July 2027 Catalysts

FDA Decisions & PDUFA Dates

August 2027

102

Total Catalysts

PDUFA Dates

100

Trial Results

Companies

Week 1Jun 28 - Jul 4(8 catalysts)

PHM.MC$26.2BPhase 2

Q3 '27

Relugolix Phase 2 Est. Readout

Relugolix110

Prostate Cancer

Q3 2027~QConfirmed

00%

CT.gov

ZEALPhase 2

Q3 '27

Levetiracetam Injection Phase 2 Est. Readout

Levetiracetam Injection133

Neonatal Seizure

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q3 '27

Letrozole 2.5mg Phase 3 Est. Readout

Letrozole 2.5mg540

Ovarian Neoplasm Epithelial

Q3 2027~QConfirmed

00%

CT.gov

RGNX$403MBLA Filing

10mo

BLA Filing — RGX-202

Jul 1AI-detected

00%

Source

VKTX$3.5BPhase 3

Q3 '27

VK2735 Phase 3 Est. Readout

VK27351,100

Weight Loss

Q3 2027~QConfirmed

00%

CT.gov

UTHR$22.8BPhase 2

Q3 '27

Inhaled Treprostinil (Tyvaso Nebulizer) Phase 2 Est. Readout

Inhaled Treprostinil (Tyvaso Nebulizer)10

COPD (Chronic Obstructive Pulmonary Disease)

Q3 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q3 '27

Valsartan 40 mg Phase 2 Est. Readout

Valsartan 40 mg60

Pulmonary Arterial Hypertension

Q3 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q3 '27

ALXN1920 Phase 2 Est. Readout

ALXN192030

Primary Membranous Nephropathy

Q3 2027~QConfirmed

00%

CT.gov

Week 2Jul 5 - Jul 11(8 catalysts)

REGN$57.3BPhase 2

Q3 '27

REGN5093 Phase 2 Est. Readout

REGN509395

NSCLC

Q3 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q3 '27

AZD2389 Phase 2 Est. Readout

AZD2389104

Liver Fibrosis

Q3 2027~QConfirmed

00%

CT.gov

KLRA$2.6BPhase 2

Q3 '27

KAI-7535 Phase 2 Est. Readout

KAI-7535306

Obesity

Q3 2027~QConfirmed

00%

CT.gov

BMRN$10.6BPDUFA

Jul '27

FDA PDUFA Date Voxzogo

VoxzogoApproved

Achondroplasia

Jul 2027~Confirmed

BTDFTOrphan✅ApprovedSource

SNY$100.0BPhase 3

Q3 '27

IVIg Phase 3 Est. Readout

IVIg160

Chronic Inflammatory Demyelinating Polyneuropathy

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Placebo Phase 2 Est. Readout

peginterferon alfa-2a [Pegasys]

Hepatitis B, Chronic

Q3 2027~QConfirmed

00%

CT.gov

HNSPF$23.2BPhase 2

Q3 '27

HS-10516 + Lenvatinib Phase 2 Est. Readout

HS-10516 + Lenvatinib104

Advanced Clear Cell Renal Cell Carcinoma

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q3 '27

Liposomal doxorubicin Phase 3 Est. Readout

liposomal doxorubicin1,200

Breast Neoplasms

Q3 2027~QConfirmed

00%

CT.gov

Week 3Jul 12 - Jul 18(47 catalysts)

PFE$143.7BPhase 2

Q3 '27

Etrasimod Phase 2 Est. Readout

Etrasimod36

Alopecia Areata

Q3 2027~QConfirmed

00%

CT.gov

BIOI-B.STPhase 2

Q3 '27

BI-1910 Phase 2 Est. Readout

BI-191035

Solid Tumors

Q3 2027~QConfirmed

00%

CT.gov

SGENPhase 2

Jul '27

brentuximab vedotin Phase 2 Est. Readout

brentuximab vedotin58

Lymphoma, B-Cell

Jul 2027~Confirmed

00%

CT.gov

CORT$8.6BPhase 2

Jul '27

Nab-paclitaxel 100 mg/m^2 Phase 2 Est. Readout

Nab-paclitaxel 100 mg/m^260

Ovarian Neoplasm

Jul 2027~Confirmed

00%

CT.gov

LLY$1.0TPhase 2

Jul '27

LY4065967 Phase 2 Est. Readout

LY4065967150

Diabetic Peripheral Neuropathic Pain

Jul 2027~Confirmed

00%

CT.gov

KRYS$10.3BPhase 2

Jul '27

Opdualag Phase 2 Est. Readout

Opdualag240

Cancer

Jul 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Q3 '27

Acalabrutinib Phase 3 Est. Readout

Acalabrutinib607

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

SKBBYPhase 2

Jul '27

BL-B01D1 Phase 2 Est. Readout

BL-B01D1198

Advanced Biliary Tract Cancer

Jul 2027~Confirmed

00%

CT.gov

TVTX$5.1BPhase 3

Jul '27

Pegtibatinase Phase 3 Est. Readout

Pegtibatinase70

Homocystinuria

Jul 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

MRI contrast-enhancing preparations Phase 3 Est. Readout

MRI contrast-enhancing preparations160

Multiple Sclerosis

Q3 2027~QConfirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Jul '27

SHR4640 ；Febuxostat Phase 2 Est. Readout

SHR4640 ；Febuxostat340

Primary Gout and Hyperuricemia

Jul 2027~Confirmed

00%

CT.gov

MESO$18.4BPhase 3

Jul '27

Rexlemestrocel-L + HA mixture Phase 3 Est. Readout

Rexlemestrocel-L + HA mixture300

Degenerative Disc Disease

Jul 2027~Confirmed

00%

CT.gov

NTLA$2.2BPhase 3

Jul '27

nexiguran ziclumeran Phase 3 Est. Readout

nexiguran ziclumeran60

Neuromuscular Disease

Jul 2027~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Jul '27

ANG003 Dose A Phase 2 Est. Readout

ANG003 Dose A113

Exocrine Pancreatic Insufficiency (EPI)

Jul 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 2

Q3 '27

Acalabrutinib Phase 2 Est. Readout

Acalabrutinib80

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

NBIX$15.9BPhase 3

Jul '27

NBI-1065845 Phase 3 Est. Readout

NBI-1065845200

Major Depressive Disorder

Jul 2027~Confirmed

00%

CT.gov

APLS$5.3BPhase 3

Jul '27

Pegcetacoplan Phase 3 Est. Readout

Pegcetacoplan100

C3G

Jul 2027~Confirmed

00%

CT.gov

BBOT$606MPhase 2

Jul '27

AG10 Phase 2 Est. Readout

AG1055

Amyloid Cardiomyopathy

Jul 2027~Confirmed

00%

CT.gov

FOLD$4.5BPhase 3

Jul '27

Cipaglucosidase alfa Phase 3 Est. Readout

Cipaglucosidase Alfa36

Pompe Disease (Late-onset)

Jul 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Jul '27

Combined Oral Contraceptive Phase 3 Est. Readout

Combined Oral Contraceptive800

Endometriosis

Jul 2027~Confirmed

00%

CT.gov

KRYS$10.3BPhase 2

Jul '27

KB707 Phase 2 Est. Readout

KB707240

Lung Cancer, Non-small Cell

Jul 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Jul '27

Upadacitinib (ABT-494) Phase 3 Est. Readout

Upadacitinib (ABT-494)950

Ulcerative Colitis (UC)

Jul 2027~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Jul '27

Efgartigimod PH20 SC Phase 3 Est. Readout

Efgartigimod PH20 SC631

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Jul 2027~Confirmed

00%

CT.gov

SKBBYPhase 3

Jul '27

SKB264 Phase 3 Est. Readout

SKB264430

Metastatic Breast Cancer

Jul 2027~Confirmed

00%

CT.gov

COAG$1.4BPhase 2

Jul '27

HMB-002 (Part A) Phase 2 Est. Readout

HMB-002 (Part A)108

Von Willebrand Disease (VWD)

Jul 2027~Confirmed

00%

CT.gov

SWTOYPhase 2

Jul '27

Pacritinib Phase 2 Est. Readout

Pacritinib26

Waldenström Macroglobulinemia

Jul 2027~Confirmed

00%

CT.gov

SOBI.ST$14.6BPhase 2

Jul '27

Emapalumab Phase 2 Est. Readout

Emapalumab5

Macrophage Activation Syndrome

Jul 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Jul '27

Tisagenlecleucel Phase 2 Est. Readout

tisagenlecleucel30

Follicular Lymphoma

Jul 2027~Confirmed

00%

CT.gov

YMAB$391MPhase 2

Jul '27

131 I-omburtamab Phase 2 Est. Readout

131 I-omburtamab31

Desmoplastic Small Round Cell Tumor

Jul 2027~Confirmed

00%

CT.gov

YMAB$391MPhase 2

Jul '27

humanized anti-GD2 antibody Phase 2 Est. Readout

humanized anti-GD2 antibody46

Recurrent Osteosarcoma

Jul 2027~Confirmed

00%

CT.gov

IPIX$9MPhase 3

Jul '27

Reference Drug Phase 3 Est. Readout

Reference Drug312

Retinal Vein Occlusion With Macular Edema

Jul 2027~Confirmed

00%

CT.gov

HSCSWPhase 2

Jul '27

Activin ligand-trap biological therapy Phase 2 Est. Readout

Activin ligand-trap biological therapy48

Heart Failure With Preserved Ejection Fraction

Jul 2027~Confirmed

00%

CT.gov

BGNEPhase 2

Jul '27

HIPEC Phase 2 Est. Readout

HIPEC34

Gastric Cancer

Jul 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Jul '27

Isatuximab Phase 2 Est. Readout

Isatuximab8

Plasma Cell Myeloma Refractory

Jul 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Jul '27

Relatlimab Phase 2 Est. Readout

Relatlimab57

Advanced Gastric Cancer

Jul 2027~Confirmed

00%

CT.gov

ALVO$1.2BPhase 3

Jul '27

AVT29 (proposed aflibercept HD biosimilar) Phase 3 Est. Readout

AVT29 (proposed aflibercept HD biosimilar)256

Diabetic Macular Edema

Jul 2027~Confirmed

00%

CT.gov

BGNEPhase 2

Q3 '27

Luteinizing Hormone Releasing Hormone Phase 2 Est. Readout

Luteinizing Hormone Releasing Hormone32

Prostate Cancer

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q3 '27

Pembrolizumab Phase 3 Est. Readout

pembrolizumab200

Colorectal Neoplasms

Q3 2027~QConfirmed

00%

CT.gov

TVTX$5.1BPhase 2

Jul '27

Pegtibatinase Phase 2 Est. Readout

Pegtibatinase39

Homocystinuria

Jul 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Q3 '27

Venetoclax Phase 3 Est. Readout

Venetoclax607

Acute Myeloid Leukemia (AML)

Q3 2027~QConfirmed

00%

CT.gov

MGNX$263MPhase 2

Jul '27

Lorigerlimab Phase 2 Est. Readout

lorigerlimab80

Androgen-Independent Prostatic Cancer

Jul 2027~Confirmed

00%

CT.gov

NBIX$15.9BPhase 3

Jul '27

Placebo Phase 3 Est. Readout

NBI-1065846200

Anhedonia

Jul 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q3 '27

AZD5863 Phase 2 Est. Readout

AZD5863280

Gastric Cancer

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

JSB462 Phase 2 Est. Readout

JSB462138

Prostatic Cancer, Castration-Resistant

Q3 2027~QConfirmed

00%

CT.gov

BMY$110.3BPhase 2

Q3 '27

Luspatercept Phase 2 Est. Readout

Luspatercept189

Anemia

Q3 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q3 '27

Tiratricol Phase 2 Est. Readout

Triac22

Allan-Herndon-Dudley Syndrome

Q3 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 3

Q3 '27

Avacopan Phase 3 Est. Readout

Avacopan19

Vasculitis

Q3 2027~QEstimated

00%

CT.gov

Week 4Jul 19 - Jul 25(9 catalysts)

RHHBY$316.4BPhase 3

Q3 '27

Intravitreal Ranibizumab 0.5 mg Injection Phase 3 Est. Readout

Intravitreal Ranibizumab 0.5 mg Injection672

Diabetic Macular Edema

Q3 2027~QConfirmed

00%

CT.gov

REC.MI$11.3BPhase 2

Q3 '27

LCI699 Phase 2 Est. Readout

LCI69912

Cushing Syndrome

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

EYU688 Phase 2 Est. Readout

EYU688108

Dengue

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

LXE408 Phase 2 Est. Readout

LXE408130

Chagas Disease

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q3 '27

MK-8527 Phase 3 Est. Readout

MK-85274,390

Human Immunodeficiency Virus (HIV)

Q3 2027~QConfirmed

00%

CT.gov

VRTX$114.6BPhase 2

Q3 '27

VX-407 Phase 2 Est. Readout

VX-40724

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Q3 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q3 '27

PF-07248144 Phase 3 Est. Readout

PF-07248144400

Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

GSK$101.7BPhase 2

Q3 '27

Dostarlimab Phase 2 Est. Readout

Dostarlimab316

Neoplasms, Rectal

Q3 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q3 '27

Rilzabrutinib Phase 3 Est. Readout

Rilzabrutinib192

Immune Thrombocytopenia

Q3 2027~QConfirmed

00%

CT.gov

Week 5Jul 26 - Aug 1(30 catalysts)

AZNCF$290.6BPhase 3

Q3 '27

Dato-DXd Phase 3 Est. Readout

Dato-DXd625

Metastatic Non-small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

DSKYF$28.8BPhase 3

Q3 '27

Nab-paclitaxel Phase 3 Est. Readout

Nab-paclitaxel625

Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

GXV813 Phase 2 Est. Readout

GXV813142

Schizophrenia

Q3 2027~QConfirmed

00%

CT.gov

ONCY$109MPhase 2

Q3 '27

Pelareorep Phase 2 Est. Readout

Pelareorep122

Anal Cancer Metastatic

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

Nazartinib Phase 2 Est. Readout

Nazartinib29

Advanced Solid Tumors Which Are cMET-dependent

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

Glycopyrronium bromide 25ug Phase 2 Est. Readout

Glycopyrronium bromide 25ug42

Asthma

Q3 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q3 '27

Capmatinib Phase 2 Est. Readout

Capmatinib29

Carcinoma, Non-Small-Cell Lung

Q3 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 3

Q3 '27

Volrustomig Phase 3 Est. Readout

Volrustomig1,116

Non-small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

JNJ$549.8BPhase 3

Q3 '27

Daratumumab Phase 3 Est. Readout

Daratumumab864

Multiple Myeloma

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Polatuzumab vedotin Phase 2 Est. Readout

Polatuzumab Vedotin99

Non-Hodgkin's Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

JNJ$549.8BPhase 3

Q3 '27

Talquetamab Phase 3 Est. Readout

Talquetamab864

Multiple Myeloma

Q3 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 2

Q3 '27

INCB000928 Phase 2 Est. Readout

INCB00092898

Anemia

Q3 2027~QConfirmed

00%

CT.gov

GNMSF$18.3BPhase 3

Q3 '27

Acasunlimab Phase 3 Est. Readout

Acasunlimab191

PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Atezolizumab Phase 2 Est. Readout

Bevacizumab 15 mg/kg518

Advanced Liver Cancers

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Glofitamab Phase 2 Est. Readout

Glofitamab99

Diffuse Large B-cell Lymphoma

Q3 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q3 '27

Volrustomig Phase 2 Est. Readout

Volrustomig180

Non-small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q3 '27

Anagrelide Phase 3 Est. Readout

Anagrelide340

Essential Thrombocythemia

Q3 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q3 '27

Ritlecitinib Phase 3 Est. Readout

Ritlecitinib1,571

Stable Nonsegmental Vitiligo

Q3 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q3 '27

Carboplatin Phase 2 Est. Readout

Gefitinib180

Non-Small Cell Lung Cancer

Q3 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q3 '27

Bomedemstat Phase 3 Est. Readout

Bomedemstat340

Thrombocythemia, Essential

Q3 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q3 '27

Paclitaxel Phase 2 Est. Readout

Adavosertib180

Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation

Q3 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q3 '27

Tremelimumab Phase 2 Est. Readout

Tremelimumab55

Non Small Cell Lung Cancer NSCLC

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

Ribociclib Phase 2 Est. Readout

Ribociclib60

Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 3

Q3 '27

ABP 938 8 mg Phase 3 Est. Readout

ABP 938 8 mg304

Neovascular Age-related Macular Degeneration

Q3 2027~QConfirmed

00%

CT.gov

ONT.L$724MPhase 2

Q3 '27

Investigational Medicinal Product Phase 2 Est. Readout

Investigational Medicinal Product72

HIV/AIDS and Infections

Q3 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q3 '27

Cemiplimab Phase 2 Est. Readout

cemiplimab15

Advanced Cutaneous Squamous Cell Carcinoma

Q3 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q3 '27

Durvalumab Phase 2 Est. Readout

Durvalumab55

Triple Negative Breast Cancer

Q3 2027~QConfirmed

00%

CT.gov

MAIA$85MPhase 3

Q3 '27

Vinorelbine Phase 3 Est. Readout

Vinorelbine300

Carcinoma, Non-Small -Cell Lung

Q3 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q3 '27

RO7126209 Phase 2 Est. Readout

RO7126209241

Alzheimers Disease

Q3 2027~QEstimated

00%

CT.gov

NVSEF$269.0BPhase 3

Q3 '27

Ribociclib 200Mg Oral Tablet Phase 3 Est. Readout

Ribociclib 200Mg Oral Tablet1,684

Breast Cancer Female

Q3 2027~QConfirmed

00%

CT.gov

June 2027 Full Calendar August 2027

Get July Catalysts in Your Inbox

Subscribe to receive weekly digests of upcoming PDUFA dates and clinical trial results. Never miss an important FDA decision.

About PDUFA Dates in July 2027

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