ITM Isotope Technologies Munich

ITM Isotope Technologies Munich is the largest supplier of non-carrier-added lutetium-177, sold as EndolucinBeta, and the developer of ITM-11, or 177Lu-edotreotide. ITM-11 was positive in the COMPETE phase 3 trial in gastroenteropancreatic neuroendocrine tumours in 2025, and the company is investing in actinium-225 supply. In July 2026 ITM grouped its drug pipeline into Lumara Bio, a division inside ITM that uses its isotope supply. On 10 August 2026 the FDA issued a complete response letter for ITM-11, citing manufacturing and third-party facility items rather than the clinical or safety data, and ITM said it intends to resubmit. On 21 September 2026 Telix agreed to acquire ITM for 1.65 billion US dollars upfront, mostly in Telix shares, plus up to 700 million dollars tied to ITM-11 approvals and sales; the deal needs Telix shareholder and regulatory approval and is expected to close by the end of 2026. OnCo links it to neuroendocrine tumours, to somatostatin receptor 2 as a target, to peptide receptor radionuclide therapy and the therapeutic isotope supply chain, to the radiopharmaceutical roadmap, and to the idea of building Western ytterbium-176 enrichment so lutetium-177 has more than one supplier. Manufacturing cost and time for radioactive medicines is the bottleneck it sits inside. Whether a supplier can also succeed as a drug developer is the open question.