FDA July 2026 Preview: Key Decisions Spanning Oncology, Nephrology, and Cardiology
核心洞察
The FDA faces a packed July 2026 with PDUFA dates for therapies targeting hepatocellular carcinoma (搜索), multiple myeloma (搜索), IgA nephropathy, and advanced breast cancer (搜索).
Elevar Therapeutics (搜索)' rivoceranib plus camrelizumab could become a new first-line option for unresectable hepatocellular carcinoma (搜索) based on phase 3 CARES-310 trial data.
Vera Therapeutics seeks accelerated approval for atacicept in IgA nephropathy after the ORIGIN phase 3 trial met its primary endpoint of reduced proteinuria at week 36.
The US Food and Drug Administration is set to issue decisions on more than a dozen therapies across multiple specialties in July 2026, with high-stakes rulings expected in oncology, nephrology, cardiology, and psychiatry. The upcoming Prescription Drug User Fee Act (PDUFA) dates reflect a wave of innovation spanning cell therapies, targeted small molecules, and novel delivery systems.
Oncology Decisions Dominate the Calendar
The oncology space accounts for several of the month's most anticipated decisions. Orca Bio (搜索)'s Orca-T, an investigational allogeneic T-cell immunotherapy, faces a July 6 PDUFA date for its Biologics License Application (BLA). The therapy is being evaluated for hematologic malignancies including acute leukemias and myelodysplastic syndromes, and has received both Regenerative Medicine Advanced Therapy and Orphan Drug designations from the FDA for the prevention of graft-versus-host disease or death in patients eligible for hematopoietic stem cell transplant.
Celcuity's gedatolisib, an investigational inhibitor of the phosphoinositide 3-kinase/AKT/mammalian target of rapamycin pathway, has a July 17 target action date. The New Drug Application (NDA) covers patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA wild-type advanced breast cancer (搜索), supported by results from the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial.
On July 23, Elevar Therapeutics (搜索) awaits a decision on its resubmitted NDA for rivoceranib in combination with camrelizumab as first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (搜索). Rivoceranib is an investigational oral vascular endothelial growth factor receptor tyrosine kinase inhibitor administered with camrelizumab, an anti-programmed death-1 antibody. The application is based on findings from the phase 3 CARES-310 trial.
The same day, Sanofi faces a revised PDUFA date for its BLA for the subcutaneous formulation of Sarclisa (isatuximab-irfc) in combination with approved standard-of-care regimens for multiple myeloma (搜索) across all currently approved US indications for the intravenous formulation. If approved, the subcutaneous formulation would be administered using an on-body injector.
Nephrology: Atacicept and the ORIGIN Data
Vera Therapeutics has a July 7 PDUFA date for its BLA seeking accelerated approval of atacicept in patients with immunoglobulin A nephropathy (搜索) (IgAN). Atacicept is an investigational soluble recombinant fusion protein that binds B-cell activating factor and A PRoliferation-Inducing Ligand. The ORIGIN phase 3 trial met its primary endpoint with reduced proteinuria at week 36 in a prespecified interim analysis. Vera also reported that across the ORIGIN program in IgAN, the safety profile of atacicept appeared comparable to placebo.
Cardiology: A Faster Route for Furosemide
MannKind (搜索)'s supplemental NDA for the FUROSCIX ReadyFlow Autoinjector (搜索) carries a July 26 PDUFA date. The device, an investigational alternative delivery system for the approved FUROSCIX on-body infusor, is designed to deliver subcutaneous furosemide in less than 10 seconds for the treatment of edema in adults with chronic heart failure (搜索) or chronic kidney disease (搜索). The application is supported by results from an open-label, randomized crossover study of 21 healthy volunteers in which the autoinjector demonstrated bioavailability comparable to intravenous furosemide and produced similar urine output and urinary sodium and potassium excretion at 6, 8, and 12 hours. MannKind reported that treatment was generally well tolerated with respect to injection-site pain.
Additional Decisions Across Specialties
In radiology, Ascelia Pharma's Orviglance faces a July 3 decision for use during contrast-enhanced liver magnetic resonance imaging in patients with severe kidney impairment. The NDA is supported by nine clinical studies, and Orviglance met the primary endpoint in the phase 3 SPARKLE trial by improving visualization of focal liver lesions in patients with impaired kidney function.
Otsuka's centanafadine, an investigational once-daily norepinephrine, dopamine, and serotonin reuptake inhibitor for attention-deficit/hyperactivity disorder (搜索) in children, adolescents, and adults, has a July 24 PDUFA date. A phase 3b study of adults with ADHD and comorbid anxiety found that centanafadine improved ADHD symptoms compared with placebo.
Viatris awaits a July 30 decision on its investigational low-dose estrogen combined hormonal contraceptive weekly patch, a once-weekly transdermal patch for women of childbearing potential with a body mass index below 30 kg/m². The application is supported by results from a multicenter, open-label, single-arm phase 3 study evaluating contraceptive efficacy, safety, and patch adhesion performance.
Looking Ahead: Endocrinology
Beyond July, Corcept Therapeutics has resubmitted its NDA for relacorilant, an oral glucocorticoid receptor antagonist that modulates cortisol activity, for the treatment of patients with Cushing's syndrome (搜索). The resubmission is supported by data from the pivotal GRACE trial, the phase 3 GRADIENT trial, a long-term extension study, and earlier-stage development data.