Fusion Pharmaceuticals, Inc.

iStock, Ihor Reshetniak Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies. The emergence of actinium-225 as the next big thing in radiopharmaceuticals is fueling a race to add and access manufacturing capacity for the isotope. With leading drugmakers moving candidates deeper into clinical testing, actinium-225 suppliers have invested to increase capacity and struck a string of deals to meet their customers’ demands for the alpha emitter. Lutetium-177, a beta-emitting isotope, has defined the growing radiopharmaceutical industry since the FDA approved Novartis’ Lutathera in 2018. Novartis uses the same isotope in Pluvicto, a radioligand therapy that the FDA approved in 2022. Combined, Lutathera and Pluvicto, both cancer drugs, generated sales of $2.8 billion for Novartis in 2025. Drugmakers are continuing to invest in cancer medicines based on lutetium-177. Novartis is run multiple trials to build on its leadership, ITM filed for approval in November and companies including Eli Lilly are moving assets through the clinic. At the same time, the sector’s focus is expanding beyond lutetium-177, with companies studying a growing set of isotopes led by actinium-225 in pursuit of a competitive advantage. Now, suppliers of the alpha emitter are ramping up. Adding Actinium-225 Capacity Compared to lutetium-177, actinium-225 emits more energy over a smaller area. Therapies based on it could be more efficacious, as they are thought to cause more double-strand DNA breaks in cancer cells and result in less damage to healthy tissues. Novartis discussed its expansion into alpha emitters, and actinium in particular, at an R&D day in 2019, but it took a few more years for the sector to ignite. From October 2023 to March 2024, AstraZeneca, Bristol Myers Squibb and Lilly each struck deals to buy biotechs developing drug candidates based on actinium-225. The proliferation of programs has strained the supply chain, leading BMS’ RayzeBio to pause a Phase 3 trial over a shortage of actinium-225 in 2024. Manufacturing Surge in Radiopharmaceutical R&D Puts Pressure on Unique Supply Chain The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics. November 18, 2025 · 4 min read · Nick Paul Taylor Read more Oak Ridge National Laboratory (ORNL) has been the main supplier of actinium-225 for almost 30 years. The R&D center, which is funded by the Department of Energy (DOE), makes the isotope via decay of thorium-229 left over from nuclear programs in the 1940s and 1950s. ORNL has increased shipments, but the growth in demand has outpaced its ability to boost output. Multiple groups are working to increase supply. TerraPower Isotopes is increasing access to actinium-225 generated through natural decay by working with Isotek to recover the thorium-229 from uranium-233 stockpiles managed by the DOE. Overseen by the DOE, ORNL and two other national laboratories have used accelerator beam facilities to make actinium-225 from thorium-232. However, material generated in that process is contaminated with actinium-227, leading to the development of alternative approaches such as cyclotrons and linear accelerators. NorthStar CEO Frank Scholz told BioSpace that considerations related to yield, reliability and scalability informed his company’s decision to use electron accelerator–based technology to make actinium-225. Scholz said NorthStar selected the technology after calculating it would need to buy 10 to 15 cyclotrons, depending on the model, to meet its supply needs. “That would mean a significant amount of [capital expenditure] and mean using multiple machines that could fail and need to be maintained,” Scholz said. “The decision goes beyond the pure technical aspect, which we value, and is ultimately a holistic business case.” NorthStar’s actinium-225 is made without the addition of stable elements, resulting in a more potent product known as a non-carrier-added isotope. NorthStar recently claimed to be the first to produce commercial-scale non-carrier-added actinium-225 using electron accelerator technology. BWXT Medical makes non-carrier-added actinium-225 at TRIUMF, Canada’s particle accelerator center. Niowave uses a superconducting electron linear accelerator. Eckert & Ziegler use a cyclotron-based method. Drugmakers Secure Supply The investments in capacity reflect industry demand for actinium-225. AstraZeneca struck a 10-year supply agreement with Niowave in December. The deal, which extended an earlier agreement, secured AstraZeneca a source of actinium-225 for use in drug candidates it acquired in its $2.4 billion Fusion Pharmaceuticals buyout in 2024. Fusion partnered with BWXT Medical to access the isotope in 2023. Bayer has entered into a string of actinium-225 supply agreements in recent years, agreeing to source the isotope from BWXT , Ionetix , NorthStar and PanTera between 2022 and 2024. Cellectar Biosciences diversified its supply chain by striking deals to access the isotope from NorthStar , ITM , Nusano and Ionetix in 2024 and 2025. Point Biopharma, which Eli Lilly bought for $1.4 billion, partnered with Ionetix to source actinium-225 in 2021. Lilly invested in Ionetix in 2024. Ariceum Therapeutics penned a deal in 2025 for actinium-225 from ITM’s joint venture with Canadian Nuclear Laboratories. Eckert & Ziegler has inked a series of deals, agreeing to supply actinium-225 to Actinium Pharmaceuticals , GlyTherix and SK Biopharmaceuticals . Investments in drug candidates based on other isotopes indicate the need for manufacturing capabilities to keep evolving. Nucleus RadioPharma CEO Steve Hahn told BioSpace that copper-67 and astatine-211 are isotopes that are not made in sufficient quantities. The isotopes are part of an increasingly diverse pipeline. Justin Butler, a partner at Eclipse Ventures, told BioSpace he anticipates there will be drug candidates not only involving lutetium and actinium, but also lead and copper isotopes. “We need to have the capabilities to be able to work with all of those if this industry is really going to become as big as we think it can be.”

AstraZeneca doubled down on radiopharmaceuticals last March with its $2 billion buyout of Fusion Pharmaceuticals. Pharma giant AstraZeneca has expanded its supply deal with Michigan-based medical radioisotope producer Niowave, establishing a 10-year deal for the delivery of Actinium-225 (Ac-225), a radioisotope that has shown promise in the development of targeted cancer therapy. AZ exercised its option to increase capacity in order to secure reliable supply of the isotope for the drugmaker’s expanding pipeline of radioconjugates, which use alpha particles to target and eliminate cancer cells, Niowave said in a Dec. 18 press release.Financial terms of the supply deal weren’t disclosed.“Our expanded agreement with AstraZeneca underscores Niowave's central role in scaling high-quality production of medical radioisotopes for the development of targeted cancer treatments,” Mike Zamiara, Niowave’s chief executive, said in a statement. “We are pleased to play a role in ensuring that AstraZeneca's promising pipeline of radioconjugates have the isotope supply they need.”Niowave, which was spun out of Michigan State University's National Superconducting Cyclotron Laboratory in 2005, boasts superconducting linear accelerator technology and radiochemistry that allow for sustainable production to address the limited supply of Ac-225.The radioisotope emits alpha particles that deliver very potent and DNA-destructive energy that can be delivered precisely to destroy tumors while limiting any damage to surrounding healthy tissue, the company explained. For its part, AZ doubled down on radiopharmaceuticals last March with its $2 billion buyout of Fusion Pharmaceuticals. AZ had initially collaborated with Fusion beginning in 2020 before moving to purchase its partner, whose lead candidate, FPI-2265, is a PSMA-directed radiotherapy in phase 2 development as a treatment for metastatic castration-resistant prostate cancer.  Radioisotopes form a key component in the cutting-edge cancer treatments known as radiopharmaceuticals. Deals to boost production of the specialized ingredient have gained momentum in recent years, and the pace has not let up in 2025. Last week, Bicycle Therapeutics secured a deal with two U.K. nuclear agencies for 400 tons of reprocessed uranium it needs to develop potential radioconjugate drugs to treat cancer.And, in August, Nusano opened the doors to 190,000-square-foot production facility in Salt Lake City that is capable of churning out more than 40 different radioisotopes used for cancer diagnostics and therapeutics.Earlier this year, meanwhile, Ratio Therapeutics unveiled plans to build a new research and manufacturing plant, also in Salt Lake City, while PharmaLogic shelled out an undisclosed sum in April to take a majority stake in Norway’s Agilera Pharma.The move by PharmaLogic fits into the company’s strategy to become a global CDMO leader focused specifically on radiopharmaceuticals.

Châtillon, France, October 30, 2025 DBV Technologies Announces Appointment of Philina Lee, Ph.D. to Board of Directors DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), (the “Company” or “DBV”), a clinical-stage biopharmaceutical company, today announced the provisional appointment of a new independent director, Dr. Philina Lee, to its Board of Directors (the “Board”), effective October 30, 2025. Dr. Lee is appointed in replacement of Daniel Soland, subject to the ratification by the Company’s shareholders at the next annual meeting of shareholders. Dr. Lee will also serve as a member of the Compensation Committee of the Board. With this addition, the Company’s Board comprises ten directors. “We are pleased to welcome Philina Lee as a new independent director to the Board,” said Michel de Rosen, Chairman of the Board. “Philina’s extensive experience building successful biopharmaceutical organizations and commercializing pharmaceutical products will add tremendous value as the Company moves closer to potential commercialization.” Dr. Lee joins DBV following a distinguished tenure at Blueprint Medicines where she progressed through increasingly senior roles, culminating in her leadership of the company’s commercial organization as Chief Commercial Officer, overseeing the successful launch and growth of AYVAKIT®. She previously was on the Board of Directors at Fusion Pharmaceuticals, where she served on both the Nomination and Governance Committee and the Research and Development Committee. “I am honored to join DBV’s Board at such a pivotal time for the Company, as it continues to advance VIASKIN® Peanut for children and toddlers with peanut allergy,” said Dr. Lee. “I look forward to serving on the Compensation Committee and contributing to DBV’s growth and success.” About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). VIASKIN is a registered trademark of DBV Technologies. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactBrett WhelanDBV Technologiesbrett.whelan@dbv-technologies.com Attachment