October 2026 Catalysts

FDA Decisions & PDUFA Dates

November 2026

120

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Sep 28 - Oct 4(12 catalysts)

BAYRY$42.5BPhase 2

Oct '26

Larotrectinib monotherapy Phase 2 Est. Readout

Larotrectinib monotherapy13

Differentiated Thyroid Cancer

Oct 2026~Confirmed

00%

CT.gov

TPST$18MTrial Start

Trial Start — In Vivo CAR-T

Oct 1AI-detected

Source

IONS$12.2BPDUFA

Oct '26

FDA PDUFA Date drug candidate (standard)

drug candidateNDA

disease condition

Oct 2026~AI-detected

✓PositiveSEC

ARGX$56.5BPhase 3

Oct '26

Efgartigimod PH20 SC Phase 3 Est. Readout

Efgartigimod PH20 SC173

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Oct 2026~Confirmed

✓PositiveCT.gov

ANGO$502MEarnings

ANGO Earnings Report

Oct 1Confirmed

Source

GSK$101.7BPDUFA

FDA PDUFA Date Belumosudil (priority)

BelumosudilNDA

chronic graft-versus-host disease

Oct 1AI-detected

✅ApprovedSEC

ATALF$47MConference

Conference

Oct 1AI-detected

Source

NUVB$1.9BPDUFA

FDA PDUFA Date NUV-868 (priority)

NUV-868NDA

prostate cancer

Oct 1AI-detected

00%

SEC

NUV-868 FDA decision page →

COCP$14MPhase 2

Oct '26

CDI-988 Phase 2 Est. Readout

CDI-98840

Norovirus

Oct 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Oct '26

Iptacopan (LNP023) Phase 2 Est. Readout

Iptacopan (LNP023)170

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Oct 2026~Confirmed

✗NegativeCT.gov

INCY$19.6BConference

Conference

Oct 1AI-detected

Source

CNTB$126MConference

Conference — ATTR

Oct 2AI-detected

Source

Week 2Oct 5 - Oct 11(14 catalysts)

PPCB$84MEarnings

PPCB Earnings Report

Oct 5Confirmed

Source

SOBI.ST$14.6BPhase 3

Oct '26

Pacritinib Phase 3 Est. Readout

Physician's Choice medications407

Primary Myelofibrosis

Oct 2026~Confirmed

00%

CT.gov

MRNA$25.4BPhase 2

Oct '26

mRNA-1189 Phase 2 Est. Readout

mRNA-1189867

Epstein-Barr Virus Infection

Oct 2026~Confirmed

00%

CT.gov

VERA$2.5BPDUFA

FDA PDUFA Date VTR-297 (standard)

AtaciceptPhase 3

IgA Nephropathy (IgAN)

Oct 6AI-detected

✓PositiveSEC

CELG-RIPhase 3

Oct '26

BMS-986278 Phase 3 Est. Readout

BMS-9862781,255

Idiopathic Pulmonary Fibrosis

Oct 2026~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Oct '26

Benralizumab Phase 3 Est. Readout

Benralizumab4

Asthma

Oct 2026~Confirmed

✗NegativeCT.gov

REGN$57.3BPhase 3

Oct '26

Dupilumab Phase 3 Est. Readout

Dupilumab880

Atopic Dermatitis (AD)

Oct 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Oct '26

Tobemstomig Phase 2 Est. Readout

Axitinib199

Renal Cell Carcinoma

Oct 2026~Confirmed

00%

CT.gov

NEOG$2.0BEarnings

NEOG Earnings Report

Oct 8Confirmed

Source

NRIX$1.8BEarnings

NRIX Earnings Report

Oct 8Confirmed

Source

BYRN$134MEarnings

BYRN Earnings Report

Oct 8Confirmed

Source

PFE$143.7BPhase 3

Oct '26

Rimegepant Phase 3 Est. Readout

Rimegepant200

Acute Migraine

Oct 2026~Confirmed

✗NegativeCT.gov

INCY$19.6BPhase 3

Oct '26

Ruxolitinib Cream Phase 3 Est. Readout

Ruxolitinib Cream550

Nonsegmental Vitiligo With Genital Involvement

Oct 2026~Confirmed

00%

CT.gov

AAGH$6MConference

Conference

Oct 9AI-detected

Source

Week 3Oct 12 - Oct 18(38 catalysts)

CELG-RIPhase 2

Oct '26

CC-92480 Phase 2 Est. Readout

CC-92480260

Multiple Myeloma

Oct 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 3

Oct '26

Ravulizumab Phase 3 Est. Readout

Ravulizumab202

Paroxysmal Nocturnal Hemoglobinuria

Oct 2026~Confirmed

✗NegativeCT.gov

JNJ$549.8BEarnings

JNJ Earnings Report

Oct 13Confirmed

Source

GSK$101.7BPhase 2

Oct '26

Cobolimab Phase 2 Est. Readout

Cobolimab83

Melanoma

Oct 2026~Confirmed

00%

CT.gov

BMRN$10.6BPhase 3

Oct '26

INZ-701 Phase 3 Est. Readout

INZ-70112

Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency

Oct 2026~Confirmed

✓PositiveCT.gov

SNY$100.0BPhase 3

Oct '26

Itepekimab (SAR440340) Phase 3 Est. Readout

Itepekimab (SAR440340)231

Chronic Rhinosinusitis With Nasal Polyps

Oct 2026~Confirmed

00%

CT.gov

GSK$101.7BPhase 2

Oct '26

Momelotinib Phase 2 Est. Readout

Momelotinib56

Primary Myelofibrosis

Oct 2026~Confirmed

00%

CT.gov

RAPP$1.8BPhase 2

Oct '26

RAP-219 Phase 2 Est. Readout

RAP-219224

Focal Onset Seizures

Oct 2026~Confirmed

00%

CT.gov

NVSEF$269.0BPhase 3

Oct '26

Inclisiran Phase 3 Est. Readout

Inclisiran16,124

Atherosclerotic Cardiovascular Disease

Oct 2026~Confirmed

00%

CT.gov

HSCSWPhase 3

Oct '26

Omega-3 fatty acids (fish oil) Phase 3 Est. Readout

omega-3 fatty acids (fish oil)25,119

Cancer

Oct 2026~Confirmed

00%

CT.gov

CELG-RIPhase 2

Oct '26

Relatlimab Phase 2 Est. Readout

Relatlimab38

Advanced Gastric Cancer

Oct 2026~Confirmed

00%

CT.gov

KZIA$11.2BPhase 2

Oct '26

Abemaciclib Phase 2 Est. Readout

Abemaciclib50

CDK Gene Mutation

Oct 2026~Confirmed

00%

CT.gov

IMGNPhase 2

Oct '26

IMGN853 Phase 2 Est. Readout

IMGN85350

Endometrial Cancer

Oct 2026~Confirmed

00%

CT.gov

IMCR$1.5BPhase 2

Oct '26

Brenetafusp Phase 2 Est. Readout

Brenetafusp410

Select Advanced Solid Tumors

Oct 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Oct '26

VV1 Phase 2 Est. Readout

VV187

Melanoma

Oct 2026~Confirmed

00%

CT.gov

LLY$1.0TPhase 3

Oct '26

Baricitinib Phase 3 Est. Readout

Baricitinib595

Systemic Juvenile Idiopathic Arthritis

Oct 2026~Confirmed

✓PositiveCT.gov

NVS$284.2BPhase 2

Oct '26

ribociclib Phase 2 Est. Readout

Bicalutamide37

Triple Negative Breast Cancer

Oct 2026~Confirmed

00%

CT.gov

MPLT$1.2BPhase 2

Oct '26

ML-004 (IR)/(ER) tablet Phase 2 Est. Readout

ML-004 (IR)/(ER) tablet150

Autism Spectrum Disorder

Oct 2026~Confirmed

~MixedCT.gov

PHM.MC$26.2BPhase 2

Oct '26

ICP-332 Tablets Phase 2 Est. Readout

ICP-332 Tablets172

Chronic Spontaneous Urticaria (CSU)

Oct 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Oct '26

carmustine, etoposide, cytarabine, melphalan Phase 2 Est. Readout

carmustine, etoposide, cytarabine, melphalan59

Diffuse Large B-cell Lymphoma (DLBCL)

Oct 2026~Confirmed

00%

CT.gov

CLDX$2.5BPhase 2

Oct '26

Barzolvolimab Phase 2 Est. Readout

barzolvolimab120

Prurigo Nodularis

Oct 2026~Confirmed

✗NegativeCT.gov

AZNCF$290.6BPhase 2

Oct '26

Osimertinib Phase 2 Est. Readout

Osimertinib48

Non-Small Cell Lung Cancer

Oct 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 3

Oct '26

[O-15]-Water PET Myocardial Perfusion Imaging (MPI) Phase 3 Est. Readout

[O-15]-Water PET Myocardial Perfusion Imaging (MPI)215

Coronary Artery Disease

Oct 2026~Confirmed

00%

CT.gov

PHIL.MI$1.0BPhase 2

Oct '26

Onfekafusp alfa Phase 2 Est. Readout

Onfekafusp alfa226

Glioblastoma

Oct 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Oct '26

YL201 for Injection Phase 2 Est. Readout

YL201 for Injection990

Advanced Solid Tumor

Oct 2026~Confirmed

00%

CT.gov

MIRM$6.5BPhase 3

Oct '26

Maralixibat Phase 3 Est. Readout

Maralixibat90

Biliary Atresia

Oct 2026~Confirmed

00%

CT.gov

GILD$153.7BPhase 2

Oct '26

Sacituzumab Govitecan-hziy Phase 2 Est. Readout

Sacituzumab Govitecan-hziy53

Triple Negative Breast Cancer

Oct 2026~Confirmed

00%

CT.gov

SUPN$2.6BPhase 2

Oct '26

SPN-817 Phase 2 Est. Readout

SPN-817258

Focal Onset Seizures

Oct 2026~Confirmed

00%

CT.gov

CORT$8.6BPhase 2

Oct '26

Dazucorilant 300 mg Phase 2 Est. Readout

Dazucorilant 300 mg279

Amyotrophic Lateral Sclerosis

Oct 2026~Confirmed

00%

CT.gov

VNDA$349MPhase 2

Oct '26

iloperidone Phase 2 Est. Readout

iloperidone240

Schizophrenia

Oct 2026~Confirmed

00%

CT.gov

ABOS$163MPhase 2

Oct '26

sabirnetug Phase 2 Est. Readout

sabirnetug542

Alzheimer Disease

Oct 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 3

Oct '26

BHV-7000 Phase 3 Est. Readout

BHV-7000390

Focal Epilepsy

Oct 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Oct '26

Glofitamab Phase 2 Est. Readout

89Zr-Df-IAB22M2C211

Non-Hodgkins Lymphoma

Oct 2026~Confirmed

00%

CT.gov

VTRS$17.9BPDUFA

FDA PDUFA Date MR-141

Oct 17AI-detected

✅ApprovedSource

VTRS$17.9BNDA Filing

NDA Filing - MR-141

Oct 17AI-detected

00%

Source

BGNEPhase 2

Oct '26

BGB-45035 Phase 2 Est. Readout

BGB-4503549

Rheumatoid Arthritis

Oct 2026~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Oct '26

Tarlatamab Phase 2 Est. Readout

Tarlatamab40

Small Cell Lung Cancer

Oct 2026~Confirmed

00%

BTDFTOrphanCT.gov

ISCO$3MConference

Conference

Oct 18AI-detected

Source

Week 4Oct 19 - Oct 25(16 catalysts)

BTSG$12.8BEarnings

BTSG Earnings Report

Oct 19Confirmed

Source

SMMT$10.7BEarnings

SMMT Earnings Report

Oct 19Confirmed

Source

PFE$143.7BPhase 2

Oct '26

PF-07264660 Phase 2 Est. Readout

PF-07264660340

Atopic Dermatitis

Oct 2026~Confirmed

00%

CT.gov

ELV$84.4BEarnings

2mo

ELV Earnings Report

Oct 20Confirmed

Source

DSKYF$28.8BPhase 2

Oct '26

DS-3939a Phase 2 Est. Readout

DS-3939a590

Advanced Solid Tumor

Oct 2026~Confirmed

00%

CT.gov

GILD$153.7BPDUFA

2mo

FDA PDUFA Date lenacapavir (standard)

LenacapavirPhase 3

HIV Prevention

Oct 20AI-detected

BTDFT✅ApprovedSEC

DGX$21.6BEarnings

2mo

DGX Earnings Report

Oct 20Confirmed

Source

PHM.MC$26.2BPhase 3

Oct '26

Tralokinumab + TCS Phase 3 Est. Readout

Tralokinumab + TCS195

Atopic Dermatitis

Oct 2026~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Oct '26

SEP-363856 Phase 3 Est. Readout

SEP-363856522

Schizophrenia

Oct 2026~Confirmed

✓PositiveCT.gov

ABT$154.0BEarnings

2mo

ABT Earnings Report

Oct 21Confirmed

Source

AMGN$182.2BPhase 3

Oct '26

Dazodalibep Phase 3 Est. Readout

Dazodalibep434

Sjögren's Syndrome (SS)

Oct 2026~Confirmed

✓PositiveCT.gov

RHHBY$316.4BPhase 3

Oct '26

Ocrelizumab Phase 3 Est. Readout

Ocrelizumab927

Multiple Sclerosis

Oct 2026~Confirmed

✗NegativeCT.gov

ZNTL$263MConference

2mo

Conference — azenosertib

Oct 23AI-detected

Source

IDYA$2.7BConference

2mo

Conference — Darovasertib

Oct 23AI-detected

Source

CMPX$364MConference

2mo

Conference — tovecimig

Oct 23AI-detected

Source

ATALF$47MConference

2mo

Conference

Oct 25AI-detected

Source

Week 5Oct 26 - Nov 1(40 catalysts)

GALDY$50.4BPhase 3

Oct '26

Nemolizumab Phase 3 Est. Readout

Nemolizumab500

Prurigo Nodularis

Oct 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 3

Oct '26

Inclisiran sodium 300 mg Phase 3 Est. Readout

Inclisiran sodium 300 mg609

Coronary Artery Disease

Oct 2026~Confirmed

✓PositiveCT.gov

AZN$273.6BPhase 2

Oct '26

Lenvatinib Phase 2 Est. Readout

Lenvatinib294

Hepatocellular Carcinoma

Oct 2026~Confirmed

✓PositiveCT.gov

RHHBY$316.4BPhase 3

Oct '26

Risdiplam Phase 3 Est. Readout

Risdiplam259

Muscular Atrophy, Spinal

Oct 2026~Confirmed

✓PositiveCT.gov

BGNEPhase 2

Oct '26

Zanubrutinib Phase 2 Est. Readout

Zanubrutinib45

Refractory Mantle Cell Lymphoma

Oct 2026~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 3

Oct '26

Odevixibat Phase 3 Est. Readout

Odevixibat180

Alagille Syndrome

Oct 2026~Confirmed

00%

CT.gov

REC.MI$11.3BPhase 2

Oct '26

Pasireotide Diaspartate Phase 2 Est. Readout

Pasireotide Diaspartate93

Post-Bariatric Hypoglycemia

Oct 2026~Confirmed

00%

CT.gov

MRK$281.2BPDUFA

2mo

FDA PDUFA Date tildrakizumab

tildrakizumabPhase 2

Psoriasis

Oct 29Confirmed

✅ApprovedSource

GILD$153.7BPDUFA

Oct '26

FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)

LenacapavirPhase 3

HIV Prevention

Oct 2026~AI-detected

BTDFT✅ApprovedSource

MRK$281.2BPhase 3

Oct '26

Lenvatinib Phase 3 Est. Readout

Lenvatinib1,653

Non-small Cell Lung Cancer

Oct 2026~Confirmed

✓PositiveCT.gov

NVSEF$269.0BPhase 3

Oct '26

ianalumab Phase 3 Est. Readout

Ianalumab226

Primary Immune Thrombocytopenia (ITP)

Oct 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Oct '26

GAd-209-FSP low dose Phase 2 Est. Readout

GAd-209-FSP low dose115

Solid Tumor, Adult

Oct 2026~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Oct '26

Blinatumomab 9ug Phase 2 Est. Readout

Blinatumomab 9ug44

Acute Lymphoblastic Leukemia

Oct 2026~Confirmed

✓PositiveCT.gov

SNYNF$99.8BPhase 2

Oct '26

venglustat (GZ402671) Phase 2 Est. Readout

venglustat (GZ402671)12

Gaucher Disease Type 1

Oct 2026~Confirmed

00%

CT.gov

VRTX$114.6BPhase 3

Oct '26

VX-121/TEZ/D-IVA Phase 3 Est. Readout

VX-121/TEZ/D-IVA822

Cystic Fibrosis

Oct 2026~Confirmed

00%

CT.gov

JNGHFPhase 3

Oct '26

SHR6390 Phase 3 Est. Readout

SHR63905,274

Advanced Breast Cancer

Oct 2026~Confirmed

00%

CT.gov

SRPT$1.9BPhase 3

Oct '26

Eteplirsen Phase 3 Est. Readout

Eteplirsen160

Duchenne Muscular Dystrophy

Oct 2026~Confirmed

00%

CT.gov

TAK$48.9BPhase 2

Oct '26

TAK-788 Phase 2 Est. Readout

TAK-788334

Carcinoma, Non-Small-Cell Lung

Oct 2026~Confirmed

00%

CT.gov

ANNX$189MPhase 3

Oct '26

Vonaprument Phase 3 Est. Readout

Vonaprument659

Geographic Atrophy

Oct 2026~Confirmed

00%

CT.gov

MAAT.PA$56MPhase 2

Oct '26

Pooled allogeneic fecal microbiotherapy Phase 2 Est. Readout

Pooled allogeneic fecal microbiotherapy387

Transplant Complication

Oct 2026~Confirmed

00%

CT.gov

ADAG$233MPhase 2

Oct '26

ADG126 Phase 2 Est. Readout

ADG126186

Advanced/Metastatic Solid Tumors

Oct 2026~Confirmed

00%

CT.gov

TEVA$36.7BPhase 3

Oct '26

TEV-56248 Phase 3 Est. Readout

TEV-562482,772

Asthma

Oct 2026~Confirmed

00%

CT.gov

TEVA$36.7BPhase 2

Oct '26

TEV-53408 Phase 2 Est. Readout

TEV-5340850

Celiac Disease

Oct 2026~Confirmed

✓PositiveCT.gov

SYRE$7.7BPhase 2

Oct '26

SPY002-072 Phase 2 Est. Readout

SPY002-072285

Rheumatoid Arthritis

Oct 2026~Confirmed

00%

CT.gov

TKPHF$47.7BPhase 3

Oct '26

TAK-788 Phase 3 Est. Readout

TAK-788354

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Oct 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Oct '26

Pembrolizumab Phase 2 Est. Readout

pembrolizumab30

Colorectal Neoplasms

Oct 2026~Confirmed

00%

CT.gov

CELG-RIPhase 3

Oct '26

Apixaban Phase 3 Est. Readout

Apixaban20,284

Lymphoma

Oct 2026~Confirmed

00%

CT.gov

IVBXF$19.2BPhase 2

Oct '26

IBI3003 Phase 2 Est. Readout

IBI3003116

Multiple Myeloma

Oct 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Oct '26

Lenvatinib Phase 2 Est. Readout

Lenvatinib30

Non-small Cell Lung Cancer

Oct 2026~Confirmed

00%

CT.gov

ORNBV.HE$10.7BPhase 2

Oct '26

ODM-208 Phase 2 Est. Readout

ODM-208204

Prostate Cancer Metastatic

Oct 2026~Confirmed

00%

CT.gov

RYTM$6.6BPhase 2

Oct '26

Setmelanotide Phase 2 Est. Readout

Setmelanotide18

Genetic Obesity

Oct 2026~Confirmed

✓PositiveCT.gov

AMGN$182.2BPhase 2

Oct '26

anvumetostat Phase 2 Est. Readout

AMG 19361

MTAP-deleted NSCLC

Oct 2026~Confirmed

00%

CT.gov

PCSA$6MData Readout

2mo

Data Readout — VAX-31

Oct 31AI-detected

00%

Source

OLMA$831MPhase 3

Oct '26

Palazestrant Phase 3 Est. Readout

Palazestrant1,000

Breast Cancer

Oct 2026~Estimated

00%

CT.gov

VKTX$3.5BPhase 3

2mo

Phase 3 Results - VK2735

VK2735

Weight Loss

Oct 31AI-detected

00%

Source

INMB$39MRegulatory

2mo

Regulatory — Ebstrocel

Oct 31AI-detected

00%

Source

AZN$273.6BPhase 3

Oct '26

Capivasertib Phase 3 Est. Readout

Capivasertib293

Triple Negative Breast Neoplasms

Oct 2026~Confirmed

✓PositiveCT.gov

ZEALPhase 3

Oct '26

glepaglutide Phase 3 Est. Readout

Glepaglutide145

Short Bowel Syndrome

Oct 2026~Confirmed

00%

CT.gov

DWTX$52MPhase 2

2mo

Phase 2 — Halneuron®

Oct 31AI-detected

00%

Source

PHM.MC$26.2BPhase 2

Oct '26

TOP-N53 Phase 2 Est. Readout

TOP-N5315

Digital Ulcers in Systemic Sclerosis

Oct 2026~Confirmed

00%

CT.gov

September 2026 Full Calendar November 2026

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About PDUFA Dates in October 2026

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for October 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.