November 2026 Catalysts

FDA Decisions & PDUFA Dates

December 2026

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Oct 26 - Nov 1(8 catalysts)

VRTX$114.6BPDUFA

2mo

FDA PDUFA Date

CasgevyPhase 3

Sickle Cell Disease

Nov 1Confirmed

BTDFTOrphan✓PositiveSource

CRBP$153MPhase 2

Nov '26

CRB-601 monoclonal antibody Phase 2 Est. Readout

CRB-601 monoclonal antibody156

Solid Tumor

Nov 2026~Confirmed

00%

CT.gov

BMY$110.3BPhase 3

Nov '26

KarXT Phase 3 Est. Readout

KarXT274

Bipolar-I Disorder With Mania or Mania With Mixed Features

Nov 2026~Confirmed

✓PositiveCT.gov

AVEOPhase 2

Nov '26

Tivozanib Phase 2 Est. Readout

Tivozanib48

Renal Cell Carcinoma

Nov 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Nov '26

Dupilumab Phase 2 Est. Readout

Dupilumab96

Atopic Dermatitis (AD)

Nov 2026~Confirmed

00%

CT.gov

AGIO$2.0BPDUFA

2mo

PDUFA

Nov 1AI-detected

00%

Source

AGIO FDA decision page →

ESALYPhase 2

Nov '26

Lenvatinib Phase 2 Est. Readout

Lenvatinib50

Hepatocellular Carcinoma

Nov 2026~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Nov '26

JNT-517 Tablet Phase 3 Est. Readout

JNT-517 Tablet120

Phenylketonuria (PKU)

Nov 2026~Confirmed

✓PositiveCT.gov

Week 2Nov 2 - Nov 8(10 catalysts)

GSK$101.7BPhase 2

Nov '26

Dostarlimab Phase 2 Est. Readout

Dostarlimab154

Neoplasms, Rectal

Nov 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Nov '26

cemiplimab Phase 2 Est. Readout

Fixed Dose Combination (FDC) cemiplimab+fianlimab151

Melanoma

Nov 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 3

Nov '26

LOU064 (blinded) Phase 3 Est. Readout

LOU064 (blinded)100

Chronic Spontaneous Urticaria

Nov 2026~Confirmed

✓PositiveCT.gov

REGN$57.3BPhase 3

Nov '26

Cemiplimab Phase 3 Est. Readout

cemiplimab415

Advanced Cutaneous Squamous Cell Carcinoma

Nov 2026~Confirmed

00%

CT.gov

IQV$28.0BPhase 2

Nov '26

Bedaquiline, pretomanid and TBD09 Phase 2 Est. Readout

Bedaquiline, pretomanid and TBD09150

Drug Susceptible Pulmonary Tuberculosis

Nov 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Nov '26

Fitusiran Phase 3 Est. Readout

Fitusiran281

Hemophilia

Nov 2026~Confirmed

00%

CT.gov

INCY$19.6BPhase 2

Nov '26

parsaclisib + itacitinib Phase 2 Est. Readout

parsaclisib + itacitinib112

B-Cell Malignancies

Nov 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Nov '26

Mometasone furoate nasal spray (MFNS) Phase 3 Est. Readout

Mometasone furoate nasal spray (MFNS)210

Chronic Rhinosinusitis With Nasal Polyps

Nov 2026~Confirmed

✗NegativeCT.gov

SNY$100.0BPhase 2

Nov '26

Mometasone furoate nasal spray (MFNS) Phase 2 Est. Readout

Mometasone furoate nasal spray (MFNS)60

Chronic Rhinosinusitis With Nasal Polyps

Nov 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Nov '26

Acetaminophen and Ibuprofen Phase 2 Est. Readout

Acetaminophen and Ibuprofen90

Stomach Neoplasms

Nov 2026~Confirmed

00%

CT.gov

Week 3Nov 9 - Nov 15(41 catalysts)

MNPR$452MConference

2mo

Conference — ALXN1840

Nov 9AI-detected

Source

TAK$48.9BPDUFA

2mo

FDA PDUFA Date TAK-721 (priority)

TAK-771Phase 3

Primary Immunodeficiency Diseases (PID)

Nov 10Confirmed

✓PositiveSEC

BMY$110.3BPhase 3

Nov '26

Milvexian Phase 3 Est. Readout

Milvexian12,532

Ischemic Stroke; Ischemic Attack, Transient

Nov 2026~Confirmed

✓PositiveCT.gov

DSKYF$28.8BPhase 3

Nov '26

Taxane Phase 3 Est. Readout

Taxane1,157

Breast Cancer; HER2-positive; Metastatic

Nov 2026~Confirmed

✓PositiveCT.gov

REGN$57.3BPhase 2

Nov '26

Olatorepatide Phase 2 Est. Readout

Olatorepatide120

Overweight or Obesity

Nov 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Nov '26

Inavolisib Phase 3 Est. Readout

Inavolisib420

Breast Cancer

Nov 2026~Confirmed

✓PositiveCT.gov

SMMT$10.7BBLA Filing

2mo

BLA Filing — ivonescimab

Nov 14AI-detected

00%

Source

ATOS$17MPhase 2

Nov '26

(Z)-endoxifen Phase 2 Est. Readout

(Z)-endoxifen87

Breast Neoplasms

Nov 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Nov '26

REGN2810 Phase 2 Est. Readout

REGN281026

Non-small Cell Lung Cancer

Nov 2026~Confirmed

00%

CT.gov

SKBBYPhase 3

Nov '26

SKB264 Phase 3 Est. Readout

SKB264406

Metastatic Breast Cancer

Nov 2026~Confirmed

✓PositiveCT.gov

HSCS$6MPhase 3

Nov '26

Tadalafil Phase 3 Est. Readout

Tadalafil42

Fontan Palliation

Nov 2026~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Nov '26

carboplatin AUC 2/paclitaxel Phase 2 Est. Readout

carboplatin AUC 2/paclitaxel64

Esophageal Adenocarcinoma

Nov 2026~Confirmed

00%

CT.gov

BYSI$66MPhase 2

Nov '26

Plinabulin Phase 2 Est. Readout

Plinabulin17

Chemotherapy-induced Neutropenia

Nov 2026~Confirmed

00%

CT.gov

PCRX$879MPhase 2

Nov '26

Enekinragene Inzadenovec (PCRX-201) Phase 2 Est. Readout

Enekinragene Inzadenovec (PCRX-201)135

Osteoarthritis (OA) of the Knee

Nov 2026~Estimated

00%

CT.gov

BEIGF$40.9BPhase 2

Nov '26

Sonrotoclax Phase 2 Est. Readout

Dexamethasone246

Relapsed/Refractory Multiple Myeloma

Nov 2026~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 3

Nov '26

BGB-16673 Phase 3 Est. Readout

BGB-16673250

B-cell Malignancy

Nov 2026~Estimated

00%

CT.gov

TLPPF$2.6BPDUFA

2mo

FDA PDUFA Date TLX250-CDx (standard)

Zirconium Zr 89 GirentuximabPhase 2

Clear Cell Renal Cell Carcinoma

Nov 15Confirmed

✓PositiveSEC

SDZ.SW$34.2BPhase 3

Nov '26

CYB704 Phase 3 Est. Readout

CYB704183

Relapsing Multiple Sclerosis

Nov 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Nov '26

Isatuximab Phase 2 Est. Readout

Isatuximab40

Plasma Cell Myeloma Refractory

Nov 2026~Confirmed

00%

CT.gov

CAMX.ST$3.1BPhase 3

Nov '26

CAM2029 Phase 3 Est. Readout

CAM2029332

Gastro-enteropancreatic Neuroendocrine Tumor

Nov 2026~Confirmed

00%

CT.gov

BGNEPhase 2

Nov '26

Tislelizumab (BGB-A317) Phase 2 Est. Readout

Tislelizumab (BGB-A317)200

MSI-H/dMMR Solid Tumors

Nov 2026~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

Nov '26

ABBV-932 Phase 2 Est. Readout

ABBV-932315

Generalized Anxiety Disorder (GAD)

Nov 2026~Confirmed

00%

CT.gov

APTOF$4MPhase 2

Nov '26

Tuspetinib Phase 2 Est. Readout

Tuspetinib240

Leukemia, Myeloid, Acute

Nov 2026~Confirmed

00%

CT.gov

APGE$1.8BPhase 2

Nov '26

APG777 Phase 2 Est. Readout

APG777470

Atopic Dermatitis

Nov 2026~Confirmed

00%

CT.gov

LLY$1.0TPhase 2

Nov '26

LY3938577 Phase 2 Est. Readout

LY3938577100

Diabetes Mellitus, Type 2

Nov 2026~Confirmed

00%

CT.gov

VIR$1.5BPhase 2

Nov '26

Bulevirtide Phase 2 Est. Readout

Bulevirtide100

Viral Hepatitis

Nov 2026~Confirmed

00%

CT.gov

MCUJF$8MPhase 3

Nov '26

Pyridoxal Phosphate Phase 3 Est. Readout

Pyridoxal Phosphate15

Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency

Nov 2026~Confirmed

00%

CT.gov

CRVS$1.0BPhase 3

Nov '26

Soquelitinib Phase 3 Est. Readout

Soquelitinib150

Peripheral T-Cell Lymphoma, Not Otherwise Specified

Nov 2026~Confirmed

00%

CT.gov

JNGHFPhase 2

Nov '26

SHR-A1811 combined with Pyrotinib. Phase 2 Est. Readout

SHR-A1811 combined with Pyrotinib.364

HER2-expressing Advanced Solid Tumors

Nov 2026~Confirmed

00%

CT.gov

ZURA$356MPhase 2

Nov '26

Tibulizumab Dose A Phase 2 Est. Readout

Tibulizumab Dose A225

Hidradenitis Suppurativa (HS)

Nov 2026~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Nov '26

Bupivacaine Liposome Injection Phase 2 Est. Readout

Bupivacaine Liposome Injection96

Local Analgesia Via Nerve Block

Nov 2026~Confirmed

00%

CT.gov

ONC$400.5BPhase 2

Nov '26

Zanubrutinib Phase 2 Est. Readout

Zanubrutinib94

Chronic Lymphocytic Leukemia

Nov 2026~Confirmed

00%

CT.gov

KPRX$9MPhase 2

Nov '26

KIO-104 Phase 2 Est. Readout

KIO-10428

Macular Edema

Nov 2026~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 2

Nov '26

Tacabrutideg Phase 2 Est. Readout

BGB-16673645

B-cell Malignancy

Nov 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Nov '26

CAL101 Phase 2 Est. Readout

CAL101150

Idiopathic Pulmonary Fibrosis

Nov 2026~Confirmed

00%

CT.gov

KYKOY$8.2BPhase 2

Nov '26

DA-EPOCH Protocol Phase 2 Est. Readout

DA-EPOCH Protocol22

T Cell Lymphoma

Nov 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Nov '26

ABT-101 Phase 2 Est. Readout

ABT-10161

Advanced Solid Tumor

Nov 2026~Confirmed

00%

CT.gov

NAMS$3.5BPhase 2

Nov '26

obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks Phase 2 Est. Readout

obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks69

Dyslipidemias

Nov 2026~Confirmed

00%

CT.gov

NAMS$3.5BPhase 3

Nov '26

Obicetrapib Phase 3 Est. Readout

Obicetrapib9,541

Dyslipidemias

Nov 2026~Confirmed

00%

CT.gov

ALKS$7.5BPhase 2

Nov '26

ALKS 2680 Phase 2 Est. Readout

ALKS 2680126

Narcolepsy Type 2

Nov 2026~Confirmed

✓PositiveCT.gov

BNTX$22.8BPhase 2

Nov '26

RO7198457 intravenous (IV) Phase 2 Est. Readout

RO7198457 intravenous (IV)327

Colorectal Cancer Stage II

Nov 2026~Confirmed

✗NegativeCT.gov

Week 4Nov 16 - Nov 22(4 catalysts)

UCBJY$53.9BPhase 3

Nov '26

Zilucoplan Phase 3 Est. Readout

Zilucoplan8

Generalized Myasthenia Gravis

Nov 2026~Confirmed

00%

CT.gov

AZN$273.6BPhase 2

Nov '26

AZD0901 Phase 2 Est. Readout

AZD0901226

Gastric Cancer

Nov 2026~Confirmed

✗NegativeCT.gov

CELG-RIPhase 3

Nov '26

Deucravacitinib Phase 3 Est. Readout

Deucravacitinib774

Psoriatic Arthritis

Nov 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Nov '26

RO7269162 Phase 2 Est. Readout

RO7269162256

Alzheimer's Disease

Nov 2026~Confirmed

00%

CT.gov

Week 5Nov 23 - Nov 29(7 catalysts)

LGNDZPDUFA

3mo

FDA PDUFA Date LIGAND PHARMACEUTICALS INC (standard)

LIGAND PHARMACEUTICALS INCNDA

Nov 23AI-detected

00%

SEC

LIGAND PHARMACEUTICALS INC FDA decision page →

TECX$566MPhase 2

Nov '26

TX000045- Dose A Phase 2 Est. Readout

TX000045- Dose A180

Pulmonary Hypertension

Nov 2026~Confirmed

00%

CT.gov

AZN$273.6BPhase 2

Nov '26

AZD0754 Phase 2 Est. Readout

AZD075460

Metastatic Prostate Cancer

Nov 2026~Confirmed

~MixedCT.gov

PHM.MC$26.2BPhase 3

Nov '26

ICP-332 Tablets Phase 3 Est. Readout

ICP-332 Tablets552

Chronic Spontaneous Urticaria (CSU)

Nov 2026~Confirmed

00%

CT.gov

ISCO$3MPDUFA

3mo

FDA PDUFA Date (priority review)

Nov 27AI-detected

✓PositiveSource

NUVL$3.6BNDA Filing

3mo

NDA Filing — neladalkib

Nov 27AI-detected

00%

Source

PFE$143.7BPhase 3

Q4 '26

Rimegepant Phase 3 Est. Readout

Rimegepant723

Acute Migraine

Q4 2026~QConfirmed

00%

CT.gov

Week 6Nov 30 - Dec 6(22 catalysts)

SMMT$10.7BPDUFA

3mo

PDUFA — Ivonescimab

Nov 30AI-detected

00%

Source

SMMT FDA decision page →

TKPHF$47.7BPhase 2

Nov '26

TAK-360 Phase 2 Est. Readout

TAK-36092

Narcolepsy Type 2

Nov 2026~Confirmed

00%

CT.gov

TKPHF$47.7BPhase 3

Nov '26

TAK-360 Phase 3 Est. Readout

TAK-360500

Narcolepsy Type 2

Nov 2026~Estimated

00%

CT.gov

TXMD$9MPhase 3

Nov '26

GS1191-0445 injection Phase 3 Est. Readout

GS1191-0445 injection50

Hemophilia A

Nov 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Q4 '26

rilzabrutinib Phase 3 Est. Readout

Rilzabrutinib4

Immune Thrombocytopenia

Q4 2026~QConfirmed

00%

CT.gov

IMCR$1.5BPhase 2

Nov '26

IMC-R117C Phase 2 Est. Readout

IMC-R117C600

Cancer

Nov 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Nov '26

RNK08954 Phase 2 Est. Readout

RNK0895460

KRAS G12D Mutations

Nov 2026~Confirmed

00%

CT.gov

CUBT$1.1BPDUFA

Q4 '26

FDA PDUFA Date (priority review)

Q4 2026~QAI-detected

00%

Source

RHHBY$316.4BNDA Filing

3mo

NDA Filing — giredestrant

Nov 30AI-detected

00%

Source

QNCX$15MPhase 3

Q4 '26

Dexamethasone sodium phosphate Phase 3 Est. Readout

Dexamethasone sodium phosphate105

Ataxia Telangiectasia

Q4 2026~QConfirmed

00%

CT.gov

VTRS$17.9BPhase 2

Nov '26

MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN) Phase 2 Est. Readout

MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)60

Contraception

Nov 2026~Confirmed

00%

CT.gov

AURA$655MPhase 2

Q4 '26

AU-011 Phase 2 Est. Readout

AU-01124

Eye Cancer

Q4 2026~QConfirmed

00%

CT.gov

MRNA$25.4BPhase 2

Nov '26

mRNA-3745 Phase 2 Est. Readout

mRNA-374515

Glycogen Storage Disease

Nov 2026~Confirmed

00%

CT.gov

SKBBYPhase 3

Nov '26

A166 Phase 3 Est. Readout

A166365

HER2-positive Breast Cancer

Nov 2026~Confirmed

00%

CT.gov

BIOA$923MPhase 2

Nov '26

Oral BGE-102 Phase 2 Est. Readout

Oral BGE-102160

Obesity and Cardiovascular Risk

Nov 2026~Confirmed

00%

CT.gov

TAK$48.9BPhase 2

Nov '26

TAK-360 Phase 2 Est. Readout

TAK-36088

Idiopathic Hypersomnia

Nov 2026~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Nov '26

Anvumetostat Phase 2 Est. Readout

Anvumetostat329

Advanced MTAP-null Solid Tumors

Nov 2026~Confirmed

00%

CT.gov

RHHBY$316.4BRegulatory

3mo

Regulatory — Gazyva/Gazyvaro

Nov 30AI-detected

✓PositiveSource

VRTX$114.6BPDUFA

3mo

FDA PDUFA Date povetacicept (accelerated review)

PovetaciceptPhase 3

Primary Membranous Nephropathy

Nov 30Confirmed

✓PositiveSource

RHHBY$316.4BPDUFA

3mo

FDA PDUFA Date (priority review)

Nov 30AI-detected

✓PositiveSource

BAVA.CO$2.3BPhase 2

Nov '26

Jynneos Phase 2 Est. Readout

Jynneos970

Monkeypox (Mpox)

Nov 2026~Confirmed

00%

CT.gov

ARVN$495MPhase 2

Nov '26

ARV-806 Phase 2 Est. Readout

ARV-806159

KRAS G12D Mutation

Nov 2026~Confirmed

00%

CT.gov

October 2026 Full Calendar December 2026

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About PDUFA Dates in November 2026

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for November 2026. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.