Upcoming June 2026 Prescription Drug User Fee Act dates include regulatory decisions for investigational therapies targeting COVID-19 infection prevention, complicated urinary tract infections, nicotine dependence, hyperphosphatemia, severe hypertriglyceridemia, and chronic thyroid eye disease.
Infectious Disease
Ensitrelvir
The US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2026, for Shionogi’s ensitrelvir, an investigational oral SARS-CoV-2 main protease inhibitor, for postexposure prophylaxis of COVID-19 infections. In the phase III SCORPIO-PEP trial, a 5-day course of ensitrelvir reduced the risk of symptomatic COVID-19 infections by 67% compared with placebo among household contacts exposed to an infected individual, with similar adverse event rates reported between treatment groups.
Source: Shionogi
Urology
Tebipenem HBr
The FDA has assigned a PDUFA target action date of June 18, 2026, for GSK’s New Drug Application (NDA) for tebipenem HBr for adult patients with complicated urinary tract infections (UTI), including pyelonephritis. Tebipenem HBr is an investigational oral treatment for complicated UTIs. In the phase III PIVOT-PO trial, tebipenem HBr demonstrated noninferiority compared with intravenous imipenem-cilastatin in overall response at the test-of-cure visit following the study’s early stop for efficacy. Researchers also reported clinical and microbiological response rates at the test-of-cure visit, with a safety profile generally similar to imipenem-cilastatin and other carbapenem antibiotics.
Source: GSK
Pulmonology
Cytisinicline
The FDA has assigned a PDUFA target action date of June 20, 2026, for Achieve Life Sciences’ NDA for cytisinicline for smoking cessation in adult patients with nicotine dependence. Cytisinicline is an investigational plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors. In the ORCA-OL safety study, patients received 3 mg of cytisinicline thrice daily for up to 52 weeks, with no new safety signals identified and adverse events predominantly mild or moderate.
Source: Achieve Life Sciences
Nephrology
Oxylanthanum Carbonate
The FDA has assigned a PDUFA target action date of June 29, 2026, for Unicycive Therapeutics’ resubmitted NDA for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. Oxylanthanum carbonate is an investigational oral phosphate binder that uses proprietary nanoparticle technology to deliver high phosphate-binding potency and reduce pill burden. The NDA is supported by data from multiple clinical and preclinical studies, including tolerability and bioequivalence studies, with the FDA reporting no concerns related to the therapy’s preclinical, clinical, or safety data in the original submission.
Source: Unicycive Therapeutics
Cardiology
Olezarsen
The FDA has assigned a PDUFA target action date of June 30, 2026, for Priority Review of Ionis Pharmaceuticals’ supplemental NDA for olezarsen to treat severe hypertriglyceridemia. Olezarsen is an investigational RNA-targeted therapy that lowers production of apolipoprotein C-III, a regulator of triglyceride metabolism in the blood. In the phase III CORE and CORE2 studies, olezarsen demonstrated placebo-adjusted triglyceride reductions of up to 72% and an 85% reduction in acute pancreatitis events. With nearly 90% of treated patients achieving triglyceride levels below 500 mg/dL, researchers reported favorable safety and tolerability findings.
Source: Ionis Pharmaceuticals
Ophthalmology
Veligrotug
The FDA has assigned a PDUFA target action date of June 30, 2026, for Viridian Therapeutics’ Biologics License Application for veligrotug for the treatment of thyroid eye disease. The application is supported by positive phase III THRIVE and THRIVE-2 trial data, in which veligrotug met primary and secondary endpoints in patients with active and chronic thyroid eye disease.
Source: Viridian Therapeutics
