September 2026
Radiopharmaceuticals: September 2026 in Review
Radiopharma news, decoded for investors, manufacturers, clinicians, scientists, and policy watchers.
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.
- Telix Agrees to Acquire ITM for Up to $2.35 Billion, Radiopharma's Second Mega-Merger in Two Months
- Two Lutathera Equivalents Clear FDA in September; Novartis Licenses a $900M Radioligand Asset the Same Month
- Perspective Pairs an Alpha Emitter With Keytruda; a Hypoxia Tracer Earns Breakthrough Status; Norroy Advances a Phase III Trial in China
- Five Financing and Supply Chain Moves Worth Tracking This Month
- 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.
- 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.
- 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.
- 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.
- 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.
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.
- GlobeNewswire: Telix and ITM Join Forces to Create a Radiopharmaceutical Powerhouse
- FierceBiotech: Telix beams into Novartis's territory with $1.65B ITM acquisition
- STAT: Radiopharma companies ITM, Telix merge after one receives surprise FDA rejection
- Radiology Business: Telix and ITM merge in $1.65B deal
- GlobeNewswire: FDA Approves Telix's Brain Cancer Imaging Drug Pixclara
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.
- FiercePharma: FDA approves first radioligand equivalent, Curium's copycat of Lutathera
- CancerNetwork: FDA approves BEXLUTRY for GEP-NETs
- CancerNetwork: BRAVNETSA earns final FDA approval in GEP-NETs
- MedPath: Lantheus gains FDA approval for BRAVNETSA
- Pharmaceutical Executive: Novartis-BoomRay global license agreement
- FierceBiotech: Novartis secures new radioligand deal as competition strengthens
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.
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.
- Ionetix: Ionetix begins shipping astatine-211
- AuntMinnie: Ionetix begins shipping At-211 in North America
- Bionity: ABX acquires biotech start-up TRIMT
- BioSpace: Ratio Therapeutics enters research collaboration with RayzeBio
- Cooley: Ratio Therapeutics enters research collaboration and license agreement with RayzeBio
- TipRanks: Oncoinvent seeks NOK 140 million for ovarian cancer trial and Phase 3 plans
- FiercePharma: NorthStar locks down $180M as radiopharmaceutical isotope, CDMO expansion plans advance
- PharmaSource: NorthStar Medical Technologies Secures Up to $185M Growth Capital Facility
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.
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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