Curium Signs $8B Lantheus Deal and Adds a HER2 Tracer; BWXT Sells Its Medical Business the Same Day

Curium – Lantheus (Aug. 3): Curium and Lantheus Holdings announced a definitive merger agreement, converting the acquisition talks Bloomberg reported in late July, and covered in last month's issue, into a signed deal. Curium will acquire Lantheus for $102.50 per share in cash at closing, plus a contingent value right worth up to $12.00 per share tied to sales milestones across three franchises through fiscal year 2030: prostate cancer diagnostics, neurology diagnostics, and the DEFINITY ultrasound-enhancing business. Total consideration, including the CVR, reaches up to $114.50 per share, valuing the deal at approximately $8.0 billion, a 38% premium to the 60-day volume-weighted average price. The combined company will operate across diagnostics and therapeutics in more than 70 countries. Closing is expected in the first half of 2027, pending Lantheus shareholder approval and regulatory clearances.

BWXT – Nordic Capital (Aug. 3, same day): BWX Technologies announced it will sell its BWXT Medical division, including Kinectrics' stable medical isotopes business, to Nordic Capital in a transaction valued at up to $800 million, expected to close by year-end pending regulatory approval. BWXT keeps a minority stake and will continue supplying specialized isotope and radiochemical expertise, while redirecting resources toward its core nuclear-national-security and commercial nuclear-power businesses. Nordic Capital said it intends to help the unit "scale, expand capabilities and advance its market presence in radiopharmaceuticals." BWXT has roughly tripled the medical business's revenue since acquiring it in 2018.

Curium – Abscint SA (Aug. 10): Curium also acquired Abscint SA, a Belgian biotech developing ABS-011, a gallium-68-labeled PET radiodiagnostic tracer built on a radiolabeled single-domain antibody. ABS-011 targets HER2 and is in a Phase 2b trial in Belgium (HERMIA, NCT06369831) for breast and gastric cancers; deal terms were not disclosed. The tracer is designed for same-day, whole-body HER2 imaging with rapid clearance of unbound tracer, intended to map HER2 expression across multiple lesions rather than relying on a single biopsy site. Curium Biopharma CEO Chait Tatineni called it an asset that "builds on our commitment to advancing innovative radiopharmaceuticals for patients."

FDA Rejects ITM's Lead Radiotherapy Over Manufacturing Issues; NRC Drafts New Rules for Calculating Patient-Release Doses

ITM (Aug. 7 & 10): The FDA issued a Complete Response Letter for ITM-11 (177Lu-edotreotide), ITM's lead candidate for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which had beaten everolimus on progression-free survival in the Phase 3 COMPETE trial. The agency raised no clinical or nonclinical safety concerns; the CRL is limited to Chemistry, Manufacturing and Controls (CMC) issues and a third-party commercial-facility inspection. CEO Dr. Andrew Cavey said the company's "confidence in ITM-11's therapeutic potential has not wavered" and that it plans to resubmit after addressing the FDA's feedback with its manufacturing partners. The rejection lands three weeks after ITM stood up Lumara Bio, a new division built specifically to commercialize this drug.

NRC (Aug. 11): The NRC published a draft Revision 2 of Regulatory Guide 8.39, covering the release of patients administered radioactive material (Docket NRC-2026-3730). It replaces a 2024 draft that stalled after feedback calling it too technically complex; this revision adds worked examples and updated methodology drawn from NCRP Report No. 155. Substantively, it introduces a specific methodology for calculating caregiver and family-member doses, aligns dose-limit definitions with the pending "Reforming and Modernizing the NRC's Radiation Protection Framework" rulemaking, and updates release-timing guidance to reflect medical practice since the 2020 revision. It does not apply backfitting requirements to existing licensees. Comments are due September 10. This follows the NRC's proposed rule easing radiopharmaceutical licensee burden that was still in its comment period as of last month's issue, part of a broader pattern of the agency modernizing radiation-protection rules ahead of a November deadline.

Lantheus Wins an Alzheimer's Imaging Approval; A Kidney Cancer Tracer Gets Fast-Tracked; Radiopharm Theranostics Advances Three Programs

TAUKLARIFY, Lantheus (Aug. 14): The FDA approved TAUKLARIFY (florquinitau F-18 injection, also known as MK-6240), a tau PET imaging agent for adults with cognitive impairment being evaluated for Alzheimer's disease. Two blinded-read studies across more than 500 subjects supported approval, with inter-reader agreement (kappa) of 0.92 and 0.86 across the two studies, and adverse events limited mostly to headache (0.7%) and nausea (0.2%) in a 1,734-subject safety population. CEO Mary Anne Heino said tau PET "provides information that complements amyloid PET and other diagnostic tools." The approval lands the same month Lantheus agreed to be acquired by Curium, above.

68Ga-NYM096, NORROY Bioscience (Aug. 19): The FDA granted Breakthrough Therapy and Fast Track designations to 68Ga-NYM096, a CAIX-targeted PET imaging agent for clear cell renal cell carcinoma, developed by Wuxi, China-based NORROY Bioscience. The designations rest on preliminary clinical data; further findings are due at the 2026 EANM Congress. NORROY, founded in 2021, holds six FDA IND clearances and six NMPA approvals across its pipeline and plans Phase 1 trials for NYM096 in both China and the US.

Radiopharm Theranostics (Aug. 17, 20 & 26): The company had an active month across its full pipeline. It confirmed an FDA End-of-Phase 2 meeting on October 1 for RAD 101, its brain-metastasis PET tracer, to settle Phase 3 trial design; the underlying Phase 2b data showed 93% concordance with MRI. Separately, a Data Safety and Monitoring Committee cleared RAD202, a HER2-targeted Lu-177 antibody, to advance to a 180 mCi dose cohort, and the company dosed its first patient in the second cohort (70 mCi) of BetaBart (RV-01), a Lu-177 B7-H3 antibody developed with MD Anderson Cancer Center.

JNM Finds Lu-177-PSMA Patients in Brazil Wait 2.8x Longer Than in Europe

Access gap (Aug. 20): A retrospective analysis of 91 patients across four Brazilian and two European centers found diagnostic access to PSMA PET/CT was similar between Brazil (median 17.5 days) and Europe (19 days), but therapeutic access to Lu-177-PSMA diverged sharply: 59 days in Brazil versus 21 days in Europe, a 2.8-fold gap. The roughly 38-day delay represents about 8% of the median overall survival (15.3 months) reported in pivotal trials, and two Brazilian patients in the cohort died while awaiting therapy.

PSMA PET after focal therapy (also Aug. 20): A separate, single-center study of 112 patients who underwent focal therapy (HIFU, cryoablation, or laser ablation/electroporation) found 68Ga-PSMA-11 PET/CT detected intraprostatic recurrence with 85% sensitivity, versus 82% for MRI in a 39-patient validation subcohort with biopsy confirmation. Interreader agreement was only moderate (Fleiss κ=0.4).

Same-day dosimetry (Aug. 14 tip sheet): A 158-patient study found that early, same-day post-therapy SPECT/CT after Lu-177-PSMA-617 treatment was associated with overall survival, supporting same-day dosimetry as a practical prognostic tool rather than a research-only exercise.

Moffitt Launches a Radiopharmaceutical Program Within a $600M Campus; IU Health Opens a $40M Theranostics Center; Akiram and ITM Sign a Lutetium-177 Supply Deal

Moffitt Cancer Center (Aug. 25): Moffitt launched its Radiopharmaceutical Program within Speros, a 775-acre campus in Pasco County, where more than $600 million in broader infrastructure investment from Moffitt, the State of Florida, and Pasco County is supporting capabilities that include radiochemistry labs inside a 255,000-square-foot Discovery and Innovation Center opening this fall and a planned Integrated Theranostics Center combining radioisotope production with translational research. The launch coincides with the FORGE Coalition, formed in May with the University of South Florida and other regional partners, projected to carry a $2.6 billion economic impact and generate more than 11,000 jobs. "Moffitt is in a unique position to lead" in theranostics, said CEO Dr. Patrick Hwu.

IU Health (Aug. 19): Indiana University Health launched a Theranostics Center of Excellence combining molecular imaging, precision diagnostics, and targeted radionuclide therapy, backed by a $40 million commitment, including a $20 million philanthropic gift from the Lechleiter and Tobias families matched by IU Health. The center opens with FDA-approved theranostic treatments for prostate and neuroendocrine cancers and clinical-trial access for other cancer types, with expansion planned to Bloomington, Fort Wayne, Lafayette, and the North Indianapolis metro area under Dr. Jason Allen, chair of IU's Department of Radiology and Imaging Sciences.

Akiram Therapeutics – ITM (Aug. 20): Akiram and ITM signed a supply agreement for non-carrier-added lutetium-177 to support Akiram's AKIR001, an antibody-radionuclide conjugate targeting CD44v6-expressing solid tumors (lung, head and neck, thyroid, and gynecological cancers), currently in a Phase 1 trial at Karolinska University Hospital. Financial terms were not disclosed.

Defence Therapeutics (Aug. 17 & 31): The small-cap Canadian firm, better known for its Accum® drug-delivery platform, formalized a move into radiopharma: it named Dr. Ryan Simms, a 20-year radiopharma veteran previously at Fusion Pharmaceuticals (acquired by AstraZeneca for roughly $2 billion in 2024), as COO and Head of Radiopharmaceutical Programs, then outlined parallel preclinical programs pairing Accum with an alpha emitter (actinium-225) and a beta emitter (lutetium-177). Both programs are still preclinical, with no lead candidate, partner, or clinical timeline named yet.

Actinium Pharmaceuticals (Aug. 14): Actinium issued four new or advancing patent families around Actimab-A, covering solid-tumor and low-peripheral-blast AML indications with terms extending into the late 2030s and 2043, amended its IND to add a second manufacturer for Actimab-A ahead of clinical milestones expected from the second half of 2026 through 2027, and disclosed that NYSE American granted it a compliance plan running through November 27, 2027, the maximum extension available, after an equity shortfall.

Five Supply Chain Moves Worth Tracking This Month

Oklo (Aug. 6): Oklo's Groves test reactor achieved first criticality at a greenfield site in Lockhart, Texas, less than a year after groundbreaking, the first reactor under the DOE's Reactor Pilot Program to go critical on private land. Oklo describes it as establishing "the operational foundation for future commercial isotope production" for healthcare and other applications; no specific isotope has been named yet.

Thor Medical (Aug. 5): Norway's Thor Medical completed its first commercial customer delivery from AlphaOne, its newly commissioned industrial-scale site at Herøya Industrial Park, shipping high-purity thorium-228; commercial production at the site began July 31. AlphaOne is designed to produce Th-228 and related alpha-emitter products supporting lead-212 and radium-224 supply chains for targeted alpha therapies, via a thorium-decay chain rather than a reactor or accelerator. The company is ramping toward a volume equivalent to 21,000 patient doses over three years.

Life Couriers (Aug. 17): JLL Partners completed its acquisition of Life Couriers, the Munich-based specialty logistics firm that carries radiopharmaceuticals and other time-critical materials across the US, Europe, Central America, and Asia, from Auctus Capital Partners. New CEO Edward DeMartini previously led The Quick Group, a Kuehne + Nagel subsidiary; JLL cited "heightened demand for crucial radiopharmaceutical and medical logistics solutions" as the rationale.

RayzeBio / BMS (Aug. 27): Indiana Governor Mike Braun announced that Bristol Myers Squibb's RayzeBio will invest $173 million in a roughly 450,000-square-foot manufacturing facility in Whitestown, plus an expansion of its Indianapolis site, to build capacity for actinium-based therapies targeting neuroendocrine, liver, and prostate cancers. The project is expected to create up to 100 high-wage jobs by the end of 2029.

Rosatom – Curium (Aug. 25): Russia's Rosatom brought two production lines online in pilot operation at a new radiopharmaceutical plant in the Kaluga region, with full-scale production planned for 2028. The same week, Curium's North America CEO publicly emphasized the company's own Lu-177 vertical integration as a resiliency advantage, comments that landed just three weeks after Curium's own merger agreement with Lantheus, above, and against the backdrop of Novartis's continued Pluvicto dominance ($1.3 billion in H1 2026 sales, up 50% year-over-year).

Ratio Therapeutics Closes a $70M Series C Backed by BMS and Eli Lilly

Ratio Therapeutics closed a $70 million Series C on August 3, with participation from Duquesne Family Office, Bristol Myers Squibb, Catalio Capital Management, Eli Lilly, and Wasatch Group. Proceeds will advance the ATLAS study of lead asset [Ac-225]RTX-2358 in advanced sarcomas, move a next-generation radioligand candidate into clinical trials, expand the discovery pipeline into new oncology targets, and scale manufacturing. The company's platform combines its Trillium pharmacokinetic-tuning technology with the Macropa chelator platform, spanning FAP-targeted therapeutics, a GRPR program, mono- and bispecific radioligand therapies, and imaging assets.