May 2027 Catalysts

FDA Decisions & PDUFA Dates

June 2027

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Apr 26 - May 2(11 catalysts)

TXMD$9MPhase 2

Q2 '27

ALT-100 mAb Phase 2 Est. Readout

ALT-100 mAb15

Acute Respiratory Distress Syndrome (ARDS)

Q2 2027~QConfirmed

00%

CT.gov

IPIX$9MPhase 2

Q2 '27

S095035 Phase 2 Est. Readout

S09503560

MTAP-deleted Solid Tumors

Q2 2027~QConfirmed

00%

CT.gov

ZEALPhase 2

Q2 '27

Incobotulinumtoxin-A 100 UNIT Injection Phase 2 Est. Readout

Incobotulinumtoxin-A 100 UNIT Injection80

Diabetic Neuropathy, Painful

Q2 2027~QConfirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Q2 '27

89Zr-Patritumab deruxtecan Phase 2 Est. Readout

89Zr-Patritumab deruxtecan16

Non-Small Cell Lung Carcinoma

Q2 2027~QConfirmed

00%

CT.gov

AXSM$12.9BPDUFA

8mo

FDA PDUFA Date AXS-12

AXS-12 (reboxetine)Phase 3

Narcolepsy

May 1Confirmed

00%

Source

AXS-12 (reboxetine) FDA decision page →

CMPS$1.7BPhase 2

Q2 '27

CTX-009 Phase 2 Est. Readout

CTX-00950

Glioblastoma

Q2 2027~QConfirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Q2 '27

Regorafenib (CT) Phase 2 Est. Readout

Regorafenib (CT)16

Colorectal Cancer

Q2 2027~QConfirmed

00%

CT.gov

CLTS$431KPhase 2

Q2 '27

Flotufolastat F18 Phase 2 Est. Readout

Flotufolastat F18120

Prostatic Neoplasms

Q2 2027~QConfirmed

00%

CT.gov

AXSM$12.9BNDA Filing

8mo

NDA Filing — AXS-12

May 1AI-detected

00%

Source

AGY.L$6MPhase 2

Q2 '27

Research Grade RG-RV Phase 2 Est. Readout

Research Grade RG-RV75

Asthma

Q2 2027~QConfirmed

00%

CT.gov

PFE$143.7BPhase 2

Q2 '27

15-valent pneumococcal conjugate vaccine (PCV15) Phase 2 Est. Readout

15-valent pneumococcal conjugate vaccine (PCV15)605

Pneumococcal Disease

Q2 2027~QConfirmed

00%

CT.gov

Week 2May 3 - May 9(7 catalysts)

AZN$273.6BPhase 2

Q2 '27

Fluorouracil (5-FU) Phase 2 Est. Readout

Fluorouracil (5-FU)452

Gastric Cancer

Q2 2027~QConfirmed

00%

CT.gov

AMGN$182.2BPhase 3

Q2 '27

Bisphosphonate Phase 3 Est. Readout

Bisphosphonate111

Osteogenesis Imperfecta

Q2 2027~QConfirmed

00%

CT.gov

AGY.L$6MPhase 3

Q2 '27

Dihydroartemisinin-piperaquine (DP) Phase 3 Est. Readout

Dihydroartemisinin-piperaquine (DP)924

Malaria

Q2 2027~QConfirmed

00%

CT.gov

UCBJY$53.9BPhase 3

Q2 '27

Rozanolixizumab Phase 3 Est. Readout

Rozanolixizumab113

Generalized Myasthenia Gravis

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Frexalimab Phase 3 Est. Readout

Cholestyramine1,655

Multiple Sclerosis

Q2 2027~QConfirmed

00%

CT.gov

IVBXF$19.2BPhase 3

Q2 '27

IBI362 Phase 3 Est. Readout

IBI362260

Type 2 Diabetes

Q2 2027~QConfirmed

00%

CT.gov

RGNX$403MPDUFA

May '27

FDA PDUFA Date Regenxbio gene therapy (unnamed)

Regenxbio gene therapy (unnamed)NDA

Duchenne muscular dystrophy

May 2027~AI-detected

00%

Source

Week 3May 10 - May 16(32 catalysts)

REGN$57.3BPhase 2

Q2 '27

Ubamatamab Phase 2 Est. Readout

Tocilizumab890

Recurrent Ovarian Cancer

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q2 '27

Baloxavir Marboxil Phase 3 Est. Readout

Baloxavir Marboxil1,100

Influenza

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Prevnar 20 vaccine Phase 3 Est. Readout

Prevnar 20 vaccine2,320

Pneumococcal Immunization

Q2 2027~QConfirmed

00%

CT.gov

NVO$203.2BPhase 3

Q2 '27

Cagrilintide Phase 3 Est. Readout

Cagrilintide330

Obesity or Overweight

Q2 2027~QConfirmed

00%

CT.gov

CELG-RIPDUFA

8mo

FDA PDUFA Date mezigdomide

MezigdomidePhase 3

Relapsed or Refractory Multiple Myeloma

May 13Confirmed

00%

Source

JNJ$549.8BPhase 3

Q2 '27

Nipocalimab Phase 3 Est. Readout

Nipocalimab201

Arthritis, Rheumatoid

Q2 2027~QConfirmed

00%

CT.gov

ZEALPhase 3

May '27

Dexamethasone Oral Phase 3 Est. Readout

Dexamethasone Oral80

Rheumatic Fever

May 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Q2 '27

ALN-CIDEB Phase 2 Est. Readout

ALN-CIDEB132

Metabolic Dysfunction-Associated Steatotic Liver Disease

Q2 2027~QConfirmed

00%

CT.gov

ALPMY$24.1BPhase 2

May '27

Enzalutamide Phase 2 Est. Readout

Enzalutamide50

Progressive Metastatic Prostate Cancer

May 2027~Confirmed

00%

CT.gov

SKBBYPhase 2

May '27

Lenvatinib Phase 2 Est. Readout

Lenvatinib33

Advanced Hepatocellular Carcinoma

May 2027~Confirmed

00%

CT.gov

IRON$2.7BPhase 2

May '27

DISC-0974 Phase 2 Est. Readout

DISC-0974150

Myelofibrosis; Anemia

May 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

Clotting factor concentrates (CFC) or bypassing agents (BPA) Phase 3 Est. Readout

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

Hemophilia

Q2 2027~QConfirmed

00%

CT.gov

ABBV$382.5BPhase 3

May '27

Ubrogepant Phase 3 Est. Readout

Ubrogepant1,059

Migraine

May 2027~Confirmed

00%

CT.gov

BOLT$11MPhase 2

May '27

BDC-4182 Phase 2 Est. Readout

BDC-4182122

Gastric Cancer Adenocarcinoma Metastatic

May 2027~Confirmed

00%

CT.gov

LLY$1.0TPhase 3

May '27

Standard therapy for INCS Phase 3 Est. Readout

Standard therapy for INCS510

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

May 2027~Confirmed

00%

CT.gov

JNGHFPhase 3

May '27

Paclitaxel Injection Phase 3 Est. Readout

Paclitaxel Injection300

Ovarian Cancer

May 2027~Confirmed

00%

CT.gov

RVMD$34.7BPhase 2

Q2 '27

RMC-6236 Phase 2 Est. Readout

RMC-62361,130

Colorectal Cancer

Q2 2027~QConfirmed

00%

CT.gov

RCUS$3.1BPhase 2

May '27

Zimberelimab Phase 2 Est. Readout

Zimberelimab169

Non Small Cell Lung Cancer

May 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

May '27

Lutikizumab Phase 2 Est. Readout

Lutikizumab83

Hidradenitis Suppurativa

May 2027~Confirmed

00%

CT.gov

VXRT$174MPhase 2

May '27

VXA-CoV2-3.1 Phase 2 Est. Readout

VXA-CoV2-3.110,400

SARS-CoV2

May 2027~Confirmed

00%

CT.gov

VACH$256MPhase 2

May '27

VY7523 Phase 2 Est. Readout

VY752352

Alzheimer's Disease (AD)

May 2027~Confirmed

00%

CT.gov

VTRS$17.9BPhase 3

May '27

Transdermal system containing progestin Phase 3 Est. Readout

Transdermal system containing progestin1,630

Female Contraception

May 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

May '27

Carfilzomib Phase 2 Est. Readout

Carfilzomib44

Multiple Myeloma

May 2027~Confirmed

00%

CT.gov

OTSKF$34.0BPhase 2

May '27

IRL757 Phase 2 Est. Readout

IRL75775

PARKINSON DISEASE (Disorder)

May 2027~Confirmed

00%

CT.gov

TXMD$9MPhase 3

May '27

Leriglitazone Phase 3 Est. Readout

Leriglitazone40

Cerebral Adrenoleukodystrophy (cALD)

May 2027~Confirmed

00%

CT.gov

KLRA$2.6BPhase 2

May '27

Ribupatide Phase 2 Est. Readout

Ribupatide264

Obesity

May 2027~Confirmed

00%

CT.gov

VCRE$4.6BPhase 2

May '27

Buloxibutid Phase 2 Est. Readout

Buloxibutid378

Idiopathic Pulmonary Fibrosis (IPF)

May 2027~Confirmed

00%

CT.gov

SKBBYPhase 3

May '27

SKB264 Phase 3 Est. Readout

SKB264420

Metastatic Breast Cancer

May 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

May '27

12 cm2 - 2 Active DMTS Patches Phase 2 Est. Readout

12 cm2 - 2 Active DMTS Patches150

Agitation

May 2027~Confirmed

00%

CT.gov

ZURA$356MPhase 2

May '27

Tibulizumab Phase 2 Est. Readout

Tibulizumab80

Systemic Sclerosis (SSc)

May 2027~Confirmed

00%

CT.gov

ALKS$7.5BPhase 3

May '27

ALKS 2680 Dose 3 Phase 3 Est. Readout

ALKS 2680 Dose 3176

Narcolepsy Type 2

May 2027~Confirmed

00%

CT.gov

NVO$203.2BPhase 2

Q2 '27

CDR132L Phase 2 Est. Readout

CDR132L200

Heart Failure

Q2 2027~QConfirmed

00%

CT.gov

Week 4May 17 - May 23(11 catalysts)

UCBJY$53.9BPhase 2

Q2 '27

Galvokimig Phase 2 Est. Readout

Galvokimig160

Atopic Dermatitis

Q2 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 3

Q2 '27

Acetylsalicylic Acid (ASA) Phase 3 Est. Readout

Acetylsalicylic Acid (ASA)2,000

Symptomatic Venous Thromboembolism (VTE)

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 3

Q2 '27

PCV21 vaccine Phase 3 Est. Readout

PCV21 vaccine1,714

Pneumococcal Immunization

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q2 '27

GIA632 Phase 2 Est. Readout

GIA63234

Atopic Dermatitis

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

Pentavalent Meningococcal ABCYW vaccine Phase 2 Est. Readout

Pentavalent Meningococcal ABCYW vaccine750

Meningococcal Immunization

Q2 2027~QConfirmed

00%

CT.gov

SNY$100.0BPhase 2

Q2 '27

SAR402663 Phase 2 Est. Readout

SAR40266366

Neovascular Age-related Macular Degeneration

Q2 2027~QConfirmed

00%

CT.gov

TAK$48.9BPhase 3

Q2 '27

Zasocitinib Phase 3 Est. Readout

Zasocitinib600

Psoriatic Arthritis

Q2 2027~QConfirmed

00%

CT.gov

NONOF$215.0BPhase 3

Q2 '27

Cagrilintide Phase 3 Est. Readout

Cagrilintide285

Obesity

Q2 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 3

Q2 '27

Nemtabrutinib Phase 3 Est. Readout

Nemtabrutinib300

Chronic Lymphocytic Leukemia

Q2 2027~QConfirmed

00%

CT.gov

BIIB$29.0BPhase 3

Q2 '27

BIIB017 (peginterferon beta-1a) Phase 3 Est. Readout

BIIB017 (peginterferon beta-1a)152

Multiple Sclerosis, Relapsing-Remitting

Q2 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q2 '27

Platinum-based chemotherapy Phase 2 Est. Readout

Platinum-based chemotherapy120

Non-Small Cell Lung Cancer

Q2 2027~QConfirmed

00%

CT.gov

Week 5May 24 - May 30(18 catalysts)

REPL$841MPDUFA

May '27

FDA PDUFA Date RP1

RP1Phase 2

Non-Small Cell Lung Cancer (NSCLC)

May 2027~AI-detected

00%

Source

ALM.MC$4.3BPhase 2

Q2 '27

LAD191 Phase 2 Est. Readout

LAD191200

Hidradenitis Suppurativa

Q2 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Q2 '27

ARV-766 Part A&B Phase 2 Est. Readout

ARV-766 Part A&B164

Prostate Cancer Metastatic

Q2 2027~QConfirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Q2 '27

Centanafadine XR Phase 3 Est. Readout

Centanafadine XR80

Attention-deficit/Hyperactivity Disorder

Q2 2027~QConfirmed

00%

CT.gov

MBX$2.0BPhase 2

Q2 '27

400 µg of MBX 2109 once-weekly by subcutaneous injection Phase 2 Est. Readout

400 µg of MBX 2109 once-weekly by subcutaneous injection60

Hypoparathyroidism

Q2 2027~QConfirmed

00%

CT.gov

RNTX$78MPhase 2

Q2 '27

Placebo Phase 2 Est. Readout

LTI-01120

Pleural Effusion

Q2 2027~QConfirmed

00%

CT.gov

OTSKF$34.0BPhase 3

Q2 '27

BPaQM Phase 3 Est. Readout

BPaQM532

Pulmonary Tuberculosis

Q2 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 2

Q2 '27

AZD5305 Phase 2 Est. Readout

AZD5305702

Ovarian Cancer

Q2 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 3

Q2 '27

Danicopan Phase 3 Est. Readout

Danicopan6

C3 Glomerulonephritis

Q2 2027~QConfirmed

00%

CT.gov

SWTXPhase 2

Q2 '27

Nirogacestat oral tablet Phase 2 Est. Readout

Nirogacestat oral tablet20

Desmoid Tumor

Q2 2027~QConfirmed

00%

CT.gov

BMY$110.3BPDUFA

May '27

FDA PDUFA Date Camzyos

CamzyosNDA

symptomatic oHCM in adolescents aged 12 to under 18 years

May 2027~AI-detected

✅ApprovedSource

JNGHFPhase 2

Q2 '27

KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection) Phase 2 Est. Readout

KN046 (Recombinant Humanized PD-L1/CTLA-4 Bispecific Single Domain Antibody Fc Fusion Protein Injection)54

Advanced Non-small Cell Lung Cancer

Q2 2027~QConfirmed

00%

CT.gov

HNPHYPhase 2

Q2 '27

HS-10542 Phase 2 Est. Readout

HS-1054250

Paroxysmal Nocturnal Hemoglobinuria

Q2 2027~QConfirmed

00%

CT.gov

TXMD$9MPhase 2

Q2 '27

Ublituximab Phase 2 Est. Readout

Ublituximab350

Relapsing Remitting Multiple Sclerosis

Q2 2027~QConfirmed

00%

CT.gov

ISCO$3MPDUFA

May '27

FDA PDUFA Date IBI343 (arcotatug tavatecan)

IBI343 (arcotatug tavatecan)NDA

Advanced refractory gastric cancer

May 2027~AI-detected

00%

Source

AGY.L$6MPhase 2

Q2 '27

Vancomycin (IV) Phase 2 Est. Readout

Vancomycin (IV)25

Healthy Volunteer

Q2 2027~QConfirmed

00%

CT.gov

WXIPhase 2

Q2 '27

NWRD08 administered by electroporation Phase 2 Est. Readout

NWRD08 administered by electroporation150

High-grade Squamous Intraepithelial Lesion (HSIL)

Q2 2027~QConfirmed

00%

CT.gov

ACRV$67MPhase 2

Q2 '27

ACR-368 Phase 2 Est. Readout

ACR-368350

Endometrial Adenocarcinoma

Q2 2027~QConfirmed

00%

CT.gov

Week 6May 31 - Jun 6(6 catalysts)

CGTX$130MPhase 2

Q2 '27

CT1812 Phase 2 Est. Readout

CT1812540

Early Alzheimer's Disease

Q2 2027~QConfirmed

00%

CT.gov

ILPLFPhase 2

Q2 '27

Dexamethasone oral Phase 2 Est. Readout

Dexamethasone oral60

Breast Neoplasms

Q2 2027~QConfirmed

00%

CT.gov

HSCSWPhase 2

Q2 '27

Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2 Phase 2 Est. Readout

Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH250

Postural Tachycardia Syndrome (POTS)

Q2 2027~QConfirmed

00%

CT.gov

DAWN$2.2BPhase 2

Q2 '27

Tovorafenib Phase 2 Est. Readout

Tovorafenib141

Low-grade Glioma

Q2 2027~QConfirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Q2 '27

EXE-346 Phase 2 Est. Readout

EXE-34650

Ileal Pouch

Q2 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Q2 '27

Calciumfolinat Phase 2 Est. Readout

Calciumfolinat677

Gastric Cancer

Q2 2027~QConfirmed

00%

CT.gov

April 2027 Full Calendar June 2027

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About PDUFA Dates in May 2027

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