September 2026 Catalysts

FDA Decisions & PDUFA Dates

October 2026

247

Total Catalysts

PDUFA Dates

122

Trial Results

174

Companies

Week 1Aug 31 - Sep 6(50 catalysts)

MRK$281.2BPhase 3

Sep '26

Letermovir 480 mg once daily Phase 3 Est. Readout

Letermovir 480 mg once daily30

Kidney Transplant; Complications

Sep 2026~Confirmed

✓PositiveCT.gov

AZNCF$290.6BPhase 2

Sep '26

AZD1775 Phase 2 Est. Readout

AZD177549

Uterine Cancer

Sep 2026~Confirmed

00%

CT.gov

RDHL$41.4BM&A

Past

Acquisition ($37.5M)

Sep 1AI-detected

✓CompletedSource

PFE$143.7BPhase 2

Sep '26

ARV-471 Phase 2 Est. Readout

Abemaciclib37

Breast Cancer

Sep 2026~Confirmed

✓PositiveCT.gov

PHM.MC$26.2BPhase 2

Sep '26

Brimonidine tartrate Gel Phase 2 Est. Readout

Brimonidine tartrate Gel60

EGFR Inhibitor-associated Rash

Sep 2026~Confirmed

00%

CT.gov

GSK$101.7BPhase 2

Sep '26

Belrestotug Phase 2 Est. Readout

Belrestotug316

Neoplasms, Head and Neck

Sep 2026~Confirmed

00%

CT.gov

HSCSWPhase 3

Sep '26

Hydroxyurea Phase 3 Est. Readout

Hydroxyurea400

Sickle Cell Disease

Sep 2026~Confirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Sep '26

fenfluramine Phase 3 Est. Readout

fenfluramine25

Dravet Syndrome

Sep 2026~Confirmed

00%

CT.gov

BEAM$3.5BConference

Past

Conference — BEAM-302

Sep 1AI-detected

✓CompletedSource

NONOF$215.0BPhase 2

Sep '26

Semaglutide Phase 2 Est. Readout

Semaglutide465

Diabetes Mellitus, Type 2

Sep 2026~Confirmed

00%

CT.gov

IDYA$2.7BConference

Past

Conference — Darovasertib

Sep 1AI-detected

✓CompletedSource

TGTX$8.1BPhase 3

Sep '26

Ublituximab Phase 3 Est. Readout

Ublituximab800

Non-Hodgkins Lymphoma

Sep 2026~Confirmed

00%

CT.gov

PMVP$60MOffering

Past

Stock Offering — $50 million

Sep 1AI-detected

✓CompletedSource

ATALF$47MM&A

Past

Acquisition

Sep 1AI-detected

✓CompletedSource

SNY$100.0BPDUFA

Past

FDA PDUFA Date Tirzepatide (standard)

Sep 1AI-detected

✅ApprovedSEC

ARDX$1.5BPhase 3

Sep '26

Tenapanor 50 MG Phase 3 Est. Readout

Tenapanor 50 MG180

Irritable Bowel Syndrome With Constipation (IBS-C)

Sep 2026~Confirmed

00%

CT.gov

NBP$177MEarnings

Past

NBP Earnings Report

Sep 2Confirmed

✓CompletedSource

AVLN$1.4BEarnings

Past

AVLN Earnings Report

Sep 2Confirmed

✓CompletedSource

ANAB$1.7BEarnings

Past

ANAB Earnings Report

Sep 2Confirmed

✓CompletedSource

SLN$982MOffering

Past

Stock Offering

Sep 2AI-detected

✓CompletedSource

PFE$143.7BPhase 2

Sep '26

PF-07868489 Phase 2 Est. Readout

PF-0786848997

Pulmonary Arterial Hypertension

Sep 2026~Confirmed

✓PositiveCT.gov

SCTX$297MEarnings

Past

Scribe Reports Financial Results

Sep 2Confirmed

?UnknownSource

CFOO$13MPDUFA

Sep '26

FDA PDUFA Date Zurletrectinib (priority review)

ZurletrectinibNDA

pediatric solid tumors

Sep 2026~AI-detected

?UnknownSource

ATTO$891MEarnings

Past

Attovia Reports Financial Results

Sep 2Confirmed

?UnknownSource

TAK$48.9BPDUFA

Past

FDA PDUFA Date Rusfertide (priority review)

RusfertideNDA

Polycythemia Vera

Sep 2AI-detected

✓PositiveSource

RHHBY$316.4BPhase 3

Sep '26

RO7204239 Phase 3 Est. Readout

RO7204239259

Obesity

Sep 2026~Estimated

✓PositiveCT.gov

NVO$203.2BPhase 3

Sep '26

Ziltivekimab Phase 3 Est. Readout

Ziltivekimab10,000

Heart Failure

Sep 2026~Confirmed

✓PositiveCT.gov

NVO$203.2BRegulatory

Past

Regulatory Decision - Ozempic

Sep 3AI-detected

✓PositiveSource

LTGO$1.1BEarnings

Past

Latigo Reports Financial Results

Sep 3Confirmed

?UnknownSource

NYXH$72MData Readout

Past

Data Readout - Genio

Sep 3AI-detected

✓PositiveSource

RNXT$41MData Readout

Past

Data Readout - TAMP™ Platform

Sep 3AI-detected

✓PositiveSource

MOBI$474MEarnings

Past

MOBI Earnings Report

Sep 3Confirmed

✓CompletedSource

PDEX$206MEarnings

Past

PDEX Earnings Report

Sep 3Confirmed

✓CompletedSource

JAGX$386MOffering

Past

JAGX — Stock Offering (424B5)

Sep 3Confirmed

✓CompletedSource

GSK$101.7BM&A

Past

Acquisition — Hutchmed ($110M)

Sep 3AI-detected

✓CompletedSource

KLTO$38MM&A

Past

Greenland M&A / Acquisition

Sep 4Confirmed

?UnknownSource

PURR$1.2BPDUFA

Past

FDA PDUFA Date Hyperlaid (standard)

HyperlaidNDA

Obesity

Sep 4AI-detected

?UnknownSEC

MTNB$5MOther

Past

Matinas Corporate Update

Sep 4Confirmed

?UnknownSource

PFE$143.7BOther

Past

Other

Sep 4AI-detected

✗NegativeSource

IBIO$84MEarnings

Past

IBIO Earnings Report

Sep 4Confirmed

✓CompletedSource

IMMP$546MEarnings

Past

IMMP Earnings Report

Sep 4Confirmed

✓CompletedSource

ENLV$150MEarnings

Past

ENLV Earnings Report

Sep 4Confirmed

✓CompletedSource

INDV.L$2.3BM&A

Past

Acquisition — Supernus

Sep 4AI-detected

✓CompletedSource

SUPN$2.6BM&A

Past

Acquisition — Indivior

Sep 4AI-detected

✓CompletedSource

CELG-RIPhase 2

Sep '26

BMS-986490 Phase 2 Est. Readout

BMS-986490360

Advanced Solid Tumors

Sep 2026~Confirmed

00%

CT.gov

RARE$2.7BPhase 3

Sep '26

setrusumab Phase 3 Est. Readout

setrusumab6

Osteogenesis Imperfecta, Type I

Sep 2026~Confirmed

✗NegativeCT.gov

HLUYYPhase 3

Sep '26

Eptinezumab Phase 3 Est. Readout

Eptinezumab285

Chronic Migraine in Children

Sep 2026~Confirmed

00%

CT.gov

ALK-B.CO$8.1BPhase 3

Sep '26

HDM SLIT-tablet (12 SQ-HDM) Phase 3 Est. Readout

HDM SLIT-tablet (12 SQ-HDM)327

Allergic Rhinoconjunctivitis

Sep 2026~Confirmed

00%

CT.gov

ICPTPhase 2

Sep '26

Placebo Phase 2 Est. Readout

Obeticholic acid (10 mg)80

Compensated Cirrhosis

Sep 2026~Confirmed

00%

CT.gov

IVBXF$19.2BPhase 3

Sep '26

IBI306 Phase 3 Est. Readout

IBI306198

Homozygous Familial Hypercholesterolemia

Sep 2026~Confirmed

00%

CT.gov

Week 2Sep 7 - Sep 13(46 catalysts)

PFE$143.7BPDUFA

Sep '26

FDA PDUFA Date lead asset (priority review)

Sep 2026~AI-detected

✅ApprovedSource

NVO$203.2BPhase 3

Sep '26

CagriSema (Cagrilintide B and Semaglutide I) Phase 3 Est. Readout

CagriSema (Cagrilintide B and Semaglutide I)609

Obesity

Sep 2026~Confirmed

✓PositiveCT.gov

INBX$1.4BPhase 2

Past

Phase 2 — INBRX-106

Sep 8AI-detected

✓PositiveSource

ENGNWEarnings

Past

enGene Reports Financial Results

Sep 8Confirmed

?UnknownSource

ROIV$22.6BPhase 2

Past

Phase 2 — mosliciguat

Sep 8AI-detected

✓PositiveSource

AZN$273.6BRegulatory

Past

Regulatory Decision - Etcamah

Sep 8AI-detected

✓PositiveSource

TEVJF$52.1BOffering

Past

TEVJF — Stock Offering (424B5)

Sep 8Confirmed

✓CompletedSource

PFE$143.7BPDUFA

Past

FDA PDUFA Date lead asset (priority review)

Sep 8AI-detected

✅ApprovedSource

REGN$57.3BData Readout

Past

REGN ALERT: Hagens Berman Alerts Regeneron Pharmaceuticals, Inc. (REGN) Investors to Pending Securities Fraud Class Action Amid Disclosures About Key Trial's Protocol and Ultimate Failure

Sep 9Estimated

00%

Source

ETON$890MConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

NNOX$113MEarnings

Past

NNOX Earnings Report

Sep 9Confirmed

✓CompletedSource

MRK$281.2BM&A

Past

Acquisition

Sep 9AI-detected

✓CompletedSource

IMUX$193MConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

ANIX$99MEarnings

Past

ANIX Earnings Report

Sep 9Confirmed

✓CompletedSource

SCNI$4.5BEarnings

Past

SCNI Earnings Report

Sep 9Confirmed

✓CompletedSource

ANIX$99MConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

JAZZ$14.1BConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

KNSA$1.1BConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

RNTX$78MConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

RGEN$7.4BConference

Past

Conference

Sep 9AI-detected

✓CompletedSource

TYRA$1.7BData Readout

Past

Data Readout — Dabogratinib

Sep 9AI-detected

✗NegativeSource

TYRA$1.7BPhase 2

Past

TYRA-300 Phase 2 Est. Readout

TYRA-300310

Locally Advanced Urothelial Carcinoma

Sep 9Confirmed

~MixedCT.gov

CMPS$1.7BData Readout

Past

Data Readout - COMP360

Sep 9AI-detected

✓PositiveSource

YARW$101MOffering

Past

Stock Offering

Sep 10AI-detected

✓CompletedSource

NHPAPM&A

Past

National M&A / Acquisition

Sep 10Confirmed

?UnknownSource

SNY$100.0BPhase 3

Sep '26

Itepekimab (SAR440340) Phase 3 Est. Readout

Itepekimab (SAR440340)59

Chronic Obstructive Pulmonary Disease

Sep 2026~Confirmed

00%

CT.gov

TEVA$36.7BOffering

Past

Stock Offering — $4.9 billion

Sep 10AI-detected

✓CompletedSource

KMTS$1.2BEarnings

Past

KMTS Earnings Report

Sep 10Confirmed

✓CompletedSource

BHVN$2.0BRegulatory

Past

Regulatory Decision - BHV-7000

Sep 10AI-detected

✗NegativeSource

PHM.MC$26.2BPhase 2

Sep '26

Plitidepsin 1.5 mg/day Phase 2 Est. Readout

Plitidepsin 1.5 mg/day90

Post COVID-19 Condition

Sep 2026~Confirmed

00%

CT.gov

ATALF$47MConference

Past

Conference

Sep 10AI-detected

✓CompletedSource

IRON$2.7BPhase 2

Sep '26

DISC-3405 Phase 2 Est. Readout

DISC-340560

Polycythemia Vera (PV)

Sep 2026~Confirmed

✓PositiveCT.gov

ENGN$112MEarnings

Past

ENGN Earnings Report

Sep 10Confirmed

✓CompletedSource

VNDA$349MPDUFA

Sep '26

FDA PDUFA Date Imsidolimab (standard review)

ImsidolimabPhase 2

Acne Vulgaris

Sep 2026~AI-detected

✓PositiveSource

TXMD$9MPhase 3

Sep '26

Brepocitinib PO QD Phase 3 Est. Readout

Brepocitinib PO QD371

Uveitis, Posterior

Sep 2026~Confirmed

00%

CT.gov

THQ$792MRegulatory

Past

abrdn Healthcare Opportunities Fund (THQ) and abrdn World Healthcare Fund (THW) Announce New Managed Distribution Policies and Declare Monthly Distributions

Sep 11Confirmed

📊Data ReleasedSource

KRSA$10.4BEarnings

Past

Korsana Reports Financial Results

Sep 11Confirmed

?UnknownSource

ADCT$139MConference

Past

Conference

Sep 11AI-detected

✓CompletedSource

PCYCPhase 2

Sep '26

Ibrutinib Phase 2 Est. Readout

Ibrutinib30

Diffuse Large B Cell Lymphoma Relapsed

Sep 2026~Confirmed

00%

CT.gov

RHHBY$316.4BM&A

Past

Acquisition — Verona Pharma ($1.1B)

Sep 11AI-detected

✓CompletedSource

KPTI$204MPhase 3

Sep '26

Selinexor (combination therapy) Phase 3 Est. Readout

Selinexor (combination therapy)501

Relapsed/Refractory Diffuse Large B-cell Lymphoma

Sep 2026~Confirmed

✓PositiveCT.gov

BTAI$37MM&A

Past

Acquisition — Teva Pharmaceutical Industries ($125M)

Sep 13AI-detected

Source

TEVA$36.7BM&A

Past

Acquisition — BioXcel ($125M)

Sep 13AI-detected

Source

GILD$153.7BPhase 3

Sep '26

Sacituzumab Govitecan-hziy Phase 3 Est. Readout

Sacituzumab Govitecan-hziy443

Triple Negative Breast Cancer

Sep 2026~Confirmed

✗NegativeCT.gov

GEHC$28.0BM&A

Past

Acquisition ($1B)

Sep 13AI-detected

Source

EIKN$520MConference

Past

Conference

Sep 13AI-detected

Source

Week 3Sep 14 - Sep 20(89 catalysts)

TYRA$1.7BOffering

Past

Stock Offering — $400 Million

Sep 14AI-detected

Source

FVNNUM&A

Past

II M&A / Acquisition

Sep 14Confirmed

?UnknownSource

SPTX$973MEarnings

Past

SPTX Earnings Report

Sep 14Confirmed

Source

COEPWM&A

Past

Z M&A / Acquisition

Sep 14Confirmed

?UnknownSource

DMAAR$2MM&A

Past

Drugs M&A / Acquisition

Sep 14Confirmed

?UnknownSource

RNXT$41MConference

Past

Conference — RenovoCath®

Sep 14AI-detected

Source

PBSV$12MEarnings

Past

Pharma-Bio Reports Financial Results

Sep 14Confirmed

?UnknownSource

ELTX$73MConference

Past

Conference

Sep 14AI-detected

Source

CRBP$153MData Readout

Past

Data Readout — CRB-913

Sep 14AI-detected

✓PositiveSource

BIVI$13MOffering

Past

BIVI — Stock Offering (424B5)

Sep 14Confirmed

Source

KMTS$1.2BEarnings

Past

KESTRA Reports Financial Results

Sep 14Confirmed

?UnknownSource

BNR$82MEarnings

Past

BNR Earnings Report

Sep 14Confirmed

Source

SVA$465MPhase 2

Sep '26

Sinovac PCV24 Phase 2 Est. Readout

Sinovac PCV24420

Pneumococcal Infectious Disease

Sep 2026~Confirmed

00%

CT.gov

WVE$1.2BPhase 2

Sep '26

WVE-006 Phase 2 Est. Readout

WVE-00624

Alpha-1 Antitrypsin Deficiency

Sep 2026~Confirmed

00%

CT.gov

SLN$982MPhase 2

Sep '26

SLN124 Phase 2 Est. Readout

SLN12469

Polycythemia Vera

Sep 2026~Confirmed

✓PositiveCT.gov

SUPN$2.6BPhase 3

Sep '26

SPN-812 Phase 3 Est. Readout

SPN-8121,400

Attention-Deficit/Hyperactivity Disorder

Sep 2026~Confirmed

00%

CT.gov

GNMSF$18.3BPhase 2

Sep '26

Vincristine Phase 2 Est. Readout

Vincristine49

Follicular Lymphoma (FL)

Sep 2026~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Sep '26

BAY2599023 (DTX201) Phase 2 Est. Readout

BAY2599023 (DTX201)11

Hemophilia A

Sep 2026~Confirmed

✓PositiveCT.gov

GILD$153.7BPhase 2

Sep '26

TAF Phase 2 Est. Readout

TAF150

HBeAg-positive Chronic Hepatitis B

Sep 2026~Confirmed

00%

CT.gov

MAZE$1.4BPhase 2

Sep '26

MZE829 Phase 2 Est. Readout

MZE82974

Proteinuric Kidney Disease

Sep 2026~Confirmed

00%

CT.gov

IRON$2.7BPhase 3

Sep '26

DISC-1459 Phase 3 Est. Readout

DISC-1459183

Erythropoietic Protoporphyria

Sep 2026~Confirmed

00%

CT.gov

MGNX$263MPhase 2

Sep '26

lorigerlimab Phase 2 Est. Readout

lorigerlimab154

Androgen-Independent Prostatic Cancer

Sep 2026~Confirmed

00%

CT.gov

KPTI$204MPhase 2

Sep '26

Selinexor Phase 2 Est. Readout

Selinexor112

Multiple Myeloma, Refractory

Sep 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 2

Sep '26

MET233 and MET097 Phase 2 Est. Readout

MET233 and MET097381

Obesity and Obesity-related Medical Conditions

Sep 2026~Confirmed

00%

CT.gov

VNDA$349MPhase 2

Sep '26

Trichostatin A Phase 2 Est. Readout

Trichostatin A50

Onychomycosis of Toenail

Sep 2026~Confirmed

00%

CT.gov

ITCIPhase 3

Sep '26

Lumateperone Phase 3 Est. Readout

Lumateperone470

Major Depressive Disorder

Sep 2026~Confirmed

00%

CT.gov

LLY$1.0TPhase 3

Sep '26

LY3650150 Phase 3 Est. Readout

LY3650150450

Perennial Allergic Rhinitis (PAR)

Sep 2026~Confirmed

✓PositiveCT.gov

GALDY$50.4BPhase 2

Sep '26

nemolizumab Phase 2 Est. Readout

Nemolizumab50

Prurigo Nodularis

Sep 2026~Confirmed

00%

CT.gov

ORIC$879MPhase 2

Sep '26

ORIC-114 Phase 2 Est. Readout

ORIC-114350

Solid Tumors

Sep 2026~Confirmed

00%

CT.gov

EWTX$4.0BPhase 2

Sep '26

Sevasemten 10 mg Phase 2 Est. Readout

Sevasemten 10 mg244

Becker Muscular Dystrophy

Sep 2026~Confirmed

✓PositiveCT.gov

PCSA$6MPhase 2

Sep '26

PCS6422 and capecitabine Phase 2 Est. Readout

PCS6422 and capecitabine90

Breast Cancer

Sep 2026~Confirmed

00%

CT.gov

HLUYYPhase 2

Sep '26

Lu AG13909 Phase 2 Est. Readout

Lu AG1390918

Cushing's Disease

Sep 2026~Confirmed

00%

CT.gov

HPHA.DE$134MPhase 2

Sep '26

nilotinib Phase 2 Est. Readout

nilotinib75

Chronic Myeloid Leukemia

Sep 2026~Confirmed

00%

CT.gov

AMGN$182.2BConference

Past

Conference

Sep 15AI-detected

Source

VERA$2.5BPhase 2

Sep '26

Atacicept Phase 2 Est. Readout

Atacicept90

IgA Nephropathy (IgAN)

Sep 2026~Confirmed

✓PositiveCT.gov

MRK$281.2BPhase 3

Sep '26

Carboplatin Phase 3 Est. Readout

Cisplatin (as radiosensitizer)990

Endometrial Neoplasms

Sep 2026~Confirmed

✓PositiveCT.gov

NAMS$3.5BPhase 2

Sep '26

Obicetrapib 10mg Phase 2 Est. Readout

Obicetrapib 10mg100

Antioxidant Absorption

Sep 2026~Confirmed

00%

CT.gov

TEVJF$52.1BPhase 2

Sep '26

TEV-53408 Phase 2 Est. Readout

TEV-5340850

Celiac Disease

Sep 2026~Confirmed

✓PositiveCT.gov

RARE$2.7BRegulatory

Past

Regulatory — UX111

Sep 15AI-detected

✓PositiveSource

NVSEF$269.0BPhase 2

Sep '26

TOUR006 - 20 MG Phase 2 Est. Readout

TOUR006 - 20 MG79

Thyroid Eye Disease

Sep 2026~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Sep '26

IVIG (Intravenous Immunoglobulin) Phase 3 Est. Readout

IVIG (Intravenous Immunoglobulin)154

Multifocal Motor Neuropathy (MMN)

Sep 2026~Confirmed

✓PositiveCT.gov

BNN.DE$66MPhase 2

Sep '26

Nabiximols Phase 2 Est. Readout

Nabiximols120

Glioblastoma

Sep 2026~Confirmed

00%

CT.gov

BGNEPhase 2

Sep '26

SX-682 Phase 2 Est. Readout

SX-68225

Pancreatic Cancer

Sep 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Sep '26

Pembrolizumab Phase 2 Est. Readout

pembrolizumab193

Colorectal Neoplasms

Sep 2026~Confirmed

00%

CT.gov

ARQT$3.3BPhase 2

Sep '26

Topical roflumilast 0.3% foam Phase 2 Est. Readout

Topical roflumilast 0.3% foam10

Hidradenitis Suppurativa

Sep 2026~Confirmed

00%

CT.gov

HIMS$10.1BRegulatory

Past

Shareholders who lost money in shares of acquired Hims & Hers Health, Inc. (NYSE: HIMS) should contact Wolf Haldenstein Immediately

Sep 15Confirmed

📊Data ReleasedSource

CYTK$9.8BPhase 2

Sep '26

CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) Phase 2 Est. Readout

CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)60

Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Sep 2026~Confirmed

00%

CT.gov

DSGN$777MPhase 2

Sep '26

DT-168 Phase 2 Est. Readout

DT-16828

Fuchs Endothelial Corneal Dystrophy

Sep 2026~Confirmed

00%

CT.gov

SKBBYPhase 2

Sep '26

PRT-064040 nasal spray Phase 2 Est. Readout

PRT-064040 nasal spray456

Migraine

Sep 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Sep '26

DPI-386 Nasal Gel Phase 2 Est. Readout

DPI-386 Nasal Gel80

Motion Sickness, Space

Sep 2026~Confirmed

00%

CT.gov

GTHXPhase 2

Sep '26

Trilaciclib Phase 2 Est. Readout

Trilaciclib36

TNBC - Triple-Negative Breast Cancer

Sep 2026~Confirmed

00%

CT.gov

CELG-RIPhase 2

Sep '26

Corticosteroid Phase 2 Est. Readout

Corticosteroid12

Heart Transplantation

Sep 2026~Confirmed

00%

CT.gov

RZLT$483MPhase 3

Past

Phase 3

Sep 15AI-detected

✗NegativeSource

CGTX$130MConference

Past

Conference — zervimesine

Sep 15AI-detected

Source

BHVN$2.0BPhase 2

Sep '26

Taldefgrobep Alfa Phase 2 Est. Readout

Taldefgrobep Alfa150

Obesity

Sep 2026~Confirmed

✗NegativeCT.gov

HSCS$6MEarnings

Past

HeartSciences Reports Financial Results

Sep 15Confirmed

?UnknownSource

PCSA$6MM&A

Past

Acquisition ($200M)

Sep 15AI-detected

Source

ERNAWData Readout

Past

Data Readout - ERNA-201

Sep 15AI-detected

✓PositiveSource

AZNCF$290.6BPhase 2

Sep '26

Tezepelumab Phase 2 Est. Readout

Tezepelumab42

Asthma

Sep 2026~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Sep '26

Adalimumab Phase 3 Est. Readout

adalimumab40

Pyoderma Gangrenosum

Sep 2026~Confirmed

✓PositiveCT.gov

ABBV$382.5BConference

Past

Conference

Sep 15AI-detected

Source

ALKS$7.5BPhase 3

Sep '26

Olanzapine Phase 3 Est. Readout

ALKS 3831220

Schizophrenia

Sep 2026~Confirmed

00%

CT.gov

AVIR$349MPhase 3

Sep '26

Bemnifosbuvir-Ruzasvir (BEM/RZR) Phase 3 Est. Readout

Bemnifosbuvir-Ruzasvir (BEM/RZR)880

HEPATITIS C VIRUS CHRONIC INFECTION

Sep 2026~Confirmed

✓PositiveCT.gov

NUVB-WTPDUFA

Past

FDA PDUFA Date taletrectinib

TaletrectinibPhase 3

Non-small Cell Lung Cancer (NSCLC)

Sep 16Confirmed

✓PositiveSource

HALO$8.1BOffering

Past

Stock Offering — $1.05 billion

Sep 16AI-detected

Source

RZLT$483MEarnings

Past

RZLT Earnings Report

Sep 16Confirmed

Source

ASMB$388MConference

Past

Conference

Sep 16AI-detected

Source

MNKD$1.2BM&A

Past

Acquisition

Sep 16AI-detected

Source

NNDM$282MEarnings

Past

NNDM Earnings Report

Sep 16Confirmed

Source

GILD$153.7BM&A

Past

Acquisition

Sep 16AI-detected

Source

ODTX$916MEarnings

Past

ODTX Earnings Report

Sep 16Confirmed

Source

NVS$284.2BM&A

Past

Acquisition ($125M)

Sep 16AI-detected

Source

ZEALRegulatory

Past

Zeydovio EMA Unknown

GlepaglutidePhase 3

Short Bowel Syndrome

Sep 17Confirmed

✅ApprovedSource

VRTX$114.6BPhase 3

Sep '26

Biological/Vaccine Phase 3 Est. Readout

Biological/Vaccine10

Type 1 Diabetes

Sep 2026~Confirmed

00%

CT.gov

IPHA$170MEarnings

Past

IPHA Earnings Report

Sep 17Confirmed

Source

POAI$20MM&A

Past

Axe M&A / Acquisition

Sep 17Confirmed

?UnknownSource

NONOF$215.0BRegulatory

Past

Frehemgo EMA Unknown

Sep 17Confirmed

✅ApprovedSource

CLDWWOffering

Past

CLDWW — Stock Offering (424B5)

Sep 17Confirmed

Source

RHHBY$316.4BPhase 2

Sep '26

Ocrelizumab Test Formulation Phase 2 Est. Readout

Ocrelizumab Test Formulation193

Multiple Sclerosis

Sep 2026~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Sep '26

emodepside Phase 2 Est. Readout

emodepside578

Onchocerciasis

Sep 2026~Confirmed

✓PositiveCT.gov

IONS$12.2BPhase 3

Sep '26

Olezarsen Phase 3 Est. Readout

Olezarsen885

Familial Chylomicronemia Syndrome

Sep 2026~Confirmed

✗NegativeCT.gov

BLSM$465MEarnings

Past

BlossomHill Reports Financial Results

Sep 18Confirmed

?UnknownSource

MRK$281.2BPhase 2

Sep '26

Nemtabrutinib Phase 2 Est. Readout

Nemtabrutinib190

Chronic Lymphocytic Leukemia

Sep 2026~Confirmed

~MixedCT.gov

NUVL$3.6BPDUFA

Past

FDA PDUFA Date zidesamtinib

Zidesamtinib (NVL-520)Phase 2

Locally Advanced Solid Tumor

Sep 18Confirmed

✓PositiveSource

NUVL$3.6BNDA Filing

Past

NDA Filing — neladalkib

Sep 18AI-detected

00%

Source

NVO$203.2BM&A

Past

Acquisition

Sep 18AI-detected

Source

NSRX$37MOffering

Past

NSRX — Stock Offering (424B5)

Sep 18Confirmed

Source

TEVA$36.7BPhase 3

Sep '26

Fp/ABS Phase 3 Est. Readout

Fp/ABS724

Asthma

Sep 2026~Confirmed

00%

CT.gov

CGEN$196MPhase 1

Tomorrow

Phase 1 — MAIA-Ovarian

Sep 20AI-detected

00%

Source

Week 4Sep 21 - Sep 27(23 catalysts)

ABVX$7.8BEarnings

ABVX Earnings Report

Sep 21Confirmed

Source

HYFT$70MEarnings

HYFT Earnings Report

Sep 21Confirmed

Source

CRDL$122MPhase 3

Sep '26

CardiolRx Phase 3 Est. Readout

CardiolRx110

Acute Myocarditis

Sep 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 2

Sep '26

PF-07275315 Phase 2 Est. Readout

PF-07275315340

Asthma

Sep 2026~Confirmed

00%

CT.gov

NKGN$8MConference

Conference — troculeucel

Sep 22AI-detected

Source

MNKD$1.2BPDUFA

FDA PDUFA Date MannKind's product (standard)

MannKind's productNDA

diabetes

Sep 22AI-detected

✓PositiveSEC

PHM.MC$26.2BPhase 2

Sep '26

T3011 Phase 2 Est. Readout

T301130

Solid Tumor

Sep 2026~Confirmed

00%

CT.gov

MRNA$25.4BPhase 2

Sep '26

mRNA-1403 Phase 2 Est. Readout

mRNA-14051,407

Norovirus Acute Gastroenteritis

Sep 2026~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 2

Sep '26

Sonrotoclax Phase 2 Est. Readout

Sonrotoclax114

Waldenstrom Macroglobulinemia

Sep 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 2

Sep '26

PF-07220060 Phase 2 Est. Readout

PF-07220060362

Liposarcoma

Sep 2026~Confirmed

✓PositiveCT.gov

TRAX$608MRegulatory

Regulatory

Sep 23AI-detected

✓PositiveSource

PFE$143.7BPhase 3

Sep '26

PF-07220060 Phase 3 Est. Readout

PF-072200601,035

Liposarcoma

Sep 2026~Estimated

✗NegativeCT.gov

AZNCF$290.6BPhase 2

Sep '26

Acalabrutinib Phase 2 Est. Readout

Acalabrutinib49

Phase I: Relapsed or Refractory B-cell Malignancies

Sep 2026~Confirmed

00%

CT.gov

GBIO$36MConference

Conference

Sep 23AI-detected

Source

IVBXF$19.2BPhase 2

Sep '26

IBI362 Phase 2 Est. Readout

IBI362141

Type 2 Diabetes

Sep 2026~Confirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Sep '26

YTB323 Phase 2 Est. Readout

YTB32321

Systemic Lupus Erythematosus

Sep 2026~Confirmed

00%

CT.gov

IVA$690MEarnings

IVA Earnings Report

Sep 25Confirmed

Source

CADL$609MConference

Conference — Aglatimagene Besadenovec

Sep 26AI-detected

Source

NUVL$3.6BPDUFA

FDA PDUFA Date NUV-1034 (standard)

Neladalkib (NVL-655)Phase 3

Non-small Cell Lung Cancer

Sep 26Confirmed

✓PositiveSEC

AZNCF$290.6BPhase 2

Sep '26

Zibotentan/Dapagliflozin Phase 2 Est. Readout

Zibotentan/Dapagliflozin224

Chronic Kidney Disease With High Proteinuria

Sep 2026~Confirmed

00%

CT.gov

ZEALPhase 3

Sep '26

Gentamicin, Cefazolin and Vancomycin Phase 3 Est. Readout

Gentamicin, Cefazolin and Vancomycin1,003

Implant Complication

Sep 2026~Confirmed

00%

CT.gov

INCY$19.6BRegulatory

Regulatory

Sep 26AI-detected

00%

Source

BIIB$29.0BPhase 3

Sep '26

Litifilimab Phase 3 Est. Readout

Litifilimab562

Lupus Erythematosus, Systemic

Sep 2026~Confirmed

✓PositiveCT.gov

Week 5Sep 28 - Oct 4(39 catalysts)

BNTC$417MEarnings

BNTC Earnings Report

Sep 28Confirmed

Source

MLTX$1.4BPhase 3

Sep '26

Sonelokimab Phase 3 Est. Readout

Sonelokimab35

Hidradenitis Suppurativa

Sep 2026~Confirmed

✓PositiveCT.gov

TVTX$5.1BPDUFA

Sep '26

FDA PDUFA Date undisclosed drug candidate (standard)

undisclosed drug candidateNDA

undisclosed

Sep 2026~AI-detected

00%

SEC

OCGN$420MPhase 3

Sep '26

OCU410ST Phase 3 Est. Readout

OCU410ST51

Stargardt Disease

Sep 2026~Confirmed

00%

CT.gov

HSCSWPhase 2

Sep '26

64Cu-FBP8 Phase 2 Est. Readout

64Cu-FBP830

Alzheimer Disease

Sep 2026~Confirmed

00%

CT.gov

INCY$19.6BPhase 2

Sep '26

INCB099280 Phase 2 Est. Readout

INCB09928063

Advanced Solid Tumor

Sep 2026~Confirmed

✓PositiveCT.gov

RHHBY$316.4BPhase 3

Sep '26

Phesgo Phase 3 Est. Readout

Phesgo230

Locally Advanced or Metastatic Breast Cancer

Sep 2026~Confirmed

✓PositiveCT.gov

SRXH$66MEarnings

SRXH Earnings Report

Sep 29Confirmed

Source

DSKYF$28.8BPhase 2

Sep '26

Ifinatamab deruxtecan Phase 2 Est. Readout

Ifinatamab deruxtecan123

Esophageal Squamous Cell Carcinoma

Sep 2026~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 3

Sep '26

Durvalumab Phase 3 Est. Readout

Oleclumab1,051

Non-Small Cell Lung Cancer

Sep 2026~Confirmed

00%

CT.gov

PFE$143.7BPDUFA

Sep '26

FDA PDUFA Date lead asset (priority review)

Sep 2026~AI-detected

✅ApprovedSource

VNDA$349MPDUFA

FDA PDUFA Date Hetlioz (standard)

Sep 30AI-detected

✅ApprovedSEC

CRBP$153MPhase 1

Phase 1 — CRB-913

Sep 30AI-detected

✓PositiveSource

IVVD$286MPhase 3

Phase 3 — VYD2311

Sep 30AI-detected

00%

Source

QURE$2.9BBLA Filing

BLA Filing

Sep 30AI-detected

00%

Source

BEIGF$40.9BPhase 3

Sep '26

Oxaliplatin Phase 3 Est. Readout

Oxaliplatin920

Advanced Unresectable Gastric Adenocarcinoma

Sep 2026~Confirmed

00%

CT.gov

QURE$2.9BPhase 2

Sep '26

AMT-162 Phase 2 Est. Readout

AMT-16220

Amyotrophic Lateral Sclerosis

Sep 2026~Confirmed

00%

CT.gov

HLUYYPhase 2

Sep '26

Lu AG13909 Phase 2 Est. Readout

Lu AG1390942

Congenital Adrenal Hyperplasia

Sep 2026~Confirmed

00%

CT.gov

HNPHYPhase 3

Sep '26

Topotecan Phase 3 Est. Readout

Topotecan460

Small Cell Lung Cancer

Sep 2026~Confirmed

✓PositiveCT.gov

RHHBY$316.4BPhase 3

Sep '26

Crizotinib Phase 3 Est. Readout

Crizotinib217

Neoplasms

Sep 2026~Confirmed

✓PositiveCT.gov

SRRK$5.7BPDUFA

PDUFA

Sep 30AI-detected

✓PositiveSource

HSCS$6MPhase 2

Sep '26

Dapagliflozin 10 MG [Farxiga] Phase 2 Est. Readout

Dapagliflozin 10 MG [Farxiga]18

Chronic Kidney Diseases

Sep 2026~Confirmed

00%

CT.gov

AGY.L$6MPhase 3

Sep '26

Antimalarial monoclonal antibodies Phase 3 Est. Readout

Antimalarial monoclonal antibodies398

Malaria

Sep 2026~Confirmed

00%

CT.gov

RPTX$114MPhase 2

Sep '26

RP-3500 Phase 2 Est. Readout

RP-350049

Solid Tumor

Sep 2026~Confirmed

00%

CT.gov

TLSA$146MPhase 2

Phase 2 — intranasal foralumab

Sep 30AI-detected

✓PositiveSource

HSCSWPhase 2

Sep '26

Metformin hydrochloride extended-release tablets Phase 2 Est. Readout

Metformin hydrochloride extended-release tablets100

Asthma

Sep 2026~Confirmed

00%

CT.gov

DSKYF$28.8BPhase 3

Sep '26

Dato-DXd Phase 3 Est. Readout

Dato-DXd744

Metastatic Non-small Cell Lung Cancer

Sep 2026~Confirmed

00%

CT.gov

VNRX$12MTrial Start

Trial Start - DETECSEPS

Sep 30AI-detected

Source

SYRE$7.7BData Readout

Data Readout

Sep 30AI-detected

00%

Source

TPTXPhase 2

Sep '26

Oral repotrectinib (TPX-0005) Phase 2 Est. Readout

Oral repotrectinib (TPX-0005)75

Locally Advanced Solid Tumors

Sep 2026~Confirmed

00%

CT.gov

BIOI-B.STPhase 2

Sep '26

Acalabrutinib Phase 2 Est. Readout

BI-1206140

Indolent B-Cell Non-Hodgkin Lymphoma

Sep 2026~Confirmed

00%

CT.gov

RYTM$6.6BPhase 3

Sep '26

Setmelanotide Phase 3 Est. Readout

Setmelanotide39

Genetic Obesity

Sep 2026~Confirmed

00%

CT.gov

HNSA.ST$314MPhase 2

Sep '26

GNT0003 Phase 2 Est. Readout

GNT00033

Crigler-Najjar Syndrome

Sep 2026~Confirmed

00%

CT.gov

MRTXPhase 2

Sep '26

Adagrasib oral dose of 400 mg twice daily tablets Phase 2 Est. Readout

Adagrasib oral dose of 400 mg twice daily tablets90

Advanced NSCLC

Sep 2026~Confirmed

00%

CT.gov

HGZDYPhase 3

Sep '26

IBI112 Phase 3 Est. Readout

IBI112104

Psoriasis

Sep 2026~Confirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Sep '26

Staccato alprazolam Phase 3 Est. Readout

Staccato alprazolam350

Stereotypical Prolonged Seizures

Sep 2026~Confirmed

00%

CT.gov

RVMD$34.7BRegulatory

Regulatory Decision - daraxonrasib

daraxonrasibPhase 3

NSCLC (Non-small Cell Lung Cancer)

Sep 30AI-detected

✓PositiveSource

CELG-RIPhase 2

Sep '26

BMS-986449 Phase 2 Est. Readout

BMS-986449100

Advanced Solid Tumors

Sep 2026~Confirmed

00%

CT.gov

CGTX$130MPhase 2

Sep '26

golexanolone Phase 2 Est. Readout

golexanolone84

Primary Biliary Cholangitis (PBC)

Sep 2026~Confirmed

00%

CT.gov

August 2026 Full Calendar October 2026

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About PDUFA Dates in September 2026

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