Lutetium Dotatate LU-177

iStock, f11photo Constructing the cGMP facility will increase availability of actinium-225, a nuclear material central to radiopharmaceutical programs at AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis. TerraPower Isotopes has committed $450 million to build a manufacturing facility in Philadelphia, setting the company up to increase production capacity for a key radioisotope by 20-fold. The company, which was co-founded by Bill Gates, is working to increase availability of the alpha-emitting isotope actinium-225. Because actinium-225 emits more energy than lutetium-177, the beta-emitting isotope in Novartis’ Lutathera and Pluvicto, companies have identified the nuclear material as an enabler of next-generation radioligand therapies. Rising demand has stretched supply, leading Bristol Myers Squibb’s RayzeBio to pause a Phase 3 trial over a shortage of actinium-225 in 2024. The situation has led companies including TerraPower to invest in capacity to make actinium-225. Manufacturing Radiopharma Sector Races To Secure Actinium-225 Supply as Pipelines Expand Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies. February 17, 2026 · 4 min read · Nick Paul Taylor Read more Having initially served the market from Washington State, TerraPower announced Tuesday that it is establishing a presence on the East Coast by building a cGMP-compliant production facility in Philadelphia. Actinium-225 has a half-life of less than 10 days, making proximity to patients a key consideration when choosing the location of manufacturing plants. The Commonwealth of Pennsylvania, which is investing $10 million in the project, said TerraPower will create 225 full-time jobs in Philadelphia over the next three years. The staff will work at a 250,000-square-foot facility that TerraPower is leasing on the site of the former Philadelphia Energy Solutions refinery. The company expects to start making actinium-225 at the facility in 2029. TerraPower evaluated more than 350 locations in the U.S. and visited 49 sites in eight metropolitan areas before choosing Philadelphia’s Bellwether District as its East Coast base, according to its announcement. The radioisotope manufacturer has disclosed actinium-225 supply deals with companies including Aktis Oncology , Clarity Pharmaceuticals and Point Biopharma , which Eli Lilly bought for $1.4 billion in 2023. TerraPower also struck a deal with PanTera, a European company that supplies actinium-225 to Bayer. Historically, Oak Ridge National Laboratory met industry demand for actinium-225 through the decay of thorium-229 left over from nuclear weapons programs in the 1940s and 1950s. TerraPower, which was founded in 2018, and other companies invested in capacity as demand rose. BWXT Medical, Eckert & Ziegler, Ionetix, ITM, Niowave, NorthStar Medical Radioisotopes and Nusano are among the companies now supplying the isotope. The suppliers are supporting an expanding pipeline. With companies including AstraZeneca, BMS, Lilly and Novartis entering the space, the number of new clinical trials involving actinium-225 has surged since the start of last year.

BEDFORD, Mass., March 02, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that it has received U.S. Food and Drug Administration (FDA) tentative approval for the Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent 1 version of LUTATHERA ® (lutetium Lu 177 dotatate). LUTATHERA ® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. “As the first radioequivalent to LUTATHERA to receive FDA tentative approval, PNT2003 marks an important step forward in Lantheus’ work to advance treatment options for patients with GEP-NETs. This milestone comes at a time when advances in imaging and evolving clinical guidelines are enabling the identification of more patients who stand to benefit from targeted radiopharmaceutical therapies. As the leading radiopharmaceutical-focused company, we remain committed to meeting this growing demand and look forward to making PNT2003 available to patients pending final FDA approval,” said Mary Anne Heino, Chief Executive Officer of Lantheus. The FDA tentative approval indicates that the FDA has completed its review of the ANDA and that it meets the requirements for approval under the Federal Food, Drug and Cosmetics Act. Full approval of the ANDA is subject to the expiration of the 30-month stay in June 2026, triggered in connection with a Hatch-Waxman patent litigation. Lantheus licensed exclusive worldwide rights (excluding certain territories) to PNT2003 from POINT Biopharma Global, Inc. in December 2022. To read the press release announcing that licensing transaction, please click here . POINT was acquired by Eli Lilly and Company in December 2023. About GEP-NETs Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity. 2 Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients. 3 Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis. 4,5 About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and the United Kingdom, Lantheus has been providing radiopharmaceutical solutions for more than 70 years. For more information, visit . Safe Harbor for Forward-Looking and Cautionary Statements This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential FDA full approval of PNT2003 and statements regarding Lantheus’ expectations, hopes, beliefs, intentions or strategies regarding the future. Forward-looking statements may be identified by their use of terms such as “forward,” “look” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. 1 The term radioequivalent is used to describe a radiopharmaceutical whose mechanism of action is determined to be equivalent to that of the reference product approved by the FDA, or a similar regulator outside of the US. 2 Neuroendocrine Tumors. Cleveland Clinic. Published June 26, 2024. Accessed May 22, 2025. 3 Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320. 4 Kolarova T, et.al. P-136 Survey of challenges in access to diagnostics and treatment for neuroendocrine tumor patients (SCAN): Early diagnosis and treatment availability. Annals of Oncology, Volume 31, S134. 5 Raphael MJ, Chan DL, Law C, Singh S. Principles of diagnosis and management of neuroendocrine tumours. CMAJ. 2017 Mar 13;189(10):E398-E404. doi: 10.1503/cmaj.160771. PMID: 28385820; PMCID: PMC5359105. LUTATHERA ® is a registered trademark of Novartis AG and/or its affiliates. Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533 media@lantheus.com