Biotech Catalyst Calendar

Upcoming PDUFA dates, Phase 2/3 readouts, and advisory committee meetings sourced from ClinicalTrials.gov. Updated weekly.

465 active catalysts tracked34 Phase 2 Readout18 Phase 3 Readout1 PDUFA

Upcoming Events

March 2026

AMGNPhase 2 ReadoutBlinatumomab — Acute Lymphoblastic Leukemia, Philadelphia Chromosome-Positive

Mar 31, 2026

INCYPhase 2 ReadoutRuxolitinib Topical Cream — Exanthema, Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy

Mar 31, 2026

INCYPhase 2 ReadoutDoxorubicin — Resectable Sarcoma

Mar 31, 2026

INCYPhase 2 ReadoutRuxolitinib — Hodgkin Lymphoma

Mar 31, 2026

April 2026

AMGNPhase 2 ReadoutAMG 193 — MTAP-null Non-Small-Cell Lung Cancer, MTAP-null Solid Tumors

Apr 1, 2026

REGNPhase 2 ReadoutSarilumab SAR153191 (REGN88) — Juvenile Idiopathic Arthritis

Apr 1, 2026

INCYPhase 3 ReadoutTafasitamab — Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma

Apr 1, 2026

INCYPhase 2 Readoutretifanlimab — Endometrial Cancer

Apr 14, 2026

16d

REGNPhase 2 ReadoutFianlimab — Resectable Non-small Cell Lung Cancer

Apr 17, 2026

19d

REGNPhase 2 ReadoutCemiplimab — Colon Cancer

Apr 30, 2026

BIIBPhase 2 ReadoutBIIB122 225 mg — Parkinson Disease

Apr 30, 2026

IONSPhase 3 ReadoutEplontersen — Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Apr 30, 2026

May 2026

INCYPhase 2 ReadoutCyclophosphamide — B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

May 1, 2026

INCYPhase 2 ReadoutINCB177054 — Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors

May 8, 2026

BIIBPhase 2 ReadoutBIIB080 — Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease Dementia

May 14, 2026

REGNPhase 2 ReadoutDupilumab — Colitis Ulcerative

May 15, 2026

REGNPhase 2 ReadoutTrevogrumab-Part A — Obesity

May 18, 2026

AMGNPhase 3 ReadoutRomiplostim — Chemotherapy-induced Thrombocytopenia

May 20, 2026

AMGNPhase 2 Readoutsotorasib — KRAS p.G12C Mutant Advanced Solid Tumors

May 30, 2026

INCYPhase 2 ReadoutAxatilimab — Hodgkin Lymphoma

May 31, 2026

June 2026

REGNPhase 2 ReadoutREGN9933 — Venous Thromboembolism

Jun 1, 2026

BIIBPhase 3 ReadoutBiogen Inc. — Choroideremia, X-Linked Retinitis Pigmentosa

Jun 4, 2026

REGNPhase 3 ReadoutDupilumab — Lichen Simplex Chronicus

Jun 8, 2026

REGNPhase 3 ReadoutDupilumab — Lichen Simplex Chronicus

Jun 8, 2026

INCYPhase 2 Readoutpovorcitinib — Moderate to Severe Asthma

Jun 15, 2026

INCYPhase 2 ReadoutItacitinib — Diffuse Large B Cell Lymphoma

Jun 20, 2026

INCYPhase 2 Readoutitacitinib — Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease

Jun 22, 2026

CELCPhase 3 ReadoutGedatolisib — Breast Cancer

Jun 30, 2026

AMGNPhase 2 ReadoutDaratumumab — Myeloma, Multiple Myeloma

Jun 30, 2026

AMGNPhase 2 Readoutavutometinib and sotorasib — Non Small Cell Lung Cancer, KRAS Activating Mutation

Jun 30, 2026

AMGNPhase 2 ReadoutBlinatumomab 9ug — Acute Lymphoblastic Leukemia, B-cell Non Hodgkin Lymphoma, Pre B-Cell Acute Lymphoblastic Leukaemia

Jun 30, 2026

AMGNPhase 3 ReadoutSotorasib — Non-Small Cell Lung Cancer (NSCLC)

Jun 30, 2026

AMGNPhase 2 ReadoutAMG 193 — Advanced MTAP-null Solid Tumors

Jun 30, 2026

INCYPhase 2 ReadoutINCMGA00012 — Well-differentiated/Dedifferentiated Liposarcoma

Jun 30, 2026

IONSPhase 3 ReadoutION363 — Amyotrophic Lateral Sclerosis

Jun 30, 2026

July 2026

INCYPhase 2 ReadoutINCA034176 — Chronic Graft-versus-host-disease

Jul 3, 2026

REGNPhase 2 ReadoutOdronextamab — B-cell Non-Hodgkin Lymphoma (B-NHL)

Jul 6, 2026

INCYPhase 3 ReadoutRuxolitinib — Atopic Dermatitis

Jul 13, 2026

AMGNPhase 3 ReadoutTezepelumab — Eosinophilic Esophagitis

Jul 14, 2026

REGNPhase 3 Readoutmibavademab — Generalized Lipodystrophy

Jul 14, 2026

CELCPDUFAgedatolisib — HR+/HER2- breast cancer

Jul 17, 2026

INCYPhase 2 ReadoutINCB099280 — Advanced Solid Tumor

Jul 22, 2026

INCYPhase 2 ReadoutPemigatinib — Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation

Jul 31, 2026

BIIBPhase 3 ReadoutNusinersen — Muscular Atrophy, Spinal

Jul 31, 2026

August 2026

AMGNPhase 3 ReadoutApremilast — Plaque Psoriasis

Aug 6, 2026

REGNPhase 2 ReadoutItepekimab (SAR440340) — Chronic Rhinosinusitis Without Nasal Polyps

Aug 7, 2026

INCYPhase 3 ReadoutRuxolitinib Cream — NonSegmental Vitiligo

Aug 10, 2026

AMGNPhase 3 ReadoutDazodalibep — Sjogren's Syndrome

Aug 19, 2026

REGNPhase 2 ReadoutREGN7075 — Advanced Solid Tumors

Aug 19, 2026

September 2026

INCYPhase 3 ReadoutTafasitamab — Diffuse Large B-cell Lymphoma

Sep 1, 2026

BIIBPhase 3 ReadoutLitifilimab — Lupus Erythematosus, Systemic

Sep 27, 2026

INCYPhase 2 ReadoutINCB099280 — Cutaneous Squamous Cell Carcinoma

Sep 28, 2026

INCYPhase 2 ReadoutRetifanlimab — Soft Tissue Sarcoma, Sarcoma,Soft Tissue, Sarcoma

Sep 29, 2026

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Recent Outcomes

INCYPhase 3 ReadoutPositiveRetifanlimab

Mar 29, 2026

AMGNPhase 3 ReadoutPositiveAMG 510

Mar 29, 2026

AMGNPhase 3 ReadoutPositiveInebilizumab

Mar 29, 2026

ALNYPhase 3 ReadoutPositiveVutrisiran

Mar 29, 2026

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