GE HealthCare Agrees to Acquire SOFIE Biosciences for $945 Million

GE HealthCare agreed to acquire SOFIE Biosciences, a Trilantic North America-backed contract manufacturer of PET radiopharmaceuticals, in an all-cash deal valued at $945 million. SOFIE operates 15 CMO sites and 21 cyclotrons across the US, plus a dedicated theranostics CDMO site, and already manufactures GE HealthCare's own Flyrcado (flurpiridaz F 18). The deal also includes SOFIE's FAPI-74, a Phase III pan-cancer PET tracer; GE HealthCare already held rights to it outside the US through an earlier licensing agreement, and this acquisition brings the rest of the program, and the company that originated it, under GE's ownership. The transaction is expected to close in the first half of 2027, pending regulatory approval; SOFIE will continue operating as an independent manufacturing partner to its existing customers, including companies that compete with GE HealthCare.

This resolves a story we flagged as unconfirmed last issue: the Financial Times reported GE HealthCare was in talks to buy SOFIE for roughly the same figure back on September 13, and both companies declined to comment at the time. It took three more weeks for the companies to actually sign.

Two Pending Megamergers Move Closer to Closing

Lantheus – Curium: Lantheus shareholders approved the company's merger with Curium US Holdings at a special meeting, with about 97% of voted shares, 55.5 million of 57.2 million, in favor. The vote satisfies a key closing condition for the deal, first announced in August; Lantheus has not disclosed an expected closing date.

Telix – ITM: Telix filed its Notice of General Meeting for the shareholder vote needed to close its acquisition of ITM, setting the vote for December 1 and naming two new director nominees. The filing is a procedural step rather than a new announcement, but it's the first concrete date attached to closing that deal since it was announced in September. Telix also reported Q3 revenue of $245 million, up 19% year over year from $206 million, driven by its Illuccix and Gozellix diagnostics; its Precision Medicine segment grew 30% to $201 million, while Manufacturing Solutions declined 6% to $44 million.

Ekalia Launches, and Signs Telix as Its First Customer Within Days

IBA and Framatome formed Ekalia, a joint venture combining IBA's cyclotron technology with Framatome's nuclear industrial expertise, to build an international production network for astatine-211. Neither company had offered At-211 production at scale on its own; the joint venture is what lets them do it together. Ekalia's first production site is planned for Nantes, France, with commissioning expected in 2028; a second site is planned in the US.

Three days later, Ekalia named its first customer: an IBA alpha-beam cyclotron will be installed at Telix's RLS Radiopharmacies site in Trevose, Pennsylvania, giving Telix dedicated, long-term priority access to At-211 for TLX102-Tx, its investigational glioblastoma therapy, with capacity also earmarked for academic and industry research. The announcements don't specify who owns the cyclotron itself or runs it day to day; what's confirmed is that Ekalia supplies the production technology and expertise, and Telix gets guaranteed access without having to build its own At-211 production capability from scratch, something neither company had been able to offer independently before this deal.

Actinium-225's Supply Chain Keeps Expanding, in China and in Europe

NorthStar named Quarkmed, a Beijing-based contract research organization founded in 2011, as its registration agent in China, giving companies using NorthStar's no-carrier-added actinium-225 a path to fully translated, eCTD-compliant dossiers for Chinese IND filings. NorthStar says the partnership should mean faster responses to regulatory inquiries and fewer delays from translation, communication, and time-zone differences; it's preparing to support multiple customer IND applications in China. This is NorthStar's second major move since September's $185 million growth financing from Hercules Capital.

In Belgium, Belgoprocess and PanTera reached two separate milestones on the same actinium-225 supply chain within the same week. At its Dessel site, Belgoprocess began opening a new batch of thorium-229 capsules sourced through one of PanTera's international partners, material that feeds PanTera's early Ac-225 supply for ongoing clinical studies. Separately, the two companies signed a long-term agreement for Belgoprocess to purify radium that PanTera has held, stored at Belgium's SCK CEN nuclear research center for more than 40 years, earmarked for PanTera's Actinium Production Center in Mol, where large-scale commercial production is expected to start in 2029. PanTera says a third Belgian partner, IRE in Fleurus, will begin opening capsules and producing its own actinium-225 next year, a combination the companies describe as making Belgium the largest Ac-225 source in Europe.

Nuclidium Doses Its First Patient, Then Locks In Copper-67 Manufacturing

Nuclidium, a Swiss radiopharmaceutical developer, imaged its first patient in a Phase II trial of Cu-61-NU101, a copper-61 labeled PSMA PET tracer for metastatic prostate cancer. The trial will enroll about 34 patients in the US, benchmarked against an already FDA-approved F-18 PSMA tracer. Thirteen days later, Nuclidium signed a long-term partnership with NorthStar, which will produce copper-67, the therapeutic isotope paired with Cu-61 in Nuclidium's platform, and provide cGMP manufacturing at its Beloit, Wisconsin campus for Nuclidium's two lead candidates: NU101 in prostate cancer and NU201 in breast cancer. Nuclidium plans to begin several Cu-67 therapy studies in both indications in the coming months.

Eckert & Ziegler Expands on Two Fronts: Brazil Supply, German Manufacturing

Eckert & Ziegler – TerThera: TerThera, a Netherlands-based radionuclide producer, signed a supply agreement to deliver GMP, non-carrier-added terbium-161 to Eckert & Ziegler's Brazilian unit, marking TerThera's return to the Brazilian market after a six-year absence; it previously supplied lutetium-177 there for almost two decades.

Eckert & Ziegler – Germany: Separately, Eckert & Ziegler Therapeutics received German GMP manufacturing authorization for actinium-225, enabling investigational patient use from that site. The company also outlined plans for commercial-scale Ac-225 production at its China joint venture facility in Jintan, targeted for early 2027.

Nusano Signs a Multi-Isotope Deal With a Taiwan-Based Developer

Nusano signed a multi-isotope supply agreement, covering lutetium-177, actinium-225, indium-111, zirconium-89, and terbium-161, with Primo Biotechnology, a Taiwan-based radiopharmaceutical developer, to support Primo's cancer therapy pipeline. No financial terms were disclosed.

Jubilant Builds Out Both Ends of Its Supply Chain

"Jubilant" here refers to Jubilant Pharmova, an Indian pharmaceutical group headquartered in Noida, with two separate subsidiaries making news this month: Jubilant DraxImage, its radiopharmaceutical manufacturing arm in Kirkland, Quebec, and Jubilant Radiopharma, its US network of 46 radio-pharmacies that handles distribution. Neither story below is about a Canadian company acting alone.

AtomVie – Jubilant Radiopharma: AtomVie Global Radiopharma, a Canadian radiopharmaceutical CDMO based in Hamilton, Ontario, signed a partnership putting its radiopharmaceuticals through Jubilant Radiopharma's US distribution network, with Jubilant handling regulatory receipt, compliance, and last-mile delivery to clinical trial sites. AtomVie already offers its own clinical supply services, but manufacturing in Canada for US trial sites still requires a US-based partner to receive product and distribute it domestically; that's the gap this partnership fills.

Jubilant DraxImage: Separately, Jubilant DraxImage will invest CAD 94.5 million, about $66.2 million, to modernize its Kirkland, Quebec facility, aiming to double production of RubyFill, its rubidium-82 cardiac PET agent; the facility also makes technetium-99m and iodine-131 products. Canada's Strategic Response Fund is contributing CAD 23.8 million toward the project. This is a different Jubilant subsidiary doing a different thing, manufacturing capacity rather than distribution, in the same month.

A New US Supplier Commits to Terbium-161

The University of Missouri Research Reactor (MURR) announced it will begin supplying terbium-161 to the global market, starting with monthly batches of radiochemical-grade material in December 2026. MURR, which already produces more than 30 isotopes for research, education, and industrial use, plans to offer active pharmaceutical ingredient grade Tb-161 by the end of 2026 to support expanded clinical trials, then scale to weekly, GMP-compliant batches by the end of 2027. Tb-161 is a beta-emitter with a decay profile similar to lutetium-177, plus additional low-energy electron emissions that may improve its effect on small or isolated tumor cells; it currently has few commercial-scale suppliers.

RayzeBio's Phase 3 Trial Hits Its Primary Endpoint in Neuroendocrine Tumors

Bristol Myers Squibb announced positive topline results from the planned interim analysis of ACTION-1, the Phase 3 trial of RYZ101 (225Ac-DOTATATE), RayzeBio's actinium-225-labeled therapy. The trial compared RYZ101 against investigator's choice of standard of care in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) whose disease had progressed after Lu-177-based therapy. The study met its primary endpoint, progression-free survival by blinded independent central review, with a statistically significant and clinically meaningful improvement; the companies described the safety results as consistent with RYZ101's known profile. Full data have not yet been presented at a medical conference.

Lead-212 Shows Up in Two Cancers, and Gets Its First Industrial-Scale Plant

Perspective Therapeutics: Perspective presented updated interim data from its Phase 1/2a trial of [212Pb]VMT-α-NET (bamzireotide navoxetan) in patients with unresectable or metastatic, SSTR2-expressing neuroendocrine tumors who had not previously received radiopharmaceutical therapy. Across 68 patients in three dose cohorts, objective response rates ranged from 33% at the 5.0 mCi dose to 50% at the 6.0 mCi dose, with disease control rates of 89% and 95% respectively. Progression-free survival across all cohorts was 86% at six months and 72% at eighteen months, with no dose-limiting toxicities. The company is targeting Phase 3 site start-up around year-end, pending an End-of-Phase 2 meeting with the FDA.

AdvanCell: Separately, AdvanCell reported updated Phase I data for ADVC001 (TheraPb), a lead-212 PSMA-targeted therapy for metastatic castration-resistant prostate cancer, across 22 patients in seven dose-schedule cohorts with a median follow-up of 14.1 months. At the recommended Phase 2 dose, patients achieved an 80% PSA50 response rate and a 100% objective response rate among those with RECIST-measurable lesions, with a median radiographic progression-free survival of 11.2 months and no new safety signals after an additional 12 months of follow-up beyond last year's data.

Orano Med: Manufacturing caught up with that clinical momentum this month. Orano Med inaugurated ATLab Valenciennes, in Onnaing, France, Europe's first industrial-scale facility dedicated to lead-212 radioligand therapies. The €29 million site, which includes about €3.8 million in France 2030 public funding, is built around Pb-212's defining constraint: a 10.6-hour half-life that forces production, shipping, and patient administration to happen within about 24 hours. Initial capacity is up to 10,000 doses a year, with the company saying that could be multiplied roughly fivefold at full scale.

Clarity's Copper-67 Prostate Cancer Trial Reaches Its Enrollment Target

Clarity Pharmaceuticals reported that its SECuRE trial, testing copper-67 SAR-bisPSMA in metastatic castration-resistant prostate cancer, reached its enrollment target of 16 patients in the main cohort-expansion group. Among evaluable participants receiving up to six cycles at 8 GBq, 63% achieved a PSA50 response and 26% achieved PSA90; disease control reached 81%, including 31% with a complete response or undetectable PSA. Enrollment continues in a separate arm combining the therapy with enzalutamide.

Clarity also presented its Co-PSMA diagnostic imaging data again at EANM this month, where it won a Top Rated Oral Presentation. We're not treating that as new news: the company's own Executive Chairperson, Dr. Alan Taylor, described the results as having "already been published" in European Urology and presented at the European Association of Urology's 2026 congress earlier in the year. The EANM session appears to have been a restatement with added recognition, not updated data.

ITM Publishes the Dose-Response Data Behind Its August Rejection

ITM and partner Lumara Bio presented dose-response data from the Phase 3 COMPETE trial of 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors. Among 106 evaluable patients, objective response rate rose from 12% at the lowest cumulative tumor dose quartile to 64% at the highest, with three complete responses occurring above 86.1 Gy of cumulative tumor dose. The companies also presented early-pipeline data: Ga-DPI-4452, a CAIX-targeted PET agent, showed a 91.8% abnormal-finding rate among patients with confirmed clear cell renal cell carcinoma, out of 98 patients enrolled with suspected or proven ccRCC overall, and Tb-DOTA-LM3, using a lower peptide mass, boosted tumor dose to 23.3 Gy/GBq versus 12.5 Gy/GBq without new dose-limiting toxicities.

ITM-11 is the same product that received an FDA Complete Response Letter in August. The FDA's letter cited chemistry, manufacturing, and controls deficiencies tied to inspection findings at a third-party commercial manufacturing site, not ITM's own facility, and did not request additional clinical data; ITM has said its safety and efficacy data package stands and that it's working to resubmit. Telix is acquiring ITM in part to carry that resubmission through the FDA, in a deal with an enterprise value of $1.65 billion, paid mostly in Telix stock, plus up to $700 million in earn-outs tied to ITM-11's approval and sales, for a total potential value of up to $2.35 billion. This dose-response data doesn't address the manufacturing finding directly, but it's new information for both the resubmission and for Telix shareholders weighing the acquisition ahead of their December 1 vote.

A Combination Trial and a New Imaging Target

LUNAR trial: A UCLA-led study published in European Urology found that adding two cycles of Lu-177 PNT2002 before stereotactic body radiotherapy extended median progression-free survival from 7.4 to 17.6 months in patients with oligorecurrent, hormone-sensitive prostate cancer. This is an academic, combination-therapy trial rather than a company-sponsored registration study, but it's a substantial effect size for sequencing an existing radioligand therapy earlier in the disease course.

Full-Life Technologies: Separately, at EANM, Full-Life Technologies presented first-in-human imaging data for 111In-FL-261, a c-MET-targeted tracer, in 10 non-small cell lung cancer patients. Tumor uptake increased over time (SUVmax of 13.8, 25.7, and 43.2 at 4, 24, and 72 hours) and correlated with c-MET expression levels, with no serious tracer-related adverse events.

A Federal Grant Aims to Make Tampa Bay a Radiopharmaceutical Hub

The US Economic Development Administration awarded $47.3 million to FORGE, the Florida Oncology and Radiopharmaceutical Growth Engine, a coalition led by Moffitt Cancer Center and its Speros life sciences campus in Pasco County, together with the University of South Florida, Embarc Collective, and Pasco-Hernando State College. Combined with matching funds, the award brings total project investment to roughly $88.2 million, aimed at building out radiopharmaceutical manufacturing capacity, supporting isotope-focused startups, and training a specialized workforce; USF Health's Taneja College of Pharmacy will receive $6 million specifically to build CORE Select, a nuclear pharmacy training program led by Nick Carris, PharmD. The coalition projects roughly 4,000 regional jobs once the hub is fully operational.

CMS's Quiet Month, and a November Decision to Watch

CMS: CMS's routine October 1 payment-system updates added 29 new drug and radiopharmaceutical billing codes to the hospital outpatient system and 12 to the ambulatory surgical center system, while ending transitional pass-through payment status for several existing codes. These are the standard quarterly administrative cycles CMS runs four times a year, not a policy shift. The substantive story is still ahead: CMS's proposed CY2027 Hospital Outpatient Prospective Payment System rule, which would raise the diagnostic radiopharmaceutical packaging threshold and reorganize nuclear medicine payment categories, is due as a final rule on November 5.

Journal of Nuclear Medicine: October's print issue centered on dosing questions rather than new agents: a randomized Phase 2 comparison of dose-intensified versus standard 177Lu-PSMA-597 dosing in metastatic castration-resistant prostate cancer, a French real-world outcomes study of 177Lu-PSMA-617 under early access, and first-in-human normal-tissue dosimetry data for intraperitoneal radium-224 microparticle therapy.

Radiopharm Theranostics: Separately, Radiopharm Theranostics completed an End-of-Phase 2 meeting with the FDA for RAD101, its brain-metastasis PET imaging candidate, describing the meeting as "highly constructive." The company expects official minutes within about 30 days; no regulatory pathway details have been disclosed yet.