Investment in metabolic disease has been shaken up dramatically after recent clinical trials achieved 83% insulin independence rates.
Late-2025 M&A activity reached record valuations as major pharmaceutical companies raced to secure curative platforms rather than symptom-management franchises.
This pivot toward functional cures, rather than chronic insulin dependence, is now defining the strategic roadmaps of companies such as Avant Technologies, Novo Nordisk, Eledon Pharmaceuticals, Viking Therapeutics and Tandem Diabetes Care.
Analysts project the regenerative medicine market will surge from $37.98bn in 2025 to $88.85bn by 2030, driven by curative cell therapies now entering pivotal trials.
Meanwhile, FDA expedited review pathways have awarded more than 350 designations across diabetes and metabolic diseases in the past three years, compressing clinical timelines by 30% and creating an urgent investment window as breakthrough therapies rush towards commercial launch.
The diabetes market represents a substantial opportunity.
According to the International Diabetes Federation, 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, which is projected to reach 853 million by 2050.
Avant Technologies is developing cell-based therapies for diabetes, ageing and chronic diseases using a proprietary encapsulation technology that protects genetically modified therapeutic cells from immune rejection.
The company operates through two strategic joint ventures focused on addressing massive global health markets.
The first, Insulinova, is a partnership with SGAustria Pte., through which Avant is developing treatments for type 1 and insulin-dependent type 2 diabetes.
The approach centres on a cell encapsulation technology that allows genetically modified insulin-producing cells to survive long-term in the body without being susceptible to any immune system attacks.
This solves a fundamental problem that historically required patients to take lifelong immunosuppressive drugs with serious side effects.
"Cell encapsulation is a game-changer in the field of regenerative medicine," said Chris Winter, CEO of Avant Technologies.
"By partnering with SGAustria, we're ensuring that any genetically modified insulin-producing cells that we develop together can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life."
"This technology not only minimises risks such as immune rejection but also prevents potential complications such as cell escape or tumour formation, making it a cornerstone for safe and scalable diabetes therapies."
SGAustria's Cell-in-a-Box technology creates a protective barrier around genetically modified cells, shielding them from any immune response while allowing nutrients, oxygen and insulin to pass through freely.
Avant's second joint venture, Klothonova, partners with Singapore-based Austrianova to develop anti-ageing therapies and treatments for age-related diseases that restore circulating α-Klotho levels using genetically modified human cells that overexpress the Klotho protein.
Research from the Mayo Clinic indicates that declining α-Klotho levels are linked to arterial stiffness, endothelial dysfunction and vascular calcification.
Both joint venture projects will utilise cell-encapsulation platforms backed by more than 50 publications representing decades of development.
The potential market spans multiple therapeutic areas: the global Alzheimer's market is projected to reach $32.8bn by 2033, cardiovascular disease remains the world's leading cause of death and kidney disease affects 850 million people worldwide.
Novo Nordisk submitted a New Drug Application to the FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg), the first injectable GLP-1 receptor agonist and amylin analogue combination for weight management.
In the REDEFINE 1 Phase III trial, adults with obesity or overweight with weight-related comorbidities taking CagriSema lost an average of 23% body weight when evaluating the treatment effect if all patients stayed on treatment, with 54% of patients with obesity at baseline reaching a BMI below 30 kg/m2 at week 68.
The trial included 3417 adults, with 87.4% of patients on steroids at baseline successfully tapering to prednisone five mg per day or less by week 24.
The FDA is expected to review the CagriSema application in 2026, with Health Canada granting the first approval outside the US in August 2025.
Potential approvals are anticipated in the United Kingdom and Australia in the first half of 2026 and in Switzerland in 2027, while Novo Nordisk finalises a strategy with the European Medicines Agency to support EU marketing authorisation.
Eledon Pharmaceuticals recently announced preliminary data from six patients with type 1 diabetes treated with tegoprubart following islet transplantation at UChicago Medicine.
All six subjects achieved insulin independence after one or two transplants, with one patient maintaining HbA1c as low as 4.7% for more than 15 months without exogenous insulin.
Tegoprubart was well tolerated with no serious infections, thromboembolic events, or kidney and neurological toxicity commonly seen with calcineurin inhibitors.
"For years, clinicians have been working to find a new medication that can prevent rejection of islet cells while offering a better safety profile than calcineurin inhibitors, including tacrolimus, which remains the current standard of care but is often associated with debilitating metabolic, neurologic and cardiovascular toxicities," said Dr Piotr Witkowski, Director of the Pancreas and Islet Transplant Programme at UChicago Medicine.
"These preliminary data in the first six subjects with T1D are very encouraging, with all six subjects achieving insulin independence."
The trial has been extended to 12 subjects and Breakthrough T1D has committed to fund a second study in type 1 diabetic patients with chronic kidney disease.
Eledon is developing tegoprubart as a tacrolimus-free immunosuppression regimen for preventing transplant rejection.
Viking Therapeutics announced the completion of enrollment ahead of schedule in its Phase III VANQUISH-1 trial evaluating subcutaneous VK2735, a dual GLP-1/GIP receptor agonist, for treating obesity.
The 78-week study enrolled approximately 4650 adults with obesity or who are overweight with weight-related comorbidities, exceeding the target enrollment.
The trial is evaluating weekly VK2735 doses of 7.5 mg, 12.5 mg and 17.5 mg compared to placebo, with a primary endpoint of per cent change in body weight from baseline at 78 weeks.
"We are excited to announce completion of enrollment in VANQUISH-1 ahead of schedule," said Dr Brian Lian, CEO of Viking.
"As with prior VK2735 studies, the trial accrued rapidly and exceeded our enrollment target. We believe this speaks to the enthusiasm for new obesity treatments beyond those currently available."
The company expects to complete enrollment in its Phase III VANQUISH-2 study of VK2735 in patients with type 2 diabetes and obesity in the first quarter of 2026.
VK2735 demonstrated up to 14.7% mean body weight reduction with no signs of plateau in the Phase II VENTURE study, along with encouraging safety and tolerability.
Tandem Diabetes Care has launched its t:slim mobile application in Canada for both Android and iOS users, enabling patients to deliver boluses from compatible smartphones and wirelessly upload pump data to the cloud-based Tandem Source platform.
The secure application displays the last 24 hours of glucose trends, pump status changes, insulin therapy data and pump alerts while maintaining the t:slim X2 insulin pump's independent functionality.
Users can view pump information and program requests from either their pump or smartphone.
"With this release, we are furthering our commitment to expand our innovative, integrated solutions to customers worldwide."
"We are thrilled to be able to bring the benefits of the Tandem t:slim mobile app to our customers in Canada for both iOS and Android devices," said John Sheridan, president and CEO of Tandem Diabetes Care.