January 2027 Catalysts

FDA Decisions & PDUFA Dates

February 2027

124

Total Catalysts

PDUFA Dates

100

Trial Results

Companies

Week 1Dec 28 - Jan 3(30 catalysts)

JBIO$830MPhase 1

4mo

Phase 1 — JADE201

Jan 1AI-detected

00%

Source

EXEL$13.0BPDUFA

Jan '27

FDA PDUFA Date cabozantinib (priority)

CabozantinibPhase 3

Solid Tumors

Jan 2027~AI-detected

✅ApprovedSEC

REPL$841MPhase 2

Q1 '27

RP2 Phase 2 Est. Readout

RP24

Metastatic Uveal Melanoma

Q1 2027~QConfirmed

00%

CT.gov

UNH$364.1BOther

Jan '27

Other

Jan 2027~AI-detected

Source

RGNX$403MPhase 3

Jan '27

Phase 3

Jan 2027~AI-detected

00%

Source

RNXT$41MPhase 3

Jan '27

Phase 3

Jan 2027~AI-detected

00%

Source

NTLA$2.2BRegulatory

4mo

Regulatory — Intellia gene editor

Jan 1AI-detected

00%

Source

NBP$177MPhase 2

Jan '27

Phase 2 Results - givastomig

Jan 2027~AI-detected

00%

Source

PFE$143.7BTrial Start

Jan '27

Trial Start

Jan 2027~AI-detected

Source

CNTA$6.2BOther

Jan '27

Other

Jan 2027~AI-detected

Source

GILD$153.7BPartnership

Jan '27

Partnership - Gamgertamig

Jan 2027~AI-detected

Source

AZNCF$290.6BPhase 2

Jan '27

Cediranib Phase 2 Est. Readout

Cediranib90

Renal Cell Carcinoma

Jan 2027~Confirmed

00%

CT.gov

SGENPhase 2

Jan '27

Bleomycin Phase 2 Est. Readout

Bleomycin232

Hodgkin Lymphoma

Jan 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Jan '27

dabrafenib/trametinib Phase 2 Est. Readout

dabrafenib/trametinib20

Anaplastic Thyroid Cancer

Jan 2027~Confirmed

00%

CT.gov

CYTK$9.8BRegulatory

4mo

Regulatory — Myqorzo

Jan 1AI-detected

00%

Source

HSCSWPhase 3

Jan '27

Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet Phase 3 Est. Readout

Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet160

Obesity

Jan 2027~Confirmed

00%

CT.gov

OKUR$181MTrial Start

4mo

Trial Start

Jan 1AI-detected

Source

CCCC$459MData Readout

4mo

Data Readout — Cemsidomide

Jan 1AI-detected

00%

Source

BNN.DE$66MPhase 2

Jan '27

Vismodegib Phase 2 Est. Readout

Vismodegib124

Intracranial Meningioma

Jan 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Jan '27

golcadomide Phase 2 Est. Readout

golcadomide40

Follicular Lymphoma Stage II

Jan 2027~Confirmed

00%

CT.gov

ENGN$112MRegulatory

4mo

Regulatory — Detalimogene

Jan 1AI-detected

00%

Source

MOLN$148MData Readout

4mo

Data Readout

Jan 1AI-detected

00%

Source

TRAX$608MPhase 3

4mo

Phase 3 — psilocybin

Jan 1AI-detected

00%

Source

HSCSWPhase 2

Jan '27

129Xe Hyperpolarized Phase 2 Est. Readout

129Xe Hyperpolarized20

Pulmonary Arterial Hypertension

Jan 2027~Confirmed

00%

CT.gov

NVS$284.2BNDA Filing

4mo

NDA Filing — Rhapsido

Jan 1AI-detected

00%

Source

TNXP$191MPartnership

4mo

Partnership — TONMYA®

Jan 1AI-detected

Source

PPBT$3.2BPhase 1

4mo

Phase 1 — IM1240

Jan 1AI-detected

00%

Source

SGENPhase 2

Jan '27

Enfortumab Vedotin Phase 2 Est. Readout

Enfortumab Vedotin21

Renal Pelvis and Ureter Urothelial Carcinoma

Jan 2027~Confirmed

00%

CT.gov

TLPH$57MNDA Filing

Jan '27

NDA Filing - Niyad

Jan 2027~AI-detected

00%

Source

ARGX$56.5BPDUFA

4mo

FDA PDUFA Date efgartigimod alfa-fcab (priority)

EfgartigimodPhase 3

Postural Orthostatic Tachycardia Syndrome

Jan 3AI-detected

✅ApprovedSEC

Week 2Jan 4 - Jan 10(13 catalysts)

NUVB$1.9BPDUFA

4mo

FDA PDUFA Date taletrectinib

TaletrectinibPhase 3

Non Small Cell Lung Cancer

Jan 4Confirmed

00%

Source

Taletrectinib FDA decision page →

MRK$281.2BPhase 3

Jan '27

Trifluridine-Tipiracil Phase 3 Est. Readout

Trifluridine-Tipiracil450

Gastroesophageal Cancer

Jan 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Jan '27

AZD0780 Phase 3 Est. Readout

AZD0780473

Heterozygous Familial Hypercholesterolaemia

Jan 2027~Confirmed

00%

CT.gov

PHO.OL$150MPhase 3

Jan '27

Cysview Phase 3 Est. Readout

Cysview200

Bladder Cancer

Jan 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 2

Jan '27

AZD0780 Phase 2 Est. Readout

AZD078076

Heterozygous Familial Hypercholesterolaemia

Jan 2027~Confirmed

00%

CT.gov

NUVB$1.9BNDA Filing

Jan '27

NDA Filing — IBTROZI

Jan 2027~AI-detected

00%

Source

CELG-RIPhase 2

Jan '27

BMS-986470 Phase 2 Est. Readout

BMS-986470184

Anemia, Sickle Cell

Jan 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Jan '27

AMG 732 Phase 2 Est. Readout

AMG 73294

Thyroid Eye Disease

Jan 2027~Confirmed

00%

CT.gov

ARGX$56.5BPhase 3

Jan '27

efgartigimod administration Phase 3 Est. Readout

efgartigimod administration30

Myasthaenia Gravis

Jan 2027~Confirmed

00%

CT.gov

SNYNF$99.8BPhase 3

Jan '27

PCV21 Phase 3 Est. Readout

PCV21100

Sickle Cell Disease

Jan 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Q1 '27

Isatuximab SC-OBDS Phase 2 Est. Readout

Isatuximab SC-OBDS64

Plasma Cell Myeloma Refractory

Q1 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BBLA Filing

4mo

BLA Filing — Tecentriq

Jan 10AI-detected

00%

Source

RHHBY$316.4BPDUFA

4mo

FDA PDUFA Date Enspryng (satralizumab) (priority review)

satralizumabPhase 3

Neuromyelitis Optica Spectrum Disorder

Jan 10Confirmed

✅ApprovedSource

Week 3Jan 11 - Jan 17(40 catalysts)

HKPD$9MRegulatory

4mo

Regulatory

Jan 11AI-detected

00%

Source

OTSKF$34.0BPhase 3

Jan '27

Delamanid (DLM) Phase 3 Est. Readout

Delamanid (DLM)5,832

Tuberculosis, MDR

Jan 2027~Confirmed

00%

CT.gov

GSK$101.7BPhase 2

Q1 '27

Adjuvanted RSVPreF3 vaccine Phase 2 Est. Readout

Adjuvanted RSVPreF3 vaccine203

Respiratory Syncytial Virus Infections

Q1 2027~QConfirmed

00%

CT.gov

REGN$57.3BPhase 2

Q1 '27

Sarilumab Phase 2 Est. Readout

Sarilumab370

COVID-19

Q1 2027~QConfirmed

00%

CT.gov

NVO$203.2BPhase 2

Jan '27

UBT251 Phase 2 Est. Readout

UBT251333

Overweight

Jan 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Jan '27

Durvalumab Phase 2 Est. Readout

Durvalumab42

Triple Negative Breast Cancer

Jan 2027~Confirmed

00%

CT.gov

TLPPF$2.6BPhase 3

Jan '27

68Ga-PSMA-11 Phase 3 Est. Readout

68Ga-PSMA-11338

PCA

Jan 2027~Confirmed

00%

CT.gov

COYA$115MPhase 3

Jan '27

COYA 302 Phase 3 Est. Readout

COYA 302120

Amyotrophic Lateral Sclerosis (ALS)

Jan 2027~Confirmed

00%

CT.gov

COYA$115MPhase 2

Jan '27

COYA 302 Phase 2 Est. Readout

COYA 302120

Amyotrophic Lateral Sclerosis (ALS)

Jan 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Jan '27

Pegfilgrastim Phase 2 Est. Readout

pegfilgrastim90

Breast Cancer

Jan 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Jan '27

Olaparib Phase 2 Est. Readout

Olaparib63

Ovarian Cancer

Jan 2027~Confirmed

00%

CT.gov

RARE$2.7BPhase 3

Jan '27

setrusumab Phase 3 Est. Readout

setrusumab6

Osteogenesis Imperfecta, Type I

Jan 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 3

Jan '27

efanesoctocog alfa (BIVV001) Phase 3 Est. Readout

efanesoctocog alfa (BIVV001)261

Hemophilia A

Jan 2027~Confirmed

00%

CT.gov

TKPHF$47.7BPhase 2

Jan '27

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Phase 2 Est. Readout

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)60

Colon Cancer

Jan 2027~Confirmed

00%

CT.gov

MKKGY$72.4BPhase 2

Jan '27

Bintrafusp alfa Phase 2 Est. Readout

Bintrafusp alfa80

Advanced Soft-tissue Sarcoma

Jan 2027~Confirmed

00%

CT.gov

CALC$12MPhase 2

Jan '27

CM4620 Phase 2 Est. Readout

CM462042

Acute Pancreatitis

Jan 2027~Confirmed

00%

CT.gov

AONCWPhase 3

Jan '27

Zoledronic Acid Phase 3 Est. Readout

Zoledronic Acid120

Giant Cell Tumor of Bone

Jan 2027~Confirmed

00%

CT.gov

GILD$153.7BPhase 2

Jan '27

Tilpisertib Fosmecarbil Phase 2 Est. Readout

Tilpisertib Fosmecarbil176

Ulcerative Colitis

Jan 2027~Confirmed

00%

CT.gov

RCUS$3.1BPhase 2

Jan '27

Quemliclustat Phase 2 Est. Readout

Quemliclustat332

Gastrointestinal Tract Malignancies

Jan 2027~Confirmed

00%

CT.gov

PRAX$7.9BPhase 3

Jan '27

40 mg/day vormatrogine for 12 weeks Phase 3 Est. Readout

40 mg/day vormatrogine for 12 weeks300

Focal Epilepsy

Jan 2027~Confirmed

00%

CT.gov

EWTX$4.0BPhase 2

Jan '27

Sevasemten Dose 1 Phase 2 Est. Readout

Sevasemten Dose 176

Duchenne Muscular Dystrophy

Jan 2027~Confirmed

00%

CT.gov

IDYA$2.7BPhase 3

Q1 '27

IDE196 Phase 3 Est. Readout

IDE196420

Metastatic Uveal Melanoma

Q1 2027~QConfirmed

00%

CT.gov

RXRX$544MPhase 2

Jan '27

REC-4881 Phase 2 Est. Readout

REC-488160

AXIN1 Gene Mutation

Jan 2027~Confirmed

00%

CT.gov

LRMR$378MPhase 2

Jan '27

CTI-1601 Phase 2 Est. Readout

CTI-160185

Friedreich Ataxia

Jan 2027~Confirmed

00%

CT.gov

MLTX$1.4BPhase 3

Q1 '27

Risankizumab Phase 3 Est. Readout

Risankizumab600

Arthritis, Psoriatic

Q1 2027~QConfirmed

00%

CT.gov

RCUS$3.1BPhase 3

Jan '27

Quemliclustat Phase 3 Est. Readout

Quemliclustat610

Gastrointestinal Tract Malignancies

Jan 2027~Confirmed

00%

CT.gov

PCVX$7.4BPhase 3

Jan '27

PCV20 Phase 3 Est. Readout

PCV204,049

Pneumococcal Vaccines

Jan 2027~Confirmed

00%

CT.gov

ABBV$382.5BPhase 3

Jan '27

Upadacitinib Phase 3 Est. Readout

Upadacitinib99

Ulcerative Colitis (UC)

Jan 2027~Confirmed

00%

CT.gov

ACAD$3.7BPhase 2

Jan '27

Pimavanserin 34 mg Phase 2 Est. Readout

Pimavanserin 34 mg35

Dementia-related Psychosis

Jan 2027~Confirmed

00%

CT.gov

BIIB$29.0BPhase 2

Jan '27

Tofersen Phase 2 Est. Readout

Tofersen30

ALS (SOD1)

Jan 2027~Confirmed

00%

BTDFTOrphanCT.gov

CLVSPhase 2

Jan '27

Copanlisib Phase 2 Est. Readout

Copanlisib13

Metastatic Castration-resistant Prostate Cancer

Jan 2027~Confirmed

00%

CT.gov

AZTR$8MPhase 2

Jan '27

ATR04-484 Phase 2 Est. Readout

ATR04-48432

EGFR Inhibitor-associated Rash

Jan 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 2

Jan '27

Utidelone Phase 2 Est. Readout

Utidelone120

HER2-negative Breast Cancer Patients With Brain Metastases

Jan 2027~Confirmed

00%

CT.gov

LXRX$893MPhase 3

Jan '27

Sotagliflozin Phase 3 Est. Readout

Sotagliflozin500

Type 2 Diabetes Mellitus

Jan 2027~Confirmed

00%

CT.gov

BNN.DE$66MPhase 2

Jan '27

adMSC Phase 2 Est. Readout

adMSC12

Cognitive Dysfunction

Jan 2027~Confirmed

00%

CT.gov

CELG-RIPhase 2

Jan '27

Bleomycin Phase 2 Est. Readout

Bleomycin82

Hodgkin Lymphoma

Jan 2027~Confirmed

00%

CT.gov

ESALYPhase 2

Jan '27

Lenvatinib + Letrozole Phase 2 Est. Readout

Lenvatinib + Letrozole40

Breast Cancer

Jan 2027~Confirmed

00%

CT.gov

REC.MI$11.3BPhase 2

Jan '27

Osilodrostat 1 MG Phase 2 Est. Readout

Osilodrostat 1 MG15

Mild Autonomous Cortisol Secretion

Jan 2027~Confirmed

00%

CT.gov

MIRM$6.5BPhase 2

Jan '27

Volixibat Phase 2 Est. Readout

Volixibat260

Primary Biliary Cholangitis

Jan 2027~Confirmed

00%

CT.gov

CRBP$153MPhase 2

Jan '27

CRB-701 Phase 2 Est. Readout

CRB-701348

Solid Tumor, Adult

Jan 2027~Confirmed

00%

CT.gov

Week 4Jan 18 - Jan 24(7 catalysts)

TKPHF$47.7BPhase 3

Jan '27

Maribavir Phase 3 Est. Readout

Maribavir80

Cytomegalovirus (CMV)

Jan 2027~Confirmed

00%

CT.gov

HRMY$1.9BPDUFA

5mo

FDA PDUFA Date HBS-102 (standard)

HBS-102NDA

narcolepsy

Jan 18AI-detected

00%

SEC

HBS-102 FDA decision page →

ETON$890MPDUFA

5mo

FDA PDUFA Date ET-105 (standard)

ET-105NDA

adult refractory gastroesophageal reflux disease (rGERD)

Jan 18AI-detected

00%

SEC

ET-105 FDA decision page →

SNY$100.0BPhase 2

Jan '27

Investigational hMPV/RSV vaccine Phase 2 Est. Readout

Investigational hMPV/RSV vaccine1,530

Human Metapneumovirus Immunization

Jan 2027~Confirmed

00%

CT.gov

SNY$100.0BPhase 2

Jan '27

SAR445877 Phase 2 Est. Readout

SAR445877542

Solid Tumor

Jan 2027~Confirmed

00%

CT.gov

IRD$331MPDUFA

5mo

FDA PDUFA Date OPX-102 (standard)

OPX-102NDA

Achromatopsia

Jan 20AI-detected

00%

SEC

OPX-102 FDA decision page →

AMGN$182.2BPhase 3

Jan '27

Maridebart cafraglutide Phase 3 Est. Readout

Maridebart cafraglutide3,853

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Jan 2027~Confirmed

00%

CT.gov

Week 5Jan 25 - Jan 31(34 catalysts)

NONOF$215.0BPhase 3

Jan '27

Insulin aspart Phase 3 Est. Readout

insulin aspart877

Diabetes

Jan 2027~Confirmed

00%

CT.gov

PFE$143.7BPhase 2

Q1 '27

MET233 and MET097 Phase 2 Est. Readout

MET233 and MET097132

Obesity and Obesity-related Medical Conditions

Q1 2027~QConfirmed

00%

CT.gov

VRTX$114.6BPhase 3

Jan '27

Suzetrigine Phase 3 Est. Readout

Suzetrigine455

Pain

Jan 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Jan '27

TNO155 Phase 2 Est. Readout

TNO155344

KRAS G12C Mutant Solid Tumors

Jan 2027~Confirmed

00%

CT.gov

GSK$101.7BPhase 3

Jan '27

FF/UMEC/VI Phase 3 Est. Readout

FF/UMEC/VI292

Asthma

Jan 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 3

Q1 '27

Cemdisiran Phase 3 Est. Readout

Cemdisiran190

Paroxysmal Nocturnal Hemoglobinuria

Q1 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Q1 '27

Ranibizumab Phase 3 Est. Readout

Ranibizumab451

Diabetic Macular Edema

Q1 2027~QConfirmed

00%

CT.gov

MRNA$25.4BPhase 3

Jan '27

mRNA-1018-H5 Phase 3 Est. Readout

mRNA-1018-H54,050

Influenza

Jan 2027~Confirmed

00%

CT.gov

IDYA$2.7BPhase 2

Q1 '27

Crizotinib Phase 2 Est. Readout

Crizotinib336

Metastatic Uveal Melanoma

Q1 2027~QConfirmed

00%

CT.gov

IDYA$2.7BPhase 3

Q1 '27

Crizotinib Phase 3 Est. Readout

Crizotinib420

Metastatic Uveal Melanoma

Q1 2027~QConfirmed

00%

CT.gov

NVS$284.2BPhase 2

Jan '27

QCZ484 Phase 2 Est. Readout

QCZ484396

Hypercholesterolaemia

Jan 2027~Confirmed

00%

CT.gov

NONOF$215.0BPhase 3

Jan '27

Ziltivekimab Phase 3 Est. Readout

Ziltivekimab680

Cardiovascular Risk

Jan 2027~Confirmed

00%

CT.gov

DVAX$1.8BPhase 2

Jan '27

rF1V-1018 Phase 2 Est. Readout

rF1V-1018148

Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersenia Pestis

Jan 2027~Confirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Jan '27

Alpelisib Phase 2 Est. Readout

Alpelisib69

Breast Neoplasms

Jan 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 2

Jan '27

AZD9550 Phase 2 Est. Readout

AZD9550166

Overweight and Obesity

Jan 2027~Confirmed

00%

CT.gov

SGENPhase 3

Jan '27

disitamab vedotin Phase 3 Est. Readout

disitamab vedotin412

Breast Neoplasms

Jan 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Jan '27

Casdatifan Phase 3 Est. Readout

Casdatifan1,116

Advanced Clear Cell Renal Cell Carcinoma

Jan 2027~Estimated

00%

CT.gov

CELG-RIPhase 2

Jan '27

BMS-986369 Phase 2 Est. Readout

BMS-98636985

Relapsed or Refractory T-cell Lymphomas

Jan 2027~Confirmed

00%

CT.gov

4519.T$87.4BPhase 3

Jan '27

Afimkibart Phase 3 Est. Readout

Afimkibart400

Moderately to Severely Active Ulcerative Colitis

Jan 2027~Confirmed

00%

CT.gov

IQV$28.0BPhase 2

Jan '27

Ixovex-1 Phase 2 Est. Readout

Ixovex-118

Solid Tumor

Jan 2027~Confirmed

00%

CT.gov

PRAX$7.9BPDUFA

5mo

PDUFA — Ulixacaltamide

Jan 31AI-detected

00%

Source

PRAX FDA decision page →

LPTX$25MPhase 2

Jan '27

DKN-01 Phase 2 Est. Readout

DKN-018

Colorectal Cancer

Jan 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 3

Q1 '27

Fluorouracil (5-FU) Phase 3 Est. Readout

Fluorouracil (5-FU)520

Urinary Bladder Neoplasms

Q1 2027~QConfirmed

00%

CT.gov

CANF$8MPhase 3

5mo

Phase 3

Jan 31AI-detected

00%

Source

RHHBY$316.4BPhase 2

Jan '27

Glofitamab Phase 2 Est. Readout

Glofitamab130

Diffuse Large B-cell Lymphoma

Jan 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Jan '27

Acalabrutinib Phase 2 Est. Readout

Acalabrutinib24

Phase I: Relapsed or Refractory B-cell Malignancies

Jan 2027~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Jan '27

Obinutuzumab Phase 2 Est. Readout

Obinutuzumab130

Large B-cell Lymphoma

Jan 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 3

Jan '27

Chemoimmunotherapy Phase 3 Est. Readout

Chemoimmunotherapy984

Chronic Lymphocytic Leukemia

Jan 2027~Confirmed

00%

CT.gov

DSKYF$28.8BPhase 2

Jan '27

DS-5141b Phase 2 Est. Readout

DS-5141b8

Duchenne Muscular Dystrophy

Jan 2027~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Jan '27

Gemcitabine Phase 2 Est. Readout

Gemcitabine130

Metastatic HER2-Positive Breast Cancer

Jan 2027~Confirmed

00%

CT.gov

SCLP.L$2MPhase 2

Jan '27

SCIB1 or iSCIB1+ DNA vaccine Phase 2 Est. Readout

SCIB1 or iSCIB1+ DNA vaccine173

Malignant Melanoma

Jan 2027~Confirmed

00%

CT.gov

APLM$50MPhase 2

Jan '27

APL-101 Phase 2 Est. Readout

APL-10127

Metastatic Non Small Cell Lung Cancer

Jan 2027~Confirmed

00%

CT.gov

MRK$281.2BPhase 2

Jan '27

Nirogacestat Phase 2 Est. Readout

Nirogacestat40

Tumor

Jan 2027~Confirmed

00%

CT.gov

CELZ$8MPhase 2

Q1 '27

CELZ-201 Administration Phase 2 Est. Readout

CELZ-201 Administration18

Type 1 Diabetes

Q1 2027~QConfirmed

00%

CT.gov

December 2026 Full Calendar February 2027

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About PDUFA Dates in January 2027

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