August 2026 Catalysts

FDA Decisions & PDUFA Dates

September 2026

116

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Aug 3 - Aug 9

No catalysts this week

Week 2Aug 10 - Aug 16

No catalysts this week

Week 3Aug 17 - Aug 23(36 catalysts)

SCNX$16MEarnings

Past

Scienture Reports Financial Results

Aug 20Confirmed

?UnknownSource

TAK$48.9BPhase 2

Aug '26

TAK-360 Phase 2 Est. Readout

TAK-36088

Idiopathic Hypersomnia

Aug 2026~Confirmed

✓PositiveCT.gov

ARGX$56.5BPDUFA

Past

FDA PDUFA Date efgartigimod alfa (priority)

Efgartigimod IVPhase 3

Generalized Myasthenia Gravis

Aug 20AI-detected

✅ApprovedSEC

REPL$841MEarnings

Past

REPL Earnings Report

Aug 20Confirmed

✓CompletedSource

OCS$1.8BEarnings

Past

OCS Earnings Report

Aug 20Confirmed

✓CompletedSource

COAG$1.4BEarnings

Past

COAG Earnings Report

Aug 20Confirmed

✓CompletedSource

EXOZ$66MConference

Past

Conference

Aug 20AI-detected

✓CompletedSource

PMVP$60MEarnings

Past

PMVP Earnings Report

Aug 20Confirmed

✓CompletedSource

PRQR$198MEarnings

Past

PRQR Earnings Report

Aug 20Confirmed

✓CompletedSource

MRNA$25.4BData Readout

Past

Data Readout - Cancer Vaccine

Aug 20AI-detected

✓PositiveSource

JAGX$386MEarnings

Past

JAGX Earnings Report

Aug 20Confirmed

✓CompletedSource

COSM$24MEarnings

Past

Cosmos Reports Financial Results

Aug 20Confirmed

?UnknownSource

EVAX$29MEarnings

Past

EVAX Earnings Report

Aug 20Confirmed

✓CompletedSource

EXOZ$66MEarnings

Past

EXOZ Earnings Report

Aug 20Confirmed

✓CompletedSource

ICCM$17MData Readout

Past

West Cancer Center Receives IRB Approval to Commence IceCure's ChoICE Study for Breast Cancer Cryoablation

Aug 20Estimated

✓CompletedSource

ACUR$5MM&A

Past

ACURA M&A / Acquisition

Aug 20Confirmed

?UnknownSource

SLGL$241MPhase 3

Aug '26

Patidegib Topical Gel Phase 3 Est. Readout

Patidegib Topical Gel140

Gorlin Syndrome

Aug 2026~Confirmed

00%

CT.gov

NMAD$77MEarnings

Past

NMAD Earnings Report

Aug 20Confirmed

✓CompletedSource

ACLX$6.7BM&A

Past

Acquisition — Gilead Sciences

Aug 20AI-detected

✓CompletedSource

NVS$284.2BM&A

Past

Acquisition — Gilead Sciences

Aug 20AI-detected

✓CompletedSource

GILD$153.7BM&A

Past

Acquisition — Novartis

Aug 20AI-detected

✓CompletedSource

BAYRY$42.5BPhase 3

Past

BAY3723113 Phase 3 Est. Readout

BAY372311336

Obstructive Hypertrophic Cardiomyopathy

Aug 21Confirmed

✓CompletedCT.gov

AVAH$1.7BOffering

Past

Stock Offering — $176.25M

Aug 21AI-detected

✓CompletedSource

IPSEY$15.0BM&A

Past

Acquisition

Aug 21AI-detected

✓CompletedSource

AZN$273.6BM&A

Past

Acquisition — Gilead ($425M)

Aug 21AI-detected

✓CompletedSource

OSTX$81MOffering

Past

OSTX — Stock Offering (424B5)

Aug 21Confirmed

✓CompletedSource

SLGL$241MEarnings

Past

SLGL Earnings Report

Aug 21Confirmed

✓CompletedSource

NGEN$175MEarnings

Past

NGEN Earnings Report

Aug 21Confirmed

✓CompletedSource

BAYRY$42.5BPhase 3

Q3 '26

Darolutamide (BAY1841788, Nubeqa) Phase 3 Est. Readout

Darolutamide (BAY1841788, Nubeqa)985

Biochemically Recurrent Prostate Cancer

Q3 2026~QConfirmed

✓PositiveCT.gov

MRK$281.2BPhase 2

Aug '26

Pembrolizumab Phase 2 Est. Readout

Vibostolimab/Pembrolizumab400

Carcinoma, Renal Cell

Aug 2026~Confirmed

✓PositiveCT.gov

NVO$203.2BPhase 2

Aug '26

CagriSema (Cagrilintide B and Semaglutide I) Phase 2 Est. Readout

CagriSema (Cagrilintide B and Semaglutide I)142

Obesity

Aug 2026~Confirmed

✓PositiveCT.gov

NVO$203.2BPhase 3

Aug '26

Oral semaglutide Phase 3 Est. Readout

Oral semaglutide264

Diabetes Mellitus, Type 2

Aug 2026~Confirmed

✓PositiveCT.gov

SNYR$1MOther

Past

CHC Corporate Update

Aug 21Confirmed

?UnknownSource

CAPR$1.6BRegulatory

Past

Regulatory — deramiocel

Aug 22AI-detected

00%

Source

RHHBY$316.4BPhase 2

Aug '26

RO7204239 Phase 2 Est. Readout

RO7204239285

Obesity

Aug 2026~Confirmed

✗NegativeCT.gov

PFE$143.7BPhase 2

Aug '26

PF-07220060 + PF-07104091 combination dose escalation Phase 2 Est. Readout

PF-07220060 + PF-07104091 combination dose escalation192

Breast Cancer

Aug 2026~Confirmed

✓CompletedCT.gov

Week 4Aug 24 - Aug 30(62 catalysts)

BKHA$50MOther

Past

Black Corporate Update

Aug 24Confirmed

?UnknownSource

RHHBY$316.4BM&A

Past

Acquisition ($190M)

Aug 24AI-detected

✓CompletedSource

AZN$273.6BPhase 3

Aug '26

AZD9833 Phase 3 Est. Readout

AZD98331,370

ER-Positive HER2-Negative Breast Cancer

Aug 2026~Confirmed

✗NegativeCT.gov

MOLN$148MEarnings

Past

MOLN Earnings Report

Aug 24Confirmed

✓CompletedSource

REGN$57.3BPhase 2

Aug '26

Fianlimab Phase 2 Est. Readout

Fianlimab195

Melanoma

Aug 2026~Confirmed

✓CompletedCT.gov

REGN$57.3BPhase 2

Aug '26

Cemiplimab Phase 2 Est. Readout

cemiplimab195

Advanced Cutaneous Squamous Cell Carcinoma

Aug 2026~Confirmed

✓CompletedCT.gov

GSK$101.7BPhase 2

Aug '26

Flu mRNA (Formulation B1) Phase 2 Est. Readout

Flu mRNA (Formulation B1)960

Influenza, Human

Aug 2026~Confirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Aug '26

Brivaracetam Phase 3 Est. Readout

Brivaracetam153

Epilepsy

Aug 2026~Confirmed

✓CompletedCT.gov

ESALYPDUFA

Past

FDA PDUFA Date

Aug 24AI-detected

✅ApprovedSource

BIIB$29.0BPDUFA

Past

FDA PDUFA Date

Aug 24AI-detected

✓PositiveSource

JUNS$9MOffering

Past

JUNS — Stock Offering (424B5)

Aug 24Confirmed

✓CompletedSource

KLTOWOffering

Past

KLTOW — Stock Offering (424B5)

Aug 24Confirmed

✓CompletedSource

JNJ$549.8BPDUFA

Past

FDA PDUFA Date Ziihera

ZiiheraNDA

GEA

Aug 25AI-detected

✓PositiveSource

NVS$284.2BPhase 3

Aug '26

JDQ443 Phase 3 Est. Readout

JDQ44395

Non-Small Cell Lung Cancer

Aug 2026~Confirmed

✓PositiveCT.gov

KLRA$2.6BEarnings

Past

KLRA Earnings Report

Aug 25Confirmed

✓CompletedSource

AVXL$253MEarnings

Past

AVXL Earnings Report

Aug 25Confirmed

✓CompletedSource

IMTX$1.3BOffering

Past

Stock Offering — $150M

Aug 25AI-detected

✓CompletedSource

RHHBY$316.4BPhase 2

Aug '26

Giredestrant Phase 2 Est. Readout

Giredestrant30

Endometrial Cancer

Aug 2026~Confirmed

✓CompletedCT.gov

RHHBY$316.4BPhase 3

Aug '26

Giredestrant Phase 3 Est. Readout

Giredestrant1,050

Endometrial Cancer

Aug 2026~Estimated

✓CompletedCT.gov

RHHBY$316.4BPDUFA

Aug '26

FDA PDUFA Date Iberdomide (priority review)

IberdomidePhase 2

Multiple Myeloma

Aug 2026~AI-detected

✓PositiveSource

NVS$284.2BPhase 2

Aug '26

JDQ443 Phase 2 Est. Readout

JDQ443344

Non-Small Cell Lung Cancer

Aug 2026~Confirmed

✗NegativeCT.gov

JAZZ$14.1BBLA Filing

Aug '26

BLA Filing — Ziihera®

Aug 2026~AI-detected

✓PositiveSource

JAZZ$14.1BPDUFA

Past

PDUFA — Ziihera

Aug 25AI-detected

✅ApprovedSource

SNY$100.0BPhase 2

Aug '26

Rilzabrutinib dose 1 Phase 2 Est. Readout

Rilzabrutinib dose 130

Graves' Disease

Aug 2026~Confirmed

✗NegativeCT.gov

TNGX$4.0BEarnings

Past

Tango Reports Financial Results

Aug 25Confirmed

✗NegativeSource

BEIGF$40.9BEarnings

Past

BeOne Reports Financial Results

Aug 26Confirmed

?UnknownSource

AVAH$1.7BEarnings

Past

Aveanna Reports Financial Results

Aug 26Confirmed

✓PositiveSource

AZN$273.6BOffering

Past

Stock Offering — $2.97 billion

Aug 26AI-detected

✓CompletedSource

MESO$18.4BEarnings

Past

MESO Earnings Report

Aug 26Confirmed

✓CompletedSource

RHHBY$316.4BPhase 2

Aug '26

Satralizumab Phase 2 Est. Readout

satralizumab30

Neuromyelitis Optica Spectrum Disorder

Aug 2026~Confirmed

✓CompletedCT.gov

BKHA$50MM&A

Past

Black M&A / Acquisition

Aug 26Confirmed

?UnknownSource

CLTS$431KPhase 2

Aug '26

Lutetium (177Lu) rhPSMA-10.1 Injection Phase 2 Est. Readout

Lutetium (177Lu) rhPSMA-10.1 Injection82

Prostate Cancer

Aug 2026~Confirmed

✓CompletedCT.gov

PAHC$2.2BEarnings

Past

PAHC Earnings Report

Aug 27Confirmed

✓PositiveSource

ECOCM&A

Past

ABVC M&A / Acquisition

Aug 27Confirmed

?UnknownSource

BHVN$2.0BM&A

Past

Acquisition ($795M)

Aug 27AI-detected

✓CompletedSource

MRNA$25.4BOffering

Past

Stock Offering — $2B

Aug 27AI-detected

✓CompletedSource

IMRN$248MEarnings

Past

IMRN Earnings Report

Aug 27Confirmed

✓CompletedSource

ATHE$44.5BEarnings

Past

ATHE Earnings Report

Aug 27Confirmed

✓CompletedSource

HQY$7.1BEarnings

Past

HQY Earnings Report

Aug 27Confirmed

✓CompletedSource

LFVN$81MEarnings

Past

LFVN Earnings Report

Aug 27Confirmed

✓CompletedSource

CMMB$875MEarnings

Past

CMMB Earnings Report

Aug 27Confirmed

✓CompletedSource

PURR$1.2BEarnings

Past

PURR Earnings Report

Aug 27Confirmed

✓CompletedSource

KZIA$11.2BOffering

Past

KZIA — Stock Offering (424B5)

Aug 27Confirmed

✓CompletedSource

NAMS$3.5BConference

Past

Conference — obicetrapib

Aug 27AI-detected

✓CompletedSource

JAZZ$14.1BOffering

Past

Stock Offering — $1.1 billion

Aug 27AI-detected

✓CompletedSource

AZN$273.6BPhase 2

Aug '26

AZD2936 Phase 2 Est. Readout

AZD2936212

Non-Small-Cell Lung Carcinoma

Aug 2026~Confirmed

✓PositiveCT.gov

ENLV$150MOffering

Past

Stock Offering — $400 million

Aug 28AI-detected

✓CompletedSource

TEVA$36.7BM&A

Past

Acquisition

Aug 28AI-detected

✓CompletedSource

BTAI$37MM&A

Past

Acquisition — Teva Pharmaceutical ($57.5M)

Aug 28AI-detected

✓CompletedSource

CHRS$228MOffering

Past

CHRS — Stock Offering (424B5)

Aug 28Confirmed

✓CompletedSource

LNAI$137MEarnings

Past

LNAI Earnings Report

Aug 28Confirmed

✓CompletedSource

SHPH$21MOther

Past

Shuttle Corporate Update

Aug 28Confirmed

?UnknownSource

JUNS$9MOther

Past

JUPITER Corporate Update

Aug 28Confirmed

?UnknownSource

IBIO$84MEarnings

Past

iBio, Reports Financial Results

Aug 28Confirmed

?UnknownSource

DSKYF$28.8BData Readout

Past

Data Readout - Bempedoic Acid

Aug 29AI-detected

✓PositiveSource

NVAX$1.5BRegulatory

Past

Regulatory Decision - Nuvaxovid™

Aug 29AI-detected

✓PositiveSource

TAK$48.9BPDUFA

Aug '26

FDA PDUFA Date Potential Polycythemia Vera Treatment (standard review)

Potential Polycythemia Vera TreatmentNDA

Polycythemia Vera

Aug 2026~AI-detected

✓PositiveSource

IVBXF$19.2BPhase 2

Aug '26

IBI302 8mg dose Phase 2 Est. Readout

IBI302 8mg dose800

Neovascular Age-related Macular Degeneration

Aug 2026~Confirmed

00%

CT.gov

ALNY$36.9BData Readout

Past

Data Readout - Amvuttra

Aug 30AI-detected

✓PositiveSource

TXMD$9MPhase 2

Aug '26

NPT 2042 Phase 2 Est. Readout

NPT 204212

Epilepsy, Generalized

Aug 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 3

Aug '26

Elotuzumab Phase 3 Est. Readout

Elotuzumab492

Multiple Myeloma

Aug 2026~Confirmed

✗NegativeCT.gov

TAK$48.9BPhase 3

Aug '26

Tetravalent Dengue Vaccine (TDV) Phase 3 Est. Readout

Tetravalent Dengue Vaccine (TDV)496

Dengue Fever

Aug 2026~Confirmed

✓PositiveCT.gov

Week 5Aug 31 - Sep 6(18 catalysts)

KYKOY$8.2BPhase 2

Aug '26

Aflibercept Injection Phase 2 Est. Readout

KHK4951150

Diabetic Macular Edema (DME)

Aug 2026~Confirmed

00%

CT.gov

4151.T$1.3TPhase 2

Aug '26

KHK4951 Phase 2 Est. Readout

KHK4951150

Neovascular Age-Related Macular Degeneration (nAMD)

Aug 2026~Confirmed

00%

CT.gov

AMRN$6MConference

Past

Conference — REDUCE-IT

Aug 31AI-detected

✓PositiveSource

LGVN$16MData Readout

Past

Data Readout - ELPIS II

Aug 31AI-detected

00%

Source

GALDY$50.4BPhase 3

Aug '26

Nemolizumab Phase 3 Est. Readout

Nemolizumab1,700

Prurigo Nodularis

Aug 2026~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Aug '26

avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel Phase 2 Est. Readout

avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel40

KRAS Activating Mutation

Aug 2026~Confirmed

00%

CT.gov

SKBBYPhase 3

Aug '26

Wujia Yizhi granules Phase 3 Est. Readout

Wujia Yizhi granules570

Alzheimer's Dementia

Aug 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Aug '26

Belumosudil Phase 2 Est. Readout

Belumosudil36

Chronic Graft Versus Host Disease

Aug 2026~Confirmed

00%

CT.gov

LLY$1.0TM&A

Past

Acquisition

Aug 31AI-detected

✓CompletedSource

GRFS$5.0BEarnings

Past

GRFS Earnings Report

Aug 31Confirmed

✓CompletedSource

KPTI$204MNDA Filing

Past

NDA Filing — Selinexor plus Ruxolitinib

Aug 31AI-detected

00%

Source

IPSEY$15.0BPhase 2

Aug '26

IPN10200 Phase 2 Est. Readout

IPN10200240

Moderate to Severe Upper Facial Lines

Aug 2026~Confirmed

00%

CT.gov

IPSEY$15.0BPhase 3

Aug '26

IPN10200 Phase 3 Est. Readout

IPN10200300

Moderate to Severe Upper Facial Lines

Aug 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Aug '26

Sefaxersen (RO7434656) Phase 3 Est. Readout

Sefaxersen (RO7434656)428

Primary IgA Nephropathy

Aug 2026~Confirmed

✓PositiveCT.gov

IPN.PA$14.5BPhase 2

Aug '26

IPN10200 Phase 2 Est. Readout

IPN10200727

Moderate to Severe Upper Facial Lines

Aug 2026~Confirmed

00%

CT.gov

DSKYF$28.8BPhase 3

Aug '26

Ramucirumab Phase 3 Est. Readout

Ramucirumab490

Non-Small Cell Lung Cancer

Aug 2026~Confirmed

✓PositiveCT.gov

HNPHYPhase 3

Aug '26

Gemcitabine combined with docetaxel Phase 3 Est. Readout

Gemcitabine combined with docetaxel117

Osteosarcoma

Aug 2026~Confirmed

✓PositiveCT.gov

RHHBY$316.4BPhase 2

Aug '26

Ipatasertib Phase 2 Est. Readout

Ipatasertib146

Triple-Negative Breast Cancer

Aug 2026~Confirmed

00%

CT.gov

July 2026 Full Calendar September 2026

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About PDUFA Dates in August 2026

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