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Orano Med Provides Half-Year Progress Report and Business Outlook

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])

Daiichi Sankyo Reports First Quarter Fiscal Year 2026 Financial Results

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

"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])

CellOrigin Unveils Two Novel Solid-Tumor Cell Therapy Candidates at ASCO 2026, Partners with Walvax for In Vivo CAR Clinical Trial

On July 31, 2026 CellOrigin, a biotechnology company focused on next-generation in vivo and in vitro cell therapy technologies, reported two major progresses in both research and strategic partnership.

At the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, CellOrigin’s scientific co-founder’s team presented two new studies on solid tumor cell therapy. The first, CAR-Mix multicellular synergistic therapy, combines engineered macrophages with polyclonal T cells and has demonstrated synergistic antitumor activity in a mesothelin-positive ovarian cancer preclinical model, offering a potential polytypic immune cell approach to overcoming antigen heterogeneity in solid tumors. An IIT clinical study based on this product has been launched, and the first patient was dosed in early 2026. The initial findings indicate a generally well-tolerated safety profile and promising signs of clinical activity. The second, TMT Engager, an LNP-mRNA-based in vivo T-cell engager, enables in situ formation of T-cell–macrophage–tumor cell tripartite conjugates, a strategy designed to engage both innate and adaptive immunity against diverse tumor antigens — addressing a key limitation of current solid-tumor therapies, where tumor heterogeneity often leads to treatment resistance. This approach has demonstrated robust antitumor efficacy in preclinical models of both liver cancer and ovarian cancer.

In parallel, CellOrigin has entered into a co-development agreement with Walvax Biotechnology to jointly conduct an Investigator-Initiated Trial (IIT) for a hepatocellular carcinoma indication using mRNA-LNP-based in vivo GPC3-CAR therapy. This study is based on a preclinical study reported by the same team in the 2025 ASCO (Free ASCO Whitepaper) meeting. This partnership leverages CellOrigin’s expertise in precision CAR design, early pharmacodynamic evaluation, clinical protocol development, and full-cycle IIT execution, alongside Walvax’s industrial strengths in process quality systems, clinical-grade large-scale manufacturing, and product registration. By combining their respective technological and industrial capabilities, the two companies aim to accelerate the clinical translation of novel therapies for solid tumors.

Through sustained R&D investment, CellOrigin has established a comprehensive in vivo CAR technology platform addressing solid tumors, autoimmune diseases and organ fibrosis. Core capabilities include:

mRNA-LNP delivery technology enabling controlled organ and cell type-specific in vivo CAR expression that balances efficacy and safety;

Differentiated CAR molecule design tackling key challenges of solid tumors, such as precise lesion targeting, physical tumor barrier penetration, and promotion of polyclonal and memory T-cell formation for enhanced durability;

Full-chain translational capability, covering product design, preclinical efficacy and safety evaluation, clinical trial implementation, and regulatory filing.

CellOrigin continues to strengthen its leading position in the in vivo CAR therapy space for solid tumors. The company has built a proprietary platform portfolio—including iMAC, CAR-Vac, CAR-Mix, and TMT Engager—for immunocellular therapies targeting solid tumors, autoimmune diseases and organ fibrosis. Looking ahead, CellOrigin remains committed to scientific innovation and open collaboration, working with industry partners to advance frontier immunotherapies into the clinic and address unmet medical needs for patients.

(Press release, CellOrigin Biotech, JUL 31, 2026, View Source [SID1234669588])

IMPACT Therapeutics Signs Exclusive License Agreement with Pharmanovia for Senaparib in Europe, Middle East and North Africa, Australia and New Zealand

On July 31, 2026 IMPACT Therapeutics ("IMPACT") (07630.HK) reported that it has entered into an exclusive partnership (the "Exclusive Partnership") with Pharmanovia, a global specialty pharmaceutical company which partners with innovative biotech and large pharma to bring innovative specialty medicines to patients, to grant Pharmanovia the exclusive rights to manufacture, develop and commercialise senaparib in Europe, Middle East and North Africa, Australia and New Zealand for maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer.

KEY TRANSACTION HIGHLIGHTS

IMPACT is eligible to receive an upfront payment plus near-term regulatory milestones and commercial milestone payments upon achieving certain sales thresholds, with a total amount up to EUR423.5 million, and such further tiered royalties up to the mid-twenties (%) on product net sales;
The Exclusive Partnership expands senaparib’s global reach to 66 countries; and
Marketing Authorisation Application (MAA) of senaparib for 1L maintenance therapy for adult patients with advanced ovarian cancer in Europe was formally accepted by the European Medicines Agency (the "EMA") in August 2025, with approval expected in the second half of 2026.
Under the licensing agreement in relation to the Exclusive Partnership, IMPACT has granted exclusive manufacturing, development and commercialisation rights of senaparib for maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer to Pharmanovia in 66 countries, including, among others, all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa.

IMPACT is eligible to receive consideration up to EUR423.5 million in total consideration, comprising an upfront payment plus near-term regulatory milestones and commercial milestone payments upon achieving certain sales thresholds, and such further tiered royalties up to the mid-twenties (%) on product net sales.

The Exclusive Partnership marks the first step for IMPACT to bring its validated treatment options to patients outside of China, expanding senaparib’s business footprint across Europe, Middle East and North Africa, as well as Australia and New Zealand. IMPACT will work closely with Pharmanovia to advance the commercialisation of senaparib in the collaboration territories. By leveraging Pharmanovia’s specialist expertise and established infrastructure, we expect senaparib to reach target patients in the collaboration territories more quickly following approval, helping to deliver high-quality treatment options to address unmet medical needs. This collaboration will not only enhance the brand recognition of the product and IMPACT on a global scale, but also further broaden IMPACT’s strategic layout for global commercialisation. We expect that this collaboration will have a positive and profound impact on our development.

About SENAPARIB (IMP4297)

Senaparib is a novel, highly potent PARP1/2 inhibitor independently developed by the Company. Its unique molecular structure ensures excellent target selectivity and a wide safety window. Senaparib capsules received National Medical Products Administration of China (NMPA) approval in January 2025 as a first-line maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer achieving complete or partial response to platinum-based chemotherapy, and has been subsequently included in the National Reimbursement Drug List (NRDL) in December 2025. The Company is actively advancing the clinical and regulatory development of senaparib globally. Its Marketing Authorisation Application (MAA) in Europe was formally accepted by the EMA in August 2025, with approval expected in the second half of 2026. Concurrently, the Company is pursuing life cycle management for senaparib, exploring combination therapy opportunities, and expanding into multiple indications.

(Press release, Impact Therapeutics, JUL 31, 2026, View Source [SID1234669587])

CREATE Medicines Expands Targeted In Vivo CAR Platform Through Strategic Research Collaboration and Exclusive License Agreement with Monash University

On July 31, 2026 CREATE Medicines, Inc. ("CREATE"), a clinical-stage biotechnology company pioneering in vivo immune programming, reported a strategic research collaboration with Australia’s Monash University and its world-leading Monash Institute of Pharmaceutical Sciences (MIPS). The partnership broadens CREATE’s portfolio by accessing Monash’s advanced lipid nanoparticle (LNP) technology including proprietary binders and chemistry, strengthening its leadership in developing best-in-class targeted in vivo therapies. Targeted delivery remains one of the primary challenges in realizing the full therapeutic potential of in vivo cell therapies, requiring increasingly precise control over which immune cells receive therapeutic payloads.

Together, CREATE and MIPS will jointly advance targeted Chimeric Antigen Receptor (CAR) therapy, with the goal of enabling precise, cell-type-specific in vivo delivery of CAR payloads utilizing the targeted LNP technology. Under the agreement, CREATE receives a worldwide exclusive license to all intellectual property arising from the collaboration, together with the right to develop and commercialize CAR products directed to designated CAR targets. In turn, MIPS will receive research funding and downstream milestone and royalty payments.

"Monash brings world-class LNP engineering and paired with our already clinically validated and targeted mRNA platform, we can further apply that precision across an even broader range of targets," said Daniel Getts, PhD, Founder and Chief Executive Officer of CREATE Medicines. "Together, we will unlock a new generation of programmable medicines that reach more patients than ever before."

"Monash has built deep expertise in targeted LNP delivery, and their binder and chemistry innovations pair powerfully with our in vivo CAR platform," said Robert Hofmeister, PhD, Chief Scientific Officer of CREATE. "Together we’re building a richer targeting toolkit with new binder formats and control that gives us even more ways to program the right cells with precision."

"Our new strategic partnership with CREATE Medicines will accelerate the work of Monash’s world leading pharmaceutical researchers to design new immunotherapies and speed the translation of their work into new life-changing cancer treatments," Monash Vice-Chancellor and President Professor Sharon Pickering said. "As a globally ranked top-40 university and the most industry-connected university in Australia, Monash is at the heart of a health and medical innovation ecosystem – extending to a commercial office in Boston, the world’s biotech capital – that is leveraging industry, education, research and innovation at scale."

The research at Monash will be led by a distinguished team of scientific experts. Professor Angus Johnston, a leading expert in nanoparticle delivery biology and intracellular trafficking, will serve as Principal Investigator. He will be supported by Professor Colin Pouton, and Dr Moore Chen, who co-authored a seminal 2025 Nature Nanotechnology paper pioneering a new method of delivering mRNA to target cells.

"We’re excited to partner with CREATE to advance a shared vision for programmable medicines" said Professor Johnston. "Targeted delivery is one of the central challenges in realizing the promise of in vivo cell therapies and pairing our LNP technology with CREATE’s platform is a powerful step toward solving it."

(Press release, Create Medicines, JUL 31, 2026, View Source [SID1234669586])