Novo Nordisk A/S Announces that CagriSema Delivered Superior Outcomes in REIMAGINE 2; Sanofi’s Venglustat Clears all Primary Hurdles in Phase 3 Gaucher Disease Trial; Kyowa Kirin Reacquires Full Development and Commercialization Rights for Rocatinlimab; IMFINZI Receives CHMP Recommendation for Perioperative Treatment in Patients with Resectable Gastric and Gastroesophageal Cancers; Tenpoint Wins FDA Approval for First-Ever Combination Presbyopia Eye Drop

Novo Nordisk A/S Reports that CagriSema Achieved a 1.91-percentage-point HbA1c Reduction and 14.2% Weight Loss in Adults with Type 2 Diabetes in the REIMAGINE 2 Study

Novo Nordisk announced top-line findings from REIMAGINE 2, a phase 3 study within the global REIMAGINE programme. The results show that CagriSema achieved greater reductions in HbA1c and greater weight loss at week 68 than semaglutide across all tested doses.

REIMAGINE 2 was a 68-week trial assessing the efficacy and safety of once-weekly subcutaneous CagriSema, a fixed-dose combination of the amylin receptor agonist cagrilintide and the GLP-1 receptor agonist semaglutide, at two dose levels (2.4 mg/2.4 mg and 1.0 mg/1.0 mg). These were compared with semaglutide alone (2.4 mg and 1.0 mg), cagrilintide alone (2.4 mg), and placebo. The trial enrolled 2,728 adults with type 2 diabetes who were not adequately managed with metformin, with or without an SGLT2 inhibitor; approximately 40% were already using an SGLT2 inhibitor at the start of the study.

Assuming full treatment adherence, participants starting with an average HbA1c of 8.2% achieved a superior glucose-lowering effect with CagriSema 2.4 mg/2.4 mg, achieving a 1.91-percentage-point reduction at week 68 versus 1.76 points with semaglutide 2.4 mg. From a baseline body weight of 101 kg, those receiving CagriSema 2.4 mg/2.4 mg also experienced greater weight loss, 14.2% versus 10.2% with semaglutide, without evidence of a plateau at week 68. Additionally, 43% of participants on CagriSema reached at least 15% weight loss, and 24% achieved 20% or more.

“We are highly encouraged by the clinical results for CagriSema in people with type 2 diabetes, which reaffirm the significant weight-loss effects previously observed in the obesity studies,” said Martin Holst Lange, executive vice president, chief scientific officer, and head of R&D at Novo Nordisk. “The combination of semaglutide and cagrilintide is delivering better blood-sugar control and greater weight reduction than either treatment alone. These findings bolster our view that CagriSema could become the first amylin-based combination therapy and a strong treatment option for individuals with type 2 diabetes who are also focused on weight management.”

Based on the REIMAGINE 1 and REDEFINE 3 results, Novo Nordisk will now engage with regulatory authorities to determine the approval pathway for CagriSema in type 2 diabetes.

Sanofi’s Venglustat Achieved all Primary Endpoints in a Phase 3 Clinical Trial for Type 3 Gaucher Disease

Positive results from the phase 3 LEAP2MONO trial (NCT05222906) showed that venglustat achieved the primary endpoint and three of the four key secondary endpoints in adults and adolescents (12+) with neurological symptoms of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder.

Venglustat is an investigational glucosylceramide synthase inhibitor (GCSi) designed to reduce the buildup of harmful sugar-fat molecules in cells and tissues. Because it can cross the blood–brain barrier, it aims to address neurological aspects of GD3 for which no approved treatments exist. Sanofi’s involvement with the Gaucher community spans more than 40 years, reflecting a long-standing commitment to advancing care for rare diseases. These findings will be presented this week at the 22nd annual WORLDSymposium as late-breaking data.

“Our results highlight Sanofi’s dedication to rare disease research and the progress we hope to bring to affected communities,” said Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi. “We are particularly encouraged by the potential to meet critical unmet needs. A once-daily pill could significantly benefit Gaucher patients with neurological complications. Above all, we are grateful to the patients and families who make this research possible.”

Venglustat is also being evaluated for Fabry disease, another lysosomal storage disorder. In the phase 3 PERIDOT study (NCT05206773), both treatment groups experienced reductions in neuropathic and abdominal pain; however, the primary endpoint was not met. Further analyses are underway, and additional results will be shared at an upcoming medical meeting. A second phase 3 Fabry study, CARAT (NCT05280548), which is assessing the drug’s effect on left ventricular mass index, is ongoing.

Kyowa Kirin Regains Control of Rocatinlimab Program to Address Unmet Needs in Atopic Dermatitis

Kyowa Kirin Co., Ltd. announced that its collaboration with Amgen on the development and commercialization of rocatinlimab has ended. Kyowa Kirin will now take full responsibility for the drug worldwide, overseeing regulatory submissions and future commercialization. Amgen’s decision reflects its internal portfolio prioritization. Both companies are working together to ensure an orderly transition, with special attention to maintaining continuity for patients currently participating in clinical trials. Amgen, which has collaborated with Kyowa Kirin on various investigational medicines over the past 41 years, will continue producing rocatinlimab.

Abdul Mullick, Ph.D., President and COO of Kyowa Kirin, expressed confidence in rocatinlimab’s potential to meet the needs of patients with moderate-to-severe atopic dermatitis who seek long-lasting treatments that address chronic, unpredictable flare-ups. He highlighted the drug’s distinctive mechanism of action, which targets the OX40 receptor, and described it as a potentially unique therapy. Mullick added that Kyowa Kirin plans to build on its robust clinical program and leverage its clinical and commercial expertise to advance this strategic priority.

Rocatinlimab, discovered and developed internally by Kyowa Kirin, showcases the company’s strengths in immunology and antibody engineering. It reflects ongoing investment in treatments aimed at the root causes of chronic inflammatory diseases rather than only their symptoms. The Phase 3 ROCKET program comprises eight major studies designed to assess long-term efficacy and safety in atopic dermatitis. The trials cover a broad patient population, including adults and adolescents, patients new to systemic therapy, and individuals previously treated with biologics or JAK inhibitors, underscoring the therapy’s potential relevance across diverse clinical needs.

Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin, noted that data to date show that rocatinlimab has a generally favorable benefit–risk profile across the Phase 3 program, which has enrolled more than 3,300 patients with moderate-to-severe atopic dermatitis. He emphasized the importance of durable clinical responses, especially for patients who have persistent symptoms despite available treatments. Kyowa Kirin will continue to assess the drug’s clinical performance and plans to share additional findings at future medical conferences.

The company intends to seek regulatory approval first in the United States, then in Japan, and subsequently in other global markets.

CHMP Backs EU Approval of IMFINZI’s Perioperative Regimen for Early Gastric and Gastroesophageal Tumors

AstraZeneca’s IMFINZI (durvalumab), used together with the standard FLOT chemotherapy regimen (fluorouracil, leucovorin, oxaliplatin, and docetaxel), has received a positive recommendation for approval in the European Union for treating adults with resectable, early-stage, or locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The proposed treatment plan consists of IMFINZI plus chemotherapy before surgery (neoadjuvant), followed by the same combination after surgery (adjuvant), and then IMFINZI alone.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) based its endorsement on event-free survival (EFS) and overall survival (OS) outcomes from the Phase III MATTERHORN study. The EFS findings were presented at the 2025 ASCO Plenary Session and published concurrently in The New England Journal of Medicine.

According to a planned interim analysis, patients receiving the IMFINZI-based perioperative regimen experienced a 29% reduction in the risk of progression, recurrence, or death compared with chemotherapy alone (EFS HR 0.71; 95% CI 0.58–0.86; p<0.001). Median EFS had not yet been reached in the IMFINZI group, whereas it was 32.8 months in the control group. At one year, an estimated 78.2% of patients in the IMFINZI arm remained event-free, compared with 74.0% in the comparator group; at two years, the rates were 67.4% and 58.5%, respectively.

Final OS data showed a statistically significant and clinically relevant 22% reduction in the risk of death with IMFINZI plus FLOT compared with chemotherapy alone (OS HR 0.78; 95% CI 0.63–0.96; p=0.021). An estimated 69% of patients on the IMFINZI regimen were alive at three years, versus 62% in the control arm. The survival curves continued to diverge over successive time points, indicating increasing benefit over time. This improvement was seen across PD-L1 subgroups. OS results were presented at the ESMO Congress 2025.

Josep Tabernero, MD, PhD, principal investigator for MATTERHORN, noted that this recommendation represents a significant advance for patients in the EU, who historically face high recurrence rates and poor long-term outcomes despite surgery and chemotherapy. He highlighted that this is the first immunotherapy regimen to meaningfully extend survival in early gastric and GEJ cancers and could become a new standard of care if approved.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized that the MATTERHORN results show sustained and growing long-term survival benefits, with more than two-thirds of patients alive at three years. She described the CHMP opinion as an important milestone toward bringing another perioperative IMFINZI-based regimen to patients in Europe.

Gastric cancer is the world’s fifth leading cause of cancer-related death, with nearly one million cases diagnosed annually. In 2024, about 43,000 patients in the US, EU, and Japan received drug treatment for early-stage or locally advanced gastric or GEJ cancer, and this number is expected to rise to roughly 62,000 new cases per year in these regions by 2030.

The safety findings for the IMFINZI–FLOT combination were consistent with the established profiles of each therapy, and surgery completion rates were comparable between treatment arms. Rates of grade 3 or higher adverse events were similar as well (71.6% vs. 71.2%).

IMFINZI is already approved in the US and several other countries for this indication based on MATTERHORN results. Regulatory reviews remain ongoing in Japan and additional regions.

Tenpoint Therapeutics Ltd. Secures FDA Approval for YUVEZZI, the First Combination Eye Drop for Presbyopia

Tenpoint Therapeutics, Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, formerly known as BRIMOCHOL™ PF. It is the first and only dual-agent eye drop approved for the treatment of presbyopia in adults. Presbyopia, an age-related decline in near vision that usually begins around age 45, affects roughly two billion people worldwide, including 128 million in the United States. Broad U.S. commercial availability of YUVEZZI is anticipated in the second quarter of 2026.

The approval was supported by results from two Phase 3 clinical trials. The BRIO I study showed that the combination therapy provided superior benefits compared to each active ingredient alone, meeting a key FDA requirement for fixed-dose combination products. In the second Phase 3 trial, BRIO II, which used a vehicle control, YUVEZZI met all primary endpoints for improving near vision. Participants experienced statistically significant, three-line-or-greater gains in binocular uncorrected near visual acuity (BUNVA) lasting up to eight hours, without losing a line or more of binocular uncorrected distance visual acuity (BUDVA). YUVEZZI also demonstrated a favorable safety profile, with no treatment-related serious adverse events across more than 72,000 treatment days in BRIO II—the longest presbyopia safety study conducted to date. The most common side effects reported were headache, reduced vision, and temporary eye discomfort or irritation.

Eye redness was not frequently observed in YUVEZZI clinical trials. Reports of ocular hyperemia were low in both BRIO I and BRIO II. In BRIO II, the incidence of ocular hyperemia was lower among participants using YUVEZZI (2.8%) than among those receiving carbachol alone (10.7%).

“The FDA’s approval of YUVEZZI is an important achievement for the millions of Americans affected by presbyopia and its everyday challenges,” said Henric Bjarke, CEO of Tenpoint Therapeutics. “As the first dual-agent eye drop approved for this condition, YUVEZZI combines carbachol and brimonidine tartrate to provide sharp near vision with strong tolerability. People deserve treatments that are effective and easy to integrate into their daily routines, and YUVEZZI offers a meaningful new option. This milestone marks Tenpoint Therapeutics’ first groundbreaking therapy in our mission to drive innovation for the aging eye.”