March 2027 Catalysts

FDA Decisions & PDUFA Dates

April 2027

110

Total Catalysts

PDUFA Dates

105

Trial Results

Companies

Week 1Mar 1 - Mar 7(11 catalysts)

GSK$101.7BPDUFA

6mo

FDA PDUFA Date GSK2857916 (priority)

FeladilimabPhase 2

Multiple Myeloma

Mar 1AI-detected

✅ApprovedSEC

NONOF$215.0BPhase 3

Mar '27

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

CagriSema (Cagrilintide B and Semaglutide I)609

Obesity

Mar 2027~Confirmed

00%

CT.gov

SXTPWPhase 2

Q1 '27

Tafenoquine Phase 2 Est. Readout

Tafenoquine33

Babesiosis

Q1 2027~QConfirmed

00%

CT.gov

SGENPhase 2

Mar '27

Tucatinib Phase 2 Est. Readout

tucatinib30

Gastric Adenocarcinoma

Mar 2027~Confirmed

00%

CT.gov

DAWN$2.2BPhase 2

Mar '27

Tovorafenib Phase 2 Est. Readout

Tovorafenib57

Low-grade Glioma

Mar 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Q1 '27

Abatacept Phase 2 Est. Readout

Abatacept30

Rheumatoid Arthritis

Q1 2027~QConfirmed

00%

CT.gov

XENE$5.1BPDUFA

Mar '27

FDA PDUFA Date azetukalner (standard review)

AzetukalnerPhase 3

Major Depressive Disorder

Mar 2027~Confirmed

00%

Source

PFE$143.7BPhase 2

Q1 '27

Ritlecitinib Phase 2 Est. Readout

Ritlecitinib240

Stable Nonsegmental Vitiligo

Q1 2027~QConfirmed

00%

CT.gov

MRNA$25.4BPhase 2

Mar '27

mRNA-1647 Phase 2 Est. Readout

mRNA-164784

Cytomegalovirus Infection

Mar 2027~Confirmed

00%

CT.gov

HNSPF$23.2BPhase 3

Mar '27

HS-20089 Phase 3 Est. Readout

HS-20089468

Ovarian Cancer

Mar 2027~Confirmed

00%

CT.gov

AAPG$6.4BPhase 2

Mar '27

olverembatinib Phase 2 Est. Readout

Olverembatinib50

GIST

Mar 2027~Confirmed

00%

CT.gov

Week 2Mar 8 - Mar 14(8 catalysts)

PFE$143.7BPhase 2

Q1 '27

PF-07275315 Phase 2 Est. Readout

PF-07275315252

Asthma

Q1 2027~QConfirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Q1 '27

bimekizumab Phase 3 Est. Readout

Bimekizumab89

Chronic Plaque Psoriasis

Q1 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q1 '27

Fixed Dose Combination (FDC) cemiplimab+fianlimab Phase 2 Est. Readout

Fixed Dose Combination (FDC) cemiplimab+fianlimab150

Melanoma

Q1 2027~QConfirmed

00%

CT.gov

VRTX$114.6BPhase 2

Q1 '27

VX-264 Phase 2 Est. Readout

VX-2647

Type 1 Diabetes

Q1 2027~QConfirmed

00%

CT.gov

TVTX$5.1BPhase 2

Mar '27

Sparsentan Phase 2 Est. Readout

Sparsentan67

Focal Segmental Glomerulosclerosis

Mar 2027~Confirmed

00%

CT.gov

RYTM$6.6BPhase 3

Q1 '27

Setmelanotide Phase 3 Est. Readout

Setmelanotide39

Genetic Obesity

Q1 2027~QConfirmed

00%

CT.gov

OTSKF$34.0BPhase 2

Mar '27

Sibeprenlimab Phase 2 Est. Readout

Sibeprenlimab83

IgA Nephropathy

Mar 2027~Confirmed

00%

CT.gov

ZLAB$1.6BPhase 3

Q1 '27

ZL-1109 (VRDN-003) Phase 3 Est. Readout

ZL-1109 (VRDN-003)99

Thyroid Eye Disease (TED)

Q1 2027~QConfirmed

00%

CT.gov

Week 3Mar 15 - Mar 21(57 catalysts)

PHM.MC$26.2BPhase 2

Mar '27

EP0031 Phase 2 Est. Readout

EP0031265

NSCLC

Mar 2027~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 3

Mar '27

bendamustine Phase 3 Est. Readout

bendamustine510

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Mar 2027~Confirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Mar '27

Alpelisib (BYL719) Phase 2 Est. Readout

Alpelisib (BYL719)20

Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)

Mar 2027~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Mar '27

SHR0302 Tablets Phase 2 Est. Readout

SHR0302 Tablets176

Non-segmental Vitiligo

Mar 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Mar '27

Olaparib Phase 2 Est. Readout

olaparib20

Colorectal Cancer

Mar 2027~Confirmed

00%

CT.gov

JNGHFPhase 2

Mar '27

Rezvilutamide Phase 2 Est. Readout

Rezvilutamide96

Prostate Cancer

Mar 2027~Confirmed

00%

CT.gov

BMGL$12MPhase 3

Mar '27

Colchicine Phase 3 Est. Readout

Colchicine416

Atrial Fibrillation

Mar 2027~Confirmed

00%

CT.gov

GMAB$15.7BPhase 3

Mar '27

Epcoritamab Phase 3 Est. Readout

Epcoritamab900

Diffuse Large B-Cell Lymphoma

Mar 2027~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 3

Mar '27

bemdaneprocel Phase 3 Est. Readout

bemdaneprocel102

Parkinsons Disease (PD)

Mar 2027~Confirmed

00%

CT.gov

MOLN$148MPhase 2

Mar '27

4D-150 IVT Phase 2 Est. Readout

4D-150 IVT215

Neovascular (Wet) Age-Related Macular Degeneration

Mar 2027~Confirmed

00%

CT.gov

CLDX$2.5BPhase 2

Mar '27

Anti-CD40 Agonist Monoclonal Antibody CDX-1140 Phase 2 Est. Readout

Anti-CD40 Agonist Monoclonal Antibody CDX-114080

Ovarian Clear Cell Adenocarcinoma

Mar 2027~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Mar '27

Lanreotide Phase 2 Est. Readout

Lanreotide10

Gastroenteropancreatic Neuroendocrine Tumors

Mar 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Mar '27

Imatinib Phase 2 Est. Readout

Imatinib125

Chronic Myeloid Leukemia

Mar 2027~Confirmed

00%

CT.gov

TKPHF$47.7BPhase 3

Mar '27

FEIBA Phase 3 Est. Readout

FEIBA5

Hemophilia A

Mar 2027~Confirmed

00%

CT.gov

FARN.L$902KPhase 2

Mar '27

Bexmarilimab Phase 2 Est. Readout

Bexmarilimab181

Acute Myeloid Leukemia

Mar 2027~Confirmed

00%

CT.gov

FOLD$4.5BPhase 3

Mar '27

Miglustat Phase 3 Est. Readout

Miglustat36

Pompe Disease (Late-onset)

Mar 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Mar '27

TILT-123 Phase 2 Est. Readout

TILT-12329

Platinum-refractory Ovarian Carcinoma

Mar 2027~Confirmed

00%

CT.gov

DCPHPhase 2

Mar '27

Inlexisertib Phase 2 Est. Readout

Inlexisertib94

Non-Small Cell Lung Cancer

Mar 2027~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Mar '27

Avutometinib (VS-6766) Phase 2 Est. Readout

avutometinib (VS-6766)40

Low Grade Ovarian Serous Adenocarcinoma

Mar 2027~Confirmed

00%

CT.gov

NUVB$1.9BPhase 2

Mar '27

NUV-1511 Phase 2 Est. Readout

NUV-1511466

Advanced Solid Tumor

Mar 2027~Confirmed

00%

CT.gov

OCUL$2.1BPhase 3

Mar '27

Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 Phase 3 Est. Readout

Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24930

Non-Proliferative Diabetic Retinopathy

Mar 2027~Confirmed

00%

CT.gov

INVA$1.7BPDUFA

6mo

FDA PDUFA Date Vivus drug (standard)

Mar 15AI-detected

✅ApprovedSEC

PCVX$7.4BPhase 3

Mar '27

31-valent pneumococcal conjugate vaccine Phase 3 Est. Readout

31-valent pneumococcal conjugate vaccine1,390

Pneumococcal Vaccines

Mar 2027~Confirmed

00%

CT.gov

PEPG$124MPhase 2

Mar '27

PGN-EDODM1 Phase 2 Est. Readout

PGN-EDODM124

Myotonic Dystrophy 1

Mar 2027~Confirmed

00%

CT.gov

URGN$1.6BPhase 3

Mar '27

UGN-104 Phase 3 Est. Readout

UGN-10470

Upper Urinary Tract Urothelial Carcinoma

Mar 2027~Confirmed

00%

CT.gov

4151.T$1.3TPhase 2

Mar '27

ziftomenib Phase 2 Est. Readout

ziftomenib6

Acute Myeloid Leukemia (AML)

Mar 2027~Confirmed

00%

CT.gov

EWTX$4.0BPhase 2

Mar '27

Sevasemten Dose 2 Phase 2 Est. Readout

Sevasemten Dose 243

Duchenne Muscular Dystrophy

Mar 2027~Confirmed

00%

CT.gov

CGEN$196MPhase 2

Mar '27

COM701 Phase 2 Est. Readout

COM70160

Ovarian Cancer

Mar 2027~Confirmed

00%

CT.gov

COGT$5.9BPhase 2

Mar '27

CGT4859 Phase 2 Est. Readout

CGT4859110

Intrahepatic Cholangiocarcinoma (Icc)

Mar 2027~Confirmed

00%

CT.gov

STOK$1.9BPhase 3

Mar '27

zorevunersen Phase 3 Est. Readout

zorevunersen170

Dravet Syndrome

Mar 2027~Confirmed

00%

CT.gov

OCGN$420MPhase 2

Mar '27

OCU400 Low Dose Phase 2 Est. Readout

OCU400 Low Dose22

Retinitis Pigmentosa

Mar 2027~Confirmed

00%

CT.gov

LLY$1.0TPhase 2

Mar '27

Macupatide Phase 2 Est. Readout

Macupatide200

Obesity

Mar 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Mar '27

Cariprazine Phase 3 Est. Readout

Cariprazine380

Depression

Mar 2027~Confirmed

00%

CT.gov

ALLR$18MPhase 2

Mar '27

2X-121 Phase 2 Est. Readout

2X-12140

Advanced Ovarian Cancer

Mar 2027~Confirmed

00%

CT.gov

ALGS$225MPhase 2

Mar '27

ALG-000184 Phase 2 Est. Readout

ALG-000184200

Chronic Hepatitis B Infection

Mar 2027~Confirmed

00%

CT.gov

VTRS$17.9BPhase 3

Mar '27

Transdermal system containing progestin Phase 3 Est. Readout

Transdermal system containing progestin1,500

Female Contraception

Mar 2027~Confirmed

00%

CT.gov

MNKD$1.2BPhase 2

Mar '27

Technosphere Insulin Phase 2 Est. Readout

Basal insulin100

Type 1 Diabetes Mellitus

Mar 2027~Confirmed

00%

CT.gov

DNLI$3.7BPhase 2

Mar '27

BIIB122 225 mg Phase 2 Est. Readout

BIIB122 225 mg50

Parkinson Disease

Mar 2027~Confirmed

00%

CT.gov

JNGHFPhase 3

Mar '27

Rezvilutamide Tablets Phase 3 Est. Readout

Rezvilutamide Tablets206

Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Mar 2027~Confirmed

00%

CT.gov

DCPHPhase 2

Mar '27

Ripretinib Phase 2 Est. Readout

Ripretinib94

GIST

Mar 2027~Confirmed

00%

CT.gov

BMRN$10.6BPhase 2

Mar '27

Vosoritide Injection Phase 2 Est. Readout

Vosoritide Injection30

Short Stature Homeobox- Containing Gene SHOX Deficiency

Mar 2027~Confirmed

00%

CT.gov

GILD$153.7BPhase 2

Mar '27

Oral Lenacapavir Phase 2 Est. Readout

Optimized Background Regimen (OBR)12

HIV-1-infection

Mar 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Mar '27

Blinatumomab Phase 2 Est. Readout

Blinatumomab17

Acute Lymphoblastic Leukemia

Mar 2027~Confirmed

00%

CT.gov

SPTX$973MPhase 2

Mar '27

SPT-300 Phase 2 Est. Readout

SPT-300360

Major Depressive Disorder (MDD)

Mar 2027~Confirmed

00%

CT.gov

BIIB$29.0BPhase 3

Mar '27

baricitinib treatment Phase 3 Est. Readout

baricitinib treatment160

Rheumatoid Arthritis

Mar 2027~Confirmed

00%

CT.gov

GILD$153.7BPhase 3

Mar '27

Zimberelimab Phase 3 Est. Readout

Zimberelimab1,021

Head and Neck Squamous Cell Carcinoma

Mar 2027~Estimated

00%

CT.gov

SOBI.ST$14.6BPhase 3

Mar '27

Intravenous immunoglobulin Phase 3 Est. Readout

Intravenous immunoglobulin84

Kawasaki Disease

Mar 2027~Confirmed

00%

CT.gov

SWTOYPhase 2

Mar '27

Fludarabine and Dexamethasone Phase 2 Est. Readout

Fludarabine and Dexamethasone39

Primary Immune Regulatory Disorder

Mar 2027~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Mar '27

Efgartigimod IV Phase 3 Est. Readout

Efgartigimod IV12

Generalized Myasthenia Gravis

Mar 2027~Confirmed

00%

CT.gov

GMAB$15.7BPhase 2

Mar '27

Epcoritamab Phase 2 Est. Readout

Epcoritamab184

Diffuse Large B-Cell Lymphoma

Mar 2027~Confirmed

00%

CT.gov

VSTM$362MPhase 2

Mar '27

Defactinib Phase 2 Est. Readout

Defactinib40

Pancreatic Adenocarcinoma

Mar 2027~Confirmed

00%

CT.gov

BGNEPhase 2

Mar '27

Zanubrutinib Pill Phase 2 Est. Readout

Zanubrutinib Pill50

Leukemia, Lymphocytic, Chronic, B-Cell

Mar 2027~Confirmed

00%

CT.gov

ITCIPhase 2

Mar '27

ITI-1284 10 mg Phase 2 Est. Readout

ITI-1284 10 mg705

Generalized Anxiety Disorder

Mar 2027~Confirmed

00%

CT.gov

TAK$48.9BPhase 3

Mar '27

TAK-755 Phase 3 Est. Readout

TAK-75577

Thrombotic Thrombocytopenic Purpura (TTP)

Mar 2027~Confirmed

00%

CT.gov

PCYCPhase 3

Mar '27

Ibrutinib Phase 3 Est. Readout

Ibrutinib23

Diffuse Large B Cell Lymphoma Relapsed

Mar 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Q1 '27

BMS-986446 Phase 2 Est. Readout

BMS-986446310

Alzheimer Disease, Early Onset

Q1 2027~QConfirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Q1 '27

bimekizumab Phase 3 Est. Readout

Bimekizumab40

Chronic Plaque Psoriasis

Q1 2027~QConfirmed

00%

CT.gov

Week 4Mar 22 - Mar 28(9 catalysts)

REGN$57.3BPhase 3

Q1 '27

cemiplimab Phase 3 Est. Readout

cemiplimab560

Advanced Cutaneous Squamous Cell Carcinoma

Q1 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q1 '27

Lenvatinib Phase 2 Est. Readout

Lenvatinib730

Non-small Cell Lung Cancer

Q1 2027~QConfirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Q1 '27

Cryptosporidium parvum oocysts (ABO809) Phase 2 Est. Readout

Cryptosporidium parvum oocysts (ABO809)80

Cryptosporidiosis

Q1 2027~QConfirmed

00%

CT.gov

IVBXF$19.2BPhase 2

Q1 '27

IBI3002 Phase 2 Est. Readout

IBI3002120

Atopic Dermatitis

Q1 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q1 '27

abemaciclib Phase 3 Est. Readout

Abemaciclib1,035

Breast Cancer

Q1 2027~QEstimated

00%

CT.gov

SNY$100.0BPhase 3

Q1 '27

Fitusiran Phase 3 Est. Readout

Clotting factor concentrates (CFC) or bypassing agents (BPA)91

Hemophilia

Q1 2027~QConfirmed

00%

CT.gov

TEVA$36.7BPDUFA

Mar '27

FDA PDUFA Date Biosimilar candidate to Xolair (omalizumab)

Mar 2027~AI-detected

✅ApprovedSource

REGN$57.3BPhase 2

Q1 '27

REGN5668 Phase 2 Est. Readout

REGN5668612

Ovarian Cancer

Q1 2027~QConfirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Q1 '27

Corabotase Phase 2 Est. Readout

Corabotase132

Cervical Dystonia

Q1 2027~QConfirmed

00%

CT.gov

Week 5Mar 29 - Apr 4(25 catalysts)

SGIOY$14.8BPhase 2

Q1 '27

S-488210/S-488211 Phase 2 Est. Readout

S-488210/S-48821152

Bladder Cancer

Q1 2027~QConfirmed

00%

CT.gov

HSCS$6MPhase 2

Q1 '27

Sodium Nitroprusside (SNP) Phase 2 Est. Readout

Sodium Nitroprusside (SNP)134

Stress Disorders, Post-Traumatic

Q1 2027~QConfirmed

00%

CT.gov

AAPG$6.4BPhase 3

Q1 '27

Olverembatinib Phase 3 Est. Readout

Olverembatinib40

GIST

Q1 2027~QConfirmed

00%

CT.gov

TNGX$4.0BPhase 2

Q1 '27

TNG456 Phase 2 Est. Readout

TNG456191

Non Small Cell Lung Cancer

Q1 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q1 '27

Satralizumab Phase 3 Est. Readout

satralizumab8

Neuromyelitis Optica Spectrum Disorder

Q1 2027~QConfirmed

00%

CT.gov

CLDX$2.5BPhase 2

Q1 '27

Human CMV pp65-LAMP mRNA-pulsed autologous DCs Phase 2 Est. Readout

Human CMV pp65-LAMP mRNA-pulsed autologous DCs43

Glioblastoma

Q1 2027~QConfirmed

00%

CT.gov

CGON$5.4BPhase 3

Q1 '27

Cretostimogene Grenadenorepvec Phase 3 Est. Readout

Cretostimogene Grenadenorepvec367

High-Risk Non-Muscle-Invasive Bladder Cancer

Q1 2027~QConfirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Q1 '27

Finerenone Oral Tablet Phase 2 Est. Readout

Finerenone Oral Tablet100

Kidney Transplant; Complications

Q1 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q1 '27

AZD4360 Phase 2 Est. Readout

AZD4360117

Gastric Cancer

Q1 2027~QConfirmed

00%

CT.gov

NWRN.SW$289MPhase 3

Q1 '27

Evenamide 15 mg bid Phase 3 Est. Readout

Evenamide 15 mg bid400

Treatment-resistant Schizophrenia

Q1 2027~QConfirmed

00%

CT.gov

CGEN$196MData Readout

7mo

Data Readout — COM701

Mar 31AI-detected

00%

Source

BEIGF$40.9BPhase 2

Q1 '27

BGB-B2033 Phase 2 Est. Readout

BGB-B2033630

Metastatic Hepatocellular Carcinoma

Q1 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Q1 '27

Posaconazole IV 6 mg/kg Phase 2 Est. Readout

Posaconazole IV 6 mg/kg40

Invasive Fungal Infection

Q1 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q1 '27

E7389-LF Phase 2 Est. Readout

E7389-LF125

Solid Neoplasms

Q1 2027~QConfirmed

00%

CT.gov

IPIX$9MPhase 3

Q1 '27

Cenerimod Phase 3 Est. Readout

Cenerimod451

Lupus Erythematosus, Systemic

Q1 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q1 '27

E7386 Phase 2 Est. Readout

E7386301

Melanoma

Q1 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q1 '27

Doxorubicin Phase 2 Est. Readout

Doxorubicin301

Breast Cancer

Q1 2027~QConfirmed

00%

CT.gov

ESALYPhase 2

Q1 '27

Lenvatinib Phase 2 Est. Readout

Lenvatinib301

Hepatocellular Carcinoma

Q1 2027~QConfirmed

00%

CT.gov

MSCLF$188MPhase 2

Q1 '27

SAT-3247 Phase 2 Est. Readout

SAT-324751

Duchenne Muscular Dystrophy

Q1 2027~QConfirmed

00%

CT.gov

CGON$5.4BPhase 2

Q1 '27

Cretostimogene Grenadenorepvec Phase 2 Est. Readout

Cretostimogene Grenadenorepvec325

High-Risk Non-Muscle-Invasive Bladder Cancer

Q1 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q1 '27

Ritlecitinib 100 mg Phase 3 Est. Readout

Ritlecitinib 100 mg394

Vitiligo

Q1 2027~QConfirmed

00%

CT.gov

NVSEF$269.0BPhase 3

Q1 '27

CTL019 Phase 3 Est. Readout

CTL019200

Acute Lymphoblastic Leukemia

Q1 2027~QConfirmed

00%

CT.gov

INVA$1.7BPhase 2

Q1 '27

VI-0609 Phase 2 Est. Readout

VI-060949

Lymphoma

Q1 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q1 '27

Englumafusp alfa Phase 2 Est. Readout

Englumafusp alfa498

Lymphoma, Non-Hodgkin

Q1 2027~QConfirmed

00%

CT.gov

HURA$164MPhase 3

Q1 '27

IFx-Hu2.0 Phase 3 Est. Readout

IFx-Hu2.0118

Advanced Or Metastatic Merkel Cell Carcinoma

Q1 2027~QConfirmed

00%

CT.gov

February 2027 Full Calendar April 2027

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