September 2026

Radiopharmaceuticals: September 2026 in Review

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

t-1/2 September 2026
September 2026 · Issue 04
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Radiopharmaceuticals: the month in review

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 for September 2026, focused on their implications for decision-makers across the field.

Read by role
In this issue
  1. Telix Agrees to Acquire ITM for Up to $2.35 Billion, Radiopharma's Second Mega-Merger in Two Months
  2. Two Lutathera Equivalents Clear FDA in September; Novartis Licenses a $900M Radioligand Asset the Same Month
  3. Perspective Pairs an Alpha Emitter With Keytruda; a Hypoxia Tracer Earns Breakthrough Status; Norroy Advances a Phase III Trial in China
  4. Five Financing and Supply Chain Moves Worth Tracking This Month
What September Told Us
  1. Radiopharma just had its second mega-merger in two months.Telix's deal to acquire ITM, worth up to $2.35 billion, follows Curium's $8 billion acquisition of Lantheus in August by barely three weeks. Both bundle isotope manufacturing with diagnostics and therapeutics under one roof, and both are priced, in part, on regulatory outcomes that haven't happened yet.
  2. Three companies are now converging on the same GEP-NET market at once.Curium's BEXLUTRY and Lantheus's BRAVNETSA both cleared FDA as Lutathera equivalents in September, while Telix is acquiring ITM specifically to carry ITM-11, the same class of therapy, back through the FDA after its August rejection. Three different paths to the same indication, landing in the same several weeks.
  3. Discovery-stage deals are getting done before late-stage proof exists.Ratio Therapeutics' research collaboration with RayzeBio and Ionetix's new isotope supply line both landed in the first half of September, ahead of either program having commercial-scale demand to justify the commitment. Capital and capacity are moving on expectation, not confirmation.
  4. The alpha-emitter race is widening past actinium.Ionetix's new astatine-211 supply and Perspective's lead-212 combination with Keytruda point to sponsors diversifying isotope bets rather than consolidating around Ac-225 alone.
  5. Ac-225 capacity is expanding at the same time other isotopes are gaining ground.NorthStar's $185 million growth financing, aimed squarely at scaling actinium-225 production, lands the same month Ionetix and Perspective are putting capital and trial design behind astatine-211 and lead-212. Both are happening at once: investment in Ac-225 and investment in alternatives to it.
01 MERGERS & ACQUISITIONS

Telix Agrees to Acquire ITM for Up to $2.35 Billion, Radiopharma's Second Mega-Merger in Two Months

Telix – ITM: Telix Pharmaceuticals agreed to acquire ITM Isotope Technologies Munich, a privately held German radioisotope manufacturer, in a deal with an enterprise value of $1.65 billion on a cash-free, debt-free basis. The upfront consideration is paid primarily in Telix shares, 105.8 million shares worth approximately $1.25 billion, plus $302 million in assumed net debt and $96 million in management rollover and transaction expenses. ITM shareholders are also eligible for up to $700 million in additional earn-outs: $250 million tied to FDA approvals across three ITM-11 indications, and $450 million if ITM-11's net sales exceed $150 million in fiscal year 2030, bringing the total potential deal value to $2.35 billion. The deal is expected to close by the end of 2026, pending Telix shareholder approval.

ITM brings a profitable, cash-generative radioisotope manufacturing business spanning lutetium-177, actinium-225, and terbium-161, with 2025 revenue of $273 million growing at a 40% compound annual rate since 2021. It also brings ITM-11 (177Lu-edotreotide), the same product that received an FDA Complete Response Letter in August over manufacturing issues, not efficacy or safety. Telix brings a commercial diagnostics portfolio, Illuccix, Gozellix, and Pixclara, and three pivotal-stage therapeutics. Combined pro forma 2026 revenue is estimated to exceed $1.3 billion.

Telix – Pixclara: The deal lands the same month the FDA approved Telix's Pixclara, a PET imaging agent for glioma, a brain cancer, giving Telix its fourth approved diagnostic product heading into the ITM combination.

Implications by stakeholder
InvestorsThe upfront consideration is overwhelmingly stock, not cash, and the largest earn-out is tied to an asset that doesn't have FDA approval yet. Model the $450 million sales-based earn-out as contingent on both a successful ITM-11 resubmission and a specific sales threshold, not as committed value sitting inside the $2.35 billion headline figure.
Manufacturers & CDMOsITM's in-house Lu-177, Ac-225, and Tb-161 production moves directly into Telix's commercial organization, the second such vertical-integration deal this quarter after Curium-Lantheus. Expect fewer independent isotope-supply customers among the largest radiopharma companies going forward, as more of them acquire upstream capacity rather than contract for it.
CliniciansThe earn-out structure is explicitly betting on ITM-11 eventually clearing the FDA, the same manufacturing issues behind August's rejection. Patients awaiting ITM-11 access shouldn't expect a near-term timeline change from the acquisition announcement itself; the resubmission and action date remain the real milestone to watch.
PolicyTwo radiopharma mega-mergers in two consecutive months, both bundling isotope manufacturing, diagnostics, and therapeutics under one roof, give regulators a second, comparable transaction to weigh when assessing supply-chain concentration. Expect antitrust and critical-supply-chain scrutiny of radiopharma consolidation to intensify through year-end, not ease up after the first deal clears review.
SponsorsITM was a significant commercial isotope supplier to other sponsors' programs before this deal. Any sponsor with an existing ITM supply relationship should raise continuity questions with ITM or Telix directly now, rather than waiting for the deal to close at year-end.
02 REGULATORY

Two Lutathera Equivalents Clear FDA in September; Novartis Licenses a $900 Million Radioligand Asset the Same Month

Curium: The FDA approved Curium's BEXLUTRY (lutetium Lu 177 dotatate) through the 505(b)(2) pathway, referencing Novartis's Lutathera, for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors. The approval follows a June 2026 court ruling that cleared Curium of Novartis's patent-infringement claims over the same product.

Lantheus: Soon after, the FDA granted final approval to Lantheus's BRAVNETSA (lutetium Lu 177 dotatate) through the ANDA pathway, determining it bioequivalent and therapeutically equivalent to Lutathera. The label excludes Lutathera's pediatric indication, which remains under Novartis's separate pediatric exclusivity.

Novartis: Separately, around the same time, Novartis licensed exclusive global rights to a preclinical radioligand therapy asset from Chinese biotech BoomRay, in a deal worth up to $900 million in upfront and milestone payments plus royalties. The specific molecular target has not been disclosed, and Novartis has not described the deal as related to the Curium or Lantheus approvals; the timing is ours to flag, not theirs to explain.

Novartis reported $436 million in Lutathera sales in the first half of 2026, including $225 million in the second quarter alone. Two independent equivalence pathways clearing within the same month, against that revenue base, is the clearest signal yet that radioligand follow-on competition is arriving faster than incumbents had priced in, regardless of whether the BoomRay deal was a direct reaction to it.

Implications by stakeholder
InvestorsTwo equivalents cleared FDA within the same month, and Novartis separately licensed a new asset around the same time. Revenue models built on Lutathera's current run rate should be revisited now, not at the next earnings cycle, independent of whether the BoomRay deal turns out to be connected.
Manufacturers & CDMOsCurium's approval came through patent litigation clearance; Lantheus's came through ANDA bioequivalence. Two separate regulatory routes to the same equivalence outcome are now validated. CDMOs supporting Lu-177 dotatate capacity should plan for multiple competitors' manufacturing demand, not just the incumbent's.
CliniciansTwo equivalents arrived in a month where GEP-NET patients have effectively faced single-supplier access to Lu-177 dotatate. Treatment-slot availability should improve as manufacturing capacity diversifies across three approved sources, though likely over the next few quarters rather than immediately.
PolicyFDA cleared two independent equivalence pathways to the same complex radioligand within the same month. Sponsors building biosimilar-style strategies for other radioligands now have a working precedent to model against, not a theoretical one.
03 CLINICAL DATA

Perspective Pairs an Alpha Emitter With Keytruda; a Hypoxia Tracer Earns Breakthrough Status; Norroy Clears Phase III in China

Perspective Therapeutics: Perspective announced a clinical collaboration and supply agreement with Merck to evaluate its targeted alpha-particle therapy, [212Pb]PSV359, combined with Keytruda in FAP-α-positive solid tumors, with the trial focused on non-small cell lung cancer and colorectal cancer. The Phase 1/2a study is sponsored by Perspective; Merck supplies pembrolizumab at no cost, with no milestone payments disclosed.

Juniper Biosciences: The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia PET imaging tracer, for use in guiding radiation dose de-escalation in HPV-positive oropharyngeal cancer.

Norroy Bioscience: China's National Medical Products Administration is reported to have cleared initiation of a pivotal Phase III trial of 177Lu-NYM032, a PSMA-targeted radioligand therapy, for metastatic castration-resistant prostate cancer. This is a separate development from Norroy's earlier Phase I/II data and diagnostic-tracer work, but it rests on a single trade-press account with no company release or NMPA notice behind it, so treat the claim itself as less firmly established than the other items in this issue.

Implications by stakeholder
InvestorsMerck is supplying Keytruda rather than paying upfront. Supply-only collaborations keep a pharma major's optionality open without the capital commitment of a licensing deal; don't price a supply agreement the same way you would a cash milestone payment.
CliniciansJBS-003's Breakthrough status is specifically for dose de-escalation, not diagnosis alone. Imaging-guided de-escalation is gaining regulatory traction as a treatment strategy. Head-and-neck radiation programs should track this trial's design as a likely template for their own dose-reduction protocols.
ScientistsPerspective's combination pairs an alpha emitter with a checkpoint inhibitor rather than testing either alone. Alpha-particle radiation may be explored as an immune-priming mechanism, not just a direct cytotoxic one, which changes what endpoints matter in early readouts. Watch for immune-related biomarkers in this trial's data, not just tumor response.
SponsorsNorroy's clearance came through China's NMPA, not FDA. China is functioning as a parallel approval track for PSMA-targeted radioligands, not a sequential one that follows US approval. Sponsors planning global PSMA-therapy trials should budget for NMPA engagement early, not late.
04 FINANCING & SUPPLY CHAIN

Five Financing and Supply Chain Moves Worth Tracking This Month

Ionetix: Ionetix began shipping astatine-211, an alpha-emitting isotope with a 7.2-hour half-life produced by cyclotron irradiation of bismuth-209, to North American preclinical and clinical programs. The company describes itself as a new commercial supplier of At-211; its own SEC filing states there is currently no other commercial supplier in the US, while a competitor has announced plans to enter, so we're not calling it "first" outright.

ABX: German manufacturer ABX (Advanced Biochemical Compounds) acquired TRIMT GmbH, a Saxony-based cyclopeptide radiopharmaceutical startup. TRIMT's pipeline includes three investigational, integrin-targeted candidates: 68Ga-Trivehexin and 68Ga-Triveoctin for PET imaging, and 177Lu-Therahexin for therapy. Deal terms were not disclosed.

Ratio Therapeutics and RayzeBio: The companies entered a research collaboration and license agreement to design, evaluate, and optimize a next-generation radiopharmaceutical candidate against undisclosed cancer targets. Ratio leads the early discovery work and receives an upfront payment plus development, regulatory, and commercial milestones and royalties; RayzeBio takes exclusive worldwide rights to any resulting candidates once that work concludes.

Oncoinvent: Oncoinvent raised NOK 140 million, roughly $13 million, through a private placement at NOK 90 per share, alongside a retail offering of up to the NOK equivalent of EUR 1 million, to fund a more mature Phase 2 interim readout for Radspherin, its radium-224 therapy for peritoneal metastases from ovarian cancer, now expected in March or April 2027. The raise is also meant to extend runway into the second half of 2027 and fund regulatory preparation for a Phase 3 trial.

NorthStar Medical Technologies: NorthStar secured a growth capital facility of up to $185 million, led by Hercules Capital, with $100 million delivered upfront, to scale commercial production of no-carrier-added actinium-225 and expand manufacturing capacity at its Beloit, Wisconsin campus for contract development and manufacturing (CDMO) customers. NorthStar said the facility funds additional suites for early-stage, late-stage, and commercial radiopharmaceutical production, and pointed to an expanded partnership with Convergent Therapeutics on its CONV01-α program as one example of the demand behind the buildout.

Implications by stakeholder
InvestorsRatio took an upfront-plus-milestones deal; Oncoinvent raised equity-style capital through a private placement; NorthStar took growth debt instead of selling equity. Three different costs of capital in the same month, discovery-stage platform economics, clinical-stage dilution, and commercial-stage leverage, and each should be benchmarked on its own terms rather than lumped into one radiopharma financing trend.
Manufacturers & CDMOsABX brought three undisclosed-terms, integrin-targeted candidates in-house through acquisition, while NorthStar is putting fresh capital directly into its own Ac-225 production lines and CDMO suites to take on more outside customers. Both are capacity moves, one by buying a pipeline, one by building out manufacturing; CDMOs competing for Ac-225 and Lu-177 fill-finish work should expect NorthStar's expanded capacity to be live in the market, not just announced, as soon as its high-capacity line launches at year-end.
ScientistsAt-211 now has a new, non-academic commercial source, even short of being confirmed first, and NorthStar's buildout adds meaningful no-carrier-added Ac-225 capacity on top of it. Teams evaluating alpha-emitter platforms should reassess At-211, Ac-225, and Pb-212 together now that sourcing constraints are easing across more than one isotope at once.
PolicyNorthStar's expansion adds domestic, U.S.-based capacity for actinium-225, an isotope the country has historically had to source in part from abroad. A $185 million buildout for a critical medical isotope is the kind of investment supply-chain policymakers have been pushing for; expect this deal to get cited specifically in that conversation, not treated as routine biotech financing news.
SponsorsOncoinvent's interim Phase 2 readout slipped to March or April 2027, while NorthStar's expanded capacity, and its deepened partnership with Convergent Therapeutics on CONV01-α, points toward more Ac-225 supply becoming available to sponsors generally. Sponsors tracking either should update their own assumptions rather than relying on the prior picture of constrained Ac-225 access.

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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