Novo’s CagriSema Shows Greater Weight Loss Than Tirzepatide in REIMAGINE 5 Trial; Telix and ITM Partner to Build a Radiopharmaceutical Powerhouse; Beacon Therapeutics Reveals Positive Topline Findings from VISTA Trial of Laru-zova for XLRP; FDA Clears Inluriyo in Combination with Verzenio for Adults with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer; IntraBio Announces FDA Approval of AQNEURSA for Ataxia-Telangiectasia

Novo’s CagriSema Demonstrates Superior Weight Loss Over Tirzepatide in REIMAGINE 5

Novo Nordisk announced topline results from the Phase 3 REIMAGINE 5 and REDEFINE 9 trials evaluating once-weekly CagriSema (cagrilintide and semaglutide), an investigational therapy and the company’s next-generation approach to weight management and type 2 diabetes. The results were presented during Novo Nordisk’s Capital Markets Day investor briefing.

In the REIMAGINE 5 trial, CagriSema 1.0 mg/1.0 mg demonstrated superior weight-loss efficacy compared with tirzepatide 5 mg, delivering an estimated average weight reduction of 12.4% versus 9.1%, respectively. CagriSema also achieved a non-inferior reduction in HbA1c, with a decrease of 1.71% compared with 1.67% for tirzepatide.

In REDEFINE 9, treatment with CagriSema 1.0 mg/1.0 mg resulted in a 21.0% reduction in body weight compared with 2.0% with placebo, meeting the trial’s primary superiority endpoint. CagriSema also demonstrated greater improvements than placebo across prespecified supportive measures, including systolic blood pressure, waist-to-height ratio, and fasting lipid profile.

Martin Holst Lange, executive vice president of Research & Development and chief scientific officer at Novo Nordisk, said the findings were encouraging and highlighted the potency of combining semaglutide with cagrilintide. He noted that, despite remaining investigational, CagriSema achieved greater weight loss than tirzepatide 5 mg at the 1.0 mg/1.0 mg dose and delivered promising outcomes across obesity and type 2 diabetes. According to Lange, the findings further support the potential of CagriSema, contribute to the expanding evidence surrounding amylin biology, and reinforce Novo Nordisk’s efforts to develop next-generation treatments for obesity and type 2 diabetes.

Treatment approaches for obesity and type 2 diabetes are frequently tailored to individual patients, and some patients may not receive or continue treatment at the highest available dose of existing therapies. The latest findings provide additional evidence supporting the potential of CagriSema 1.0 mg/1.0 mg while offering further insight into how efficacy, tolerability, and dosing flexibility could contribute to more individualized treatment strategies.

During its Capital Markets Day, Novo Nordisk also presented data on painful diabetic neuropathy associated with type 2 diabetes for the first time. The company reported promising findings and said additional details would be disclosed at a later date.

Telix and ITM Forge Partnership to Create a Radiopharmaceutical Leader

Telix announced that it has entered into a strategic agreement to lead a merger with ITM Isotope Technologies Munich SE, a global leader in radioisotope production and radiopharmaceutical development. The proposed merger is expected to further strengthen Telix’s position as a vertically integrated radiopharmaceutical company with end-to-end capabilities spanning the development, manufacturing, and global delivery of innovative treatments. The combined company would be positioned as a leading player in the radiopharmaceutical industry, supported by a large-scale, world-class isotope manufacturing business, an established global distribution network, a leading commercial precision medicine platform, and a broad therapeutic radiopharmaceutical pipeline.

Established in 2004, ITM is a privately held company operating a commercial-scale radioisotope manufacturing and global distribution network that reaches more than 65 countries. The company is a major supplier of lutetium-177 (177Lu) and recorded a 40% compound annual growth rate (CAGR) between 2021 and 2025, generating annual revenue of US$273 million in 2025. This growth has been driven by rising worldwide demand for targeted radioligand therapy (TRT) and radioisotopes used in approved commercial products and clinical-stage programs. The global nuclear medicine market is projected to reach US$41 billion by 2034.

ITM also brings a complementary late-stage development pipeline, including ITM-11 (177Lu-edotreotide), a differentiated somatostatin receptor (SSTR)-targeted therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 has successfully completed the Phase 3 COMPETE trial (NCT03049189) and has fully enrolled the Phase 3 COMPOSE study (NCT04919226), which is evaluating an additional indication, with an interim analysis expected in the first half of 2027. Subject to regulatory approval, ITM-11 could enable Telix to enter the commercial therapeutic market more rapidly while expanding its presence in neuroendocrine tumors, an established and clinically important market for TRT.

According to management estimates, the combined company is expected to generate unaudited pro forma 2026 revenue and income of more than US$1.3 billion. ITM’s radioisotope manufacturing operations are profitable and cash-generative. Continued manufacturing growth, cost efficiencies, additional synergies, and optimization of the combined pipeline are expected to support a positive EBITDA contribution from 2027 onward. Regulatory approval and commercialization of ITM-11 could provide additional growth potential by generating high-margin therapeutic revenue in the near term.

Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, said the transaction places Telix at the forefront of the consolidation underway as the radiopharmaceutical sector continues to mature. He highlighted ITM’s leadership in radioisotope production, scientific capabilities, and history of innovation, noting that the companies have maintained a close working relationship for many years. According to Behrenbruch, combining the two businesses would create a company with greater commercial scale, a global supply platform, and a broad theranostic drug portfolio. The merger would also strengthen the late-stage therapeutic pipeline, including two completed Phase 3 programs, while enhancing radioisotope security and integrating critical capabilities required to provide radiopharmaceutical treatments to patients worldwide.

ITM Chief Executive Officer, Dr. Andrew Cavey, said that bringing together the two radiopharmaceutical companies would create a business with extensive capabilities across the value chain, supported by experienced teams and deep industry expertise. He noted that the respective management teams have a longstanding working relationship and a strong understanding of each company’s commercial capabilities and customer relationships. According to Cavey, the combination would position Telix and ITM to address the rapidly expanding global demand for radiopharmaceuticals while creating value for shareholders and improving access to treatments for patients.

Beacon Therapeutics Reports Positive Pivotal VISTA Trial Results for Laru-zova in XLRP

Beacon Therapeutics, a clinical-stage biotechnology company focused on developing therapies to preserve and restore vision in patients with rare and common ocular diseases, announced positive topline results from its registration-enabling VISTA trial evaluating laruparetigene zovaparvovec (laru-zova) in patients with X-linked retinitis pigmentosa (XLRP).

VISTA (NCT04850118) is a randomized, controlled study designed to assess the efficacy, safety, and tolerability of laru-zova in male patients with XLRP associated with mutations in the retinitis pigmentosa GTPase regulator (RPGR) gene. The pivotal study enrolled 85 male participants between 12 and 48 years of age and followed them for 12 months. Participants received either a high dose of 6.8 E+11 vg/eye or a low dose of 3.7 E+11 vg/eye of laru-zova. The trial successfully achieved its FDA-endorsed primary endpoint with statistical significance. Laru-zova also showed a favorable safety and tolerability profile, consistent with findings from previous clinical studies.

Lance Baldo, MD, Chief Executive Officer of Beacon Therapeutics, described the findings as a significant milestone for the hundreds of thousands of people worldwide affected by XLRP, who currently have no approved treatment options capable of slowing disease progression. He noted that the statistically significant and clinically meaningful results mark an important advancement in ocular gene therapy and highlight the potential of a one-time treatment to alter the progression of inherited retinal disease. Baldo also expressed appreciation to the patients, families, investigators, and advocacy organizations involved in the study and said the company plans to work closely with regulatory authorities to advance laru-zova toward potential availability for patients as rapidly as possible.

FDA Approves Inluriyo–Verzenio Regimen for ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–), ESR1-mutated locally advanced or metastatic breast cancer (MBC), as identified by an FDA-authorized test, whose disease has progressed following at least one line of endocrine therapy. The approval is supported by the clinical benefit demonstrated with switching to Inluriyo in combination with Verzenio at the time of clinical progression in the Phase 3 EMBER-3 trial.

The full approval is based on findings from the Phase 3 EMBER-3 study involving patients with ESR1-mutated MBC (n=159). Participants received either Inluriyo alone (n=92) or Inluriyo in combination with Verzenio (n=67) following treatment with an aromatase inhibitor (AI), with or without a CDK4/6 inhibitor, in either the adjuvant or metastatic setting. In patients with ESR1-mutated MBC, the combination of Inluriyo and Verzenio doubled median progression-free survival (PFS) compared with Inluriyo monotherapy, resulting in a median PFS of 11.1 months versus 5.5 months, respectively (HR=0.53; 95% CI, 0.35–0.80).

The Inluriyo prescribing information includes a warning and precaution regarding embryo-fetal toxicity. Additional safety information is provided in the Important Safety Information and full Prescribing Information. The Verzenio prescribing information includes warnings and precautions for severe diarrhea, neutropenia, interstitial lung disease/pneumonitis, hepatotoxicity, venous thromboembolism, embryo-fetal toxicity, and increased serum creatinine without an associated impact on renal function. Additional details are available in the Important Safety Information and full Prescribing Information.

This approval represents Inluriyo’s second FDA approval in less than one year, following its September 2025 approval as a monotherapy for adults with ER+, HER2–, ESR1-mutated MBC whose disease progressed after at least one line of endocrine therapy (ET).

Inluriyo is also under evaluation in the Phase 3 EMBER-4 trial (NCT05514054) as an adjuvant treatment for patients with ER+, HER2– early-stage breast cancer (EBC) who are at increased risk of recurrence following standard-of-care endocrine therapy, including CDK4/6 inhibitors. EMBER-4 is the largest adjuvant oral SERD clinical trial to date, enrolling more than 8,000 patients across more than 650 sites in over 30 countries worldwide. Initial results from the trial are expected in 2027.

IntraBio Secures U.S. FDA Approval for AQNEURSA in Ataxia-Telangiectasia

IntraBio Inc., a company focused on the discovery, development, and commercialization of innovative therapies for rare and common neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has approved AQNEURSA (levacetylleucine) for the treatment of ataxia in adult and pediatric patients with ataxia-telangiectasia (A-T) who weigh ≥15 kg. AQNEURSA is the first and only therapy approved globally for the treatment of A-T. In the U.S., this represents the second indication for AQNEURSA, following its initial approval in September 2024 for the treatment of neurological manifestations associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg.

Mallory Factor, Chief Executive Officer of IntraBio, described the approval as a major milestone for both the A-T community and the company. He noted that, as the first FDA-approved treatment for ataxia-telangiectasia, AQNEURSA has the potential to provide meaningful benefits to thousands of patients and their families who previously had no approved treatment options for the broad and debilitating symptoms associated with A-T. He also recognized the contributions of investigators, advocacy organizations, patients, and families involved in the research program and reaffirmed IntraBio’s commitment to helping eligible patients gain access to AQNEURSA.

A-T is a rare, progressive, and prematurely fatal autosomal-recessive neurodegenerative disorder that affects an estimated 1 in 40,000 people. The condition is marked by progressive cerebellar degeneration that leads to worsening ataxia, potentially affecting gait, truncal control, eye movements, balance, speech, and hand coordination, in addition to producing other systemic manifestations. Prior to this approval, no treatment had been approved specifically for A-T anywhere in the world.

Brad Margus, Founder of the A-T Children’s Project, characterized the FDA approval as a historic development for individuals with A-T and their caregivers, who have faced the disease for decades without a treatment specifically approved for the condition. According to Margus, the FDA decision provides the A-T community with a treatment option that has demonstrated benefits across multiple symptoms of the disease, including those that can interfere with patients’ and families’ daily lives. He expressed appreciation for the families who contributed to the research and for IntraBio’s commitment to addressing the needs of patients affected by this rare and complex disorder, while emphasizing the continued effort to ensure access for all patients who may benefit from the therapy.