Curium Reportedly Nearing $7B Deal to Acquire Lantheus

On July 27, Bloomberg reported that Curium is in advanced discussions to acquire Lantheus, with terms described at roughly $102 per share upfront plus $12.50 per share in contingent value rights, valuing the transaction near $7 billion upfront and $8 billion including the CVR. This marks a firmer stage than the reported approach covered in June's issue: sources describe the two sides as closing in on terms rather than exploring a possible sale, though no agreement has been signed and CapVest, Curium, and Lantheus all declined to comment. Lantheus shares fell 2% following the report.

The same week, Curium reintroduced its cardiac SPECT tracer thallium-201 to the US market, out of production since 2022 amid recurring technetium-99m shortages, and began teasing an unnamed new brand of Lu-177 dotatate through a coming-soon signup page, its first public hint at a follow-on product to Lutathera.

Radnostix Acquires Patient-Safety Monitoring IP from Lucerno Dynamics

Radnostix (formerly International Isotopes) closed its acquisition of key assets from Lucerno Dynamics on July 2, including the LARA System technology platform and ELLEXA Explorer software, along with the associated intellectual property. The technology detects and reduces IV extravasations during radiopharmaceutical administration, and has recently added a real-time visualization feature that lets clinicians intervene as an extravasation happens rather than discovering it afterward.

According to Lucerno Dynamics, the LARA System has been used in nearly 50,000 radiopharmaceutical administrations across the US, Australia, Singapore, Japan, and Europe. Radnostix CEO Shahe Bagerdjian said the acquired IP carries additional applications in dosimetry, uptake quantification, and potential integration with auto-infusion drug delivery systems, extending the company's device portfolio beyond isotope supply into administration monitoring.

NRC Publishes Second Major Deregulatory Rule for Medical Isotopes; Byproduct-Material Comment Period Closes

On July 27, the NRC published its proposed rule “Reducing Barriers to Medical Use Licensing” (RIN 3150-AL50, Docket NRC-2025-1237), the companion action to May's byproduct-material rulemaking that June's issue flagged as expected this quarter. The proposal would broaden the regulatory definition of physician to include foreign-trained individuals licensed to practice in the US, replace the current seven-year recentness-of-training requirement with a performance-based continuing-education model, and codify several emerging medical technologies directly into the main body of Part 35 rather than requiring case-by-case licensing guidance under Subpart K, including Y-90 microspheres, modern gamma stereotactic radiosurgery units, and Ge-68/Ga-68 and Rb-82 generators. It would also expand decay-in-storage eligibility from a 120-day to a 275-day half-life ceiling, directly benefiting onsite disposal of longer-lived materials such as lutetium-177m and cobalt-57. The NRC estimates $39.1 million in net industry savings over the 2027 to 2031 period. Comments are due September 10.

The earlier byproduct-material rulemaking closed its own comment period on schedule on July 2. ASTRO submitted supportive comments on July 1, backing the proposed exemption of short-lived radionuclides from facility-specific decommissioning cost estimates and the expanded ability for radiopharmacies to prepare and distribute radioactive microspheres, while asking the NRC to clarify that the new Standard General Licenses apply only to uses that do not require a written directive.

Telix and Radiopharm Theranostics Report New Clinical Milestones; Novartis Discontinues Lu-NeoB; Perspective Earns Orphan Designation

On July 21, Telix dosed the first patient in LUTEON1, the first Phase 3 trial of a radiopharmaceutical therapy in clear cell renal cell carcinoma. The trial evaluates TLX250-Tx (lutetium-177 girentuximab tetraxetan), a CAIX-targeted radio-antibody-drug conjugate, and uses Telix's investigational PET imaging agent TLX250-Px to identify CAIX-positive patients, the same theranostic pairing model behind the company's prostate and glioblastoma franchises. CAIX is expressed in more than 95% of ccRCC cases, a disease with a five-year survival rate near 20% once metastatic.

Radiopharm Theranostics reported updated Phase 1 data for RAD204 on July 22, a PD-L1-targeted lutetium-177 nanobody radiotherapeutic for solid tumors that have progressed on immunotherapy: the first patient in the trial's third, highest-dose cohort (90 mCi) achieved a RECIST-confirmed durable partial response, with target lesion reduction reaching 43% and holding through four treatment cycles, remaining progression-free beyond seven months with no dose-limiting toxicities observed at any dose level tested. A second patient in the same cohort showed early lesion reduction and remains on treatment. The same day, the company reported that its Phase 2b brain-metastases imaging program, RAD101, met its primary endpoint with 93% concordance against MRI and 86% sensitivity across tumor types; specificity data is expected in the fourth quarter.

Perspective Therapeutics received European orphan medicinal product designation on July 28 for [212Pb]VMT-α-NET, the same alpha-emitting SSTR2-targeted candidate the company expanded into meningioma back in June, this time covering gastroenteropancreatic neuroendocrine tumors. The designation follows a positive opinion from the EMA's Committee for Orphan Medicinal Products and, should the therapy eventually win approval, carries up to ten years of European market exclusivity along with protocol assistance and fee reductions during development.

On July 21, Novartis confirmed it has discontinued all studies of Lu-NeoB, a GRPR-targeted radioligand therapy that had been in Phase 1 development for breast cancer and Phase 2 development across solid tumors, after early clinical data did not support advancing the program further. CEO Vas Narasimhan told Fierce that the company's broader commitment to the modality is unchanged, pointing to continued Phase 1 work on the DLL3-, HER2-, and FAP-targeted candidates that sit behind Pluvicto and Lutathera, a franchise that posted 43% sales growth to $651 million in the second quarter. Asked why Novartis had, in the same period, paid $1.1 billion upfront for ADC biotech Myricx Bio, Narasimhan said certain cancer types are better served by antibody-drug conjugates than by radioligand therapies, an acknowledgment that different tumor biology calls for different treatment modalities.

Blue Earth Therapeutics and University College London initiated a Phase 1 trial (NCT07414940, announced July 9) of actinium-225 rhPSMA-10.1 in metastatic castration-resistant prostate cancer, the company's second clinical candidate on its radiohybrid PSMA platform and its first alpha-emitting one, alongside its existing Phase 2 Lu-177 rhPSMA-10.1 program.

Journal of Nuclear Medicine July Studies Advance Prognostic Scoring and Introduce New Regulatory Nomenclature

JNM's July 17 ahead-of-print release included four studies of note. Researchers combined the radiopharmaceutical 177Lu-DOTA-ABM-5G with the PARP inhibitor olaparib in preclinical pancreatic cancer models, finding that the combination amplified DNA damage and improved survival beyond either treatment alone, a rationale increasingly common in radiopharmaceutical combination strategies. Separately, investigators developed and validated the PROFILE score, which combines two PET scans with routine clinical measures to stratify patients into low, intermediate, and high survival-risk groups before starting targeted radiopharmaceutical therapy for advanced prostate cancer, validated across independent cohorts. A third study examined clonal hematopoiesis, age-related blood cell mutations, in patients receiving 177Lu-PSMA therapy, and a fourth used tau PET imaging to detect early Alzheimer's-related brain changes in cognitively healthy older adults.

A second JNM batch on July 23 focused squarely on 177Lu-PSMA-617 response monitoring. The most clinically actionable of the three: a retrospective, single-center study of 87 patients found that interim disease progression, developing in the gap between a baseline PSMA PET scan and the first treatment cycle, occurred in roughly 37% of patients, and was strongly tied to how much time had elapsed between the two, a delay beyond 30 days carried more than double the odds of progression compared with a shorter interval. PSA response and overall survival didn't differ between patients with and without interim progression, suggesting the therapy still worked once started, but the finding argues for keeping the PET-to-treatment window under 30 days, tighter than the three-month window some consensus guidance allows, or using the first posttherapy SPECT/CT as a corrected baseline when a shorter window isn't feasible. Separately, researchers externally validated an existing Ga-68-PSMA-11 PET-based prognostic model in a new cohort of 174 patients imaged instead with the newer tracer 18F-flotufolastat before 177Lu-PSMA I&T therapy, finding it predicted survival and PSA response with similar accuracy across both tracers. A third study tested whether a faster dual-energy SPECT/CT protocol, 9 or 18 minutes instead of a longer standard scan, could shorten post-therapy imaging time in 20 patients without sacrificing accuracy against standard PSMA PET.

A separate July JNM article, “The Equivalents Are Coming,” proposed a shared nomenclature for radiopharmaceutical therapies approved through the FDA's 505(b)(2) pathway as the field expands beyond neuroendocrine tumors and prostate cancer. The authors introduce the term “radioligand equivalent” to distinguish a 505(b)(2)-approved therapy, supported by bridging studies to an already-approved product, from a true generic approved through the Abbreviated New Drug Application pathway, arguing that a shared vocabulary will matter as more of these therapies reach the market through the 505(b)(2) route.

ITM Launches Lumara Bio Ahead of ITM-11 Decision; TD2 Oncology and Minerva Imaging Sign Development Partnership; Nucs AI and Segmed Team Up on Therapy-Response Data

ITM introduced Lumara Bio on July 27 as a dedicated oncology therapeutics division, bringing together the company's existing pipeline and the internal teams responsible for its development and commercialization. The timing is deliberate: ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors carries an FDA PDUFA date of August 28, the same catalyst June's issue flagged as the sector's clearest near-term regulatory decision. ITM said Lumara Bio will draw on the company's existing isotope manufacturing and supply infrastructure to support both the broader pipeline and a potential commercial launch, a structural head start most first-time radiopharmaceutical launches don't have.

TD2 Oncology and Minerva Imaging announced a partnership on July 22, combining TD2's oncology clinical and regulatory development capabilities with Minerva's radiopharmaceutical CDMO, imaging, and radiochemistry services to give sponsors a single coordinated path from early translational work through first-in-human and early-phase radioligand therapy trials. TD2 CEO Stephen Gately described the move as part of the company's long-term commitment to the RLT space, noting that advancing a radiopharmaceutical program depends on coordinating radiochemistry, CMC planning, imaging strategy, regulatory groundwork, and clinical site readiness, work that often sits across separate vendors and can otherwise create delays.

Separately, Nucs AI, which develops AI-powered imaging biomarkers for prostate cancer diagnosis and treatment-response prediction, announced a strategic partnership with Segmed on July 14, alongside a strategic investment by Segmed into Nucs AI. The partnership pairs Nucs AI's PSMA-PET/CT analysis platform with Segmed's library of more than 150 million imaging studies across 2,800 healthcare sites, extending that data infrastructure into molecular imaging and theranostics for the first time. The companies cited the VISION trial's finding that more than half of Lu-177 PSMA-treated patients did not achieve a PSA response as the kind of patient-selection problem the partnership is built to address.

Ac-225 Recycling Reaches Commercial Scale; Facility Investment Continues; BC Cancer Recall Underscores Handling Risk

Actineer, the joint venture between Canadian Nuclear Laboratories and ITM Isotope Technologies Munich, announced on July 14 the successful completion of a closed-loop process to recycle radium-226, the scarce precursor material for actinium-225. The process recovers and purifies Ra-226 for reuse across multiple production cycles without measurable degradation in yield or purity, aimed at reducing dependence on constrained global Ra-226 inventories and improving Ac-225 supply predictability through Actineer's cyclotron-based, proton-irradiation production route. The same week, Health Canada recalled a 24.80 mL vial of Fludeoxyglucose (18F) Injection distributed by BC Cancer after the vial was found cracked at the bottom, a reminder that supply disruptions in this field are as often about physical handling and packaging integrity as isotope scarcity.

On the facilities side, Telix officially opened Telix Manufacturing Solutions North Melbourne on July 16, the first Australian facility to combine radiochemistry, clinical manufacturing, patient dosing, and imaging under one roof, delivered in partnership with the Melbourne Theranostic Innovation Centre. Alliance Medical acquired Dutch manufacturer Radboud Translational Medicine on July 16 as part of its ongoing European radiopharmacy network expansion, and GE HealthCare and University Hospital Essen opened a new theranostics-focused nuclear medicine center on July 1 featuring the first installation of GE's StarGuide GX SPECT/CT system. Separately, Nusano, a Utah-based company building a linear-accelerator platform designed to produce up to 25 medical isotopes across four beam lines and 12 targets, detailed its progress in a July 5 feature, citing Utah's proximity to major air-freight hubs as a logistical advantage for distributing short-half-life materials nationally.

TerraPower Isotopes announced on July 29 a commitment to donate actinium-225 through the Oncidium Foundation's RLT-Connect program, which coordinates radioisotope donations from suppliers to patients who cannot otherwise afford radioligand therapy. The donation marks TerraPower Isotopes' entry into Oncidium's supplier network; the company said it currently ships Ac-225 on a weekly basis to drug developers and researchers globally, material it says is in use across ongoing clinical trials of targeted alpha therapies.

AdvanCell Closes $315M Series D; Radiopharm Theranostics Raises Twice in One Month

AdvanCell closed an oversubscribed $315 million Series D on July 15, led by Ally Bridge Group and Alpha Wave with continued participation from the venture arms of Sanofi and Eli Lilly and new investment from Bain Capital Life Sciences. The round funds AdvanCell's push of its lead-212 prostate cancer candidate, ADVC001, currently in a Phase 2 trial, toward Phase 3, and supports expanded manufacturing infrastructure including its recently leased Boston-area headquarters, alongside continued operations in Australia. CEO Philina Lee pointed to lead-212's 10.6-hour half-life as a practical advantage over actinium- or radium-based alpha emitters, limiting how long the isotope persists in the body after delivering its payload.

Radiopharm Theranostics raised capital twice within the month: an A$18.5 million placement and share purchase plan completed July 3, followed by a second concurrent offering, a US$4.1 million registered direct offering plus up to A$12.7 million (roughly US$8.9 million) in an additional Australian placement, announced July 24 and expected to close July 28. Combined, the two rounds total roughly $13 million in additional capital. The company said proceeds support the RAD101 Phase 3 registrational study alongside its broader clinical pipeline, working capital, and strategic partnering efforts, and the raises followed closely on the July 22 RAD204 and RAD101 data readouts covered above.