April 2027 Catalysts

FDA Decisions & PDUFA Dates

May 2027

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Mar 29 - Apr 4(10 catalysts)

SGENPhase 2

Q2 '27

Tucatinib Phase 2 Est. Readout

tucatinib18

Gastric Adenocarcinoma

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

Dronabinol Phase 2 Est. Readout

Dronabinol60

Sickle Cell Disease

Q2 2027~QConfirmed

00%

CT.gov

PBLS$3.7BPhase 2

Q2 '27

FOG-001 Phase 2 Est. Readout

FOG-001619

Cancer

Q2 2027~QConfirmed

00%

CT.gov

TLSA$146MPhase 2

Q2 '27

Foralumab Nasal Phase 2 Est. Readout

Foralumab Nasal5

Multiple System Atrophy

Q2 2027~QConfirmed

00%

CT.gov

SGENPhase 2

Q2 '27

Pertuzumab Phase 2 Est. Readout

Pertuzumab18

Metastatic Breast Cancer With a Isolated Brain Progression

Q2 2027~QConfirmed

00%

CT.gov

NVO$203.2BOther

Apr '27

Other - Wegovy

Apr 2027~AI-detected

Source

BAYRY$42.5BPhase 3

Q2 '27

Docetaxel 75 mg/m2 Phase 3 Est. Readout

Docetaxel 75 mg/m2732

Prostate Cancer

Q2 2027~QConfirmed

00%

CT.gov

ALCOX.PA$37MPDUFA

7mo

FDA PDUFA Date NCX 470

NCX 470Phase 3

Glaucoma, Open-Angle

Apr 1Confirmed

00%

Source

AZN$273.6BPhase 2

Q2 '27

AZD7760 Phase 2 Est. Readout

AZD7760231

Staphylococcus Aureus

Q2 2027~QConfirmed

00%

CT.gov

CFOO$13MPDUFA

Apr '27

FDA PDUFA Date Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323)

Trastuzumab Pamirtecan (T-Pam, DB-1303, BNT323)NDA

Unresectable or Metastatic HER2-Positive Adult Breast Cancer

Apr 2027~AI-detected

00%

Source

Week 2Apr 5 - Apr 11(9 catalysts)

ITCIPhase 3

Q2 '27

Lumateperone Phase 3 Est. Readout

Lumateperone470

Major Depressive Disorder

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Isatuximab SAR650984 Phase 3 Est. Readout

Isatuximab SAR650984475

Multiple Myeloma

Q2 2027~QConfirmed

00%

CT.gov

AGY.L$6MPhase 2

Q2 '27

MTBVAC Phase 2 Est. Readout

MTBVAC276

HIV I Infection

Q2 2027~QConfirmed

00%

CT.gov

VRTX$114.6BPhase 3

Q2 '27

Suzetrigine Phase 3 Est. Readout

Suzetrigine734

Pain

Q2 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q2 '27

Perampanel Oral Suspension Phase 2 Est. Readout

Perampanel Oral Suspension100

Pediatric Epileptic Syndrome

Q2 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 3

Q2 '27

Olaparib Phase 3 Est. Readout

Olaparib185

Breast Cancer Metastatic

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

SAR444336 Phase 2 Est. Readout

SAR44433654

Microscopic Colitis

Q2 2027~QConfirmed

00%

CT.gov

BAYRY$42.5BPhase 3

Q2 '27

Finerenone (Kerendia, BAY94-8862) Phase 3 Est. Readout

Finerenone (Kerendia, BAY94-8862)219

Chronic Kidney Disease

Q2 2027~QEstimated

00%

CT.gov

DSKYF$28.8BPhase 2

Q2 '27

U3-1402 Phase 2 Est. Readout

U3-1402139

Metastatic Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

Week 3Apr 12 - Apr 18(31 catalysts)

NVSEF$269.0BPhase 3

Q2 '27

ianalumab Phase 3 Est. Readout

Ianalumab288

Primary Immune Thrombocytopenia (ITP)

Q2 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 2

Q2 '27

Inebilizumab Phase 2 Est. Readout

Inebilizumab15

IgG4 Related Disease

Q2 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q2 '27

tofacitinib Phase 3 Est. Readout

Tofacitinib118

Rheumatoid Arthritis

Q2 2027~QConfirmed

00%

CT.gov

BMRN$10.6BPhase 2

Q2 '27

BMN 351 Phase 2 Est. Readout

BMN 35118

Duchenne Muscular Dystrophy

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q2 '27

[68Ga]Ga-NeoB Phase 2 Est. Readout

[68Ga]Ga-NeoB58

Breast Cancer

Q2 2027~QEstimated

00%

CT.gov

TKPHF$47.7BPhase 3

Q2 '27

TDV Phase 3 Est. Readout

TDV800

Healthy Volunteers

Q2 2027~QConfirmed

00%

CT.gov

TRAX$608MPDUFA

7mo

FDA PDUFA Date

Apr 14AI-detected

00%

Source

TRAX FDA decision page →

4151.T$1.3TPhase 2

Apr '27

KK2430 Phase 2 Est. Readout

KK243072

Hematologic Neoplasms

Apr 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Apr '27

Isatuximab Phase 3 Est. Readout

Isatuximab480

Plasma Cell Myeloma Refractory

Apr 2027~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Apr '27

Letrozole Phase 2 Est. Readout

Letrozole20

Low-Grade Serous Ovarian Cancer

Apr 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Apr '27

LY3537982 Phase 2 Est. Readout

LY3537982540

Carcinoma, Non-Small-Cell Lung

Apr 2027~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Apr '27

Sorafenib Phase 2 Est. Readout

Sorafenib30

Ovarian Cancer

Apr 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Apr '27

Carfilzomib Phase 2 Est. Readout

Carfilzomib300

Multiple Myeloma

Apr 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Apr '27

MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO Phase 2 Est. Readout

MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO214

Acute Myeloid Leukemia

Apr 2027~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Apr '27

Trastuzumab deruxtecan Phase 2 Est. Readout

Trastuzumab deruxtecan165

HER2-positive Breast Cancer

Apr 2027~Confirmed

00%

CT.gov

VTVT$22MPhase 3

Apr '27

Cadisegliatin 800 mg QD Phase 3 Est. Readout

Cadisegliatin 800 mg QD150

Diabetes Mellitus, Type 1

Apr 2027~Confirmed

00%

CT.gov

SGENPhase 2

Apr '27

Vinblastine Phase 2 Est. Readout

Vinblastine71

Hodgkin Lymphoma

Apr 2027~Confirmed

00%

CT.gov

XENE$5.1BPhase 3

Apr '27

XEN1101 Phase 3 Est. Readout

XEN1101160

Primary Generalized Tonic-Clonic Seizures

Apr 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 3

Apr '27

Placebo Phase 3 Est. Readout

Gefapixant 100 mg250

Refractory Chronic Cough

Apr 2027~Confirmed

00%

CT.gov

WXIPhase 2

Apr '27

D3S-001 Phase 2 Est. Readout

D3S-001442

KRAS P.G12C

Apr 2027~Confirmed

00%

CT.gov

MNOV$65MPhase 3

Apr '27

MN-166 Phase 3 Est. Readout

MN-166234

Glioblastoma

Apr 2027~Confirmed

00%

CT.gov

RAPT$1.6BPhase 2

Apr '27

RPT904 Phase 2 Est. Readout

RPT904100

Ig-E Mediated Food Allergy

Apr 2027~Confirmed

00%

CT.gov

FOLD$4.5BPhase 3

Apr '27

Cipaglucosidase alfa Phase 3 Est. Readout

Cipaglucosidase Alfa36

Pompe Disease (Late-onset)

Apr 2027~Confirmed

00%

CT.gov

NKTX$205MPhase 2

Apr '27

Fludarabine, Cyclophosphamide Phase 2 Est. Readout

Fludarabine, Cyclophosphamide120

Lupus Nephritis

Apr 2027~Confirmed

00%

CT.gov

IPIX$9MPhase 2

Apr '27

S095018 Phase 2 Est. Readout

S095018102

Non-small Cell Lung Cancer (NSCLC)

Apr 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Apr '27

IMM-101 Phase 2 Est. Readout

IMM-10180

Colorectal Cancer

Apr 2027~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Apr '27

irinotecan liposome (II) + temozolomide + fluzoparib Phase 2 Est. Readout

irinotecan liposome (II) + temozolomide + fluzoparib29

Ewing Sarcoma

Apr 2027~Confirmed

00%

CT.gov

PCYCPhase 2

Apr '27

Ibrutinib Phase 2 Est. Readout

Ibrutinib40

Diffuse Large B Cell Lymphoma Relapsed

Apr 2027~Confirmed

00%

CT.gov

ALC$11.6BPhase 2

Apr '27

AR-14034 SR implant lower dose Phase 2 Est. Readout

AR-14034 SR implant lower dose139

Neovascular Age-related Macular Degeneration (nAMD)

Apr 2027~Confirmed

00%

CT.gov

SGIOY$14.8BPhase 2

Q2 '27

S-531011 Phase 2 Est. Readout

S-531011274

Solid Tumors

Q2 2027~QConfirmed

00%

CT.gov

4519.T$87.4BPhase 3

Q2 '27

Eculizumab Phase 3 Est. Readout

Eculizumab190

Paroxysmal Nocturnal Hemoglobinuria

Q2 2027~QConfirmed

00%

CT.gov

Week 4Apr 19 - Apr 25(10 catalysts)

AMGN$182.2BPhase 3

Q2 '27

Ocrelizumab (US) Phase 3 Est. Readout

Ocrelizumab (US)152

Relapsing-remitting Multiple Sclerosis (RRMS)

Q2 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 3

Q2 '27

Camizestrant Phase 3 Est. Readout

Camizestrant4,300

Breast Cancer, Early Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Q2 '27

AZD5148 Phase 2 Est. Readout

AZD5148230

Clostridioides Difficile Infection

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

Rotavirus vaccine Phase 2 Est. Readout

Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate750

Meningitis

Q2 2027~QConfirmed

00%

CT.gov

ZEALPhase 3

Q2 '27

Preoperative chemotherapy Phase 3 Est. Readout

Preoperative chemotherapy250

Retroperitoneal Sarcoma

Q2 2027~QConfirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Q2 '27

MAS825 Phase 2 Est. Readout

MAS82530

Coronary Heart Disease

Q2 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q2 '27

Intismeran autogene Phase 2 Est. Readout

Intismeran autogene230

Bladder Cancer

Q2 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q2 '27

Ritlecitinib Phase 3 Est. Readout

Ritlecitinib400

Stable Nonsegmental Vitiligo

Q2 2027~QConfirmed

00%

CT.gov

GSK$101.7BPhase 2

Q2 '27

RTS,S/AS01E vaccine Phase 2 Est. Readout

RTS,S/AS01E vaccine238

Malaria

Q2 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 2

Q2 '27

Part A: ATM-AVI Single Dose, Cohorts 1-4 Phase 2 Est. Readout

Part A: ATM-AVI Single Dose, Cohorts 1-448

Gram-negative Bacterial Infection

Q2 2027~QConfirmed

00%

CT.gov

Week 5Apr 26 - May 2(23 catalysts)

NVS$284.2BPhase 2

Q2 '27

DII235 Phase 2 Est. Readout

DII235234

Lipoprotein Disorder

Q2 2027~QConfirmed

00%

CT.gov

ALNY$36.9BPhase 2

Q2 '27

ALN-2232 Phase 2 Est. Readout

ALN-2232156

Obesity

Q2 2027~QConfirmed

00%

CT.gov

JNJ$549.8BPhase 2

Q2 '27

Amivantamab IV Phase 2 Est. Readout

Amivantamab IV225

Advanced or Metastatic Colorectal Cancer

Q2 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 2

Q2 '27

INCB123667 Phase 2 Est. Readout

INCB123667160

Ovarian Cancer

Q2 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 3

Q2 '27

INCB123667 Phase 3 Est. Readout

INCB123667466

Ovarian Cancer

Q2 2027~QEstimated

00%

CT.gov

AMGN$182.2BPhase 3

Q2 '27

Maridebart cafraglutide Phase 3 Est. Readout

Maridebart cafraglutide279

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q2 '27

QCZ484 Phase 2 Est. Readout

QCZ484120

Hypercholesterolaemia

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Frexalimab Phase 3 Est. Readout

Frexalimab1,655

Type 1 Diabetes Mellitus

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

Frexalimab Phase 2 Est. Readout

Frexalimab197

Type 1 Diabetes Mellitus

Q2 2027~QConfirmed

00%

CT.gov

ONT.L$724MPhase 2

Q2 '27

Intravenous immunoglobulin Phase 2 Est. Readout

Intravenous immunoglobulin70

Psychosis

Q2 2027~QConfirmed

00%

CT.gov

ARGX$56.5BPhase 2

Q2 '27

Efgartigimod PH20 SC Phase 2 Est. Readout

Efgartigimod PH20 SC229

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

6R-BH4 Phase 2 Est. Readout

6R-BH4150

Renal Insufficiency, Chronic

Q2 2027~QConfirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Q2 '27

Ifinatamab deruxtecan (I-DXd) Phase 2 Est. Readout

Ifinatamab deruxtecan (I-DXd)250

Advanced Solid Tumor

Q2 2027~QConfirmed

00%

CT.gov

INCY$19.6BPhase 3

Q2 '27

Ruxolitinib Cream Phase 3 Est. Readout

Ruxolitinib Cream250

Nonsegmental Vitiligo With Genital Involvement

Q2 2027~QConfirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Q2 '27

Nusivertib Phase 2 Est. Readout

Nusivertib240

Myelofibrosis

Q2 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q2 '27

Cemiplimab Phase 2 Est. Readout

cemiplimab50

Advanced Cutaneous Squamous Cell Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

AAGH$6MPDUFA

8mo

FDA PDUFA Date

Apr 30AI-detected

00%

Source

AAGH FDA decision page →

IDYA$2.7BPhase 2

Q2 '27

Darovasertib Phase 2 Est. Readout

Darovasertib160

Uveal Melanoma

Q2 2027~QConfirmed

00%

CT.gov

IVBXF$19.2BPhase 3

Q2 '27

Febuxostat Phase 3 Est. Readout

Febuxostat600

Gout

Q2 2027~QConfirmed

00%

CT.gov

RNA$217MPhase 2

Q2 '27

AOC 1044 Phase 2 Est. Readout

AOC 104439

Duchenne Muscular Dystrophy

Q2 2027~QConfirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Q2 '27

Camrelizumab+Fluzoparib Phase 2 Est. Readout

Camrelizumab+Fluzoparib64

Germline BRCA-mutated HER2-negative Breast Cancer

Q2 2027~QConfirmed

00%

CT.gov

CELG-RIPhase 2

Q2 '27

Xanomeline and trospium chloride (KarXT) Phase 2 Est. Readout

Xanomeline and trospium chloride (KarXT)12

SCHIZOPHRENIA 1 (Disorder)

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q2 '27

von Willebrand Factor (VWF) Concentrates Phase 3 Est. Readout

von Willebrand Factor (VWF) Concentrates75

Von Willebrand Disease, Type 3

Q2 2027~QConfirmed

00%

CT.gov

March 2027 Full Calendar May 2027

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About PDUFA Dates in April 2027

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