PDUFA Dates: July 2026

HER2-positive early breast cancer that didn't fully respond to neoadjuvant therapy — the patients who still have residual invasive disease after surgery face the highest recurrence risk.

Enhertu's post-neoadjuvant sBLA is the third HER2+ breast cancer indication in eighteen months — first metastatic, then May 2026's neoadjuvant approval, now post-neoadjuvant. DESTINY-Breast05 randomized patients with residual invasive disease after standard neoadjuvant therapy to Enhertu or T-DM1 (the prior standard of care). Enhertu cut recurrence or death by 53%. The post-neoadjuvant window is where adjuvant chemo plus endocrine therapy fails most patients with HER2+ disease, and the ADC mechanism — the bystander-killing effect that worked in metastatic — now applies to earlier-stage residual disease. AstraZeneca and Daiichi Sankyo continue building the deruxtecan platform indication by indication.

IgA nephropathy — autoimmune kidney damage driven by deposits of abnormal IgA antibodies in the kidney's filtering units.

Atacicept is a fusion protein that traps two B-cell survival factors at once — BAFF and APRIL. Both factors are required for the long-lived plasma cells that produce the galactose-deficient IgA1 that drives IgAN. Existing IgAN therapies target downstream consequences — corticosteroids in Tarpeyo, endothelin receptors in Filspari, complement in Fabhalta — but atacicept is the first to silence the upstream B-cell axis. Vera Therapeutics ran the Phase 3 ORIGIN trial against placebo on background standard of care. If approved, atacicept becomes the fourth FDA-approved IgAN therapy in three years, in a disease that had zero disease-modifying options before 2022.

Parkinson's disease — the motor symptoms come from progressive loss of dopamine neurons in the substantia nigra.

Tavapadon is a D1/D5-selective dopamine receptor partial agonist — a mechanism not approved in Parkinson's before. Existing dopamine agonists (pramipexole, ropinirole, rotigotine) hit D2 and D3 receptors and carry side-effect profiles dominated by impulse-control disorders, sleep attacks, and orthostatic hypotension that often limit dose. D1/D5 agonism in principle delivers motor benefit without that D2/D3 profile. AbbVie ran three Phase 3 trials (TEMPO-1, TEMPO-2, TEMPO-3) testing tavapadon as monotherapy in early PD and as a levodopa adjunct in later disease. If approved, it would be AbbVie's first major Parkinson's product in a space currently dominated by levodopa formulations and the older dopamine agonists.

Blastic plasmacytoid dendritic cell neoplasm — a rare and aggressive blood cancer that arises from precursor dendritic cells and affects roughly 1,000 US patients.

Pivekimab sunirine is an antibody-drug conjugate targeting CD123 (the IL-3 receptor alpha chain), which is highly expressed on BPDCN blasts. CD123 already has one approved drug for BPDCN — tagraxofusp (Elzonris, 2018), an IL-3/diphtheria-toxin fusion. Pivekimab takes the ADC approach to the same target: a humanized antibody conjugated to a DNA-alkylating payload. AbbVie inherited the program through the 2023 ImmunoGen acquisition for $10.1 billion. The program carries Breakthrough designation. If approved, BPDCN — vanishingly rare in pharma terms — would have two FDA-approved targeted therapies in eight years, both hitting CD123 from different mechanistic angles.