June 2026

Radiopharmaceuticals: June 2026 in Review

Radiopharma news, decoded for investors, manufacturers, clinicians, scientists, and policy watchers.

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Radiopharmaceuticals: the month in review
June 2026 · Issue 01

Radiopharma news, read through what it means for investors, manufacturers, clinicians, scientists, and policy watchers.

A synthesis of the radiopharmaceutical industry's scientific, clinical, and business developments, focused on their implications for decision-makers across the field. This issue spans the core June 2026 news cycle and select late-May context from the SNMMI and ASCO annual meetings.

In this issue
  1. Curium Reported to Have Offered ~$7B to Acquire Lantheus
  2. Delaware Court Invalidates Novartis Patents Protecting Lutathera
  3. FDA Approves Generic Ga-68 PSMA-11; Issues Complete Response Letter to Lantheus; NRC and CMS Advance Rules
  4. Post-Pluvicto Prostate Cancer Data Lead the Annual Meetings; Radiopharmaceuticals Expand into Brain Cancers
  5. Journal of Nuclear Medicine June Studies Advance FAP Targeting, Alpha-Emitters, and PET Hardware
  6. Novartis Launches Pluvicto in India; Alpha Tau and Tolmar Sign US Prostate Cancer Commercialization Deal; Telix Signs Theranostics MOU with United Imaging
  7. Actinium-225 Supply Deals and Facilities Expand; Preclinical and Manufacturing Partnerships Deepen; Lutetium-177 Faces Geopolitical Risk
  8. Nuclidium Closes CHF 105M Series B; AdvanCell Leases US Manufacturing Site
01 MERGERS & ACQUISITIONS

Curium Reported to Have Offered ~$7B to Acquire Lantheus

On May 22, Bloomberg reported that Lantheus Holdings was weighing a sale after receiving a takeover offer from private-equity-backed Curium Pharma valuing it at roughly $7 billion, with Reuters corroborating. The story broke in late May, but the situation remained live and unresolved through June, and it directly frames two June developments below (the Lutathera patent ruling and the Lantheus FDA letter), so it leads this issue as ongoing context. Both companies declined to confirm; as of month-end no definitive agreement had been announced, so this remains a reported proposal rather than a closed transaction. A combination would bring together two of the largest pure-play radiopharmaceutical companies, with overlapping diagnostic franchises.

Lantheus reported first-quarter 2026 worldwide revenue of $377.3 million, driven by its PSMA imaging agent Pylarify alongside Definity and Neuraceq, and is operating under interim CEO Mary Anne Heino, who has framed 2027 as a growth-acceleration year. The reported offer values Lantheus near its prior trading levels and comes as the company navigates both a favorable patent ruling and a manufacturing-related FDA rejection in the same month (covered separately below).

Implications by stakeholder
InvestorsA signed agreement or 8-K would reset sector valuations; absent that within roughly 60 days of the May 22 report, the public deal signal has gone quiet, though private negotiations may still be ongoing. A transaction would consolidate a large share of the diagnostic imaging and radiotherapeutic supply stack under one owner.
Manufacturers & CDMOsA combined entity would control a larger share of both isotope production and finished-product manufacturing. Worth assessing how that changes the landscape for independent capacity if supply currently available to the market is internalized.
PolicyA combination of the two largest pure-play radiopharma companies would likely draw antitrust review given overlapping diagnostic franchises. Monitor for early signals on review scope if a deal is formally announced.
02 LEGAL & INTELLECTUAL PROPERTY

Delaware Court Invalidates Novartis Patents Protecting Lutathera

On June 18, a US federal judge in the District of Delaware (Maryellen Noreika) found all asserted claims of the Novartis/Advanced Accelerator Applications patents protecting Lutathera (177Lu-dotatate) invalid, clearing Lantheus and Curium of infringement allegations. The patents at issue, including US 10,596,276 and three patents issued in 2024, covered stable, concentrated radionuclide complex solutions. Among other arguments, the challengers asserted that the originator filed too late under the on-sale bar given prior commercial activity abroad.

The ruling removes a key barrier to generic Lutathera competition in the United States, for the first approved radioligand therapy in neuroendocrine tumors and a product that has delivered double-digit sales growth. Novartis retains the option to appeal, and the radiopharmaceutical generic pathway is more complex than for conventional small molecules, so timing of any generic entry remains uncertain.

Implications by stakeholder
InvestorsThis has the potential to shift value within the neuroendocrine therapy market: it opens a US generic pathway against a growing Novartis product while strengthening Curium's and Lantheus's neuroendocrine-tumor positions, relevant context for the Curium/Lantheus deal economics. A Novartis appeal could delay but may not prevent generic entry.
PolicyThe on-sale-bar basis is a reminder that early expanded-access or commercial activity abroad can jeopardize later US patents, a recurring vulnerability for developers who run international programs before US filing. A development to monitor over the coming quarters: whether it shapes how the sector sequences global launches against IP filing.
CliniciansGeneric Lutathera competition, once it materializes, could ease access and pricing for neuroendocrine-tumor patients over time, though the timeline depends on appeals and regulatory steps.
03 REGULATORY

FDA Approves Generic Ga-68 PSMA-11; Issues Complete Response Letter to Lantheus; NRC and CMS Advance Rules

The month's regulatory activity ran in both directions. On June 10, RadioMedix received FDA approval for a generic version of Ga-68 PSMA-11 (gallium Ga-68 gozetotide), a prostate-cancer PET imaging agent, and cleared the FDA inspection of its SPICA Center manufacturing site near Houston with no observations. The approval introduces a lower-cost diagnostic option that could broaden access to PSMA PET imaging. By contrast, on June 26 the FDA declined to approve Lantheus's Ga-68 edotreotide neuroendocrine-tumor imaging kit (LNTH-2501), citing unresolved manufacturing-facility inspection conditions at a third-party site and raising no concerns about the product's safety, effectiveness, or data.

On the rulemaking side, the NRC's proposed rule modernizing byproduct-material regulations (published May 18, comments due July 2) would eliminate decommissioning financial assurance for radionuclides with half-lives under 120 days, including Lu-177, Y-90, Ac-225, and Ra-223, ease thresholds for Ge-68/Ga-68 generators, and let commercial radiopharmacies prepare and distribute microspheres; a companion medical-use licensing rule is expected this quarter. In reimbursement, a CMS add-on payment for Tc-99m made from domestically produced molybdenum-99 is now in effect: hospitals can bill an extra $10 per dose (under a new billing code, C9176) when at least 50% of the molybdenum-99 was produced domestically, with supplier documentation required. The key pending US therapeutic decision is ITM's no-carrier-added 177Lu-edotreotide (ITM-11) for gastroenteropancreatic neuroendocrine tumors, with an FDA decision expected by August 28, 2026.

Implications by stakeholder
InvestorsIf finalized, the NRC proposal would represent a meaningful cost-structure shift, since removing decommissioning financial assurance takes a liability off the books across facility models; the CMS add-on supports demand for domestic molybdenum-99 projects. ITM's August 28 FDA decision on ITM-11 is the clearest near-term yes/no catalyst in the space.
Manufacturers & CDMOsRadioMedix's clean inspection alongside Lantheus's manufacturing-related rejection in the same month shows inspection readiness is now a strategic advantage, not a back-office function. Submit NRC comments by July 2 if the financial-assurance relief or microsphere pathway affects you, and confirm domestic molybdenum-99 documentation to bill the $10 add-on.
CliniciansA generic Ga-68 PSMA-11 should mean more commercial sources, fewer scheduling delays, and lower cost for PSMA PET imaging. The add-on payment's documentation requirement reaches procurement teams, who need supplier verification on file to bill it.
PolicyWatch the companion NRC medical-use licensing rule expected this quarter. Separately, CMS has so far declined to base diagnostic-radiopharmaceutical payment on Average Sales Price (ASP), citing incomplete reporting, and continues to use hospital-claims-based costs instead; whether that changes in future rulemaking is worth tracking, though radiopharmaceuticals were excluded from the current hospital cost survey.
04 CLINICAL DATA: ASCO & SNMMI 2026

Post-Pluvicto Prostate Cancer Data Lead the Annual Meetings; Radiopharmaceuticals Expand into Brain Cancers

Across ASCO 2026 (May 29-June 2, Chicago) and SNMMI 2026 (May 30-June 2, Los Angeles), the central clinical theme was the treatment of prostate cancer after Pluvicto, and the role of alpha-emitters in that setting. Novartis presented a Pluvicto PSMAddition subgroup analysis showing consistent benefit in hormone-sensitive disease (filings underway in the US, China, and Japan) and early Phase 1 data for its alpha-emitter 225Ac-PSMA-617, where roughly half of previously Pluvicto-treated patients achieved a PSA reduction of at least 50%, accompanied by a persistent dry-mouth (xerostomia) signal common to small-molecule alpha agents. Convergent Therapeutics presented its antibody-based CONV01-α (225Ac rosopatamab), reporting a 40% PSA50 response and 8.4-month median radiographic progression-free survival in Lu-PSMA-pretreated patients at its target dose, from two treatments, with no high-grade xerostomia and no renal toxicity.

Telix delivered a late-breaking oral presentation of safety and dosimetry data from Part 1 of its ProstACT Global Phase 3 study of TLX591-Tx (a 177Lu radio-antibody-drug conjugate) plus standard of care in metastatic castration-resistant prostate cancer, with the trial advancing to randomized Part 2 dosing. Aktis Oncology's B7-H3-targeted AKY-2519 showed robust tumor uptake and limited normal-tissue exposure in first-in-human imaging across 34 patients, supporting a Phase 1b and a planned basket trial. Actinium Pharmaceuticals presented ATNM-400, a non-PSMA 225Ac radioconjugate, with preclinical data the company described as superior to PSMA-617 radioligands in prostate cancer models, plus a non-small-cell lung cancer profile. SNMMI also dedicated an Emerging Technology session on June 1 (ET03: Alpha 2) to astatine-211 and lead-212, with RadioMedix presenting on Pb-212 clinical use, a thematic indicator that the next wave of alpha emitters beyond Ac-225 is moving into structured clinical and translational programming. On the SNMMI awards side, the meeting recognized an 18F-GP1 PET/CT clot-imaging study (Image of the Year) and a PET brain-metabolism study predicting response to amyloid-directed Alzheimer's therapy (Abstract of the Year).

Beyond the two meetings, two programs pushed radiopharmaceuticals into harder-to-treat brain and central nervous system tumors. ITM reported updated preliminary Phase 1 data (June 29) for ITM-31, an intracavitary 177Lu therapy for newly diagnosed glioblastoma developed with Helmholtz Munich and the University of Münster. The candidate targets carbonic anhydrase XII, a protein expressed in more than 90% of glioblastomas but absent in healthy brain tissue, and is injected directly into the surgical resection cavity to bypass the blood-brain barrier. Across the ten-patient dose-escalation study (NCT05533242), the therapy showed a manageable safety profile with no Grade 3 or higher hematological toxicities, and all enrolled patients remained alive in ongoing follow-up, an early signal in a disease where median survival is roughly 15 to 20 months. Separately, Perspective Therapeutics dosed the first meningioma patient with its alpha-emitter [212Pb]VMT-α-NET (June 3), opening the LEMONαDE cohort of its Phase 1/2a study (NCT05636618) and extending the candidate beyond neuroendocrine tumors to other SSTR2-expressing cancers; meningiomas are the most common primary brain tumors in adults and consistently express that target.

Implications by stakeholder
InvestorsOne of the defining variables in the post-Pluvicto race is tolerability, not just efficacy: Convergent's antibody approach (no high-grade dry mouth from two doses) versus Novartis's small-molecule alpha (a persistent dry-mouth signal). Convergent's Phase 3 initiation and Telix's ProstACT Global readout are the next catalysts to monitor, and Actinium's non-PSMA approach widens the field of targets in development.
Manufacturers & CDMOsEach of these programs is forming or scaling supply relationships now, and most depend on Ac-225 or Lu-177. The weight of PSMA data signals that franchise's maturity; differentiation is shifting to new targets (B7-H3, non-PSMA antibodies) and dosimetry-driven personalization.
CliniciansRetreatment data in post-taxane, Lu-PSMA-exposed patients is directly relevant to sequencing decisions, and tolerability differences across agents (xerostomia, renal, hematologic) will matter for patient selection as these approach approval.
ScientistsOne of the clearest scientific trends is the move beyond PSMA and somatostatin-receptor targets: B7-H3, non-PSMA antibody radioconjugates, and antibody-versus-small-molecule alpha delivery are the active design questions. ITM-31's carbonic anhydrase XII target and intracavitary delivery are a notable example of radiopharma pushing into glioblastoma, and the neuro Abstract of the Year signals growing recognition for applications outside oncology.
05 SCIENTIFIC LITERATURE

Journal of Nuclear Medicine June Studies Advance FAP Targeting, Alpha-Emitters, and PET Hardware

The peer-reviewed literature gives a cleaner read on the underlying science than conference headlines. The Journal of Nuclear Medicine's June 5 ahead-of-print collection highlighted several themes. Fibroblast activation protein (FAP) is emerging as a versatile target beyond oncology: one preclinical study paired a FAP-targeting compound for both detection and treatment of glioblastoma (improving survival alongside chemotherapy), and another used FAP-targeted PET/MRI to detect endometriosis lesions more sensitively than MRI alone.

On the therapeutic side, an experimental alpha-emitting radiopharmaceutical for previously treated gastroenteropancreatic neuroendocrine tumors was characterized for how it and its radioactive daughters distribute across tumor and healthy tissue, and a CD44v6-targeting agent slowed pancreatic ductal adenocarcinoma growth in mouse models. On imaging hardware, two ultrahigh-resolution PET systems reported standout results, one resolving fine molecular activity in the mouse brain matching autoradiography, and a next-generation human scanner producing sharp brain and breast images in first-in-human studies. Two methodological papers round out the set: a review finding that animal-to-human radiation dose prediction holds well for short-lived tracers but degrades for longer-lived ones, and a cross-country study of how patients and physicians judge clinicians who accept or reject AI recommendations.

Implications by stakeholder
ScientistsFAP is the target to watch, appearing across glioblastoma, endometriosis, and fibrosis, suggesting breadth beyond the PSMA/SSTR2 mainstream. The dosimetry-prediction review (short-lived tracers predictable, long-lived ones not) is directly relevant to first-in-human dose modeling.
Manufacturers & CDMOsThe non-oncology FAP applications point to diagnostic and therapeutic markets that aren't yet crowded. Worth tracking which move from preclinical into trials, since early-stage targets become future manufacturing demand.
CliniciansThe prostate-cancer imaging papers are the most immediately practice-relevant: protocol refinements that improved detection of recurrent disease in patient cohorts.
InvestorsThe breadth and quality of June peer-reviewed output, alpha-emitters, FAP platforms, and resolution-defining scanner hardware advancing together, is a useful counterweight to headline deal noise: the underlying science pipeline is broadening.
06 COMMERCIAL & CORPORATE

Novartis Launches Pluvicto in India; Alpha Tau and Tolmar Sign US Prostate Cancer Commercialization Deal; Telix Signs Theranostics MOU with United Imaging

Two of the most commercially advanced companies made distinct corporate moves in June. Novartis launched Pluvicto in India (announced June 15), described as the country's first regulatory-authority-approved radioligand therapy for PSMA-positive prostate cancer, a geographic expansion for a franchise that generated roughly $2 billion in 2025 and underpins the company's $5 billion peak-sales ambition. India reports nearly 250,000 new prostate cancer cases annually, many diagnosed after the disease has spread, and Novartis is leaning on the country's growing network of more than 250 nuclear medicine facilities for the rollout. That ambition still depends on label expansion into earlier-stage disease via the PSMAddition filings, set against an EU pre-chemotherapy CRPC indication the company withdrew earlier in 2026 amid regulatory resistance.

Separately, Telix signed a Memorandum of Understanding with United Imaging Healthcare North America (June 2) to evaluate a US research collaboration combining United Imaging's scanner platforms, software, and AI with Telix's molecular imaging portfolio and clinical protocols. The stated aim is to standardize and streamline theranostic imaging workflows across sites, with an initial focus on TLX101-Px (Pixclara, an F-18 brain-cancer imaging candidate). Telix also reported quarterly results (June 2) and held a June 23 educational webinar on neuro-oncology tied to its brain-cancer program.

On the alpha-therapy commercialization front, Alpha Tau Medical and Tolmar International announced a 20-year US prostate-cancer commercialization deal on June 3 for Alpha DaRT, Alpha Tau's diffusing alpha-emitter (radium-224) intratumoral therapy. Tolmar receives exclusive US rights for prostate cancer and provides Alpha Tau with $15 million for US manufacturing build-out, a $20 million equity investment at $11.99 per share (a 25% premium to the 30-day VWAP), and up to $161.5 million in clinical, regulatory, and commercial milestones for the first indication, with an option to expand into bladder cancer subject to additional payments. Alpha Tau manufactures and supplies Alpha DaRT to Tolmar at 60% of net sales. The structure is significant as the first major US commercialization deal anchoring an alpha-emitter outside the actinium-225 and lutetium-177 chains, and validates Ra-224 as a commercially viable alpha-therapy modality.

Implications by stakeholder
InvestorsNovartis's India launch is incremental geographic growth; the primary value driver remains label expansion into hormone-sensitive disease, weighed against the EU pre-chemo withdrawal. The Alpha Tau/Tolmar deal is the structurally most consequential commercial event, the first major US commercialization for an alpha-emitter outside the Ac-225 and Lu-177 chains, including a 25% equity premium that signals a substantive strategic stake by a urology-focused commercial partner. Telix's United Imaging MOU is early (an MOU, not a binding deal) but points to a scanner-plus-drug integration thesis that may influence the next round of imaging and therapeutic partnerships.
Manufacturers & CDMOsNovartis's multi-region manufacturing build-out and India commercial presence reflect deliberate geographic distribution of supply and access. Telix's vertically integrated model (imaging, therapeutics, manufacturing) makes its corporate moves a useful benchmark.
CliniciansPluvicto availability in India expands access in a large market with a heavy prostate-cancer burden. The Telix/United Imaging workflow-standardization effort, if it advances, could reduce site-to-site variability in theranostic imaging protocols.
07 SUPPLY CHAIN & MANUFACTURING

Actinium-225 Supply Deals and Facilities Expand; Preclinical and Manufacturing Partnerships Deepen; Lutetium-177 Faces Geopolitical Risk

Securing isotope supply, especially actinium-225, the scarce material at the center of the alpha-emitter category, was the month's dominant structural theme. Ratio Therapeutics was especially active, signing a strategic Ac-225 supply agreement with PanTera (June 30, an IBA/SCK CEN joint venture producing Ac-225 from thorium-229 decay now and via the radium-226 photonuclear route at commercial scale by 2028) and, separately, expanding its manufacturing collaboration with PharmaLogic (May 29) to support clinical development of its lead candidate [Ac-225]RTX-2358. Niowave and Ratio also signed a cGMP Ac-225 supply agreement (June 16). NorthStar Medical Radioisotopes and QSA Global (announced late May) established a closed-loop radium-226 purification and recycling arrangement securing the starting material for NorthStar's no-carrier-added Ac-225; and Nucleus RadioPharma signed both a master isotope supply agreement with BWXT Medical (June 5) and a strategic alliance with Thermo Fisher Scientific's PPD clinical-research business (June 15). On the lead-212 side, Thor Medical signed a collaboration and supply agreement with Minerva Imaging (June 2) to provide Pb-212 for preclinical radiopharmaceutical R&D in Europe.

These deals sit atop a fast-expanding domestic production base: Niowave broke ground on a $75 million accelerator-based Ac-225 plant in Lansing, Michigan (announced late May, operational 2028), TerraPower Isotopes broke ground on a $450 million Ac-225 facility in Philadelphia, and Cardinal Health expanded Ac-225 capacity in Indianapolis. The preclinical-services layer is consolidating too: Perceptive Discovery (a radiopharma-focused CRO) and Certis Oncology announced a collaboration (June 1) pairing Certis's patient-derived xenograft tumor models with Perceptive's radiochemistry and imaging capabilities for earlier-stage radiopharmaceutical evaluation.

On the beta-emitter side, a Bloomberg feature published June 24 detailed the fragility of the lutetium-177 supply chain. The chokepoint is ytterbium-176, the enriched rare earth isotope irradiated to produce Lu-177; Russia was historically the dominant source, and China added ytterbium to its controlled rare earths list in October (implementation suspended until November this year). ITM noted a multi-year pivot toward a North American partner (Bruce Power, Canada) and precautionary materials reordering during the Iran conflict. European Lu-177 production also depends on aging research reactors prone to outages, as the Dutch Petten reactor's 2024 shutdown demonstrated. Separately, the May/June 2026 issue of CERN Courier ran a feature titled "The age of the blockbuster-scale radiopharmaceutical" arguing that the high-power targets, isotope separation, and beam-reliability technologies developed for nuclear and high-energy physics are increasingly central to scaling novel medical radionuclide production.

Implications by stakeholder
InvestorsSponsors are diversifying across multiple Ac-225 producers rather than betting on one; the threshold that changes the outlook is commercial-scale n.c.a. Ac-225 qualified from multiple suppliers. On Lu-177, China's suspended ytterbium control (due November) is a calendar risk worth tracking, not a resolved one.
Manufacturers & CDMOsIf your pipeline depends on Ac-225, the supply deals and the domestic capacity buildout (Niowave, TerraPower, Cardinal Health) are worth understanding in detail. On Lu-177, map your feedstock origin and reactor dependency now rather than during the next outage.
CliniciansThe Lu-177 supply picture is useful context for patient and administration conversations about why those therapies occasionally face constraints, it traces to a small number of reactors and a concentrated feedstock, not random unreliability.
ScientistsCopper-based and reactor-free production paths are worth evaluating as alternatives to rare-earth and reactor dependency. The CERN Courier piece is worth a direct read if you work on isotope production and access to non-conventional isotopes.
08 FINANCING

Nuclidium Closes CHF 105M Series B; AdvanCell Leases US Manufacturing Site

Basel- and Munich-based Nuclidium closed an oversubscribed CHF 26 million Series B extension (announced May 27), bringing its total Series B to CHF 105 million (about EUR 115 million). The round, led by Kurma Growth Opportunities and Angelini Ventures with a syndicate including Wellington Partners and Intesa Sanpaolo's Neva SGR, funds Phase 1/2a trials of the company's copper-based candidates NU101 (metastatic castration-resistant prostate cancer) and NU201 (metastatic breast cancer). The copper-61 imaging / copper-67 therapy pairing avoids the reactor and rare-earth dependencies affecting the Lu-177 chain. (Announced in late May, it is included here as recent context alongside the June developments.)

On the manufacturing-footprint side, AdvanCell, the Sydney-based developer of the Pb-212 alpha therapy 212Pb-ADVC001 for prostate cancer, signed a long-term lease (announced June 22) for the entire ~128,000-square-foot building at IQHQ's Innovation Park in Andover, Massachusetts. It becomes AdvanCell's US headquarters and first US manufacturing site, supporting late-stage development and US Phase 2 enrollment while complementing its Brisbane operations.

Implications by stakeholder
InvestorsNuclidium's oversubscribed extension and AdvanCell's facility commitment signal continued investor and operator conviction. The copper platform is worth tracking as a supply-chain alternative to Lu-177's rare-earth exposure.
Manufacturers & CDMOsAdvanCell's partner-now-build-later approach (working with a CDMO while standing up its own site) is a pragmatic capacity model. A new 128,000-square-foot alpha-therapy facility near Boston is also a competitive and talent-market signal.
ScientistsCopper-61/copper-67 theranostic pairing is a differentiated approach; if you work on chelation or isotope-pair matching, Nuclidium's clinical progression is a real-world test of the copper thesis.

A note on scope. This issue reflects Leila Safavi's expert read of the radiopharmaceutical news cycle, organized by what each development means depending on where you sit in the field. It is deliberately selective rather than exhaustive.

Supporting the field

In addition to her work at Purist, Leila serves as an Ambassador for the Oncidium Foundation, a nonprofit, public-benefit organization advancing radiotheranostics worldwide through education, awareness, and equitable access to treatment. Its work spans educational materials for patients and practitioners, advocacy on access and reimbursement, and RLT-Connect, a platform connecting healthcare professionals with radioisotope suppliers to deliver donated radioligand therapy doses to patients who could not otherwise afford them. Learn more at oncidiumfoundation.org.

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