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2026 FDA PDUFA Calendar

Every upcoming FDA decision (PDUFA) date, drug, company, indication, run-up history, and market-cap cohort base rates. Tap any name for the full facts.
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Subscribing keeps it current: new dates and changes arrive automatically. 90 entries have a confirmed date and appear on that single day. 328 are guided only to a month or quarter, so they span that whole window and are prefixed with ~. We do not place an estimate on a specific day, because in a calendar app a guess looks exactly like a confirmed FDA date.
Run-up context, measured from a uniform T-120 baseline. Across 1,829 FDA decisions since 2020, the median peak gain from 120 trading days out was 17.7%, while the median move from T-120 to the day before the decision was 1.8%. The gap between those two numbers is the point: most of the move happens before the decision and is usually given back. 96% of events have a full T-120 window; the rest are excluded rather than back-filled. Full study. Past behaviour, not a forecast, and not investment advice.
Where 2026’s decisions clusterLargeMidSmallMicroNanoJULAUGSEPOCTNOVDECWeek of Jul 27 · 3 decisions · 1 Micro, 1 Small, 1 Large CAPR OTLK VTRS3Week of Aug 3 · 1 decision · 1 Large MRNAWeek of Aug 10 · 1 decision · 1 Mid LNTHWeek of Aug 17 · 6 decisions · 1 Small, 1 Mid, 2 Large, 2 Unlisted BMY BNTX CAPR CTMX EVAX RARE6Week of Aug 24 · 5 decisions · 1 Small, 4 Large GILD JAZZ ONC RPRX ZYME5Week of Aug 31 · 1 decision · 1 Large REGNWeek of Sep 7 · 1 decision · 1 Mid TLXWeek of Sep 14 · 3 decisions · 2 Mid, 1 Large NUVL RARE RPRX3Week of Sep 21 · 3 decisions · 1 Mid, 1 Large, 1 Unlisted INCY IONS MIRM3Week of Sep 28 · 5 decisions · 1 Nano, 1 Mid, 2 Large, 1 Unlisted BFRI PFE PTGX ROIV TAK5Week of Oct 5 · 1 decision · 1 Large MRKWeek of Oct 12 · 1 decision · 1 Large VTRSWeek of Oct 19 · 1 decision · 1 Small PHARWeek of Oct 26 · 4 decisions · 1 Micro, 1 Mid, 2 Large AGIO GSK INO IONS4Week of Nov 9 · 3 decisions · 1 Nano, 2 Large BTAI CYTK SMMT3Week of Nov 16 · 1 decision · 1 Small SVRAWeek of Nov 23 · 2 decisions · 1 Mid, 1 Large BBIO NUVLWeek of Nov 30 · 6 decisions · 1 Mid, 5 Large BAYRY COGT EXEL REGN RHHBY VRTX6Week of Dec 7 · 2 decisions · 1 Small, 1 Mid ANAB VNDAWeek of Dec 14 · 1 decision · 1 Large RHHBYWeek of Dec 21 · 2 decisions · 2 Mid MLYS PRAXWeek of Dec 28 · 1 decision · 1 Mid COGT54 scheduled FDA decisions across 25 weeks, stacked by market-cap tier · plus 12 more dated only to Q4. Hover a bar for the week’s tickers.
June 2026
GSK / SPRO · 2026-06-17 · ✓ Approved
Tebipenem HBr (SPR994): Complicated urinary tract infection (cUTI)…
ACHV · 2026-06-20 · ✕ CRL
Cytisinicline: Smoking cessation of cigarettes
UNCY · 2026-06-29 · ✕ CRL
Oxylanthanum Carbonate (OLC): Kidney disease
ARQT · 2026-06-29 · ✓ Approved
ZORYVE (roflumilast) Cream 0.3%: Plaque Psoriasis in Children Ages 2 to 5
LNTH · 2026-06-29 · ✕ CRL
LNTH-2501 (Gallium-68 edotreotide): Neuroendocrine tumors (NETs) in adult and…
AZN · 2026-06-12 · ✓ Approved
Truqap: Dephosphorylated Phosphatase and Tensin…
VRDN · 2026-06-26 · ✓ Approved
Veligrotug (VRDN-001): Thyroid Eye Disease (TED)
IONS · 2026-06-24 · ✓ Approved
TRYNGOLZA (olezarsen): Severe hypertriglyceridemia
July 2026
VERA · 2026-07-07 · ✓ Approved
Atacicept: IgA Nephropathy
CELC · 2026-07-14 · ✓ Approved
REVTORPYK (gedatolisib): HR+/HER2- advanced breast cancer
VTRS · 2026-07-30
Approved: MR-100A-01(Low dose estrogen weekly patch…: Contraception
August 2026
MRNA · 2026-08-05
mRNA-1010: Seasonal influenza in U.S. adults 50 years of…
LNTH · 2026-08-13
Florquinitau (MK-6240): Alzheimer's disease
ALPMY / MRK / PFE · 2026-07-10 · ✓ Approved
KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv): Muscle-invasive bladder cancer (MIBC)
BMY · 2026-08-17
iberdomide, daratumumab, and dexamethasone…: Relapsed/refractory multiple myeloma (RRMM)
CAPR · 2026-08-22
Deramiocel (CAP-1002): Duchenne Muscular Dystrophy (DMD)
RARE · 2026-08-23
DTX401 AAV gene therapy (pariglasgene…: Glycogen Storage Disease Type Ia (GSDIa)
BIIB · 2026-07-13 · ✓ Approved
LEQEMBI IQLIK (lecanemab-irmb): Early Alzheimer's disease (at-home initiation dose)
JAZZ / ONC / ZYME · 2026-08-25
Ziihera (zanidatamab-hrii): First-line HER2-positive gastroesophageal…
GILD · 2026-08-27
Bictegravir and Lenacapavir: HIV
REGN · 2026-08-31
Garetosmab: Fibrodysplasia Ossificans Progressiva (FOP)
September 2026
TLX · 2026-09-11
TLX101-Px: Recurrent or progressive glioma (brain cancer)
NUVL / RPRX · 2026-09-18
Zidesamtinib (NVL-520): ROS1 Non-small cell lung cancer (NSCLC)
OTSKY / CNS · 2026-07-24
Centanafadine: ADHD in children, adolescents, and adults
ABEO / RARE · 2026-09-19
UX111: Sanfilippo syndrome type A (MPS IIIA)
MRK · 2026-09-21
WINREVAIR (sotatercept-csrk): Pulmonary arterial hypertension (PAH, WHO*…
IONS · 2026-09-22
Zilganersen (ION373): Alexander disease
PRAX · 2026-09-27
Relutrigine (PRAX-562): Developmental epileptic encephalopathies…
BFRI · 2026-09-28
Ameluz (aminolevulinic acid hydrochloride)…: Basal cell carcinoma
TAK · 2026-09-30
Oveporexton (TAK-861-2001): Narcolepsy type 1 (NT1)
PTGX · 2026-09-30
Rusfertide: Polycythemia vera
PFE / ROIV · 2026-09-30
Brepocitinib: Dermatomyositis (DM)
NVO · 2026-09-30
Mim8: Hemophilia A
AZN · 2026-09-30
Enhertu (trastuzumab deruxtecan): HER2-positive early breast cancer
October 2026
RHHBY · 2026-10-09
Tecentriq (atezolizumab) and Tecentriq…: Stage III colon cancer
MRK · 2026-10-10
Ifinatamab deruxtecan (DS-7300): Extensive-stage small cell lung cancer (SCLC)
IRD / VTRS · 2026-10-17
MR-141 (phentolamine ophthalmic solution…: Presbyopia
PHAR · 2026-10-24
Leniolisib: Activated phosphoinositide 3-kinase delta…
INO · 2026-10-30
INO-3107: HPV 6 and HPV 11-associated Recurrent…
November 2026
BTAI · 2026-11-14
IGALMI® (dexmedetomidine): Agitation associated with bipolar I or II…
SMMT · 2026-11-14
Ivonescimab plus platinum-doublet…: EGFR-mutated, locally advanced or metastatic…
SVRA · 2026-11-22
MOLBREEVI (Molgradex): Autoimmune pulmonary alveolar proteinosis…
BBIO · 2026-11-27
BBP-418: Limb Girdle Muscular Dystrophy Type 2i…
NUVL · 2026-11-27
Neladalkib (NVL-655): ALK non-small cell lung cancer (NSCLC)
VRTX · 2026-11-30
Povetacicept (ALPN-303): Lupus nephritis, IgA nephropathy
RHHBY · 2026-11-30
Giredestrant: Early breast cancer
BAYRY · 2026-11-30
HYRNUO (sevabertinib): HER2-mutated non-small cell lung cancer…
December 2026
EXEL · 2026-12-03
XL092 with atezolizumab: Colorectal Cancer (CRC)
ANAB / VNDA · 2026-12-12
Imsidolimab (ANB019): Generalized pustular psoriasis
RHHBY · 2026-12-18
Giredestrant in combination with everolimus: ER-positive advanced breast cancer
MLYS · 2026-12-22
Lorundrostat: Uncontrolled hypertension (uHTN) or resistant…
VTRS · 2026-12-27
MR-107A-02: Pain
COGT · 2026-12-30
Bezuclastinib: Non-Advanced Systemic Mastocytosis
NVO · Q4 2026 (est.)
AM833 (CagriSema): Obesity
TAK · Q4 2026 (est.)
Rusfertide: Polycythemia vera
ABBV · Q4 2026 (est.)
Tavapadon: Early Parkinson’s disease
RHHBY · Q4 2026 (est.)
Lunsumio + Polivy: 2L+ Diffuse Large B-Cell Lymphoma (DLBCL)
ABBV · Q4 2026 (est.)
RINVOQ (upadacitinib): Non-segmental vitiligo (NSV)
AZN / GH · Q4 2026 (est.)
Camizestrant: Hormone Receptor-Positive/Human Epidermal…
GILD / MRK · Q4 2026 (est.)
Trodelvy (sacituzumab govitecan-hziy) plus…: Inoperable (unresectable) locally advanced or…
AZN · Q4 2026 (est.)
Gefurulimab: Generalised myasthenia gravis
NVS · Q4 2026 (est.)
Pluvicto (lutetium (177Lu) vipivotide…: End-stage prostate cancer
RHHBY · Q4 2026 (est.)
Gazyva: Systemic Lupus Erythematosus
BAYRY · Q4 2026 (est.)
KERENDIA (finerenone): Type 1 Diabetes and Chronic Kidney Disease
LLY · Q4 2026 (est.)
Tirzepatide: Cardiovascular outcomes
PFE · Q4 2026 (est.)
TUKYSA, trastuzumab, and pertuzumab: HER2+ Metastatic Breast Cancer
AZN · Q4 2026 (est.)
Ultomiris (ravulizumab): Immunoglobulin A nephropathy