Telix to merge with ITM in deal worth up to $2.35 billion

Melbourne, Australia-based Telix Pharmaceuticals entered into a strategic agreement to merge with ITM Isotope Technologies Munich (ITM), a private biotech that is the world’s leading supplier of therapeutic radioisotopes, according to the announcement.  

The agreement includes upfront consideration of $1.65 billion. After adjustments for debt assumption and expenses, ITM’s shareholders are expected to receive approximately $1.25 billion in Telix shares (to be released as Nasdaq ADRs after escrow).

The deal also includes contingent consideration of up to $700 million in potential regulatory and commercial sales milestone payments related to ITM’s lead radiopharmaceutical candidate, a novel targeted radionuclide therapy (TRT) agent known as ITM-11.

A Phase III trial evaluating ITM-11 as a treatment for gastronenteropancreatic neuroendocrine tumors (GEP-NETs) has been successfully completed, and a Phase III study in a second GET-NET indication has been fully enrolled. Interim analysis results from that study are expected in the first half of next year.

Dr. Christian Behrenbruch, Telix’s managing director and group CEO, stated in the announcement:

“This merger positions Telix at the forefront of the consolidation that is occurring as the industry matures. ITM is the leader in radioisotope production, with deep scientific expertise and a track record of value-adding innovation.

“We have enjoyed a close working relationship with ITM for many years. By combining our complementary strengths, we will create a company with commercial scale, world-leading supply, and the most exciting theranostic drug portfolio in the sector.

“Importantly, this combination further expands our late-stage therapeutic pipeline with two completed Phase III trials and deepens radioisotope security, while bringing together the mission-critical capabilities needed to deliver radiopharmaceutical treatments to patients around the world.”

If ITM-11 gains approval, it will compete with Novartis’ Lutathera (lutetium Lu177 dotatate) and Curium Pharma’s Bexlutry, a radioligand equivalent to Lutathera that received FDA approval earlier this month.

Although the FDA rejected ITM’s application for ITM-11 as a treatment for GEP-NETs, the only reason the agency cited for the rejection were manufacturing issues at a third-party commercial facility, according to MedCity News. No safety concerns were noted, nor were there any issues with the clinical data submitted in support of the approval request. ITM plans to resubmit the application once the manufacturing issues have been resolved.

ITM’s pipeline includes more than 10 therapeutic and diagnostic candidates in development for a variety of cancer types.

Telix’s top-selling product is Illuccix, an FDA-approved radioactive diagnostic imaging agent used with PET scans to detect prostate cancer that may have metastasized or returned. Another product, Pixclara (floretyrosine F 18), received FDA approval earlier this month as a radioactive diagnostic drug used with PET scans to differentiate between returning glioma and normal changes associated with treatment.

Telix’s pipeline includes candidates being evaluated in prostate cancer, recurrent glioblastoma, and kidney cancer.

Adding ITM-11 to its portfolio would allow Telix to diversity its revenue, continue its vertical integration strategy, and further expand the company’s global manufacturing footprint, MedCity News noted. According to the merger announcement, ITM’s manufacturing and global distribution network spans more than 65 countries.

Biopharma Dive reported that Andy Hsieh, an analyst with William Blair, wrote in a note to clients:

“We believe the transaction will allow Telix to further corner the industry and advance a range of products from development to commercialization.”

Hsieh said acquiring ITM’s manufacturing and distribution network would give Telix “even greater control over the entire radiopharmaceutical value chain,” adding that the company is on a path to “achieving global radiopharmaceutical powerhouse status.”

The merger is subject to approval by Telix’s shareholders and other customary closing conditions. If all requirements are satisfied, the transaction is expected to close by the end of the year.

Upon completion of the deal, current Telix shareholders will own approximately 76% and current ITM shareholders will own approximately 24% of Telix shares on issue.

What else you need to know

WakeMed Health & Hospitals and Atrium Health are closer to combining now that the Wake County board of commissioners has voted 5-2 to approve the proposed merger. The two nonprofit health systems, based in Raleigh, N.C., and Charlotte, respectively, announced in May their intent to combine. As part of their proposed deal, Atrium said it would invest $2 billion in Wake County to create more than 3,300 new healthcare jobs and expand services across the state.

Since the announcement, the board has been weighing feedback from the health systems’ employees, Wake County residents and others. As a result, the original transfer agreement was amended to reflect a stronger commitment to charity care, according to a news release. Additionally, Gov. Josh Stein released a statement saying Atrium had agreed to cap price increases at WakeMed to not more than 1.5 times the annual increase in Medicare costs for the next five years and had agreed to fully fund the $2 billion investment.

The health systems will move forward with the regulatory review process, though concerns about the merger still exist. North Carolina Treasurer Brad Briner released a video statement in which he said he remains “profoundly concerned” about the proposed transaction and referred to the amendments to the transfer agreement as “minor modifications engineered by the governor’s office.”

Briner said he was “echoing the call for Attorney General Jeff Jackson to step in and conduct a thorough, independent assessment of this transaction [and] its effect on prices, competition, and access.” Briner also expressed concerns about the merger’s potential effect on the state’s health plan and other employer-sponsored health plans.

Advocate Health, which combined with Atrium Health in 2022, shared a statement with Becker’s Hospital Review in which it addressed Briner’s concerns about competition and pricing. Specifically, Advocate said there would continue to be three major health systems competing in Wake County after the Atrium-WakeMed Health merger, WakeMed would remain a low-cost provider, and Atrium’s agreement to limit price increases provides a level of protection not included in any other health system transaction in North Carolina.

Oracle introduced its new cancer-specific EHR last week at the Oracle Health and Life Sciences Summit in Orlando, Fla. The EHR integrates oncology-specific workflows, AI-powered clinical intelligence pulled from various data sources, and “connected information,” Oracle noted in a press release, adding that the new “context-aware EHR” is designed to provide personalized treatment recommendations and help clinicians focus on patient care. The EHR’s embedded AI agents and built-in clinical decision support enable it to assist clinicians through patient “snapshots” and pre-visit summaries, specialized assistants for Tumor Board preparation, and guideline-grounded treatment planning, according to Oracle.

The company also unveiled plans to release five new AI capabilities to assist with revenue cycle management in the coming months. The tools are designed to improve efficiencies in the areas of prior authorization; clinical document quality integrity; charge capture and integrity; medical coding; and appeal management, Oracle said in a separate news release.

Aetna has expanded its bundled prior authorizations across all cancer types for members in eligible Medicaid states, effective Sept. 1. The bundled PAs “combine medical oncology, including chemotherapy and immunotherapy where appropriate, and/or radiation oncology services with associated high-tech imaging needs, such as MRI or CT scans, into one request submitted through a single portal,” parent company CVS Health said in a press statement. The expansion builds on a pilot Aetna launched last year and is relevant to Medicaid enrollees with providers in Florida, Illinois, Kentucky, Maryland, New Jersey, Oklahoma, Virginia, and West Virginia who use the Eviti portal to submit PAs. The insurer is planning to further expand the bundled PAs to eligible Medicare Advantage and commercial members in the first half of next year.

Health systems and insurers continue to push back against CMS’ proposed restrictions on remote patient monitoring. More than 230 healthcare organizations signed a Sept. 14 letter to CMS Administrator Mehmet Oz urging the agency not to finalize policies it proposed in July to restrict remote physiologic monitoring and remote therapeutic monitoring. If the policies are finalized, starting Jan. 1, 2027, payments for both types of remote monitoring would be permitted only when services are provided by clinical staff members who are directly employed by the billing practice; third-party vendors that provide patient monitoring services would not be eligible to receive Medicare payments.

The organizations that signed the letter, including 35 health systems, said the proposed limitations would “cause immediate and significant disruption for approximately 1 million Medicare beneficiaries who rely on remote monitoring to manage chronic conditions, avoid preventable complications, and remain connected to their care teams.”

CVS Health, Kaiser Permanente, and UnitedHealth Group sent their own letters to CMS expressing concerns about how the proposed restrictions would negatively affect patient care. CVS Health and UnitedHealth were in favor of implementing accountability standards for third-party companies, whereas Kaiser Permanente recommended withdrawing the proposed policies altogether, noting they would have “an outsized impact on integrated delivery systems,” Becker’s Health IT reported.

Mayo Clinic and Thermo Fisher Scientific are collaborating to create one of the world’s leading biomedical datasets. They are launching a company called Precure that will collect molecular data generated from 1 million biospecimens. That data will be linked with longitudinal clinical data from Mayo Clinic. Advanced AI and large-scale data analytics will be used to identify patterns within the datasets and then translate the patterns into actionable insights, the organizations explained in a press release. The purpose, they said, is to help researchers identify early biological signals of disease so they can “better understand these early changes, accelerate drug development, and create new opportunities for earlier diagnosis, intervention, and more personalized care.” Mayo Clinic will be the major owner of Precure, with Waltham, Mass.-based Thermo Fisher partnering as a minority owner.

What we’re reading

Being a Doctor Will Never Be the Same After A.I. NY Times, 9.25.26 (registration or subscription required)

A Step in the Search for the Elusive Holy Grail of Early Detection of Cancer. NEJM, 9.22.26 (registration or subscription required)

On Becoming a Gold Standard Scientist—The Importance of Pilot Clinical Trials. JAMA, 9.24.26