immutep repaid US$10 million to Dr. Reddy’s in June 2026, reducing unearned revenue accordingly, with the remaining US$7.3 million fully recognised as revenue for the financial year ended 30 June 2026. As previously disclosed, Dr. Reddy’s holds exclusive rights to develop and commercialise efti in the licensed territories, while Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan. Immutep also remains eligible for up to US$349.5 million in potential milestones along with royalties on commercial sales, and retains global manufacturing rights.

Net cash used in R&D activities was A$22.0 million for the quarter, compared with A$11.8 million in Q3 FY26, with the increase primarily reflecting higher payments relating to TACTI-004. Although the Company took immediate action following the discontinuation of TACTI-004 in March 2026, trial activity only began to slow from May 2026, with close-out and root cause analysis activities continuing through the quarter. As invoices are generally payable approximately one month after issue, TACTI-004 payments in Q4 FY26 were approximately A$8 million higher than in Q3 FY26. These payments are expected to decline significantly in subsequent quarters.

Payment for staff costs was A$2.5 million in the quarter, compared to A$2.6 million in Q3 FY26. Total net cash outflows used in operating activities in the quarter were A$38.9 million compared to net cash inflow from operating activities of A$13.5 million in Q3 FY26.

Payments to Related Parties (detailed in item 6.1 of the Appendix 4C) comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$336K.

Total net cash inflow received in investing activities for the quarter was A$21.1 million, which is mainly due to the net decrease of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the Company transferred back A$21.1 million from short-term investments that had matured to cash at bank.

After the TACTI-004 Phase III futility outcome, the Company has initiated cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions, most of which will become effective following the end of FY26. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend well into H1 of CY28.

(Press release, Immutep, JUL 31, 2026, View Source [SID1234669608])

On July 31, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), reported that its corporate rebrand to Cerenome will be completed as scheduled. Effective August 3, 2026, the Company’s name will become Cerenome, Inc. The Company’s common stock will begin trading on the Nasdaq Capital Market under the new ticker symbol "CNSY," effective market open on the same day.

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The new name reflects the Company’s de facto evolution from a therapeutics-focused organization into an integrated CNS oncology company. The Company has expanded beyond targeted radiotherapeutics because effective solutions for CNS cancer will require a multimodal approach. Cerenome will integrate precision diagnostics, targeted therapeutics, and proprietary data within a single organization to improve how CNS cancers are detected, treated, and understood.

"Fifty years of medical research has taught us that CNS cancers are not an isolated set of localized cancers but a systems problem requiring a comprehensive and unified approach to solving them," said Marc H. Hedrick, M.D., Cerenome President and Chief Executive Officer. "This journey began in earnest a couple of years ago with the acquisition of our diagnostic platform and our more recent native artificial intelligence partnership. We are already seeing the fruits of the integration of diagnostics, therapeutics, and advanced data analytics. We are excited about our future and look forward to explaining the opportunity in greater detail to stockholders and ultimately delivering improved outcomes for patients."

Cerenome’s strategy is built on three integrated and mutually reinforcing platforms:

The Company’s CNSide Diagnostic is a commercially available and reimbursed cerebrospinal fluid (CSF)-based platform supporting the cellular and multiomic characterization of cerebrospinal fluid for the diagnosis and management of patients with or at risk for CNS cancers
REYOBIQ (rhenium Re186 obisbemeda) is Cerenome’s lead investigational targeted radiotherapeutic being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancer, designed to deliver targeted radiation directly to CNS tumors while limiting systemic exposure
The Company’s data analytics and artificial intelligence platform is a proprietary and multifaceted initiative designed to integrate diverse data sets into actionable insights that support precision oncology, therapeutic development, and clinical decision-making

For patients, this integrated approach has the potential to enable earlier detection, more informed treatment decisions, disease monitoring and ultimately better outcomes. For healthcare providers, Cerenome can offer a more comprehensive systems view of the disease from diagnostic interrogation to longitudinal patient management. For academic and biopharmaceutical partners, the platform creates opportunities for research, clinical development, and collaboration. For investors, the integration of commercial diagnostics, clinical-stage therapeutics, and proprietary longitudinal data establishes a highly differentiated business case anchored by its lead assets CNSide, Reyobiq and recent artificial partnership with Ephemeral Technologies.

"The new name Cerenome combines ‘Cere,’ representing the brain and central nervous system, with ‘nome,’ reflecting the expansive knowledge sets that power precision oncology," Dr. Hedrick added. "However, our mission of improving survival in CNS cancers has not changed. We remain committed to commercializing innovative products for patients with CNS cancers while building a platform designed for long term value creation."

The Company’s existing CNSide and REYOBIQ brands will remain unchanged.

Nasdaq Trading Information
The Company’s common stock will continue to be listed on the Nasdaq Capital Market and will trade under the ticker symbol "CNSY" beginning August 3, 2026. The corporate name and ticker symbol changes do not affect shareholders’ ownership interests. Existing shares held in brokerage or book-entry accounts will automatically reflect the new corporate name and ticker symbol, and shareholders are not required to take any action.

(Press release, Plus Therapeutics, JUL 31, 2026, View Source [SID1234669592])

On July 31, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported financial results for the quarter ended June 30, 2026, and provided a corporate update.

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"We continue to make meaningful progress across our portfolio as we advance a diverse pipeline of targeted radiopharmaceutical candidates designed to address some of the most challenging cancers," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The positive Phase 2b results for RAD 101 represent an important milestone for Radiopharm and reinforce our confidence in the potential of our technologies. In addition, the early clinical signs in the third cohort of RAD 204, showing RECIST-confirmed Partial Response in the first patient treated at this dose, is creating a lot of excitement among the Clinical Investigators of our Phase I therapeutic trial. Across the organization, we are generating clinical data, advancing multiple development programs, and building the capabilities required to realize the full value of our platform. With six active clinical programs spanning both diagnostic and therapeutic applications, we believe Radiopharm is establishing a leading radiopharmaceutical company uniquely positioned to deliver innovative new medicines to patients while creating long-term value for shareholders. We remain focused on executing against our development priorities and advancing what we believe could become a new generation of precision cancer treatments."

Program and Business Updates

18F-RAD101 – Small molecule targeting fatty acid synthase radiolabelled with Fluorine-18

RAD 101 is being evaluated in a single-arm U.S. Phase 2b clinical trial for the diagnostic performance of the molecule in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel imaging small molecule to the over 300,000 patients diagnosed annually in the U.S. with cerebral metastases.

In July 2026, the Company announced that RAD 101 had met its primary endpoint, with 93% of patients treated with RAD 101 achieving concordance with MRI imaging. Additionally, an interim analysis of 14 patients from six-month follow-up and biopsy shows 86% (12/14) sensitivity.

The Company anticipates the initiation of a Phase 3, multi-center, multi-country registrational study in Q4 2026. Siemens Healthineers will manufacture and distribute doses of 18F-labeled RAD-101 through a partnership to support the Phase 3 registrational trial.

177Lu-RAD204 – Nanobody targeting PD-L1 radiolabelled with Lutetium 177

RAD 204 is being evaluated in a Phase 1 study in PD-L1-driven cancers, including Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer.

Initial data from the first six patients across the first two cohorts of the Phase 1 study showed tumor uptake in the PD-L1 positive lesions, in line with the published results of the previously conducted imaging study

Data from the third cohort (90mCi) in the Phase 1 study of RAD 204 showed that the first patient dosed at this dose level achieved a durable RECIST-confirmed partial response, with tumor shrinkage up to -43%, still progression free after 7+ months.

177Lu-RAD202 – Nanobody targeting HER2 radiolabelled with Lutetium 177

The Company continues to evaluate RAD 202 in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with positive safety and biodistribution.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, the company presented initial findings from the Phase 1 first-in-human ‘HEAT’ clinical trial for RAD 202. At the lowest dose level, RAD 202 showed meaningful tumor uptake and was generally well-tolerated in the first three treated patients, with no dose-limiting toxicities or treatment discontinuations due to adverse events being observed. Organ-level absorbed radiation doses were within expected and clinically acceptable ranges.

The Company previously received a positive recommendation from the Data Safety and Monitoring Committee to advance RAD 202 to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial. The Company expects to complete enrolment of Cohort #3 in Q3 and the entire Phase 1 Dose Escalation by 1H 2027.

Lu177-RV 01 – monoclonal antibody targeting 4Ig isoform of B7H3 radiolabelled with Lutetium 177

RV 01 (Betabart) is a monoclonal antibody targeting the 4Ig isoform of B7H3, an immune checkpoint protein that is highly expressed in tumors and not in healthy tissue. In multiple preclinical studies, RV-01 has shown tumor shrinkage and prolonged survival. This is the first radiopharmaceutical therapeutic developed by Radiopharm Ventures, a joint venture between Radiopharm Theranostics and the MD Anderson Cancer Center.

The Company continues to make progress advancing the first-in-human (FIH) Phase 1/2a clinical trial of RV 01, which is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of RV 01 in various tumor types. The trial will also determine the recommended dose of RV-01 for future studies.

Tb161-RAD 402 – Monoclonal antibody targeting KLK3 radiolabelled with Terbium 161

RAD 402 is a monoclonal antibody targeting Kallikrein Related Peptidase 3 (KLK3) radiolabelled with the radionuclide 161Tb for the treatment of prostate cancer. In preclinical mouse models, RAD 402 showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody.

The Company continues to progress its First-In-Human (FIH) Phase 1 clinical trial of RAD 402, designed to evaluate the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose and recommended Phase 2 dose for expansion.

Ga68-RAD301 – Peptide targeting αvB-integrin radiolabelled with Gallium 68

RAD 301 is being evaluated in a Phase 1 imaging trial in patients with Pancreatic Ductal Adenocarcinoma (PDAC). The αvB-integrin is a cellular marker for tumor invasion and metastatic growth, which correlates with decreased survival in several carcinomas, particularly pancreatic. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA and data from the Phase 1 trial is supportive of the Company’s decision to move to a Phase 2 imaging trial in patients with loco-regional pancreatic cancer.

Enrollment in the Phase 1 imaging trial in metastatic pancreatic cancer continues, having dosed 8 patients out of 9, with last patient expected to be dosed in 2H 2026.

Financial Update

Closing cash at the end of the quarter was $4.1 million, decreasing from $19.2 million at the end of the prior quarter. Net cash outflows from operating activities during the period was $14.97 million with direct Research and Development expenditure and staff costs accounting for 95% of the operating activities.

Following the close of the quarter, the Company received its FY25 Australian R&D Tax Incentive of $5.9 million and also completed a $12.5 million institutional offer and launched a $6 million Share Purchase Plan which is already subscribed for up to $3 million.

In compliance with Listing Rule 4.7C, payments to related parties and their associates, as detailed in item 6.1 of Appendix 4C, encompass remuneration for director fees to executive and non-executive directors, conducted in the ordinary course of business at commercial rates, excluding reimbursements for out-of-pocket expenses.

(Press release, Radiopharm Theranostics, JUL 31, 2026, View Source [SID1234669591])

On July 31, 2026 Orano Med, a subsidiary of the Orano Group specializing in nuclear medicine, reported an overview of its activities and progress made during the first half of 2026, along with a business outlook for the remainder of the year. The update covers the company’s key areas of operations, including corporate developments, clinical progress and preclinical research as well as industrial activities, and outlines priorities and initiatives for the second half of 2026.

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Frederic Desdouits, CEO of Orano Med commented: "Since joining Orano Med in April, I’ve seen strong progress across all key areas of our business. In the past six months, we’ve significantly expanded our clinical pipeline, with four active lead-212 clinical studies underway, conducted by Orano Med or our partners. With our newly inaugurated R&D center in France complementing our US research hub, we have capability to further accelerate drug candidate development. On the industrial side, we are ramping up thorium-228 production at our pilot facility, and the EUR 125 million loan from the European Investment Bank will support continued investment into our industrial platform’s development. Our GMP facilities, the ATLabs in Indianapolis and Valenciennes, remain on schedule to supply clinical doses in the US and Europe. H1 2026 marked a period of meaningful progress, and we look forward to building on this momentum."

Corporate highlights

In April, Frederic Desdouits was appointed CEO of Orano Med, bringing extensive experience in the pharmaceutical and biotechnology industries. A member of Orano Med’s Governing Board since 2022, he joined at a pivotal moment for the company, with the mission to accelerate clinical development while advancing the build-out of its industrial platform for commercial-scale production of lead-212-based treatments.

On May 18, Orano Med officially inaugurated its new global headquarters and R&D laboratories in Villejuif, located within the Paris Saclay Cancer Cluster. The 700 m² site hosts 35 employees, both corporate functions as well as its first R&D center based in France, designed to accelerate the discovery and clinical development of lead-212-based targeted alpha therapies.

In July, Orano Med announced the appointment of Caroline Germa, Jean-Pierre Bizzari and Philippe Archinard as independent members of the Governing Board dedicated to the company’s biotech activities. They will work alongside Fabrice Chouraqui, a member of the Governing Board since 2022, whose mandate continues. With deep expertise in the biotech and pharma sector, they further strengthen the Board’s ability to support Orano Med’s development.

R&D highlights

In May, along with its new headquarters, Orano Med opened its first R&D center in France within the Paris Saclay Cancer Cluster, a French government initiative launched as part of the "France 2030" program to establish a center of excellence for innovative cancer treatments. The state-of-the-art R&D laboratories will be dedicated to the development of peptide vectors for lead-212-based targeted alpha therapies (TAT) to accelerate the identification of novel drug candidates and their progression from early-stage research through clinical development. Alongside its research center in Texas, US, both R&D locations will complement each other, significantly strengthening Orano Med’s in-house discovery and development capacities.

Clinical portfolio highlights

Four clinical trials with Orano Med’s lead-212 targeted alpha therapy are currently ongoing in the US across different targets and various cancer types.

Orano Med has completed a comprehensive review of the future clinical development strategy for its lead medicine AlphaMedix, as a potential treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) expressing SSTR (somatostatin receptors). Orano Med informed its partners Sanofi and RadioMedix, as well as health authorities and leading clinical experts, that it has finalized a new clinical study protocol to initiate the next AlphaMedix trial toward the end of 2026. The protocol addresses the risk of delayed adverse events, which were observed in some patients enrolled in the previous phase 1 and phase 2 studies. The new study design aims to optimize the benefit-risk profile of the drug candidate, preserving its efficacy while addressing these adverse events. AlphaMedix phase 2 efficacy data, presented at ESMO (Free ESMO Whitepaper) 2025, demonstrated a 60% overall response rate in PRRT-naive GEP-NET patients. GEP-NETs are rare cancers with unmet needs where patients need additional treatment options.

Orano Med’s second clinical program, targeting GRPR (Gastrin-Releasing Peptide Receptor) in solid tumors (NCT05283330), is advancing to the next stage of development in the US. The phase 1/2a study is now enrolling into multiple-dose cohorts to establish the recommended phase 2 dose (RP2D). The program employs a matched-theranostic pair, utilizing ²⁰³Pb-DOTAM-GRPR1 for imaging followed by up to four therapeutic doses of ²¹²Pb-DOTAM-GRPR1. In parallel, preparation for a Clinical Trial Application (CTA) in Europe is underway, with a regulatory approval anticipated in Q4 2026. GRPR is overexpressed across many cancer types, such as colorectal cancer, breast cancer, prostate cancer, cervical cancer and glioblastoma, representing areas of high unmet medical need.

Orano Med and Molecular Partners recently announced the dosing of the first patients in a phase 1/2a clinical study targeting DLL3 (delta-like ligand 3) in small cell lung cancer and other neuroendocrine tumors (NCT07278479). Sponsored by Molecular Partners and conducted in the US, the study evaluates the safety and efficacy of MP0712, a DARPin radiolabelled with lead-212. DARPins are a novel class of custom-built protein therapeutics derived from natural binding proteins, designed for powerful and highly selective tumor cell targeting and for precise delivery of radioisotopes. SCLC is one of the most aggressive cancer types, with a five-year overall survival rate below 10%, underscoring the critical need for effective treatment options.

Another Phase 1 clinical trial, sponsored by Roche (NCT07416552), is actively recruiting patients with metastatic colorectal cancer expressing CEA (carcinoembryonic antigen). Jointly developed by Orano Med and Roche, the study evaluates an innovative "two-step pretargeted radioimmunotherapy" (PRIT) approach, in which two complementary bispecific antibodies first pretarget the tumor before capturing chelated lead-212 to destroy cancer cells. Orano Med is responsible for manufacturing chelated lead-212 used throughout the clinical program.

Industrial platform highlights

On July 1, the European Investment Bank and the Orano Group signed a EUR 125M credit line to finance the development of Orano Med and its industrial infrastructure, notably the construction of the ATEF facility, located in Bessines-sur-Gartempe, France. ATEF is the world’s first industrial facility dedicated to the large-scale production of thorium-228, a precursor of lead-212, based on our proprietary stock of thorium-232. Construction is expected to advance throughout the second half of 2026, with the building completed in H2 2027.

During the first half of 2026, the Laboratoire Maurice Tubiana (LMT) industrial pilot facility, also in Bessines-sur-Gartempe, France, made substantial progress. A capacity expansion project is on track to significantly increase thorium-228 production, enabling LMT to supply the lead-212 precursor isotope for all ongoing and planned clinical trials conducted by Orano Med and its partners in France and the US.

Orano Med controls the entire value chain of pharmaceutical production of lead-212 TAT and an industrial network is being progressively deployed to supply clinical study programs, building on the company’s long-standing and proven track record in GMP-compliant manufacturing. To date, Orano Med has produced hundreds of therapeutic doses and brings a deep experience to ensure the commissioning and qualification of the ATLab Valenciennes, in France, and the ATLab Indianapolis, in the US, scheduled by year end.

(Press release, Orano Med, JUL 31, 2026, View Source [SID1234669590])

On July 31, 2026 Daiichi Sankyo (TSE: 4568) reported financial results for the first quarter of fiscal year 2026, ending June 30, 2026.

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"Daiichi Sankyo delivered strong revenue growth in the first quarter of fiscal year 2026 as we began execution of our new Five-Year Business Plan," said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. "Three new U.S. approvals for Enhertu and Datroway were received in a single week in May, underscoring the continued strength of our portfolio where we anticipate delivering more than 20 new indications across five medicines by 2030. These results reinforce the durability of our growth trajectory and support our outlook for fiscal 2026 and beyond."

Q1 FY2026 Results
Global revenue increased 21.1% year-over-year to 574.7 billion yen, driven by the company’s global oncology products. Operating profit decreased 12.0% year-over-year to 85.1 billion yen, primarily due to EU Specialty Business restructuring expenses.

Global revenue from oncology products was driven by Enhertu and Datroway, the company’s flagship antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 239.8 billion yen, a 48.9% increase. Datroway revenue, including milestone payments, was 23.9 billion yen, a 176.4% increase.

Revenue from the Japan Business was 120.0 billion yen, driven by Lixiana and Tarlige. ASCA (Asia, South and Central America) Business revenue was 68.7 billion yen, driven by Enhertu. EU Specialty Business revenue was 74.7 billion yen, driven by Lixiana and Nilemdo/Nustendi.

Full fiscal year 2026 guidance has been revised upward from the forecast issued in May 2026. Global revenue is anticipated to increase from 2.28 to 2.34 trillion yen, driven by stronger sales anticipated in the U.S. and favorable foreign exchange rates. Operating profit is anticipated to increase from 315.0 to 320.0 billion yen.

Further details on financial performance can be found in the Financial Results Presentation Material. Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q1 FY2026 results on Friday, July 31 at 5:30 pm Japan Standard Time.

Q4 FY2025 Results Revision
Operating profit has increased from 229.1 billion yen to 258.0 billion yen. Following the announcement of the Q4 FY2025 financial results on May 11, 2026, the Company identified an error in the aggregation process for selling, general and administrative (SG&A) expenses. As a result of the decrease in SG&A expenses, operating profit has been revised upward.

Portfolio and Pipeline Highlights
Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030.

Three new breast cancer indications were approved within one week in the U.S. for Enhertu and Datroway in May 2026, including simultaneous approval of two new indications for Enhertu in the neoadjuvant and adjuvant HER2 positive early breast cancer setting based on the DESTINY-Breast11 and DESTINY-Breast05 phase 3 trials, followed by one new indication for Datroway in the first-line metastatic triple negative breast cancer (TNBC) setting for patients not candidates for immunotherapy based on the TROPION-Breast02 phase 3 trial. Datroway received approval in the EU for the same TNBC indication and Enhertu received a positive CHMP opinion for the first-line treatment of HER2 positive metastatic breast cancer based on the DESTINY-Breast09 phase 3 trial in July 2026.

A Biologics License Application (BLA) was accepted and granted priority review in the U.S. in April 2026 for ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy, with a Prescription Drug User Fee Act (PDUFA) date of October 10, 2026.

Additional regulatory approvals were received in June 2026 for medicines in other major countries/regions. Enhertu received approval in the EU for a HER2 positive metastatic tumor agnostic indication and Vanflyta was approved in China in the newly diagnosed setting of FLT3-ITD positive acute myeloid leukemia (AML).

Data from more than 25 abstracts across multiple cancers were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO26) in June 2026.

Medicine

Indication

Q1 FY2026 Update

Enhertu

Breast

Enhertu Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer (May 2026)
Enhertu Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer (July 2026)
Tumor

Agnostic

Enhertu Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors (June 2026)

Datroway

Breast

Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates (May 2026)
Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy (July 2026)

I-DXd

Lung

Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy (April 2026)

Vanflyta

AML

Vanflyta Approved in China as First and Only FLT3 Inhibitor for Patients with Newly Diagnosed FLT3-ITD Positive AML (June 2026)

Pipeline

Various

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO (Free ASCO Whitepaper) (May 2026)
Corporate Highlights
Daiichi Sankyo announced its next Five-Year Business Plan (FY2026 – FY2030) in May 2026 outlining how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a "trusted healthcare innovator transforming the lives of people through our science and technology."

As part of the company’s continued transformation into a global oncology company, Daiichi Sankyo announced in April 2026 that it will transfer in stages all of its shares of Daiichi Sankyo Healthcare Co., Ltd, its over-the-counter drug business in Japan, to Suntory Holdings Limited. The deal is estimated to be completed by June 2029.

(Press release, Daiichi Sankyo, JUL 31, 2026, https://www.businesswire.com/news/home/20260730555689/en/Daiichi-Sankyo-Reports-First-Quarter-Fiscal-Year-2026-Financial-Results [SID1234669589])