From Insulin Injections to Functional Cures: Regenerative Medicine Reshapes Diabetes

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“Our pipeline is rapidly expanding to meet the needs of people living with obesity, and this submission—under the FDA’s new expedited review program—marks an exciting step forward,” said Anna Windle, Ph.D., senior vice president, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk. “If approved, semaglutide 7.2 mg would bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring.”

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The higher-dose formulation demonstrated that 33.2% of patients achieved weight loss of 25% or more after 72 weeks, compared to 16.7% with the 2.4 mg dose.

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CRISPR Therapeutics (NASDAQ: CRSP) reported strong momentum for CASGEVY®, with nearly 300 patients referred to Authorized Treatment Centers globally and approximately 165 patients completing their first cell collection, including 50 in the third quarter of 2025. The company presented positive Phase 1 data for CTX310®, targeting ANGPTL3 for cardiovascular disease, in a late-breaking session at the American Heart Association Scientific Sessions with simultaneous publication in The New England Journal of Medicine, highlighting the potential to safely and durably lower both triglycerides and LDL following single-course IV administration. Vertex expects clear line of sight to over $100 million in total CASGEVY revenue this year with significant growth anticipated in 2026.

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“This has been another strong quarter of execution and progress across our portfolio,” said Samarth Kulkarni, Ph.D., Chairman and CEO of CRISPR Therapeutics. “CASGEVY momentum continues to build globally, reflecting growing patient engagement and clinical advancement. Enrollment has been completed in two global Phase 3 pediatric studies, and dosing is on track to complete this quarter. Additionally, positive Phase 1 data for CTX310 presented in a late-breaking presentation at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine, highlight the breadth and potential of our platform to address serious cardiovascular disease.”

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Sernova Biotherapeutics (TSX: SVA) (OTCPK: SEOVF) closed the first tranche of a private placement totaling CAD $874,600 in gross proceeds, issuing 5,466,250 units at $0.16 per unit as part of a goal to raise up to C$5 million to support its ongoing Phase 1/2 clinical trial for type 1 diabetes. Each unit consists of one common share and one warrant with an exercise price of $0.40 exercisable for 36 months, with proceeds designated for general operating capital and the launch of final Cohort C in the company’s Cell Pouch Bio-hybrid Organ trial. The company plans to incorporate tegoprubart, a novel investigational immunomodulatory antibody, in place of standard-of-care tacrolimus in Cohort C, with expectations for improved clinical outcomes given positive data on islet cell engraftment, survival and function.

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“This financing, and the anticipated subsequent tranches, plus a further increase in the previously announced settlement conversion of CAD $13.8 Million of legacy debt to equity significantly strengthens our balance sheet as we enter an exciting new phase of clinical development,” said Jonathan Rigby, CEO of Sernova. “With the launch of Cohort C, which will incorporate tegoprubart, we are building on promising clinical results to further optimize patient outcomes and move closer to a functional cure for insulin-dependent diabetes.”

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