Roche’s divarasib demonstrates superiority over approved KRAS G12C inhibitors in the Phase 3 Krascendo 1 head-to-head lung cancer trial, Vera Therapeutics’ Trutakna receives FDA accelerated approval as the first BAFF/APRIL inhibitor for IgA nephropathy, Rhythm Pharmaceuticals’ setmelanotide earns a notable NEJM publication of Phase 3 TRANSCEND data in acquired hypothalamic obesity, and Compass Pathways’ COMP360 psilocybin reports durable six-month response data from a second Phase 3 trial in treatment-resistant depression: the most significant clinical trial results 10 July 2026 has to offer from across the pipeline.
This week’s readouts spanned precision oncology, rare kidney disease, rare metabolic disease, and neuropsychiatry, delivering both regulatory milestones and high-impact journal publications. The head-to-head oncology result stands out as the week’s most notable development, representing the first Phase 3 trial to directly demonstrate that a next-generation targeted therapy can outperform approved agents within the same drug class in lung cancer. The remaining stories underscore a broader trend of clinical evidence maturing across rare disease and mental health, with new approvals and major publications reinforcing the translational progress from trial to treatment. Here, Life Science Daily News brings you the most significant clinical trial results 10 July 2026.
Roche’s Divarasib Demonstrates Superiority over Approved KRAS G12C Inhibitors in Phase 3 Lung Cancer Trial
This story was announced on 2 July and was not included in last week’s roundup. Given its clinical significance, we are covering it here.
Roche announced on 2 July positive results from the Phase 3 Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against approved first-generation KRAS G12C inhibitors sotorasib and adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). The study met its primary endpoint of progression-free survival as assessed by blinded independent central review, with divarasib achieving clinically meaningful and statistically significant improvements over the comparators. Statistical significance for overall survival, a key secondary endpoint, was also achieved at the interim analysis in this poor-prognosis patient population.
Krascendo 1 (ClinicalTrials.gov identifier: NCT06497556) is the only global head-to-head trial evaluating a KRAS G12C inhibitor in direct comparison with approved agents in this class. The Phase 3, randomised, open-label, multicentre study enrolled 338 adults who were randomised to receive either once-daily oral divarasib or either once-daily sotorasib or twice-daily adagrasib. The safety profile remained consistent with previously reported data, with no new safety signals detected and the most common treatment-related adverse events described as manageable and reversible. Numerical efficacy data, including median survival figures and hazard ratios, have not yet been disclosed; full results will be presented at an upcoming medical meeting and submitted to health authorities. The KRAS G12C mutation is found in approximately 14 per cent of NSCLC cases and is associated with poor prognosis. Divarasib received Breakthrough Therapy Designation from the FDA in 2022 and Orphan Drug Designation in 2026. Roche is advancing a comprehensive Phase 3 programme including a first-line chemotherapy-free combination trial (Krascendo 2) and an adjuvant monotherapy trial (Krascendo 3).
Vera Therapeutics’ Trutakna Receives FDA Accelerated Approval as First BAFF/APRIL Inhibitor for IgA Nephropathy
Vera Therapeutics announced on 7 July that the FDA has granted accelerated approval to Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Trutakna is the first and only approved therapy that targets both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), two cytokines that drive the immune activity underlying IgAN. The approval is based on a prespecified interim analysis of the ongoing Phase 3 ORIGIN 3 trial (NCT04716231), in which participants treated with Trutakna achieved a 46 per cent reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42 per cent reduction compared with placebo (p<0.0001) at 36 weeks. Proteinuria reduction was consistent across prespecified subgroups including age, sex, race, baseline eGFR, and baseline SGLT2 inhibitor use.
Trutakna is administered as a once-weekly 150 mg subcutaneous injection via an at-home autoinjector. The accelerated approval is based on proteinuria reduction as a surrogate endpoint; it has not been established whether Trutakna slows kidney function decline over the long term, and continued approval may be contingent upon verification of clinical benefit in the ongoing ORIGIN 3 trial, with eGFR results anticipated in the third quarter of 2026. The drug was generally well tolerated, with infections (32 per cent vs 28 per cent for placebo) and local administration reactions (30 per cent vs 5 per cent) the most common adverse events. No serious, severe, or opportunistic infections, or cases of hypogammaglobulinaemia, were observed in Trutakna-treated patients. IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide, affecting approximately 160,000 patients in the United States. At least 50 per cent of patients may progress to kidney failure or death within 10 to 20 years of diagnosis.
Rhythm Pharmaceuticals’ Setmelanotide Published in The New England Journal of Medicine for Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals announced on 8 July the publication of data from its pivotal Phase 3 TRANSCEND trial of setmelanotide in The New England Journal of Medicine. The study, the largest and longest placebo-controlled clinical trial ever conducted in patients with acquired hypothalamic obesity, evaluated setmelanotide, a melanocortin-4 receptor (MC4R) agonist, in adults and children aged four years and older.
In this 52-week, randomised, double-blind, placebo-controlled study, a total of 120 patients aged four years and older were randomised 2:1 to once-daily subcutaneous setmelanotide or placebo. Patients treated with setmelanotide (n=81) achieved a mean BMI reduction of 16.5 per cent from baseline, compared with a 3.3 per cent BMI increase in the placebo group (n=39), yielding a placebo-adjusted difference of 19.8 per cent (p<0.0001). Eighty per cent of patients on setmelanotide achieved a BMI reduction of five per cent or greater at 52 weeks, alongside clinically meaningful improvements in hunger. The drug was generally well tolerated with no new safety signals observed. Setmelanotide (IMCIVREE) was approved by the FDA in March 2026 as the first and only therapy for acquired hypothalamic obesity in adults and children aged four years and older. The European Medicines Agency’s Committee for Medicinal Products for Human Use also recommended marketing authorisation in this indication in March 2026, and a regulatory submission is currently under review in Japan. Acquired hypothalamic obesity is a rare condition characterised by accelerated and sustained weight gain caused by hypothalamic injury, most frequently following the growth or treatment of craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumours.
Compass Pathways’ COMP360 Psilocybin Reports Durable Six-Month Response in Second Phase 3 Trial for Treatment-Resistant Depression
Compass Pathways announced on 7 July the 26-week results from Part B of its second ongoing Phase 3 COMP006 trial evaluating COMP360, a synthetic formulation of psilocybin, in patients with treatment-resistant depression (TRD). The findings confirm a rapid onset and durable antidepressant profile, building on previously reported results from the first Phase 3 trial, COMP005.
The COMP006 trial enrolled nearly 600 patients with highly chronic TRD, with current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within this severe population, 39 per cent of participants in the 25 mg arm achieved a clinically meaningful reduction of 25 per cent or greater in MADRS scores by week 6 following two fixed doses of COMP360, and this response was maintained through week 26. This represents an increase from the 25 per cent response rate observed in COMP005 following a single dose, supporting the potential benefit of a second dose in enhancing clinical outcomes for some patients. COMP360 demonstrated a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events being transient and predominantly occurring on the day of dosing. Compass Pathways has initiated a rolling New Drug Application submission to the FDA and is building out its commercial infrastructure in preparation for a potential US launch.
Looking Ahead
This week’s results reflect a pipeline reaching a point of maturation across several fronts. In precision oncology, the era of best-in-class competition within targeted drug classes is now underway, with head-to-head data set to determine which agents define the next standard of care. In rare disease, novel mechanisms are translating into approvals and high-impact publications in quick succession, closing the gap between clinical evidence and patient access. And in neuropsychiatry, a psilocybin-based therapy continues to navigate a traditional regulatory pathway, with a rolling NDA now under way and durable Phase 3 data from two independent trials supporting its progress. Life Science Daily News will continue to bring you accurate, timely coverage of the clinical developments that matter most across the global life sciences pipeline.
This clinical trials roundup is produced by the Life Science Daily News editorial team. All stories are selected and written independently.
