Telix has struck a deal to buy ITM Isotope Technologies Munich for $1.65 billion upfront, securing an R&D pipeline led by a rival to Novartis’ Lutathera and a radiopharmaceutical supply network.
The takeover features up to $700 million in milestones tied to ITM-11, a radioligand therapy (RLT) that the FDA rejected on manufacturing grounds last month. Telix will pay $100 million if the FDA approves ITM-11 in a type of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) by the end of next year. A further $100 million is tied to approval in another GEP-NET indication by the end of 2030.
FDA approval in lung NETs by the end of 2031 will trigger another $50 million payment, positioning ITM investors to receive up to $250 million linked to regulatory authorizations for ITM-11. Telix could pay up to $450 million more in sales-based milestones. The commercial milestone is calculated as three times ITM-11 net global sales in excess of $150 million in 2030. The milestones reflect Telix’s hopes for ITM-11.
“This is ... a highly differentiated product. It is not a me-too product,” Telix CEO Christian Behrenbruch said on a conference call with analysts to discuss the deal. “It has a differentiated clinical profile. We believe that’s supported in the data. We also see a clinical and label profile for this asset that’s highly differentiated that we think lends itself to some unique commercial strategies.”
William Blair analysts welcomed the deal, writing in a Monday morning note to investors that they “are extremely bullish on the future growth prospect of the combined Telix-ITM entity.” The optimism reflects the potential for ITM to vertically integrate and expand Telix’s manufacturing network while adding R&D assets, including ITM-11, to its pipeline.
When rejecting ITM-11, the FDA cited chemistry, manufacturing and controls issues and items identified during an inspection of a third-party commercial facility. ITM plans to refile, but the timing is subject to remediation and talks with the FDA. Resubmission or an agreement between Telix and ITM on the path forward is a closing condition for the takeover, although Behrenbruch expressed confidence in the resubmission.
“We know this third-party facility very well, and the broader regulatory context,” the CEO said. “Through our own experience, including [imaging agent] Pixclara, we have demonstrated that a CRL is not the end of the road where the underlying product profile is very strong, and this is certainly the case here.”
Telix markets radioisotopes for imaging prostate and brain cancer and is developing RLTs. The company’s phase 3 pipeline includes TLX591, a PSMA-targeted drug candidate that could compete with Novartis’ prostate cancer blockbuster Pluvicto. ITM-11 could accelerate Telix’s entry into the commercial therapeutic market and expand its presence in neuroendocrine tumors.
The combined company’s planned two-front attack on Novartis’ RLT business is underpinned by facilities for making and distributing radiopharmaceuticals. ITM supplies lutetium-177 for Pluvicto. The isotope, which has other suppliers, is also the cancer-killing agent in Lutathera, ITM-11 and TLX591.
ITM reported $273 million in sales in 2025, with Telix expecting the combined company to generate $1.3 billion this year.