Lutetium (177 Lu) Vipivotide Tetraxetan

iStock, Love Employee 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. Some of the world’s biggest drugmakers have invested heavily in radiopharmaceuticals in recent years, striking multi-billion dollar deals to secure assets with the potential to transform cancer treatment. Frontrunner Novartis recently opened a 10,000-square-foot facility as part of a $23 billion investment in U.S. infrastructure. Yet the rapid emergence of the sector has strained the infrastructure needed to support the modality, whose unique needs range from the reactors that generate isotopes to the facilities that treat patients. Companies have encountered challenges as the radiotherapy sector has emerged. RayzeBio paused enrollment in a Phase III trial of RYZ101 last year due to a shortage of the radioisotope actinium-225. Novartis faced quality issues and shortages as it scaled up production of Lutathera and Pluvicto to meet rising demand. The setbacks point to the central role of the supply chain in access to these therapies. “The lack of access to these drugs, for a lot of folks, was not necessarily due to a limitation of science, but due to a limitation of the logistics and manufacturing and engineering needed to get these drugs out to the world at a cost of scale that matters,” Justin Butler, a partner at Eclipse Ventures, told BioSpace . For lutetium-177, the isotope used in Lutathera and Pluvicto, the problem is simple, said Uriah Orland, director of communications at the University of Missouri Research Reactor (MURR), the sole U.S. producer of the isotope. “The demand is much higher than the supply right now.” The Rise of Radiopharma Radioligand therapies (RLTs) treat cancer by delivering radioactive isotopes to tumor cells. Novartis made early moves into the space in 2017 and 2018, paying a combined $6 billion to buy Advanced Accelerator Applications and Endocyte in the span of 12 months. The clinical and commercial success of Novartis’ Lutathera and Pluvicto, which generated $2 billion between them over the first nine months of 2025, showed the promise of the modality. AstraZeneca , Bristol Myers Squibb and Eli Lilly each joined Novartis in the sector by paying between $1.4 billion and $4.1 billion to acquire radiopharmaceutical specialists in 2023 and 2024. RLT development has increased as these and other leading drugmakers have entered the sector. Sponsors posted 12 trials involving actinium-225, a radioactive isotope, to the ClinicalTrials.gov registry between 2008 and 2021. From 2022 to 2024, 12 more were added. Then this year, activity exploded, as sponsors including AstraZeneca, Bayer, Novartis and BMS’ RayzeBio posted 13 trials in the first nine months of 2025. Companies need access to specialized manufacturing and supply capabilities to get such treatments to patients. Butler worked with Mayo Clinic on how to meet that need, leading the investor to conclude that there is no one technological solution for RLT supply. He compares RLT manufacture and delivery to rocket science. “Any good rocket scientist will tell you that there’s not any one part of rocket science that’s that hard. It’s making the entire thing work all together and not blow up,” Butler explained. “That’s a lot like the radiopharmaceutical space. There’s no one thing.” Orchestrating Supply The exact capabilities needed to make RLTs and ship them to patients vary from isotope to isotope, but the overarching challenges facing each product are similar. Production begins with isotope generation. Actinium-225 sources include thorium-229 decay and accelerator beam facilities. Lutetium-177, the active ingredient in Lutathera and Pluvicto, is made in a nuclear research reactor. Once generated, the isotopes start to decay. Isotope half-lives vary—actinium-225’s is 9.92 days versus 6.65 days for lutetium-177—but all impose a short deadline for getting the drug to patients. Frank Scholz, CEO of NorthStar Medical Radioisotopes, told BioSpace that people outside the sector underestimate the complexity created by half-lives. The ticking clock means materials cannot be stored without losing value. Shipping delays can result in no drug being available to treat a patient on the scheduled day. Systems such as the enterprise resource planning platforms that companies use to manage business processes must reflect the fact that the material is decaying by the hour. At the final step of the supply chain, healthcare facilities need specialized infrastructure and staff training to handle the products and deal with the resulting radioactive waste. Most cancer patients are treated in community oncology clinics that may lack such capabilities. Some patients will travel to large academic medical centers for treatment, but others will remain cut off from RLTs until more sites add capabilities. Activities to make and supply the therapies are covered by regulations that go beyond the FDA rules that apply to all medicines. The Nuclear Regulatory Commission oversees the reactors used to make isotopes, and the Department of Transportation regulates shipments in transit. Scholz said the level of regulatory scrutiny is another thing about RLTs that people outside the space often don’t fully appreciate. Companies will need to understand and manage such issues for RLTs to become a cornerstone of cancer care. And tests of the robustness of the supply chain are on the horizon. With Phase III data on assets including RYZ101 expected next year, the sector is closing in on clinical evidence that could drive increased commercial use of a growing range of RLTs.

With the Halda Therapeutics deal, Johnson & Johnson is strengthening its oncology pipeline with a novel cancer-killing platform and a prostate cancer candidate. \n Johnson & Johnson is paying $3.05 billion to acquire Halda Therapeutics, obtaining a novel cell death platform while strengthening its prostate cancer franchise built on Erleada.At the center of the acquisition is Halda’s regulated induced proximity targeting chimera (RIPTAC) platform, which gives rise to bifunctional small molecules that simultaneously bind a tumor-specific protein and a protein with essential function to cell survival in efforts to induce cancer cell death.This novel “hold and kill” mechanism could address cancer’s ability to develop resistance by evolving bypass mechanisms, according to Halda.Monday’s announcement comes shortly after Halda reported early phase 1 data for the platform’s lead candidate, HLD-0915, the crown jewel of J&J’s proposed $3.05 billion cash deal.HLD-0915 targets androgen receptor and bromodomain 4 (BRD4). In an ongoing phase 1/2 trial, Halda enrolled 31 patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed on prior therapies, including at least one androgen receptor pathway inhibitor such as J&J’s Erleada. The patients may have received up to two prior taxane chemotherapies and may have also had prior exposure to radioligand therapy such as Novartis’ Pluvicto.Among 22 patients who completed at least two cycles of the once-daily oral drug at various doses, 59% achieved a greater than 50% reduction in the prostate-specific antigen, and 32% of patients demonstrated a higher than 90% reduction, according to results presented at the AACR-NCI-EORTC triple meeting last month.Halda described treatment-related adverse events (TRAEs) as “infrequent and generally low grade.” One patient who received the drug at the highest, 100-mg dose experienced dose-limiting toxicity of liver enzyme and bilirubin elevations. All grade 3 or above TRAEs across doses were reversible, and no treatment-related deaths were reported, according to the Boston biotech.Based on the results, Halda has selected the two middle doses tested—25 mg and 50 mg—for dose expansion testing to determine the dose for registrational studies. J&J’s R&D head of innovative medicine, John Reed, M.D., Ph.D., said in a Nov. 17 press release that HLD-0915 demonstrated “impressive preliminary efficacy and a strong early safety profile” from the phase 1/2 results. The company plans to accelerate the ongoing study, he said.“Given the existing unmet need, this once-daily therapy has the potential to transform patient outcomes with its novel precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment,” J&J said in the release.The proposed acquisition will further beef up J&J’s pipeline in prostate cancer, on which the pharma company has placed many bets beyond the FDA-approved Erleada and Akeega.J&J recently advanced pasritamig, a T-cell engager targeting kallikrein 2 (KLK2), into phase 3 testing as a monotherapy in late-line mCRPC. Another phase 3 is being planned that will pair the bispecific with docetaxel. Previously, the company’s anti-KLK2 radioligand therapy candidate, JNJ-6420, was linked to four deaths in an early-stage trial.In a phase 1 trial conducted in pretreated mCRPC patients, pasritamig at the recommended phase 2 dose achieved a 42.4% PSMA50 response rate.As part of its $2 billion acquisition of Ambrx Biopharma last year, J&J also obtained an antibody-drug conjugate targeting PSMA, the same target as Pluvicto. In addition to HLD-0915, Halda’s RIPTAC-based pipeline also includes several earlier-stage candidates for breast, lung and other tumor types. The platform may also help create targeted therapies beyond oncology, J&J noted.“This acquisition further strengthens our deep oncology pipeline with an exciting lead asset in prostate cancer and a platform capable of treating multiple cancers and diseases beyond oncology, providing a potential mid- and long-term catalyst for growth,” Jennifer Taubert, J&J’s chair of innovative medicines, said in a Nov. 17 statement. “We look forward to combining Halda’s pipeline, platform and people with our world class R&D, commercial and manufacturing capabilities and advancing our goal of bringing these therapies to patients around the world.”In a separate release, Halda said the transaction is expected to close “within the next few months.”Full-on acquisitions—versus licensing—appear to be on the rise among Big Pharma lately. Pfizer just beat out Novo Nordisk to acquire obesity biotech Metsera for up to $10 billion, with a once-monthly injectable GLP-1 candidate as the deal’s centerpiece. Merck & Co. is shelling out $9.2 billion to take over Cidara Therapeutics, along with a non-vaccine influenza prevention med that was ditched by J&J.