June 2027 Catalysts

FDA Decisions & PDUFA Dates

July 2027

135

Total Catalysts

PDUFA Dates

126

Trial Results

Companies

Week 1May 31 - Jun 6(10 catalysts)

EIKN$520MPhase 2

Q2 '27

IMP1734 Phase 2 Est. Readout

IMP1734156

Advanced Solid Tumor

Q2 2027~QConfirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Q2 '27

Apatinib and Adebrelimab in Combination With chemotherapy Phase 2 Est. Readout

Apatinib and Adebrelimab in Combination With chemotherapy38

Intrahepatic Cholangiocarcinoma (Icc)

Q2 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 2

Q2 '27

Ruxolitinib Phase 2 Est. Readout

Ruxolitinib130

MPN (Myeloproliferative Neoplasms)

Q2 2027~QConfirmed

00%

CT.gov

AAPG$6.4BPhase 2

Q2 '27

APG-115 Phase 2 Est. Readout

APG-115100

AML

Q2 2027~QConfirmed

00%

CT.gov

AAPG$6.4BPhase 2

Q2 '27

APG-2575 Phase 2 Est. Readout

APG-2575100

T-Prolymphocytic Leukemia

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Fexofenadine (loratadine if not available) Phase 3 Est. Readout

Fexofenadine (loratadine if not available)284

Pruritus

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 3

Q2 '27

Pelabresib Phase 3 Est. Readout

Pelabresib50

Hematologic Malignancy

Q2 2027~QConfirmed

00%

CT.gov

GSK$101.7BPhase 2

Q2 '27

Momelotinib Phase 2 Est. Readout

Momelotinib80

Primary Myelofibrosis

Q2 2027~QConfirmed

00%

CT.gov

CGON$5.4BPDUFA

Jun '27

FDA PDUFA Date

Bladder Cancer

Jun 2027~AI-detected

✅ApprovedSource

CRSP$5.2BPhase 3

Q2 '27

CTX001 Phase 3 Est. Readout

CTX00113

Beta-Thalassemia

Q2 2027~QConfirmed

00%

CT.gov

Week 2Jun 7 - Jun 13(11 catalysts)

AZNCF$290.6BPhase 2

Q2 '27

Tozorakimab Phase 2 Est. Readout

Tozorakimab540

Asthma

Q2 2027~QConfirmed

00%

CT.gov

ESALYPhase 3

Q2 '27

Lenvatinib Phase 3 Est. Readout

Lenvatinib249

Hepatocellular Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

PCV21 vaccine Phase 3 Est. Readout

20vPCV licensed vaccine2,195

Pneumococcal Immunization

Q2 2027~QConfirmed

00%

CT.gov

TAK$48.9BPhase 3

Q2 '27

Vedolizumab Phase 3 Est. Readout

Upadacitinib396

Crohn's Disease

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Fenebrutinib Phase 2 Est. Readout

Fenebrutinib12

Relapsing Multiple Sclerosis

Q2 2027~QConfirmed

00%

CT.gov

VRTX$114.6BPhase 3

Q2 '27

CTX001 Phase 3 Est. Readout

CTX00126

Beta-Thalassemia

Q2 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q2 '27

Pembrolizumab Phase 2 Est. Readout

Antihistamine230

Esophageal Squamous Cell Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

OCUL$2.1BPDUFA

Jun '27

FDA PDUFA Date Axpaxli

AxpaxliNDA

wet age-related macular degeneration (wet AMD)

Jun 2027~AI-detected

00%

Source

DSKYF$28.8BPhase 2

Q2 '27

I-DXd Phase 2 Est. Readout

I-DXd60

Oesophageal Squamous Cell Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

LQDA$6.3BPDUFA

Jun '27

FDA PDUFA Date Relacorilant

RelacorilantNDA

Cushing's Syndrome

Jun 2027~AI-detected

📋CRLSource

OTLK$191MPDUFA

Jun '27

FDA PDUFA Date

Eye disease/condition

Jun 2027~AI-detected

✅ApprovedSource

Week 3Jun 14 - Jun 20(53 catalysts)

NONOF$215.0BPhase 2

Q2 '27

Semaglutide Phase 2 Est. Readout

Semaglutide233

Diabetes Mellitus, Type 2

Q2 2027~QConfirmed

00%

CT.gov

ALPMY$24.1BPhase 2

Jun '27

Enfortumab Vedotin Phase 2 Est. Readout

Enfortumab vedotin60

Metastatic Urothelial Cancer

Jun 2027~Confirmed

00%

CT.gov

TXMD$9MPhase 3

Jun '27

Veverimer Phase 3 Est. Readout

Veverimer150

CKD

Jun 2027~Confirmed

00%

CT.gov

AVLN$1.4BPhase 2

Jun '27

AP01 Phase 2 Est. Readout

AP01375

Pulmonary Fibrosis

Jun 2027~Confirmed

00%

CT.gov

MOLN$148MPhase 3

Jun '27

EYLEA® (aflibercept) Injection 2 mg (0.05mL) Phase 3 Est. Readout

4D-150 IVT (3E10 vg/eye)480

Macular Neovascularization Secondary to Age-Related Macular Degeneration

Jun 2027~Confirmed

00%

CT.gov

GNMSF$18.3BPhase 3

Jun '27

Vincristine Phase 3 Est. Readout

Vincristine900

Follicular Lymphoma (FL)

Jun 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Jun '27

Pembrolizumab Phase 2 Est. Readout

pembrolizumab47

Colorectal Neoplasms

Jun 2027~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Jun '27

Mosunetuzumab Phase 2 Est. Readout

Mosunetuzumab80

Non-Hodgkin Lymphoma

Jun 2027~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Jun '27

HRS-4642+AG +Adebrelimab Phase 2 Est. Readout

HRS-4642+AG +Adebrelimab30

Pancreatic Cancer

Jun 2027~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Jun '27

Darolutamide Phase 2 Est. Readout

Darolutamide100

High-Risk Localized Prostate Cancer

Jun 2027~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Jun '27

panitumumab Phase 2 Est. Readout

panitumumab150

Colorectal Cancer

Jun 2027~Confirmed

00%

CT.gov

GNMSF$18.3BPhase 3

Jun '27

Epcoritamab Phase 3 Est. Readout

Epcoritamab900

DLBCL

Jun 2027~Confirmed

00%

CT.gov

ETRA$810MPhase 3

Jun '27

ELA026 Phase 3 Est. Readout

ELA026156

Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Jun 2027~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Jun '27

VS-7375 Phase 2 Est. Readout

VS-7375180

Pancreatic Ductal Adenocarcinoma

Jun 2027~Confirmed

00%

CT.gov

GILD$153.7BPhase 2

Jun '27

Sacituzumab govitecan-hziy (SG) Phase 2 Est. Readout

Sacituzumab govitecan-hziy (SG)270

Triple Negative Breast Cancer

Jun 2027~Confirmed

00%

CT.gov

FDMT$481MPhase 3

Jun '27

4D-150 IVT (3E10 vg/eye) Phase 3 Est. Readout

4D-150 IVT (3E10 vg/eye)480

Neovascular Age-Related Macular Degeneration (nAMD)

Jun 2027~Confirmed

00%

CT.gov

KPTI$204MPhase 2

Jun '27

Selinexor 60 mg Phase 2 Est. Readout

Selinexor 60 mg58

Myelofibrosis

Jun 2027~Confirmed

00%

CT.gov

FDMT$481MPhase 2

Jun '27

4D-710 Phase 2 Est. Readout

4D-71030

Cystic Fibrosis Lung

Jun 2027~Confirmed

00%

CT.gov

SKBBYPhase 2

Jun '27

Test product HY0001a for injection Phase 2 Est. Readout

Test product HY0001a for injection261

Solid Tumor

Jun 2027~Confirmed

00%

CT.gov

MANE$3.9BPhase 3

Jun '27

VDPHL01 QD Phase 3 Est. Readout

VDPHL01 QD552

Androgenetic Alopecia (AGA)

Jun 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Jun '27

Upadacitinib Phase 3 Est. Readout

Upadacitinib110

Ulcerative Colitis (UC)

Jun 2027~Confirmed

00%

CT.gov

IONS$12.2BPhase 3

Jun '27

Olezarsen Phase 3 Est. Readout

Olezarsen24

Familial Chylomicronemia Syndrome

Jun 2027~Confirmed

00%

CT.gov

MIRM$6.5BPhase 3

Jun '27

Brelovitug 900 mg Phase 3 Est. Readout

Brelovitug 900 mg150

Chronic Hepatitis D Infection

Jun 2027~Confirmed

00%

CT.gov

LNTH$6.8BPhase 3

Jun '27

[18F]PI-2620 Phase 3 Est. Readout

[18F]PI-2620200

Alzheimer Disease

Jun 2027~Confirmed

00%

CT.gov

AKBA$287MPhase 2

Jun '27

Praliciguat Phase 2 Est. Readout

Praliciguat60

Focal Segmental Glomerulosclerosis

Jun 2027~Confirmed

00%

CT.gov

BGNEPhase 2

Jun '27

Zanubrutinib Phase 2 Est. Readout

Zanubrutinib56

Refractory Mantle Cell Lymphoma

Jun 2027~Confirmed

00%

CT.gov

ARWR$11.5BPhase 2

Jun '27

ARO-MAPT-SC Phase 2 Est. Readout

ARO-MAPT-SC112

Alzheimer Disease

Jun 2027~Confirmed

00%

CT.gov

GILD$153.7BPhase 3

Jun '27

Sacituzumab govitecan-hziy (SG) Phase 3 Est. Readout

Sacituzumab govitecan-hziy (SG)1,514

Triple Negative Breast Cancer

Jun 2027~Confirmed

00%

CT.gov

TNGX$4.0BPhase 2

Jun '27

RMC-9805 Phase 2 Est. Readout

RMC-9805616

PDAC

Jun 2027~Confirmed

00%

CT.gov

RXRX$544MPhase 2

Jun '27

REC-4881 Phase 2 Est. Readout

REC-488167

AXIN1 Gene Mutation

Jun 2027~Confirmed

00%

CT.gov

SKBBYPhase 3

Jun '27

Investigator's choice of chemotherapy Phase 3 Est. Readout

Investigator's choice of chemotherapy490

Gastric Adenocarcinoma

Jun 2027~Confirmed

00%

CT.gov

IMMP$546MPhase 3

Jun '27

eftilagimod alfa Phase 3 Est. Readout

eftilagimod alfa756

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

Jun 2027~Confirmed

00%

CT.gov

ARCT$214MPhase 2

Jun '27

ARCT-032 Phase 2 Est. Readout

ARCT-03233

Cystic Fibrosis

Jun 2027~Confirmed

00%

CT.gov

4519.T$87.4BPhase 2

Q2 '27

DONQ52 Phase 2 Est. Readout

DONQ5292

Celiac Disease

Q2 2027~QConfirmed

00%

CT.gov

INKT$11MPhase 2

Jun '27

agenT-797 Phase 2 Est. Readout

agenT-79790

Pneumonia

Jun 2027~Confirmed

00%

CT.gov

KYMR$7.4BPhase 2

Jun '27

KT-621 Phase 2 Est. Readout

KT-621200

Atopic Dermatitis

Jun 2027~Confirmed

00%

CT.gov

RVMD$34.7BPhase 2

Jun '27

RMC-6291 Phase 2 Est. Readout

RMC-6291616

Non-Small Cell Lung Cancer, NSCLC

Jun 2027~Confirmed

00%

CT.gov

BEAM$3.5BPhase 2

Jun '27

BEAM-302 Phase 2 Est. Readout

BEAM-302106

Alpha 1-Antitrypsin Deficiency

Jun 2027~Confirmed

00%

CT.gov

ORKA$4.4BPhase 2

Jun '27

ORKA-001 Phase 2 Est. Readout

ORKA-001160

Plaque Psoriasis

Jun 2027~Confirmed

00%

CT.gov

DAWN$2.2BPhase 3

Jun '27

Tovorafenib Phase 3 Est. Readout

Chemotherapeutic Agent418

Low-grade Glioma

Jun 2027~Confirmed

00%

CT.gov

HUMA$205MPhase 3

Jun '27

Acellular Tissue Engineered Vessel (ATEV) Phase 3 Est. Readout

Acellular Tissue Engineered Vessel (ATEV)121

End Stage Renal Disease (ESRD)

Jun 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Jun '27

Vipoglanstat Phase 2 Est. Readout

Vipoglanstat190

Endometriosis

Jun 2027~Confirmed

00%

CT.gov

JNGHFPhase 2

Jun '27

HRS-4642 Phase 2 Est. Readout

HRS-4642130

Pancreatic Cancer

Jun 2027~Confirmed

00%

CT.gov

JNGHFPhase 3

Jun '27

Pyrotinib Phase 3 Est. Readout

pyrotinib2,135

Non Small Cell Lung

Jun 2027~Confirmed

00%

CT.gov

SGENPhase 2

Jun '27

Enfortumab vedotin Phase 2 Est. Readout

Enfortumab Vedotin23

Renal Pelvis and Ureter Urothelial Carcinoma

Jun 2027~Confirmed

00%

CT.gov

ALKS$7.5BPhase 3

Jun '27

ALKS 2680 Dose 1 Phase 3 Est. Readout

ALKS 2680 Dose 1150

Narcolepsy Type 1

Jun 2027~Confirmed

00%

CT.gov

ZYME$1.7BPhase 3

Jun '27

Futibatinib Phase 3 Est. Readout

Futibatinib800

Biliary Tract Neoplasms

Jun 2027~Confirmed

00%

CT.gov

PHVS$2.3BPhase 3

Jun '27

Deucrictibant Phase 3 Est. Readout

Deucrictibant32

Hereditary Angioedema

Jun 2027~Confirmed

00%

CT.gov

NRSNWPhase 3

Jun '27

Intensified protocol Phase 3 Est. Readout

Intensified protocol486

Glioblastoma

Jun 2027~Confirmed

00%

CT.gov

TRAX$608MPDUFA

Jun '27

FDA PDUFA Date Cemdisiran

CemdisiranNDA

Generalized Myasthenia Gravis (gMG)

Jun 2027~AI-detected

✅ApprovedSource

AZN$273.6BPhase 3

Q2 '27

Placebo Phase 3 Est. Readout

exenatide360

Type 2 Diabetes Mellitus

Q2 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 3

Q2 '27

Mibavademab Phase 3 Est. Readout

mibavademab4

Generalized Lipodystrophy

Q2 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q2 '27

CT3001 Phase 2 Est. Readout

CT300178

Solid Tumor, Adult

Q2 2027~QConfirmed

00%

CT.gov

Week 4Jun 21 - Jun 27(9 catalysts)

JHPCY$45.1BPDUFA

Jun '27

FDA PDUFA Date Sumecigrel Capsule

Sumecigrel CapsuleNDA

antiplatelet

Jun 2027~AI-detected

00%

Source

ITCIPhase 3

Q2 '27

Lumateperone low dose Phase 3 Est. Readout

Lumateperone low dose160

Irritability Associated With Autism Spectrum Disorder

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

Short-Acting Beta Agonists (SABA) Phase 2 Est. Readout

Short-Acting Beta Agonists (SABA)556

Asthma

Q2 2027~QConfirmed

00%

CT.gov

ITCIPhase 3

Q2 '27

Lumateperone high dose Phase 3 Est. Readout

Lumateperone high dose160

Irritability Associated With Autism Spectrum Disorder

Q2 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 2

Q2 '27

Vaccine Candidate #1 Phase 2 Est. Readout

Vaccine Candidate #1770

Healthy Adults

Q2 2027~QConfirmed

00%

CT.gov

BPMCPhase 2

Q2 '27

Avapritinib Phase 2 Est. Readout

avapritinib251

Solid Tumor, Unspecified, Child

Q2 2027~QConfirmed

00%

CT.gov

ALM.MC$4.3BPhase 2

Q2 '27

LAD603 Phase 2 Est. Readout

LAD603136

Alopecia Areata

Q2 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q2 '27

Suvorexant Phase 3 Est. Readout

Suvorexant300

Insomnia

Q2 2027~QConfirmed

00%

CT.gov

APLS$5.3BPhase 2

Q2 '27

APL-3007, pegcetacoplan (APL-2) Phase 2 Est. Readout

APL-3007, pegcetacoplan (APL-2)240

Geographic Atrophy Secondary to Age-related Macular Degeneration

Q2 2027~QConfirmed

00%

CT.gov

Week 5Jun 28 - Jul 4(52 catalysts)

CELG-RIPhase 3

Q2 '27

Xanomeline/Trospium Chloride Phase 3 Est. Readout

Xanomeline/Trospium Chloride424

Mania

Q2 2027~QConfirmed

00%

CT.gov

GSK$101.7BPhase 2

Q2 '27

GSK4524101 Phase 2 Est. Readout

GSK4524101135

Neoplasms

Q2 2027~QConfirmed

00%

CT.gov

JNGHFPhase 3

Q2 '27

SHR-A1811 Phase 3 Est. Readout

SHR-A1811360

Advanced Non-small Cell Lung Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Trastuzumab Phase 2 Est. Readout

Trastuzumab378

Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Trastuzumab Emtansine Phase 2 Est. Readout

Trastuzumab Emtansine378

Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q2 '27

Astegolimab Phase 3 Est. Readout

Astegolimab2,000

Chronic Obstructive Pulmonary Disease (COPD)

Q2 2027~QConfirmed

00%

CT.gov

AAPG$6.4BPhase 3

Q2 '27

olverembatinib Phase 3 Est. Readout

Bosutinib333

Chronic Myeloid Leukemia

Q2 2027~QConfirmed

00%

CT.gov

NTLA$2.2BPhase 3

10mo

Phase 3 — lonvo-z

Jun 30AI-detected

00%

Source

AZN$273.6BPhase 2

Q2 '27

AZD9793 Intravenous (IV) monotherapy Phase 2 Est. Readout

AZD9793 Intravenous (IV) monotherapy304

Hepatocellular Carcinoma

Q2 2027~QEstimated

00%

CT.gov

AZN$273.6BPhase 3

Q2 '27

Durvalumab Phase 3 Est. Readout

cisplatin + fluorouracil640

Esophageal Squamous Cell Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 3

Q2 '27

Etelcalcetide Phase 3 Est. Readout

Etelcalcetide24

Secondary Hyperparathyroidism

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q2 '27

Placebo Phase 3 Est. Readout

peginterferon alfa-2a [Pegasys]420

Hepatitis B, Chronic

Q2 2027~QConfirmed

00%

CT.gov

JNGHFPhase 3

Q2 '27

Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan Phase 3 Est. Readout

Ramucirumab / Paclitaxel/ Docetaxel/ Irinotecan360

HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Q2 2027~QConfirmed

00%

CT.gov

LBRX$860MPhase 3

10mo

Phase 3 — LB-102

Jun 30AI-detected

00%

Source

TXMD$9MPhase 2

Q2 '27

IMC-001 Phase 2 Est. Readout

IMC-00130

Extranodal NK/T-cell Lymphoma, Nasal Type

Q2 2027~QConfirmed

00%

CT.gov

TSHA$1.8BData Readout

10mo

Data Readout — REVEAL

Jun 30AI-detected

00%

Source

INDP$442MPhase 2

Q2 '27

Decoy20 Phase 2 Est. Readout

Decoy20120

Solid Tumor, Adult

Q2 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q2 '27

Cemiplimab Phase 2 Est. Readout

cemiplimab32

Advanced Cutaneous Squamous Cell Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q2 '27

Rapcabtagene autoleucel single agent Phase 2 Est. Readout

Rapcabtagene autoleucel single agent217

Chronic Lymphocytic Leukemia

Q2 2027~QConfirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Q2 '27

Enzomenib Phase 2 Est. Readout

Enzomenib606

Leukemia, Myeloid, Acute

Q2 2027~QConfirmed

00%

CT.gov

PCVX$7.4BPhase 3

Jun '27

Phase 3 Results - VAX-31

Jun 2027~AI-detected

00%

Source

BCAX$1.5BTrial Start

Jun '27

Trial Start

Jun 2027~AI-detected

Source

CLRB$22MPhase 3

Jun '27

Phase 3 Results

Jun 2027~AI-detected

00%

Source

DAWN$2.2BPhase 3

Jun '27

Phase 3 — Tovorafenib

Jun 2027~AI-detected

00%

Source

MIRM$6.5BPhase 3

Q2 '27

Bulevirtide 2 mg and Brelovitug - 300 mg Phase 3 Est. Readout

Bulevirtide 2 mg and Brelovitug - 300 mg172

Chronic Hepatitis D Infection

Q2 2027~QConfirmed

00%

CT.gov

IVBXF$19.2BPhase 3

Q2 '27

IBI343 Phase 3 Est. Readout

IBI343201

Pancreatic Cancer

Q2 2027~QConfirmed

00%

CT.gov

CELG-RIPhase 2

Q2 '27

nab-paclitaxel Phase 2 Est. Readout

nab-Paclitaxel46

Non-Small Cell Lung Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q2 '27

Ranibizumab (10 mg/mL) Phase 3 Est. Readout

Ranibizumab (10 mg/mL)68

Neovascular Age-related Macular Degeneration

Q2 2027~QConfirmed

00%

CT.gov

BGNEPhase 3

Q2 '27

Gemcitabine Hydrochloride Phase 3 Est. Readout

Gemcitabine Hydrochloride420

Urothelial Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

TAK$48.9BPhase 3

Q2 '27

Vedolizumab IV Phase 3 Est. Readout

Vedolizumab IV70

Moderately to Severely Active Ulcerative Colitis

Q2 2027~QConfirmed

00%

CT.gov

BGNEPhase 3

Q2 '27

Cisplatin Phase 3 Est. Readout

Fluorouracil (5-FU)25

Esophageal Squamous Cell Carcinoma (ESCC)

Q2 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q2 '27

FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) Phase 2 Est. Readout

FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)80

Metastatic Colorectal Cancer

Q2 2027~QConfirmed

00%

CT.gov

JNGHFPhase 2

Q2 '27

JSKN016 Phase 2 Est. Readout

JSKN016180

Inoperable Locally Advanced HER2-Negative Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

RO7247669 Phase 2 Est. Readout

RO7247669170

Melanoma

Q2 2027~QConfirmed

00%

CT.gov

SKBBYPhase 2

Q2 '27

Tagitanlimab Phase 2 Est. Readout

Tagitanlimab28

Prostate Cancer (Adenocarcinoma)

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 3

Q2 '27

Milrinone infusion Phase 3 Est. Readout

Milrinone infusion316

Post-ligation Cardiac Syndrome

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

2-Hydroxybenzylamine Phase 2 Est. Readout

2-Hydroxybenzylamine72

Familial Hypercholesterolemia

Q2 2027~QConfirmed

00%

CT.gov

PHVS$2.3BPhase 3

10mo

Phase 3 — deucrictibant XR

Jun 30AI-detected

00%

Source

BGNEPhase 3

Q2 '27

Tislelizumab Phase 3 Est. Readout

BGB-A425420

Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2

Q2 2027~QConfirmed

00%

CT.gov

BLTE$5.9BPhase 3

Q2 '27

Tinlarebant Phase 3 Est. Readout

Tinlarebant429

STGD1

Q2 2027~QConfirmed

00%

CT.gov

NUOXPhase 2

Q2 '27

NanO2TM Phase 2 Est. Readout

NanO2TM87

Glioblastoma Multiforme

Q2 2027~QConfirmed

00%

CT.gov

SKBBYPhase 2

Q2 '27

SKB571 for injection Phase 2 Est. Readout

SKB571 for injection70

Lung Cancer (Non-Small Cell)

Q2 2027~QConfirmed

00%

CT.gov

DSKYF$28.8BPhase 3

Q2 '27

Etoposide Phase 3 Est. Readout

Etoposide25

Non-small Cell Lung Cancer

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

Fluticasone Phase 2 Est. Readout

Fluticasone45

Bronchiolitis Obliterans Syndrome

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

Zuranolone Phase 2 Est. Readout

Zuranolone6

Post Stroke Depression

Q2 2027~QConfirmed

00%

CT.gov

TEVA$36.7BPhase 3

Q2 '27

Deutetrabenazine Phase 3 Est. Readout

Deutetrabenazine30

Huntington Disease

Q2 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q2 '27

NVG-2089 Phase 2 Est. Readout

NVG-208930

Immune Thrombocytopenia (ITP)

Q2 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q2 '27

ABSK-011+BSC Phase 2 Est. Readout

ABSK-011+BSC141

Hepatocellular Carcinoma (HCC)

Q2 2027~QConfirmed

00%

CT.gov

LNAI$137MPartnership

10mo

Partnership

Jun 30AI-detected

Source

RHHBY$316.4BPhase 2

Q2 '27

Obinutuzumab Phase 2 Est. Readout

Obinutuzumab72

Large B-cell Lymphoma

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Venetoclax Phase 2 Est. Readout

Venetoclax72

Chronic Lymphocytic Leukemia

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Pertuzumab Phase 2 Est. Readout

Pertuzumab378

Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

May 2027 Full Calendar July 2027

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About PDUFA Dates in June 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for June 2027. 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.