Weekly international regulatory approvals, licensing collaborations, mergers & acquisitions, clinical developments, and financial performance of top global pharmaceutical companies — September 21–27, 2026

• Bristol Myers Squibb: On September 25, Bristol Myers Squibb released pre-specified results from the pivotal Phase 3 EXCALIBER-RRMM trial, evaluating ZENBEXUS (iberdomide) in combination with daratumumab and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM). Among 420 evaluable patients, with a median follow-up of 15.7 months, the study met its co-primary endpoints—statistically significant and clinically meaningful improvement in minimal residual disease (MRD)-negative complete response (CR) rate and progression-free survival (PFS). The MRD-negative CR rate was markedly higher in the ZENBEXUS arm versus the control arm (41.1% vs. 20.7%; odds ratio = 2.75). These data will be presented at the 23rd Annual Meeting of the International Myeloma Society (IMS 2026) and simultaneously published in The Lancet Oncology. Treatment benefits were consistent across pre-specified subgroups, including patients with prior lenalidomide exposure or lenalidomide resistance—including resistance during their most recent line of therapy. Overall response rate (ORR) was 88.9% in the ZENBEXUS arm versus 76.1% in the control arm; rates of complete response or better were nearly doubled (45.9% vs. 24.9%). Grade 3/4 neutropenia occurred in 84.3% of ZENBEXUS-treated patients versus 11.3% in the control group, predominantly during the first two treatment cycles. Most cases were manageable with granulocyte colony-stimulating factor (G-CSF) support and temporary dose interruptions (ZENBEXUS dose reductions due to neutropenia: 13.2%; discontinuations due to neutropenia: 1.0%). Grade 3/4 infections occurred in 39.2% of ZENBEXUS-treated patients versus 21.6% in controls; fatal infections remained low (2.0% vs. 1.5%). Peripheral sensory neuropathy incidence was significantly lower in the ZENBEXUS arm (any grade: 12.3% vs. 42.6%; grade 3/4: 2.9% vs. 5.4%). ZENBEXUS is an oral CELMoD (Cereblon E3 Ligase Modulator), a CRBN (cereblon) protein degrader. It binds to CRBN within the E3 ubiquitin ligase complex, altering CRBN’s conformation to recruit IKZF family transcription factors—Ikaros (IKZF1) and Aiolos (IKZF3)—to the CRBN complex. This leads to ubiquitination and subsequent proteasomal degradation of Ikaros and Aiolos. Their degradation collapses survival signaling in myeloma cells, inducing tumor cell apoptosis. • Novo Nordisk: On September 21, Novo Nordisk announced primary results from two Phase 3 trials—REIMAGINE 5 and REDEFINE 9—for its investigational once-weekly combination CagriSema (cagrilintide + semaglutide).

The next card after GLP-1: Why are Eli Lilly and Novo Nordisk both betting on amylin?

Benjamin Bikman, metabolic health expert at Brigham Young University, commented: “These results are encouraging. Weight loss with such therapies tends to be lower in patients with type 2 diabetes than in non-diabetic individuals.” David Risinger, analyst at Leerink Partners, forecasts that Eli Lilly’s eloralintide portfolio could generate $23.2 billion in annual sales by the end of 2035. The monotherapy is expected to launch in 2029, followed by combination therapies in 2030. He believes the standalone eloralintide may hold even greater potential, as “more than 10 million people may have tried GLP-1 therapies but failed to achieve sufficient efficacy, experienced tolerability issues, or encountered genetic limitations.” Ken Custer, President of Cardiovascular and Metabolic Health at Eli Lilly, stated in an interview: “Patients may not achieve their full therapeutic goals with tirzepatide alone—or with eloralintide monotherapy alone.” Bikman similarly noted that combination therapy offers new hope for patients whose weight loss has plateaued on tirzepatide monotherapy. Yet Eli Lilly still faces substantial hurdles to clear. The current data derive from smaller Phase 2 trials; Phase 3 trials are scheduled to begin later this year. Tolerability remains a key challenge: discontinuation rates due to adverse events ranged from 10.8% to 27% across different-dose combination arms, compared with only 2.9% in the tirzepatide monotherapy arm. Dr. Caroline Apovian, Co-Director of the Weight Management Center at Brigham and Women’s Hospital, bluntly remarked, “27% is not a good number.” Bikman emphasized, “A therapy is only effective if patients can stay on it—so tolerability in Phase 3 trials will be just as critical as efficacy.” Novo Nordisk’s amylin strategy: CagriSema to launch next year Novo Nordisk’s investment in amylin therapeutics spans many years. Its amylin analogue cagrilintide has demonstrated robust weight-loss effects as a monotherapy in late-stage clinical trials. When combined with semaglutide, the resulting product—CagriSema—has shown even greater weight reduction in clinical studies and is expected to launch early next year. Standalone cagrilintide and high-dose CagriSema are anticipated to launch in 2028. New data released by Novo Nordisk this week show that CagriSema’s benefits extend beyond weight loss. In a one-year brain imaging (fMRI) study, the drug reduced “food noise”—persistent thoughts about food—and improved organ and bone health. The study revealed that CagriSema altered how brain regions associated with craving, reward, and self-control responded to high-calorie foods in people with obesity or overweight. “Signals in the brain changed in a way linked to improvements in quality of life,” said Dr. Martin Holst Lange, Novo Nordisk’s Chief Scientific Officer, in an interview. Novo Nordisk is also developing amycretin (also known as zenagamtide), a single-molecule dual agonist mimicking both GLP-1 and amylin. It is being tested in both once-weekly injectable and daily oral tablet formulations. Positive Phase 2 clinical results were reported earlier this year.

Novo's CagriSema Achieves 25% Average Weight Loss in Women, Analysis Shows

Oct 20, 2026

Novo Nordisk reported CagriSema achieved 25% average weight loss in women during late-stage trials, significantly outperforming placebo. An FDA decision is expected by year-end for the obesity treatment combining cagrilintide and semaglutide.

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Novo's CagriSema Achieves 25% Average Weight Loss in Women, Analysis Shows

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