December 2026 Catalysts

FDA Decisions & PDUFA Dates

January 2027

252

Total Catalysts

PDUFA Dates

211

Trial Results

155

Companies

Week 1Nov 30 - Dec 6(29 catalysts)

JHPCY$45.1BPhase 2

Dec '26

Camrelizumab plus apatinib CohortA Phase 2 Est. Readout

Camrelizumab plus apatinib CohortA70

Gestational Trophoblastic Neoplasia

Dec 2026~Confirmed

00%

CT.gov

KZIA$11.2BPhase 2

Dec '26

PAXALISIB Phase 2 Est. Readout

PAXALISIB25

Primary Central Nervous System Lymphoma

Dec 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Dec '26

Axatilimab Phase 2 Est. Readout

Axatilimab35

TNBC - Triple-Negative Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

AXSM$12.9BPhase 2

Dec '26

Solriamfetol Phase 2 Est. Readout

Solriamfetol46

Multiple Sclerosis

Dec 2026~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Dec '26

Pandemic flu H5 HA mRNA SD2 vaccine Phase 2 Est. Readout

Pandemic flu H5 HA mRNA SD2 vaccine720

Pandemic Influenza Immunization

Dec 2026~Confirmed

00%

CT.gov

UPB$340MConference

Dec '26

Conference Presentation

Dec 2026~AI-detected

Source

CMPS$1.7BPhase 3

Dec '26

CTX-009 Phase 3 Est. Readout

CTX-009168

Glioblastoma

Dec 2026~Confirmed

00%

CT.gov

ZNTL$263MPhase 2

Q4 '26

azenosertib Phase 2 Est. Readout

azenosertib170

High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Q4 2026~QConfirmed

00%

CT.gov

RNAC$283MPhase 2

Dec '26

Descartes-08 Phase 2 Est. Readout

Descartes-086

Systemic Lupus Erythematosus (SLE)

Dec 2026~Confirmed

00%

CT.gov

MLYS$2.0BRegulatory

3mo

Regulatory

Dec 1AI-detected

00%

Source

VNDA$349MPhase 3

Dec '26

Tradipitant Phase 3 Est. Readout

Tradipitant280

Motion Sickness

Dec 2026~Confirmed

00%

CT.gov

GILD$153.7BPDUFA

Dec '26

FDA PDUFA Date

Dec 2026~AI-detected

✅ApprovedSource

NRSN$28MNDA Filing

3mo

NDA Filing — PrimeC

Dec 1AI-detected

00%

Source

ACLX$6.7BPDUFA

Dec '26

FDA PDUFA Date

Dec 2026~AI-detected

00%

Source

CELG-RIPhase 2

Dec '26

Relatlimab Phase 2 Est. Readout

Relatlimab90

Advanced Gastric Cancer

Dec 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Dec '26

Tocilizumab 20 MG/ML Phase 2 Est. Readout

Tocilizumab 20 MG/ML200

Sars-CoV2

Dec 2026~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 2

Dec '26

Bendamustine Phase 2 Est. Readout

bendamustine65

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Dec 2026~Confirmed

00%

CT.gov

NRSNWRegulatory

3mo

Regulatory

Dec 1AI-detected

00%

Source

CRIS$16MData Readout

3mo

Data Readout — zanubrutinib

Dec 1AI-detected

00%

Source

SNY$100.0BPhase 3

Dec '26

PCV21 Phase 3 Est. Readout

PCV211,268

Pneumococcal Infections

Dec 2026~Confirmed

00%

CT.gov

MRK$281.2BPDUFA

Dec '26

FDA PDUFA Date - Zanzalintinib

ZanzalintinibPhase 3

Renal Cell Carcinoma

Dec 2026~AI-detected

✓PositiveSource

ZEALPhase 3

Dec '26

Bacillus Calmette-Guerin Vaccine Intravesical Phase 3 Est. Readout

Bacillus Calmette-Guerin Vaccine Intravesical500

Transitional Cell Carcinoma

Dec 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Dec '26

Lu-PSMA-617 Phase 2 Est. Readout

Lu-PSMA-61710

Liver Cancer

Dec 2026~Confirmed

✗NegativeCT.gov

JAZZ$14.1BPhase 2

Q4 '26

Lurbinectedin Phase 2 Est. Readout

Lurbinectedin60

Refractory Ewing Sarcoma

Q4 2026~QConfirmed

00%

CT.gov

HRGN$25MPhase 2

Dec '26

Theophylline Phase 2 Est. Readout

Theophylline29

Pseudohypoparathyroidism

Dec 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 3

Dec '26

Ritlecitinib higher dose Phase 3 Est. Readout

Ritlecitinib higher dose208

Severe Alopecia Areata

Dec 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Dec '26

REGN7999 Phase 2 Est. Readout

REGN799919

Non-Transfusion Dependent Beta-Thalassemia (NTDT)

Dec 2026~Estimated

00%

CT.gov

ESALYPhase 2

Dec '26

Lecanemab Phase 2 Est. Readout

Lecanemab105

Preclinical Alzheimer's Disease

Dec 2026~Confirmed

00%

CT.gov

PFE$143.7BPhase 3

Q4 '26

VLA15 Phase 3 Est. Readout

VLA151,712

Lyme Borreliosis

Q4 2026~QConfirmed

00%

CT.gov

Week 2Dec 7 - Dec 13(6 catalysts)

AZN$273.6BPhase 3

Dec '26

eculizumab Phase 3 Est. Readout

Eculizumab21

Atypical Hemolytic Uremic Syndrome

Dec 2026~Confirmed

✓PositiveCT.gov

ALVO$1.2BPDUFA

Dec '26

FDA PDUFA Date AVT16 (vedolizumab biosimilar) (standard review)

AVT16 (vedolizumab biosimilar)NDA

Entyvio indication (inflammatory bowel disease)

Dec 2026~AI-detected

00%

Source

AZN$273.6BPhase 2

Dec '26

Baxdrostat/dapagliflozin Phase 2 Est. Readout

Baxdrostat/dapagliflozin218

Chronic Kidney Disease and Hypertension

Dec 2026~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Dec '26

Baxdrostat/dapagliflozin Phase 3 Est. Readout

Baxdrostat/dapagliflozin5,000

Chronic Kidney Disease and Hypertension

Dec 2026~Estimated

✗NegativeCT.gov

PFE$143.7BPhase 2

Dec '26

disitamab vedotin Phase 2 Est. Readout

disitamab vedotin372

Urothelial Carcinoma

Dec 2026~Confirmed

00%

CT.gov

BNN.DE$66MPhase 2

Dec '26

Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir Phase 2 Est. Readout

Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir22

Leptomeningeal Metastasis of Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

Week 3Dec 14 - Dec 20(85 catalysts)

NVO$203.2BPhase 2

Dec '26

NNC0662-0419 Phase 2 Est. Readout

NNC0662-0419224

Overweight

Dec 2026~Confirmed

✓PositiveCT.gov

NVS$284.2BPhase 2

Dec '26

AAA617 Phase 2 Est. Readout

68Ga-PSMA-1123

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Dec 2026~Confirmed

✗NegativeCT.gov

PHM.MC$26.2BPhase 2

Dec '26

Delgocitinib cream Phase 2 Est. Readout

Delgocitinib cream135

Chronic Hand Eczema

Dec 2026~Confirmed

00%

CT.gov

AMGN$182.2BPhase 3

Dec '26

ABP 234 Phase 3 Est. Readout

ABP 234163

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

CELG-RIPhase 2

Dec '26

BMS-986435 Phase 2 Est. Readout

BMS-986435227

Heart Failure

Dec 2026~Confirmed

00%

CT.gov

EPRX$434MPhase 2

Dec '26

EP-104GI Phase 2 Est. Readout

EP-104GI117

Eosinophilic Esophagitis

Dec 2026~Confirmed

00%

CT.gov

MOLN$148MPhase 2

Dec '26

PMD-026 Phase 2 Est. Readout

PMD-02661

Metastatic Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Dec '26

Association atezolizumab + BDB001 + RT Phase 2 Est. Readout

Association atezolizumab + BDB001 + RT247

Solid Tumor, Adult

Dec 2026~Confirmed

00%

CT.gov

HSCSWPhase 3

Dec '26

Aspirin 81mg Phase 3 Est. Readout

Aspirin 81mg48

Pulmonary Disease, Chronic Obstructive

Dec 2026~Confirmed

00%

CT.gov

AGY.L$6MPhase 2

Dec '26

6-diazo-5-oxo-L-norleucine (DON) Phase 2 Est. Readout

6-diazo-5-oxo-L-norleucine (DON)152

Malaria, Cerebral

Dec 2026~Confirmed

00%

CT.gov

HSCS$6MPhase 3

Dec '26

Entresto Pill Phase 3 Est. Readout

Entresto Pill45

Congenital Heart Disease

Dec 2026~Confirmed

00%

CT.gov

AVLN$1.4BPhase 2

Dec '26

AP02 Phase 2 Est. Readout

AP02160

Idiopathic Pulmonary Fibrosis (IPF)

Dec 2026~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 2

Dec '26

SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 Phase 2 Est. Readout

SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316324

Advanced Non-small Cell Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

IPSEY$15.0BPhase 3

Dec '26

Corabotase Phase 3 Est. Readout

Corabotase309

Moderate to Severe Glabellar Lines

Dec 2026~Confirmed

00%

CT.gov

ARGX$56.5BPhase 2

Dec '26

Efgartigimod Alfa Phase 2 Est. Readout

Efgartigimod Alfa20

Optic Neuritis

Dec 2026~Confirmed

00%

CT.gov

4519.T$87.4BPhase 3

Dec '26

Ifosfamide or dacarbazine Phase 3 Est. Readout

Ifosfamide or dacarbazine351

Non-metastatic Soft-tissue Sarcoma

Dec 2026~Confirmed

00%

CT.gov

SGENPhase 2

Dec '26

Tucatinib Oral Tablet Phase 2 Est. Readout

Tucatinib Oral Tablet30

Leptomeningeal Metastasis

Dec 2026~Confirmed

00%

CT.gov

YMAB$391MPhase 2

Dec '26

Hu3F8 With GM-CSF Phase 2 Est. Readout

Hu3F8 With GM-CSF186

Neuroblastoma

Dec 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Dec '26

pTVG-AR Phase 2 Est. Readout

Degarelix57

Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

TKPHF$47.7BPhase 2

Dec '26

Ixazomib Phase 2 Est. Readout

Ixazomib79

Multiple Myeloma

Dec 2026~Confirmed

00%

CT.gov

GDERF$48.7BPhase 2

Dec '26

nemolizumab Phase 2 Est. Readout

Nemolizumab50

Moderate-to-Severe Atopic Dermatitis

Dec 2026~Confirmed

00%

CT.gov

JNGHFPhase 2

Dec '26

SHR-3167 Injection Phase 2 Est. Readout

SHR-3167 Injection102

Diabetes Mellitus, Type 2

Dec 2026~Confirmed

00%

CT.gov

CNTB$126MPhase 2

Dec '26

Rademikibart Phase 2 Est. Readout

Rademikibart40

Asthma Acute

Dec 2026~Confirmed

00%

CT.gov

ALPMY$24.1BPhase 2

Dec '26

ZEN003694 Phase 2 Est. Readout

ZEN003694200

Metastatic Castration-Resistant Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Dec '26

Ranibizumab (LUCENTIS®) Phase 3 Est. Readout

Ranibizumab (LUCENTIS®)671

AMD

Dec 2026~Confirmed

✓PositiveCT.gov

SKBBYPhase 2

Dec '26

Envafolimab+Lenvatinib Phase 2 Est. Readout

Envafolimab+Lenvatinib108

Advanced Endometrial Cancer

Dec 2026~Confirmed

00%

CT.gov

TRAW$29MPhase 2

Dec '26

TRX-100 Phase 2 Est. Readout

TRX-100105

Influenza

Dec 2026~Confirmed

00%

CT.gov

MDGL$11.7BPhase 2

Dec '26

Resmetirom Phase 2 Est. Readout

Resmetirom120

NASH

Dec 2026~Confirmed

00%

CT.gov

ANRO$798MPhase 2

Dec '26

ALTO-300 Phase 2 Est. Readout

ALTO-300321

Major Depressive Disorder

Dec 2026~Confirmed

00%

CT.gov

PCRX$879MPhase 3

Dec '26

ZILRETTA Phase 3 Est. Readout

ZILRETTA150

Glenohumeral Osteoarthritis

Dec 2026~Confirmed

00%

CT.gov

AXSM$12.9BPhase 3

Dec '26

Solriamfetol 300 mg Phase 3 Est. Readout

Solriamfetol 300 mg450

Binge-Eating Disorder

Dec 2026~Confirmed

00%

CT.gov

ABBV$382.5BPhase 2

Dec '26

Eluxadoline Phase 2 Est. Readout

Eluxadoline95

Irritable Bowel Syndrome

Dec 2026~Confirmed

00%

CT.gov

KRYS$10.3BPhase 2

Dec '26

KB801 Phase 2 Est. Readout

KB80160

Neurotrophic Keratitis

Dec 2026~Confirmed

00%

CT.gov

AAPG$6.4BPhase 2

Dec '26

APG2575 Phase 2 Est. Readout

APG257575

Chronic Lymphocytic Leukemia

Dec 2026~Confirmed

00%

CT.gov

PRAX$7.9BPhase 3

Dec '26

1.0mg/kg/day PRAX-562 Phase 3 Est. Readout

1.0mg/kg/day PRAX-562160

Developmental and Epileptic Encephalopathy 1

Dec 2026~Confirmed

00%

CT.gov

CNTA$6.2BPhase 2

Dec '26

ORX750 Phase 2 Est. Readout

ORX750248

Narcolepsy Type 1

Dec 2026~Confirmed

00%

CT.gov

EXAS$20.0BPhase 2

Dec '26

Modified FOLFIRINOX Phase 2 Est. Readout

Modified FOLFIRINOX25

Locally Advanced Pancreatic Adenocarcinoma

Dec 2026~Confirmed

00%

CT.gov

KPTI$204MPhase 2

Dec '26

Selinexor Phase 2 Est. Readout

Selinexor244

Multiple Myeloma, Refractory

Dec 2026~Confirmed

00%

CT.gov

KRRO$187MPhase 2

Dec '26

KRRO-110 Phase 2 Est. Readout

KRRO-11064

Alpha-1 Anti-trypsin Deficiency

Dec 2026~Confirmed

00%

CT.gov

BEAM$3.5BPhase 2

Dec '26

BEAM-201 Phase 2 Est. Readout

BEAM-2015

Lymphoblastic Lymphoma

Dec 2026~Confirmed

00%

CT.gov

OMER$744MPhase 2

Dec '26

OMS906 study drug Phase 2 Est. Readout

OMS906 study drug25

Paroxysmal Nocturnal Hemoglobinuria

Dec 2026~Confirmed

00%

CT.gov

DSGN$777MPhase 2

Dec '26

DT-216P2 Phase 2 Est. Readout

DT-216P220

Friedreich Ataxia

Dec 2026~Confirmed

00%

CT.gov

VRNA$1.1BPhase 2

Dec '26

Ensifentrine Phase 2 Est. Readout

Ensifentrine56

Chronic Obstructive Pulmonary Disease

Dec 2026~Confirmed

00%

CT.gov

WXIPhase 3

Dec '26

Mesenchymal Stem Cells Phase 3 Est. Readout

Mesenchymal Stem Cells520

Knee Osteoarthritis

Dec 2026~Confirmed

00%

CT.gov

DMAC$315MPhase 3

Dec '26

Recombinant human tissue kallikrein Phase 3 Est. Readout

Recombinant human tissue kallikrein728

Acute Stroke

Dec 2026~Confirmed

00%

CT.gov

LLY$1.0TPhase 2

Dec '26

LY3537021 Phase 2 Est. Readout

LY3537021204

Nausea

Dec 2026~Confirmed

00%

CT.gov

GEHC$28.0BPhase 2

Dec '26

Regadenoson Phase 2 Est. Readout

Regadenoson54

Myocardial Ischemia

Dec 2026~Confirmed

00%

CT.gov

NKGN$8MPhase 2

Dec '26

SNK01 Phase 2 Est. Readout

SNK0136

Moderate Alzheimer Disease

Dec 2026~Confirmed

00%

CT.gov

DNLI$3.7BPhase 2

Dec '26

DNL593 Phase 2 Est. Readout

DNL59385

Frontotemporal Dementia

Dec 2026~Confirmed

00%

CT.gov

PHAT$868MPhase 2

Dec '26

Vonoprazan Phase 2 Est. Readout

Vonoprazan80

Non-Erosive Gastro-Esophageal Reflux Disease

Dec 2026~Confirmed

00%

CT.gov

MDWD$179MPhase 3

Dec '26

EscharEx (EX-03) Phase 3 Est. Readout

EscharEx (EX-03)216

Venous Leg Ulcer (VLU)

Dec 2026~Confirmed

00%

CT.gov

MANE$3.9BPhase 3

Dec '26

VDPHL01 Phase 3 Est. Readout

VDPHL01480

Androgenetic Alopecia

Dec 2026~Confirmed

00%

CT.gov

VIR$1.5BPhase 3

Dec '26

Elebsiran Phase 3 Est. Readout

Elebsiran150

Viral Hepatitis

Dec 2026~Confirmed

00%

CT.gov

MDGL$11.7BPhase 3

Dec '26

Resmetirom Phase 3 Est. Readout

Resmetirom845

NASH

Dec 2026~Confirmed

00%

CT.gov

BHVN$2.0BPhase 3

Dec '26

BHV-7000 Phase 3 Est. Readout

BHV-7000390

Bipolar Disorder

Dec 2026~Confirmed

00%

CT.gov

GILD$153.7BPhase 2

Dec '26

anitocabtagene-autoleucel Phase 2 Est. Readout

anitocabtagene-autoleucel136

Multiple Myeloma

Dec 2026~Confirmed

00%

CT.gov

VNDA$349MPhase 3

Dec '26

VQW-765 Phase 3 Est. Readout

VQW-765500

Performance Anxiety

Dec 2026~Confirmed

00%

CT.gov

KRYS$10.3BPhase 3

Dec '26

KB803 Phase 3 Est. Readout

KB80316

Dystrophic Epidermolysis Bullosa

Dec 2026~Confirmed

00%

CT.gov

ALZN$5MPhase 2

Dec '26

Lithium carbonate Phase 2 Est. Readout

Lithium carbonate20

Bipolar I Disorder

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 2

Dec '26

Lenvatinib + Envafolimab Phase 2 Est. Readout

Lenvatinib + Envafolimab170

Solid Tumors

Dec 2026~Confirmed

00%

CT.gov

AXSM$12.9BPhase 3

Dec '26

Solriamfetol 150 mg Phase 3 Est. Readout

Solriamfetol 150 mg450

Excessive Sleepiness

Dec 2026~Confirmed

00%

CT.gov

ATXS$718MPhase 3

Dec '26

navenibart Phase 3 Est. Readout

navenibart157

Hereditary Angioedema (HAE)

Dec 2026~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 3

Dec '26

Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide Phase 3 Est. Readout

Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide220

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 3

Dec '26

carboplatin or cisplatin Phase 3 Est. Readout

carboplatin or cisplatin432

Non-Small Cell Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

HLYK$6MPhase 2

Dec '26

EC5026 oral tablet Phase 2 Est. Readout

EC5026 oral tablet18

Parkinson's Disease (PD)

Dec 2026~Confirmed

00%

CT.gov

ABVX$7.8BPhase 2

Dec '26

Obefazimod Phase 2 Est. Readout

Obefazimod212

Moderately to Severely Active Crohn Disease

Dec 2026~Confirmed

00%

CT.gov

SOBI.ST$14.6BPhase 2

Dec '26

Lupron Phase 2 Est. Readout

Lupron82

Leukemia

Dec 2026~Confirmed

00%

CT.gov

ESALYPhase 2

Dec '26

Lenvatinib Phase 2 Est. Readout

Lenvatinib64

Hepatocellular Carcinoma

Dec 2026~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Dec '26

Tremelimumab Phase 2 Est. Readout

Tremelimumab29

Non Small Cell Lung Cancer NSCLC

Dec 2026~Confirmed

00%

CT.gov

CLTS$431KPhase 2

Dec '26

Androgen Deprivation Therapy (ADT) +/- bicalutamide Phase 2 Est. Readout

Androgen Deprivation Therapy (ADT) +/- bicalutamide23

Intermediate Risk Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

ARDX$1.5BPhase 2

Dec '26

Tenapanor Phase 2 Est. Readout

Tenapanor30

Hyperphosphatemia

Dec 2026~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Dec '26

TH9619 Phase 2 Est. Readout

TH961943

Solid Tumor

Dec 2026~Confirmed

00%

CT.gov

OCS$1.8BPhase 3

Dec '26

licaminlimab Phase 3 Est. Readout

licaminlimab160

Dry Eye Disease

Dec 2026~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Dec '26

Association of darolutamide and EBRT Phase 2 Est. Readout

Association of darolutamide and EBRT62

Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

ASND$15.0BPhase 2

Dec '26

Navepegritide Phase 2 Est. Readout

Navepegritide24

Achondroplasia

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Dec '26

PolyCore (Polydextrin, L-Carnitine, D-xylitol) Phase 2 Est. Readout

PolyCore (Polydextrin, L-Carnitine, D-xylitol)84

Congestive Heart Failure

Dec 2026~Confirmed

00%

CT.gov

ALPMY$24.1BPhase 2

Dec '26

Enfortumab Vedotin Phase 2 Est. Readout

Enfortumab vedotin25

Metastatic Urothelial Cancer

Dec 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Dec '26

Satralizumab Phase 3 Est. Readout

satralizumab122

Neuromyelitis Optica Spectrum Disorder

Dec 2026~Confirmed

✓PositiveCT.gov

SNY$100.0BPhase 2

Dec '26

SAR442970 Phase 2 Est. Readout

SAR44297099

Crohn's Disease

Dec 2026~Confirmed

00%

CT.gov

DRUG$623MPDUFA

3mo

FDA PDUFA Date CAM2029

Dec 18AI-detected

00%

Source

DRUG FDA decision page →

CAMX.ST$3.1BPDUFA

3mo

FDA PDUFA Date CAM2029

CAM2029Phase 3

Gastro-enteropancreatic Neuroendocrine Tumor

Dec 18Confirmed

✗NegativeSource

ADVB$7MPDUFA

Q4 '26

FDA PDUFA Date

Q4 2026~QAI-detected

00%

Source

RHHBY$316.4BNDA Filing

Dec '26

NDA Filing — giredestrant

Dec 2026~AI-detected

00%

Source

ABBV$382.5BPhase 2

Q4 '26

MEDI0618 Phase 2 Est. Readout

MEDI0618488

Migraine

Q4 2026~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q4 '26

Alectinib Phase 3 Est. Readout

Alectinib71

Non-Small Cell Lung Cancer

Q4 2026~QConfirmed

00%

CT.gov

Week 4Dec 21 - Dec 27(15 catalysts)

UCBJY$53.9BPhase 3

Q4 '26

Bimekizumab Phase 3 Est. Readout

Bimekizumab40

Chronic Plaque Psoriasis

Q4 2026~QConfirmed

00%

CT.gov

MLYS$2.0BPDUFA

4mo

PDUFA — lorundrostat

LorundrostatPhase 3

Obstructive Sleep Apnea

Dec 22AI-detected

00%

Source

Lorundrostat FDA decision page →

MRK$281.2BPhase 2

Dec '26

Lenvatinib Phase 2 Est. Readout

Lenvatinib40

Non-small Cell Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

SNYNF$99.8BPhase 2

Dec '26

frexalimab Phase 2 Est. Readout

frexalimab84

Focal Segmental Glomerulosclerosis

Dec 2026~Confirmed

00%

CT.gov

VRTX$114.6BPhase 2

Q4 '26

IVA Phase 2 Est. Readout

IVA39

Cystic Fibrosis

Q4 2026~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Dec '26

AAA517 Phase 2 Est. Readout

AAA51749

Prostatic Neoplasm

Dec 2026~Confirmed

00%

CT.gov

GTHXPhase 2

Dec '26

Lurbinectedin Phase 2 Est. Readout

Lurbinectedin30

Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

HMDCF$2.5BPDUFA

Dec '26

FDA PDUFA Date Sovleplenib (priority review)

HMPL-523(300mg PO QD)Phase 3

Warm Antibody Autoimmune Hemolytic Anemia

Dec 2026~AI-detected

00%

Source

GILD$153.7BPDUFA

Dec '26

FDA PDUFA Date bictegravir 75 mg/lenacapavir 50 mg (priority review)

LenacapavirPhase 3

HIV Prevention

Dec 2026~AI-detected

BTDFT✅ApprovedSource

PFE$143.7BPhase 2

Q4 '26

Ritlecitinib 50 mg Phase 2 Est. Readout

Ritlecitinib 50 mg200

Chronic Spontaneous Urticaria

Q4 2026~QConfirmed

00%

CT.gov

IPIX$9MPhase 3

Dec '26

Gemcitabine hydrochloride and albumin binding paclitaxel Phase 3 Est. Readout

Gemcitabine hydrochloride and albumin binding paclitaxel512

Locally Advanced Pancreatic Cancer

Dec 2026~Confirmed

00%

CT.gov

IQV$28.0BPhase 3

Dec '26

Oregovomab Phase 3 Est. Readout

Oregovomab615

Carcinoma, Ovarian Epithelial

Dec 2026~Confirmed

00%

CT.gov

IDIAPDUFA

Dec '26

FDA PDUFA Date BOND-003

BOND-003NDA

Dec 2026~AI-detected

00%

Source

CNTA$6.2BPDUFA

Dec '26

FDA PDUFA Date epilepsy drug

epilepsy drugNDA

epilepsy

Dec 2026~AI-detected

00%

Source

HKPD$9MPhase 2

Dec '26

EGCG and Quinine Sulfate Vaginal Suppository Phase 2 Est. Readout

EGCG and Quinine Sulfate Vaginal Suppository45

High-risk HPV (Any Strain)

Dec 2026~Confirmed

00%

CT.gov

Week 5Dec 28 - Jan 3(117 catalysts)

GSK$101.7BPhase 2

Q4 '26

Niraparib Phase 2 Est. Readout

Niraparib30

Ovarian Neoplasms

Q4 2026~QConfirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Dec '26

CM355 Phase 2 Est. Readout

CM355184

Hematoma

Dec 2026~Confirmed

00%

CT.gov

BNN.DE$66MPhase 2

Dec '26

CBD Phase 2 Est. Readout

CBD40

Alzheimer Disease

Dec 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Dec '26

Alirocumab Phase 2 Est. Readout

Alirocumab420

Homozygous Familial Hypercholesterolemia

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Dec '26

NRC-2694-A Phase 2 Est. Readout

NRC-2694-A21

Carcinoma

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 2

Dec '26

SKB264 Phase 2 Est. Readout

SKB264321

Metastatic Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Dec '26

Lutetium Lu 177 Vipivotide Tetraxetan Phase 2 Est. Readout

Lutetium Lu 177 Vipivotide Tetraxetan15

Prostate Carcinoma

Dec 2026~Confirmed

00%

CT.gov

SGIOY$14.8BPhase 2

Dec '26

S-337395 Phase 2 Est. Readout

S-337395192

Respiratory Syncytial Virus Infections

Dec 2026~Confirmed

00%

CT.gov

RNAC$283MPhase 3

Dec '26

Decartes-08 Phase 3 Est. Readout

Decartes-08100

Myasthaenia Gravis

Dec 2026~Confirmed

00%

CT.gov

SOBI.ST$14.6BPhase 3

Dec '26

Pacritinib Phase 3 Est. Readout

Pacritinib399

VEXAS

Dec 2026~Confirmed

00%

CT.gov

SLS$1.5BPhase 2

Q4 '26

SLS009 Phase 2 Est. Readout

SLS009160

Hematologic Malignancies

Q4 2026~QConfirmed

00%

CT.gov

PFE$143.7BPhase 3

Q4 '26

ARV-471 (PF-07850327) Phase 3 Est. Readout

ARV-471 (PF-07850327)59

Breast Cancer

Q4 2026~QConfirmed

00%

CT.gov

CRL$8.9BPDUFA

4mo

FDA PDUFA Date

Dec 30AI-detected

00%

Source

CRL FDA decision page →

DRUG$623MPDUFA

4mo

FDA PDUFA Date

Dec 30AI-detected

00%

Source

DRUG FDA decision page →

SGHT$287MPhase 2

Q4 '26

BS01 Phase 2 Est. Readout

BS0120

Retinitis Pigmentosa

Q4 2026~QConfirmed

00%

CT.gov

PBM$6MPhase 2

Q4 '26

Psilocybin therapy Phase 2 Est. Readout

Psilocybin therapy87

Adjustment Disorder

Q4 2026~QConfirmed

00%

CT.gov

NTHI$189MPhase 2

Q4 '26

NEO100 Phase 2 Est. Readout

NEO10030

Residual, Progressive or Recurrent Grade II or III Meningioma

Q4 2026~QConfirmed

00%

CT.gov

PFE$143.7BPhase 2

Q4 '26

ARV-471 Phase 2 Est. Readout

ARV-47120

Advanced Breast Cancer

Q4 2026~QConfirmed

00%

CT.gov

SOBI.ST$14.6BPhase 2

Dec '26

Pacritinib Phase 2 Est. Readout

Pacritinib156

VEXAS

Dec 2026~Confirmed

00%

CT.gov

IVBXF$19.2BPhase 3

Dec '26

Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） Phase 3 Est. Readout

Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）464

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Dec 2026~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Dec '26

Encorafenib Oral Capsule + Cetuximab Phase 2 Est. Readout

Encorafenib Oral Capsule + Cetuximab30

Colorectal Cancer

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 3

Dec '26

ASKB589 Phase 3 Est. Readout

ASKB589780

Gastroesophageal Junction Adenocarcinoma

Dec 2026~Confirmed

00%

CT.gov

ALPMY$24.1BPhase 2

Dec '26

XNW27011 Phase 2 Est. Readout

XNW27011240

Pancreatic Adenocarcinoma Metastatic

Dec 2026~Confirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Dec '26

Trastzumab Deruxtecan Phase 2 Est. Readout

Trastzumab Deruxtecan116

Ovarian Cancer

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 2

Dec '26

KN035 Phase 2 Est. Readout

KN035200

Solid Tumor

Dec 2026~Confirmed

00%

CT.gov

SUPN$2.6BPhase 2

Dec '26

BIS-001ER Phase 2 Est. Readout

BIS-001ER16

Focal Impaired Awareness Seizures

Dec 2026~Confirmed

00%

CT.gov

IMCR$1.5BPhase 2

Dec '26

Tebentafusp Phase 2 Est. Readout

Tebentafusp850

Advanced Melanoma

Dec 2026~Confirmed

00%

CT.gov

CADL$609MNDA Filing

4mo

NDA Filing

Dec 31AI-detected

00%

Source

JNGHFPhase 3

Dec '26

SHR-A1811 Phase 3 Est. Readout

Pyrotinib in combination with Capecitabine.381

HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Dec 2026~Confirmed

00%

CT.gov

HSCSWPhase 2

Dec '26

S-equol Phase 2 Est. Readout

S-equol38

Chronic Kidney Diseases

Dec 2026~Confirmed

00%

CT.gov

CELG-RIPhase 2

Dec '26

Chemotherapy, albumin-bound paclitaxel Phase 2 Est. Readout

Chemotherapy, albumin-bound paclitaxel57

Glioblastoma

Dec 2026~Confirmed

00%

CT.gov

NAMS$3.5BRegulatory

Dec '26

Regulatory — obicetrapib

Dec 2026~AI-detected

00%

Source

JHPCY$45.1BPhase 2

Dec '26

SHR-A1811 Phase 2 Est. Readout

SHR-A181159

HER2 Expression / Amplification in Patients With Biliary Tract Cancer

Dec 2026~Confirmed

00%

CT.gov

MLYS$2.0BPDUFA

4mo

FDA PDUFA Date lorundrostat

LorundrostatPhase 3

Obstructive Sleep Apnea

Dec 31Confirmed

00%

Source

Lorundrostat FDA decision page →

XNCR$937MData Readout

4mo

Data Readout — XmAb819

Dec 31AI-detected

00%

Source

BGNEPhase 2

Dec '26

Zanubrutinib Oral Product Phase 2 Est. Readout

Zanubrutinib Oral Product35

Monoclonal Gammopathy of Uncertain Significance

Dec 2026~Confirmed

00%

CT.gov

VTRS$17.9BPhase 3

4mo

Phase 3 — VR-205

Dec 31AI-detected

00%

Source

HKPD$9MPhase 2

Q4 '26

EI-001 Phase 2 Est. Readout

EI-00145

Non-segmental Vitiligo

Q4 2026~QConfirmed

00%

CT.gov

CLDX$2.5BPhase 2

Dec '26

CDX-301 Phase 2 Est. Readout

CDX-301100

Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

IGC$28MPhase 2

Dec '26

IGC-AD1-Active Phase 2 Est. Readout

IGC-AD1-Active164

Alzheimer Disease

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Dec '26

No Intervention: Observational Cohort Phase 2 Est. Readout

No Intervention: Observational Cohort100

Leiomyosarcoma of Ovary

Dec 2026~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Dec '26

Dupilumab Phase 2 Est. Readout

Dupilumab240

Atopic Dermatitis (AD)

Dec 2026~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 3

Dec '26

Odevixibat Phase 3 Est. Readout

Odevixibat62

Alagille Syndrome

Dec 2026~Confirmed

00%

CT.gov

CRIS$16MData Readout

4mo

Data Readout — zanubrutinib

Dec 31AI-detected

00%

Source

IDYA$2.7BNDA Filing

4mo

NDA Filing — darovasertib

Dec 31AI-detected

00%

Source

IMUX$193MPhase 3

4mo

Phase 3

Dec 31AI-detected

00%

Source

PCYCPhase 3

Dec '26

Ibrutinib Phase 3 Est. Readout

Ibrutinib700

Diffuse Large B Cell Lymphoma Relapsed

Dec 2026~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Dec '26

Asciminib Phase 2 Est. Readout

asciminib40

Leukemia, Chronic Myelogenous

Dec 2026~Confirmed

00%

CT.gov

SUPN$2.6BPhase 2

Dec '26

SPN-821 2400 mg Phase 2 Est. Readout

SPN-821 2400 mg230

Major Depressive Disorder (MDD)

Dec 2026~Confirmed

00%

CT.gov

LCTX$302MData Readout

4mo

Data Readout — COR1

Dec 31AI-detected

00%

Source

BIOA$923MData Readout

4mo

Data Readout

Dec 31AI-detected

00%

Source

RHHBY$316.4BPhase 3

Dec '26

Inavolisib Phase 3 Est. Readout

Optional Endocrine Therapy of Investigator's Choice230

Metastatic Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 3

Dec '26

Vitamin D Phase 3 Est. Readout

Vitamin D100

Sarcopenia

Dec 2026~Confirmed

00%

CT.gov

JNGHFPhase 2

Dec '26

Dalpiciclib Phase 2 Est. Readout

entinostat60

Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

SRPT$1.9BPhase 2

Dec '26

SRP-1003 IV Infusion Phase 2 Est. Readout

ARO-DM1 Intravenous (IV) Infusion78

Myotonic Dystrophy 1

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 3

Dec '26

Eribulin Phase 3 Est. Readout

Eribulin376

HR+HER2- Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

SGENPhase 2

Dec '26

Sunitinib Phase 2 Est. Readout

Sunitinib720

Lymphoma, Non-Hodgkin

Dec 2026~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 3

Dec '26

Androgen blockade + radiation therapy Phase 3 Est. Readout

Androgen blockade + radiation therapy630

Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

GSK$101.7BPhase 2

Q4 '26

MMB Phase 2 Est. Readout

MMB237

Primary Myelofibrosis (PMF)

Q4 2026~QConfirmed

00%

CT.gov

GOVX$5MPhase 2

Dec '26

COVID-19 Vaccine Phase 2 Est. Readout

COVID-19 Vaccine63

COVID-19 Infection

Dec 2026~Confirmed

00%

CT.gov

GALD.SW$46.0BPhase 3

Dec '26

Trifarotene Phase 3 Est. Readout

Trifarotene561

Acne Vulgaris

Dec 2026~Confirmed

00%

CT.gov

AAPG$6.4BPhase 3

Dec '26

lisaftoclax +BTK inhibitor Phase 3 Est. Readout

lisaftoclax +BTK inhibitor400

CLL/SLL

Dec 2026~Confirmed

00%

CT.gov

SGIOY$14.8BPhase 2

Dec '26

Sivopixant Phase 2 Est. Readout

Sivopixant60

Sleep Apnea

Dec 2026~Confirmed

00%

CT.gov

IBO$8MPhase 2

Dec '26

IMP9064 Phase 2 Est. Readout

IMP906461

Solid Tumor

Dec 2026~Confirmed

00%

CT.gov

BPMCPhase 2

Dec '26

BLU-808 Phase 2 Est. Readout

BLU-808105

Chronic Inducible Urticaria

Dec 2026~Confirmed

00%

CT.gov

ESLA$49MPhase 2

Dec '26

EB103 Phase 2 Est. Readout

EB10321

B-Cell Non-Hodgkin's Lymphoma (NHL)

Dec 2026~Confirmed

00%

CT.gov

SKBBYPhase 2

Dec '26

KL590586 Capsule Phase 2 Est. Readout

KL590586 Capsule414

Advanced Solid Tumor

Dec 2026~Confirmed

00%

CT.gov

IVBXF$19.2BPhase 2

Dec '26

IBI302 Phase 2 Est. Readout

IBI302150

Diabetic Macular Oedema

Dec 2026~Confirmed

00%

CT.gov

BEIGF$40.9BPhase 2

Dec '26

Fludarabine Phase 2 Est. Readout

Fludarabine24

Recurrent Transformed Chronic Lymphocytic Leukemia

Dec 2026~Confirmed

00%

CT.gov

JHPCY$45.1BPhase 3

Dec '26

Fuzuloparib , Abiraterone acetate and Prednisone Phase 3 Est. Readout

Fuzuloparib , Abiraterone acetate and Prednisone496

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Dec 2026~Confirmed

00%

CT.gov

NVO$203.2BNDA Filing

Dec '26

NDA Filing - etavopivat

EtavopivatPhase 3

Sickle Cell Disease

Dec 2026~AI-detected

00%

Source

SOBI.ST$14.6BPhase 2

Dec '26

Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) Phase 2 Est. Readout

Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)57

Autoimmune Inner Ear Disease

Dec 2026~Confirmed

00%

CT.gov

ACTU$50MPhase 2

Dec '26

FOLFIRNINOX Phase 2 Est. Readout

FOLFIRNINOX70

Pancreatic Adenocarcinoma

Dec 2026~Confirmed

00%

CT.gov

IPN.PA$14.5BPhase 2

Dec '26

Onivyde Phase 2 Est. Readout

Onivyde90

Recurrent Solid Tumor

Dec 2026~Confirmed

00%

CT.gov

HNPHYPhase 3

Dec '26

Almonertinib Phase 3 Est. Readout

Almonertinib192

Lung Cancer

Dec 2026~Confirmed

00%

CT.gov

CLTS$431KPhase 2

Dec '26

Arm A: 177Lu rhPSMA-10.1 Phase 2 Est. Readout

Arm A: 177Lu rhPSMA-10.16

Prostate Cancer

Dec 2026~Confirmed

00%

CT.gov

NAMSWRegulatory

4mo

Regulatory — Ubeslo

Dec 31AI-detected

✓PositiveSource

TAK$48.9BPhase 3

Dec '26

Maribavir Phase 3 Est. Readout

Maribavir20

Cytomegalovirus (CMV)

Dec 2026~Confirmed

00%

CT.gov

WXIPhase 3

Dec '26

Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks，then Standard Treatment alone for12 weeks Phase 3 Est. Readout

Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks，then Standard Treatment alone for12 weeks44

Pediatric Hereditary Kidney Diseases

Dec 2026~Confirmed

00%

CT.gov

BCAB$118MPhase 2

Dec '26

BA3011 Phase 2 Est. Readout

BA301160

Ovarian Cancer

Dec 2026~Confirmed

00%

CT.gov

BMY$110.3BPhase 2

Dec '26

Nivolumab 40 mg in 4 ml Injection Phase 2 Est. Readout

Nivolumab 40 mg in 4 ml Injection112

Uterine Cervical Neoplasms

Dec 2026~Confirmed

00%

CT.gov

KOD$2.3BPhase 3

4mo

KSI-101 Phase 3 Est. Readout

KSI-101150

Macular Edema Secondary to Inflammation

Dec 31Confirmed

00%

CT.gov

NRSN$28MNDA Filing

4mo

NDA Filing — PrimeC

Dec 31AI-detected

00%

Source

ZEALPhase 3

Dec '26

Epoetin Alfa 40000 UNT/ML Phase 3 Est. Readout

Epoetin Alfa 40000 UNT/ML2,500

Trauma

Dec 2026~Confirmed

00%

CT.gov

BBOT$606MData Readout

4mo

Data Readout

Dec 31AI-detected

00%

Source

LRVIYPhase 3

Q4 '26

Etoricoxib + Betamethasone fixed dose Phase 3 Est. Readout

Etoricoxib + Betamethasone fixed dose72

Gout Arthritis

Q4 2026~QConfirmed

00%

CT.gov

AVIR$349MPhase 3

4mo

Phase 3 — Bemnifosbuvir

Dec 31AI-detected

00%

Source

HELP$242MPhase 3

4mo

Phase 3 — HLP003

Dec 31AI-detected

00%

Source

MNOV$65MPhase 2

Q4 '26

MN-001 Phase 2 Est. Readout

MN-00140

Non-alcoholic Steatohepatitis

Q4 2026~QConfirmed

00%

CT.gov

ABSI$1.2BData Readout

4mo

Data Readout — ABS-201

Dec 31AI-detected

00%

Source

INBS$5MRegulatory

4mo

Regulatory — Intelligent Fingerprinting Drug Screening System

Dec 31AI-detected

00%

Source

RCUS$3.1BTrial Start

Dec '26

Trial Start - PEAK-1

Dec 2026~AI-detected

Source

SRPT$1.9BData Readout

Dec '26

Data Readout

Dec 2026~AI-detected

00%

Source

SNY$100.0BPhase 2

Dec '26

Isatuximab Phase 2 Est. Readout

Isatuximab30

Plasma Cell Myeloma Refractory

Dec 2026~Confirmed

00%

CT.gov

SGENPhase 3

Q4 '26

Brentuximab vedotin Phase 3 Est. Readout

brentuximab vedotin238

Lymphoma, B-Cell

Q4 2026~QConfirmed

00%

CT.gov

SKBBYPhase 3

Dec '26

SKB264 Phase 3 Est. Readout

SKB264376

Metastatic Breast Cancer

Dec 2026~Confirmed

00%

CT.gov

IDYA$2.7BPhase 2

Q4 '26

IDE196 Phase 2 Est. Readout

IDE196341

Metastatic Uveal Melanoma

Q4 2026~QConfirmed

00%

CT.gov

INCY$19.6BPhase 2

Q4 '26

R-CHOP Phase 2 Est. Readout

R-CHOP72

Non Hodgkins Lymphoma

Q4 2026~QConfirmed

00%

CT.gov

INSM$20.8BPhase 3

Q4 '26

Treprostinil Palmitil Phase 3 Est. Readout

Treprostinil Palmitil91

Pulmonary Hypertension

Q4 2026~QConfirmed

00%

CT.gov

FOLD$4.5BPhase 3

Q4 '26

migalastat HCl 150 mg Phase 3 Est. Readout

migalastat HCl 150 mg14

Fabry Disease

Q4 2026~QConfirmed

00%

CT.gov

INO$92MPhase 2

Q4 '26

INO-5401 Phase 2 Est. Readout

INO-540152

Glioblastoma

Q4 2026~QConfirmed

00%

CT.gov

TGTX$8.1BPhase 3

Q4 '26

Ublituximab Phase 3 Est. Readout

Ublituximab360

Non-Hodgkins Lymphoma

Q4 2026~QConfirmed

00%

CT.gov

ANNX$189MPhase 3

Q4 '26

Tanruprubart Phase 3 Est. Readout

Tanruprubart30

Guillain-Barre Syndrome

Q4 2026~QConfirmed

00%

CT.gov

WXIOther

Dec '26

Other

Dec 2026~AI-detected

Source

RHHBY$316.4BNDA Filing

Dec '26

NDA Filing

Dec 2026~AI-detected

00%

Source

BMY$110.3BPhase 3

Dec '26

Phase 3 Results - Cobenfy

Dec 2026~AI-detected

00%

Source

REGN$57.3BData Readout

Dec '26

Data Readout - C5 Strategy compound

Dec 2026~AI-detected

00%

Source

KYMR$7.4BPhase 1

Dec '26

Phase 1 Results - KT-579

Dec 2026~AI-detected

00%

Source

SCYX$322MPhase 1

Dec '26

Phase 1 — SCY-247

Dec 2026~AI-detected

00%

Source

RHHBY$316.4BBLA Filing

Dec '26

BLA Filing — Gazyva/Gazyvaro

Dec 2026~AI-detected

00%

Source

HSCSWPhase 3

Dec '26

LTOWB Phase 3 Est. Readout

LTOWB1,100

Wounds and Injuries

Dec 2026~Confirmed

00%

CT.gov

HNSA.ST$314MRegulatory

4mo

Regulatory — imlifidase

Dec 31AI-detected

00%

Source

AVIR$349MPhase 3

4mo

Bemnifosbuvir-Ruzasvir Phase 3 Est. Readout

Bemnifosbuvir-Ruzasvir880

HEPATITIS C VIRUS CHRONIC INFECTION

Dec 31Confirmed

00%

CT.gov

CMND$3MPhase 2

Dec '26

CMND-100 Phase 2 Est. Readout

CMND-10084

Alcohol Use Disorder

Dec 2026~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Dec '26

Trabectedin Phase 2 Est. Readout

Trabectedin16

Mesenchymal Chondrosarcoma

Dec 2026~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Dec '26

Afimkibart Phase 2 Est. Readout

Afimkibart21

Crohns Disease

Dec 2026~Confirmed

00%

CT.gov

ZEALPhase 3

Dec '26

NSAA Phase 3 Est. Readout

NSAA1,125

Prostatic Neoplasms

Dec 2026~Confirmed

00%

CT.gov

November 2026 Full Calendar January 2027

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About PDUFA Dates in December 2026

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for December 2026. 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.