- Lumara Bio brings together ITM's existing pipeline of early- and late-stage radiopharmaceutical therapies, including lead drug candidate 177Lu-edotreotide (ITM-11), into a single, dedicated division
- New drug application for 177Lu-edotreotide is currently under FDA review with an August 28, 2026 PDUFA date; U.S. commercial readiness activities are ongoing
Garching / Munich, Germany and Princeton, New Jersey, July 27, 2026 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today introduced Lumara Bio as a dedicated oncology therapeutics division that combines ITM's existing pipeline and the internal teams supporting its development and commercialization.
Lumara Bio will operate as a defined division within ITM to focus key resources toward commercial readiness for its most advanced drug candidate, 177Lu-edotreotide (ITM-11), which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026, alongside its broader early- and late-stage drug development activities.
“As we approach ITM-11’s PDUFA date, creating the Lumara Bio division enables us to focus our internal efforts and create a structure around the teams responsible for a potential commercial launch,” said Dr. Andrew Cavey, chief executive officer of ITM. “In addition, Lumara Bio reflects the evolution of the two pillars of ITM’s business and builds on our deep expertise in isotope manufacturing and supply as well as our proven track record in radiopharmaceutical development. Lumara Bio is uniquely positioned to address the growing need for radiopharmaceutical innovation by accelerating progress across our targeted radiopharmaceutical pipeline and expanding our portfolio.”
Beyond 177Lu-edotreotide, Lumara Bio will advance ITM’s diverse pipeline of targeted radiopharmaceutical candidates spanning multiple cancer types, treatment approaches, and proprietary isotope platforms, with the goal of bringing innovative radiopharmaceutical therapies to more patients. The division builds on ITM’s scientific foundation and isotope expertise, as well as its radiopharmaceutical development and strategic scientific collaborations. Lumara Bio will leverage ITM’s isotope manufacturing and supply services to support its pipeline and potential commercial launch activities.
177Lu-edotreotide is currently under regulatory review by the U.S. Food and Drug Administration and is not approved by any regulatory authority for any use.
About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com
About Lumara Bio
Lumara Bio, a division of ITM, builds on more than two decades of radiopharmaceutical expertise and is advancing a focused pipeline of targeted therapies for cancers where treatment options remain limited. https://lumarabio.com
ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com
Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com
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