FDA Calendar
Upcoming clinical readouts, trial starts, and trial-progress milestones for U.S.-listed biotech, with official source links.
FREE BETA · Guests can view 30 days, including today (through Nov 10, 2026, ET). Sign in for the full calendar.
10 of 1,611 scheduled catalysts · 9 of 429 companies with matching events
Evidence: A regulator/SEC/trial registry · B official company source · Market data is separate context.
Scheduled catalysts
Scroll the table horizontally to view all columns →
Next CatalystCompanyDrugPrice · 30DCurrent stage
Pharming Group N.V.PHARDrugJoenja® (leniolisib)small molecule
IndicationPrimary immunodeficiencies with immune dysregulationleniolisib Phase 2 · 13 subjects with genetically defined PIDs · dose escalation
TargetPI3Kδ
Clinical dataPhase 2 data · AdditionalOct 14-17, 2026ESID 2026leniolisib Phase 2 · Additional data will be presented
AOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Achieve Life Sciences, Inc.ACHVDrugCytisinicline
IndicationE-cigarette/vaping cessation / Cigarette smoking cessationORCA-OL · adults who previously participated in the ORCA-2, ORCA-3 or ORCA-V1 trials and were actively smoking cigarettes and/or vaping daily
Targetα4β2 nicotinic acetylcholine receptor / 5-HT3 receptor
Clinical dataPhase 2 dataOct 20, 2026CHEST 2026Study details
ORCA-OL · new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented
All sources (2)
Current stagePreINDP1P2P3FilingApproved
EIKON THERAPEUTICS, INC.EIKNDrugEIK1001
IndicationStage 4 non-small cell lung cancerTeLuRide-005 · Patients with NSCLCNCT06246110 TargetTLR7 / TLR8
Clinical dataPhase 2 dataOct 26, 2026ESMO Congress 2026TeLuRide-005 · will present comprehensive updated data from TeLuRide-005
BOfficial sourceAll sources (7)
Current stagePreINDP1P2P3FilingApproved
IOVANCE BIOTHERAPEUTICS, INC.IOVADrugLifileucelautologous T cell therapy
IndicationUndifferentiated pleomorphic sarcoma and dedifferentiated liposarcomaSARATOGA · first six evaluable patients · registrational
Target—
Clinical dataPhase 2 dataOct 23-27, 2026European Society for Medical Oncology (ESMO)SARATOGA · Results will be highlighted
AOfficial source Current stagePreINDP1P2P3FilingApproved
MOLECULAR PARTNERS AGMOLNDrugMP0317multispecific protein therapeutic (DARPin)
IndicationAdvanced biliary tract cancer (cholangiocarcinoma)TACTIC · frontline settingNCT07036380 TargetCD40 / FAP
Clinical dataConference presentationOct 23-27, 2026France · European Society for Medical Oncology (ESMO) Congress 2026TACTIC · A trial-in-progress poster on the MP0317 Phase 2 study has been accepted for presentation
BOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Inventiva S.A.IVADruglanifibranorsmall molecule
IndicationMASHlanifibranor Phase 2b
TargetPPARα / PPARδ / PPARγ
Clinical dataConference presentationNov 7, 2026AASLD The Liver Meeting ® 2026Study details
lanifibranor Phase 2b · Lanifibranor Improved Liver Sinusoidal Endothelial Cell Dysfunction and Vascular Alterations Across All Stages From MASH To Cirrhosis
All sources (2)
Current stagePreINDP1P2P3FilingApproved
Vir Biotechnology, Inc.VIRDrugElebsiran and tobevibart
IndicationChronic hepatitis deltaSOLSTICE · elebsiran + tobevibart · participants with chronic hepatitis delta infection
TargetHBV RNA transcripts / HBV RNA
Clinical dataPhase 2 dataNov 8, 2026American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026SOLSTICE · Patterns of HDV RNA responses through Week 96
BOfficial source Current stagePreINDP1P2P3FilingApproved
Vir Biotechnology, Inc.VIRDrugElebsiran and tobevibart
IndicationChronic hepatitis deltaSOLSTICE · translational sub-study
TargetHBV RNA transcripts / HBV RNA
Clinical dataPhase 2 dataNov 8, 2026American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026Study details
SOLSTICE · Intrahepatic NK cell remodelling with elebsiran and tobevibart in chronic hepatitis D - A translational sub-study of the SOLSTICE trial
Current stagePreINDP1P2P3FilingApproved
FATE THERAPEUTICS INCFATEDrugFT819CAR T-cell therapy
IndicationRefractory moderate-to-severe systemic lupus erythematosus with lupus nephritis
TargetCD19
Clinical dataPhase 2 dataNov 9, 2026ACR Convergence 2026Efficacy Reveals Biomarker Candidates for Fatigue in SLE
BOfficial source Current stagePreINDP1P2P3FilingApproved
Showing 10 of 10 available events
