February 2027 Catalysts

FDA Decisions & PDUFA Dates

March 2027

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Feb 1 - Feb 7(10 catalysts)

PPCB$84MPhase 1

5mo

Phase 1 — PRP

Feb 1AI-detected

00%

Source

NVS$284.2BPhase 2

Feb '27

LEE011 Phase 2 Est. Readout

LEE01122

Teratoma

Feb 2027~Confirmed

00%

CT.gov

TVRD$25MPhase 2

Feb '27

TTI-101 Phase 2 Est. Readout

TTI-101193

Hepatocellular Carcinoma

Feb 2027~Confirmed

00%

CT.gov

AMGN$182.2BPhase 2

Feb '27

Diphenhydramine Phase 2 Est. Readout

Diphenhydramine310

Multiple Myeloma

Feb 2027~Confirmed

00%

CT.gov

EPZMPhase 2

Feb '27

Tazemetostat Phase 2 Est. Readout

Tazemetostat49

Diffuse Large B-cell Lymphoma (DLBCL)

Feb 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Feb '27

GC012F Injection Phase 2 Est. Readout

GC012F Injection20

Refractory Systemic Lupus Erythematosus

Feb 2027~Confirmed

00%

CT.gov

VRTX$114.6BPhase 2

Feb '27

VX-670 Phase 2 Est. Readout

VX-67052

Myotonic Dystrophy Type 1 (DM1)

Feb 2027~Confirmed

00%

CT.gov

PHM.MC$26.2BPhase 3

Feb '27

Basimglurant Phase 3 Est. Readout

Basimglurant166

Trigeminal Neuralgia

Feb 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Feb '27

LXH254 Phase 2 Est. Readout

LXH254134

Melanoma

Feb 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Feb '27

SoC (Coartem) Phase 2 Est. Readout

SoC (Coartem)120

Uncomplicated Plasmodium Falciparum Malaria

Feb 2027~Confirmed

00%

CT.gov

Week 2Feb 8 - Feb 14(13 catalysts)

RHHBY$316.4BPDUFA

5mo

FDA PDUFA Date Lunsumio VELO (mosunetuzumab) in combination with Polivy (polatuzumab vedotin) (accelerated review)

MosunetuzumabPhase 3

Non-Hodgkin Lymphoma

Feb 9Confirmed

00%

Source

Mosunetuzumab FDA decision page →

REGN$57.3BPhase 2

Feb '27

REGN9933 Phase 2 Est. Readout

REGN99331,200

Venous Thromboembolism

Feb 2027~Confirmed

00%

CT.gov

RHHBY$316.4BBLA Filing

5mo

BLA Filing — Lunsumio VELO

Feb 9AI-detected

00%

Source

SNY$100.0BPhase 2

Feb '27

Brivekimig Phase 2 Est. Readout

Brivekimig208

Hidradenitis Suppurativa

Feb 2027~Confirmed

00%

CT.gov

TAK$48.9BPhase 3

Feb '27

Teduglutide Phase 3 Est. Readout

Teduglutide13

Short Bowel Syndrome

Feb 2027~Confirmed

00%

CT.gov

BLTE$5.9BPDUFA

Feb '27

FDA PDUFA Date Tinlarebant (priority review)

TinlarebantPhase 3

STGD1

Feb 2027~AI-detected

00%

Source

RHHBY$316.4BPhase 2

Q1 '27

Ranibizumab Phase 2 Est. Readout

Ranibizumab251

Diabetic Macular Edema

Q1 2027~QConfirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Feb '27

AZD4144 Phase 2 Est. Readout

AZD4144124

Sepsis

Feb 2027~Confirmed

00%

CT.gov

QURE$2.9BPDUFA

Feb '27

FDA PDUFA Date uniQure Huntington's disease gene therapy (accelerated review)

uniQure Huntington's disease gene therapyNDA

Huntington's disease

Feb 2027~AI-detected

00%

Source

DCPHPDUFA

Feb '27

FDA PDUFA Date Tirabrutinib

TirabrutinibNDA

relapsed or refractory PCNSL

Feb 2027~AI-detected

✅ApprovedSource

CELG-RIPDUFA

Feb '27

FDA PDUFA Date iberdomide

IberdomidePhase 3

Multiple Myeloma

Feb 2027~Confirmed

✅ApprovedSource

EPZMPhase 3

Feb '27

Tazemetostat Phase 3 Est. Readout

Tazemetostat599

Diffuse Large B-cell Lymphoma (DLBCL)

Feb 2027~Confirmed

00%

CT.gov

ESALYPhase 2

Feb '27

E2086 Phase 2 Est. Readout

E208664

Narcolepsy

Feb 2027~Confirmed

00%

CT.gov

Week 3Feb 15 - Feb 21(35 catalysts)

RHHBY$316.4BPhase 2

Feb '27

Venetoclax Phase 2 Est. Readout

Venetoclax230

Chronic Lymphocytic Leukemia

Feb 2027~Confirmed

00%

CT.gov

HSCSWPhase 2

Feb '27

Doxycycline Phase 2 Est. Readout

Doxycycline133

Emphysema

Feb 2027~Confirmed

00%

CT.gov

BAYRY$42.5BPhase 2

Feb '27

FOLFOX chemotherapy with oxaliplatin Phase 2 Est. Readout

FOLFOX chemotherapy with oxaliplatin39

Esophagogastric Cancer

Feb 2027~Confirmed

00%

CT.gov

JNGHFPhase 2

Feb '27

FH-006 for Injection Phase 2 Est. Readout

FH-006 for Injection150

Malignant Solid Tumor

Feb 2027~Confirmed

00%

CT.gov

IQV$28.0BPhase 2

Feb '27

ER004 Phase 2 Est. Readout

ER00420

X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Feb 2027~Confirmed

00%

CT.gov

GNMSF$18.3BPhase 3

Feb '27

Pegylated liposomal doxorubicin (PLD) Phase 3 Est. Readout

Pegylated liposomal doxorubicin (PLD)530

Platinum-resistant Ovarian Cancer

Feb 2027~Confirmed

00%

CT.gov

TXMD$9MPhase 2

Feb '27

YL201 for Injection Phase 2 Est. Readout

YL201 for Injection100

Advanced Solid Tumor

Feb 2027~Confirmed

00%

CT.gov

CADL$609MPhase 2

Feb '27

aglatimagene besadenovec + valacyclovir Phase 2 Est. Readout

aglatimagene besadenovec + valacyclovir45

Prostate Cancer Patients Treated by Radiotherapy

Feb 2027~Confirmed

00%

CT.gov

ALM.MC$4.3BPhase 2

Feb '27

LAD328 Phase 2 Est. Readout

LAD32850

Hidradenitis Suppurativa

Feb 2027~Confirmed

00%

CT.gov

AZNCF$290.6BPhase 2

Feb '27

Tremelimumab Phase 2 Est. Readout

Tremelimumab18

Non Small Cell Lung Cancer NSCLC

Feb 2027~Confirmed

00%

CT.gov

DAWN$2.2BPhase 2

Feb '27

Emi-Le Phase 2 Est. Readout

Emi-Le360

Triple Negative Breast Cancer

Feb 2027~Confirmed

00%

CT.gov

RHHBY$316.4BPhase 3

Feb '27

Venetoclax Phase 3 Est. Readout

Venetoclax130

Chronic Lymphocytic Leukemia

Feb 2027~Confirmed

00%

CT.gov

ABCL$1.7BPhase 2

Feb '27

ABCL635 Phase 2 Est. Readout

ABCL635136

Vasomotor Symptoms Associated With Menopause

Feb 2027~Confirmed

00%

CT.gov

TEVA$36.7BPDUFA

Feb '27

FDA PDUFA Date olanzapine extended-release injectable suspension (standard review)

Feb 2027~AI-detected

✅ApprovedSource

ABBV$382.5BPhase 2

Feb '27

Ravagalimab Phase 2 Est. Readout

Ravagalimab180

Rheumatoid Arthritis

Feb 2027~Confirmed

00%

CT.gov

KRYS$10.3BPhase 2

Feb '27

KB707 Phase 2 Est. Readout

KB707250

Lung Cancer, Non-small Cell

Feb 2027~Confirmed

00%

CT.gov

GNLX$133MPhase 2

Feb '27

Platinum chemotherapy: carboplatin or cisplatin Phase 2 Est. Readout

Platinum chemotherapy: carboplatin or cisplatin142

Advanced Non-squamous Non-small-cell Lung Cancer

Feb 2027~Confirmed

00%

CT.gov

HRMY$1.9BPDUFA

Q1 '27

FDA PDUFA Date

Q1 2027~QAI-detected

00%

Source

SXTPWPhase 2

Feb '27

Tafenoquine 100mg Phase 2 Est. Readout

Tafenoquine 100mg40

Chronic Babesiosis

Feb 2027~Confirmed

00%

CT.gov

MGNX$263MPhase 2

Feb '27

Lorigerlimab Phase 2 Est. Readout

lorigerlimab60

Androgen-Independent Prostatic Cancer

Feb 2027~Confirmed

00%

CT.gov

ENLV$150MPhase 2

Feb '27

Allocetra Phase 2 Est. Readout

Allocetra270

Osteoarthritis, Knee

Feb 2027~Confirmed

00%

CT.gov

IPIX$9MPhase 2

Feb '27

GI-108 Phase 2 Est. Readout

GI-10876

Advanced Solid Tumor

Feb 2027~Confirmed

00%

CT.gov

BAVA.CO$2.3BPhase 2

Feb '27

MVA-BN-WEV Phase 2 Est. Readout

MVA-BN-WEV411

Encephalitis

Feb 2027~Confirmed

00%

CT.gov

REC.MI$11.3BPhase 2

Feb '27

Pasireotide Phase 2 Est. Readout

Pasireotide10

Prolactin-Producing Pituitary Tumor

Feb 2027~Confirmed

00%

CT.gov

MRNA$25.4BPhase 3

Feb '27

mRNA-1403 Phase 3 Est. Readout

mRNA-140337,864

Acute Gastroenteritis

Feb 2027~Confirmed

00%

CT.gov

ARWR$11.5BPhase 2

Feb '27

ARO-ALK7 Phase 2 Est. Readout

ARO-ALK7126

Obesity

Feb 2027~Confirmed

00%

CT.gov

MLTX$1.4BPDUFA

Feb '27

FDA PDUFA Date

inflammatory arthritis

Feb 2027~AI-detected

00%

Source

RGNX$403MPDUFA

Feb '27

FDA PDUFA Date RGX-121 (accelerated review)

RGX-121NDA

Hunter syndrome

Feb 2027~AI-detected

✅ApprovedSource

TKPHF$47.7BPhase 2

Feb '27

TAK-279 Phase 2 Est. Readout

TAK-279268

Ulcerative Colitis

Feb 2027~Confirmed

00%

CT.gov

AZN$273.6BPhase 3

Q1 '27

Zibotentan/Dapagliflozin Phase 3 Est. Readout

Zibotentan/Dapagliflozin1,835

Chronic Kidney Disease With High Proteinuria

Q1 2027~QConfirmed

00%

CT.gov

MRK$281.2BPhase 2

Feb '27

R-CHOP Protocol Phase 2 Est. Readout

R-CHOP Protocol51

B Cell Lymphoma

Feb 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 2

Q1 '27

REGN7508 Phase 2 Est. Readout

REGN7508195

Venous Thromboembolism (VTE)

Q1 2027~QConfirmed

00%

CT.gov

JHPCY$45.1BPhase 3

Feb '27

PD-1 blocking antibody Phase 3 Est. Readout

PD-1 blocking antibody593

Nasopharyngeal Carcinoma

Feb 2027~Confirmed

00%

CT.gov

SKBBYPhase 2

Feb '27

SKB518 Phase 2 Est. Readout

SKB518192

Lung Carcinoma

Feb 2027~Confirmed

00%

CT.gov

REGN$57.3BPhase 3

Feb '27

Enoxaparin Phase 3 Est. Readout

REGN99332,000

Venous Thromboembolism

Feb 2027~Confirmed

00%

CT.gov

Week 4Feb 22 - Feb 28(21 catalysts)

AZNCF$290.6BPhase 3

Feb '27

Osimertinib Phase 3 Est. Readout

Osimertinib37

Non-Small Cell Lung Cancer

Feb 2027~Confirmed

00%

CT.gov

PFE$143.7BPhase 3

Q1 '27

tofacitinib Phase 3 Est. Readout

Tofacitinib120

Rheumatoid Arthritis

Q1 2027~QConfirmed

00%

CT.gov

AZN$273.6BPhase 3

Q1 '27

Anifrolumab Phase 3 Est. Readout

Anifrolumab363

Lupus Nephritis

Q1 2027~QEstimated

00%

CT.gov

OXB.L$9MPhase 2

Feb '27

Ganfeborole Phase 2 Est. Readout

Ganfeborole2,500

Pulmonary Tuberculosis

Feb 2027~Confirmed

00%

CT.gov

LRMR$378MPDUFA

Feb '27

FDA PDUFA Date nomlabofusp (accelerated review)

CTI-1601Phase 2

Friedreich Ataxia

Feb 2027~Confirmed

00%

Source

RARE$2.7BPDUFA

6mo

FDA PDUFA Date (standard)

Feb 24AI-detected

00%

SEC

RARE FDA decision page →

UCBJY$53.9BPhase 3

Q1 '27

Brivaracetam Phase 3 Est. Readout

Brivaracetam160

Epilepsy

Q1 2027~QConfirmed

00%

CT.gov

RHHBY$316.4BPhase 2

Feb '27

Cevostamab Phase 2 Est. Readout

Cevostamab90

Multiple Myeloma

Feb 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 2

Feb '27

Alpelisib Phase 2 Est. Readout

Alpelisib24

Advanced Breast Cancer

Feb 2027~Confirmed

00%

CT.gov

NVSEF$269.0BPhase 2

Feb '27

LEE011 Phase 2 Est. Readout

BYL719255

Breast Cancer

Feb 2027~Confirmed

00%

CT.gov

NVS$284.2BPhase 3

Q1 '27

Pertuzumab Phase 3 Est. Readout

Pertuzumab19

Advanced HER2+Breast Cancer

Q1 2027~QConfirmed

00%

CT.gov

ARDX$1.5BPhase 3

Feb '27

Tenapanor 5 mg BID Phase 3 Est. Readout

Tenapanor 5 mg BID692

Chronic Idiopathic Constipation (CIC)

Feb 2027~Confirmed

00%

CT.gov

SRPT$1.9BRegulatory

6mo

Regulatory — exon skipping drugs

Feb 28AI-detected

00%

Source

FBRX$248MPhase 2

Q1 '27

FB102 Phase 2 Est. Readout

FB102100

Celiac Disease

Q1 2027~QConfirmed

00%

CT.gov

IONS$12.2BPhase 1

Feb '27

Phase 1

Feb 2027~AI-detected

00%

Source

TRAX$608MPhase 3

6mo

Phase 3 — zipalertinib

Feb 28AI-detected

00%

Source

CELG-RIPhase 2

Feb '27

belatacept Phase 2 Est. Readout

Belatacept21

Renal Transplantation

Feb 2027~Confirmed

00%

CT.gov

BMRN$10.6BPDUFA

6mo

FDA PDUFA Date

Feb 28AI-detected

00%

Source

BMRN FDA decision page →

BMRN$10.6BNDA Filing

6mo

NDA Filing — VOXZOGO

Feb 28AI-detected

00%

Source

REGN$57.3BPhase 3

Q1 '27

REGN5715 Phase 3 Est. Readout

REGN5715350

Allergic Conjunctivitis

Q1 2027~QConfirmed

00%

CT.gov

HNSA.ST$314MPhase 2

Feb '27

Imlifidase Phase 2 Est. Readout

Imlifidase10

Kidney Transplantation in Highly Sensitized Patients

Feb 2027~Confirmed

00%

CT.gov

January 2027 Full Calendar March 2027

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About PDUFA Dates in February 2027

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