On July 31, 2026 AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) reported that it has been approved in the European Union (EU) as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Society for Medical Oncology Congress and subsequently published in Annals of Oncology.

Giuseppe Curigliano, MD, PhD, Director of the Early Drug Development Division, European Institute of Oncology, Professor of Medical Oncology, University of Milan, Italy and investigator for the TROPION-Breast02 trial, said: "For people living with metastatic triple-negative breast cancer, every new treatment option matters. Despite recent advances, more than two thirds of patients are not candidates for immunotherapy and have had limited options beyond chemotherapy. In my practice, I see firsthand the devastating impact this aggressive disease has on patients and their families. This approval of datopotamab deruxtecan provides a new treatment option for eligible patients and represents meaningful progress."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Every year, more than 80,000 people in Europe are diagnosed with triple-negative breast cancer, a disease that often affects younger women and has limited treatment options in the metastatic setting. Today’s approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said: "With this approval, Datroway is the only TROP2-directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the 1st-line setting for the treatment of patients with metastatic triple-negative breast cancer. We look forward to bringing Datroway to patients in the EU as an additional treatment option with the potential to extend survival, reflecting our commitment to advancing innovative medicines that address unmet needs for people living with cancer."

In the trial, which included patients with metastatic TNBC who experienced early relapse following prior treatment, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) compared to chemotherapy as 1st-line treatment in this patient population. Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Datroway was also associated with more robust treatment responses, including an objective response rate (ORR) of 62.5% compared to an ORR of 29.3% with chemotherapy.1

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

Based on the results of TROPION-Breast02, Datroway has been included in the ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines as a Category IA 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy, and it is the preferred option for patients who have relapsed within six months of completing adjuvant therapy.2 In addition, Datroway received a score of 4 out of 5 on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale (ESMO-MCBS), recognising the clinically meaningful benefit demonstrated in TROPION-Breast02.3

Datroway was approved in the US in May 2026 for the same indication. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 365,000 diagnoses globally each year.4,5 In Europe, there are an estimated 81,000 diagnoses of TNBC each year.4,6 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.7-9 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.7,10,11

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.7 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.7 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.12,13 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard 1st-line treatment.14

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.15 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.16,17

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are OS and progression-free survival (PFS) as assessed by blinded independent central review. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is approved in more than 30 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

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(Press release, AstraZeneca, JUL 31, 2026, View Source [SID1234669573])

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 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 Daiichi Sankyo reported First quarter financial results.

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(Presentation, Daiichi Sankyo, JUL 31, 2026, View Source [SID1234669823])

On July 31, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported the pricing of a best-efforts public offering of an aggregate of 12,376,667 shares of common stock (or pre-funded warrants in lieu thereof), and warrants (the "Common Warrants") to purchase up to 37,130,001 shares of common stock at a combined public offering price of $0.75 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants. The Common Warrants will be immediately exercisable at an exercise price of $0.75 per share and will expire five years following the initial exercise date. The offering is expected to close on or about August 3, 2026, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds of the offering to advance Annamycin through clinical development and for working capital.

Roth Capital Partners is acting as exclusive placement agent for the offering. Maxim Group LLC is acting as financial advisor to the Company.

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-297776) originally filed July 29, 2026 with the Securities and Exchange Commission ("SEC") and declared effective by the SEC on July 31, 2026. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A final prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus may be obtained, when available, from Roth Capital Partners, LLC at 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, Attn: Prospectus Department, telephone: 800-678-9147 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Moleculin, JUL 31, 2026, View Source [SID1234669575])