The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.
Atacicept for the Treatment of IgA Nephropathy
PDUFA Date: July 7, 2026
The FDA has granted Priority Review to the BLA for atacicept in the treatment of adults with immunoglobulin A nephropathy (IgAN). Atacicept is a recombinant fusion protein that binds to and inhibits the activity of BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand), 2 cytokines implicated in the pathogenesis of IgAN.
The BLA is supported by data from the phase 3 ORIGIN 3 study (ClinicalTrials.gov Identifier: NCT04716231), in which patients were randomly assigned to receive atacicept or placebo subcutaneously (SC) once weekly. Findings showed treatment with atacicept led to a 46% proteinuria reduction from baseline (as measured by urine protein-to-creatinine ratio [UPCR]), with a statistically significant 42% reduction in UPCR compared with placebo (P <.0001) at week 36 (primary endpoint).
The novel therapy, if approved, would allow patients to self-administer treatment at home via a once-weekly SC injection using an autoinjector device.
Relacorilant for Platinum-Resistant Ovarian Cancer
PDUFA Date: July 11, 2026
Relacorilant, an oral glucocorticoid receptor antagonist, is being reviewed by the FDA for the treatment of platinum-resistant ovarian cancer. By selectively binding to the glucocorticoid receptor, relacorilant modulates cortisol activity, a known driver of tumor growth.
The NDA is supported by data from the pivotal phase 3 ROSELLA trial (ClinicalTrials.gov Identifier: NCT05257408). Participants were randomly assigned to receive relacorilant in combination with nab-paclitaxel or nab-paclitaxel monotherapy.
Results showed a significant improvement in progression free survival (PFS) with the combination regimen vs nab-paclitaxel alone (hazard ratio [HR], 0.70; P =.008). Moreover, relacorilant plus nab-paclitaxel chemotherapy reduced the risk of death by 35% compared with nab-paclitaxel alone (HR, 0.65; P =.0004). Median overall survival was 16.0 months and 11.9 months, respectively.
Adverse events were similar between the groups, indicating that the addition of relacorilant confers a benefit without additional safety risks.
Gedatolisib for HR+/HER2- PIK3CA Wild-Type Breast Cancer
PDUFA Date: July 17, 2026
Celcuity is seeking approval of gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) inhibitor, for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer.
The NDA is supported by data from the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial (ClinicalTrials.gov Identifier: NCT05501886). The study evaluated gedatolisib plus fulvestrant with or without palbociclib in patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Findings showed treatment with the triplet therapy (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared with fulvestrant (HR, 0.24 [95% CI, 0.17-0.35]; P <.0001). Median PFS was 9.3 months vs 2.0 months, respectively.
Among patients treated with doublet therapy (gedatolisib and fulvestrant), the risk of disease progression or death was reduced by 67% compared with fulvestrant (HR, 0.33 [95% CI, 0.24-0.48]; P <.0001). Median PFS was 7.4 months and 2.0 months, respectively.
Centanafadine for the Treatment of ADHD
PDUFA: July 24, 2026
Priority Review was granted to the NDA for centanafadine, a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor, for the treatment of attention-deficit hyperactivity disorder (ADHD).
The application was supported by data from four phase 3 trials evaluating centanafadine in children (ClinicalTrials.gov Identifier: NCT05428033), adolescents (ClinicalTrials.gov Identifier: NCT05257265), and adults (Study 1: ClinicalTrials.gov Identifier: NCT03605680; Study 2: ClinicalTrials.gov Identifier: NCT03605836) with ADHD.
Across these studies, patients were randomly assigned to receive centanafadine orally once daily or placebo. Findings showed treatment with centanafadine statistically significantly improved ADHD symptoms compared with placebo, as measured by the ADHD Rating Scale–5 in adolescents and children, and the ADHD Investigator Symptom Rating Scale in adults. In a post hoc analysis of adult ADHD patients, centanafadine was also found to improve patient-reported executive function and emotional dysregulation.
Subcutaneous Furosemide Autoinjector for Edema Treatment
PDUFA: July 26, 2026
The FDA is reviewing the supplemental NDA for Furoscix ReadyFlowTM autoinjector to treat edema in adults with chronic heart failure or chronic kidney disease. Designed to deliver an intravenous (IV)-equivalent dose of furosemide (80mg/mL) via a SC injection in under 10 seconds, the ReadyFlow would provide a rapid alternative to the currently approved Furoscix on-body infusor. The existing infusor system delivers 80mg of furosemide over 5 hours (30mg in the first hour, followed by 12.5mg per hour for the subsequent 4 hours).
The application for the Furoscix ReadyFlow autoinjector is supported by data from a randomized, open-label, single-dose, 2-way crossover phase 1 study (ClinicalTrials.gov Identifier: NCT06167707), which compared the pharmacokinetics and pharmacodynamics of SC furosemide administered via the autoinjector with IV furosemide in healthy adults aged 45 to 80 years.
Furosemide administered via the autoinjector demonstrated a bioavailability of 107.3% (90% CI, 103.9%-110.8%), meeting the standard 80%-125% bioequivalence criteria. Additionally, urine output, urinary sodium excretion and urinary potassium excretion were comparable between individuals who received furosemide via the autoinjector vs those who received IV administration at 6, 8, and 12 hours.